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CHAPTER 13 DERMATOLOGICAL DRUGS

13.01 DRUGS FOR ECZEMA


ECZEMA
Eczema (dermatitis) includes a wide range of conditions characterised by skin inflammation.
Principal features include itch, redness, scaling and excoriations.
Eczema may be classified as endogenous or exogenous (which requires removal of precipitating factors).
The principles of management are generally the same irrespective of cause.
Rationale for drug use
Relieve symptoms.
Optimise skin hydration.
Suppress inflammation.
Prevent or eliminate infection.
Before starting treatment
Identify and eliminate potential trigger factors including:
environmental irritants, eg wool, synthetic clothing, soaps, detergents

(including bubble bath), carpets, sand, grass, raised temperatures, sweating


environmental allergens, eg preservatives, fragrances, deodorants, lanolin,
nickel, photosensitising drugs, animal hair, inhaled allergens.

A link between food allergens and eczema has not been confirmed. Exclusion diets are controversial and should only
be considered after immunological assessment and advice from a dietitian.
The role of house dust mites in eczema and other non-pulmonary conditions is unclear. There is evidence that
control of house dust mite reduces severity of symptoms, especially in patients with positive mite RAST scores or
skin prick testing, but only if very low levels of mite are achieved. Covering bedding is the most effective control
method.
Time to resolution following removal of trigger depends on numerous factors and, while usually rapid, may take up
to 3 weeks or more.
Treatment
Hydration:
Use tepid rather than hot water, bath oil or colloidal oatmeal, and soap substitutes; if soaps are used they should have
a neutral pH (mild soaps) and time spent bathing should be minimised to reduce resultant dehydration.
Soaking baths (containing bath oil or colloidal oatmeal) of 1015 minutes duration may be taken once a day in the
maintenance treatment of moderate-to-severe eczema and up to 4 times a day during disease flares to remove crusts
and dry blisters.
Wet compresses:
Wet compresses are usually soaked in tap water. Solutions of aluminium acetate (Burow's solution) or potassium
permanganate (Condy's crystals) may be used, but are usually reserved for acute infected eczema. Immediately after
hydration and applying emollient and/or topical corticosteroids, apply wet compresses for 1560 minutes to increase
the benefits of topical treatment. Reserve wet compresses for severely affected or persistent areas of eczema
(exudative or crusting lesions); inappropriate use may lead to secondary infection (folliculitis), maceration or
excessive dryness.
Moisturisers
Moisturisers may prevent exacerbation of eczema already under optimal control; apply liberally at least twice a day;
most effective when applied after bathing (water content of skin is at its greatest).
Apply moisturisers 1015 minutes before topical corticosteroids.
Creams and ointments are more effective than lotions; lotions may be substituted as condition improves. Lotions can
be applied without friction and are more cosmetically acceptable.
Topical corticosteroids
Use corticosteroids where moisturisers do not provide adequate relief. The patient's age, site of involvement and
disease extent determine the type and strength of preparation and method of application; use the least potent
preparation required to bring disease under control.
Topical immunomodulators
Pimecrolimus is marketed as an alternative to corticosteroids for short term or intermittent treatment of mild-to-

moderate eczema. Data comparing pimecrolimus with mild or moderate potency corticosteroids in either children or
adults are limited. Its place in therapy is presently unclear. It is best reserved for patients >2 years of age as there are
some concerns about toxicity in infants.
Tacrolimus ointment is marketed overseas (as 0.03% and 0.1% ointment). Trial data indicate that it may be as
effective as potent corticosteroids but it is expensive.
Tar and ichthammol
Have longer lasting anti-inflammatory properties and fewer adverse effects than topical corticosteroids, but are less
potent and messier to use, leading to reduced compliance; should not be applied to acutely inflamed skin, face,
flexures or genitals because of the potential for irritation; useful for chronic or lichenified lesions.
Antihistamines
Although commonly believed to have antipruritic effects, their therapeutic value is primarily due to their sedative
properties; newer, less sedating antihistamines are of little value, unless allergic triggers are involved, eg house dust
mite.
Sedating antihistamines are useful at night in patients having trouble getting to sleep or waking regularly because of
excessive itching.
May be used as short term adjuvants to topical corticosteroid treatment.
Systemic immunomodulators
May be used for patients with severe, disabling disease unresponsive to other treatment; their use should be initiated
and monitored by a dermatologist.
Systemic corticosteroids are useful in controlling widespread disease and severe generalised disease flares; they
produce dramatic clinical improvement but may be associated with rebound flaring after stopping; they should be
avoided in children, to reduce the risk of permanent growth retardation.
Cyclosporin may be used; azathioprine and other immunomodulating drugs have also been used.
Phototherapy
UVB phototherapy and photochemotherapy (methoxsalen and ultraviolet A irradiation, PUVA) are effective in
unresponsive eczema, but there are concerns about long term safety.
Other treatment
Oral evening primrose oil has been claimed to be effective in atopic disease, but studies have shown no therapeutic
benefit.
Herbal and complementary medicines have been used, but product quality may be variable; there are reports of
hepatotoxicity and of potent corticosteroid contaminants.
Dietary manipulation, prolonged breastfeeding of predisposed infants and dietary restriction of breastfeeding
mothers have unknown efficacy. Dietary restriction may lead to vitamin deficiency, particularly in children.
Special cases
Atopic dermatitis: Occurs in genetically predisposed individuals; diagnosed by the presence of atopy and the pattern
and distribution of eczema. Generally managed by keeping skin hydrated and using topical therapy (especially
moisturisers) for symptomatic relief.
Limit topical corticosteroid to sites of inflammation.
Nappy dermatitis: Advise parents to use highly absorbent disposable nappies, change nappies frequently, avoid use
of plastic pants (because of occlusive effect) and maximise nappy free periods. Applying a protective agent (eg zinc
or dimethicone cream) after each nappy change is also useful. Topical hydrocortisone can be used in more severe
cases or when the above measures are inadequate.
Nappy dermatitis may be complicated by candidal infection. Treat such infections with a topical azole or nystatin
and topical hydrocortisone.
Secondary infection: Treat according to the cause, whether bacterial (usually S. aureus), viral or fungal.
Seborrhoeic dermatitis in adults: Regular use of shampoo containing ketoconazole, miconazole, selenium sulfide,
pyrithione zinc, ciclopirox or coal tar is the mainstay of treatment; can also be applied to eyebrows, ears, central face
and trunk.
Coal tar preparations containing salicylic acid and/or sulfur may be used to reduce scale.
Topical corticosteroids may be used to reduce inflammation and itch, but should not be used long term. They may
also be used intermittently in combination with a topical antifungal agent.

13.01.01 Corticosteroids (Skin)

BETAMETHASONE (SKIN)
Mode of action
Anti-inflammatory, immunosuppressive and antimitotic activity against cutaneous fibroblasts and epidermal cells.
They also cause vasoconstriction which has been used to measure their potency.
Useful in a range of skin conditions including insect bite reactions, sunburn and as adjuncts to other treatments.
Indications
Inflammatory skin conditions, e.g. eczema, and psoriasis.
Contraindications
Rosacea; Acne vulgaris; Allergy to corticosteroids or preservatives in vehicle; Ulcerative conditions and/or impaired
circulation; Uncontrolled infection in area to be treated.
Specific considerations
Pregnancy: Use the lowest potency for the shortest time necessary where emollients and other simple measures are
inadequate; ADEC category A.
Skin atrophy: increases systemic absorption and skin atrophy; avoid use.
Diabetes: systemic absorption increases blood glucose; avoid extensive use.
Impaired T cell function: systemic absorption results in immunosuppression; avoid extensive use.
Elderly: Skin atrophy makes cutaneous adverse effects more likely.
Children: More susceptible to systemic absorption due to higher surface area/bodyweight ratio.
Hydrocortisone is adequate initial treatment for most children with mild-to-moderate disease. Use stronger
preparations for short periods under close supervision.
Consider a corticosteroid-free period of at least 2 weeks after each 23 week period of daily use.
Lactation: Safe to use; ensure breast area is free of corticosteroid before nursing.
Adverse effects
Relative potency, patient age, site and extent of disease, preparation type, method of application and length of
treatment determine the incidence and severity of adverse effects.
Common: folliculitis, steroid rosacea, perioral dermatitis, skin atrophy, delayed wound healing, striae, purpura,
depigmentation, telangiectasia.
Infrequent: allergic contact dermatitis.
Rare: hyperaesthesia, subcutaneous tissue atrophy, systemic effects (hypothalamic-pituitary-adrenal axis
suppression, hyperglycaemia, growth retardation, Cushing's syndrome, cataract).
Dosage
Apply sparingly 12 times a day.
Practice points
use an appropriately potent preparation for the shortest time required to

control skin disorder then stop corticosteroid


therapy can be staged (eg remove precipitating factors and use a moisture care
plan, then add topical corticosteroids, sedating antihistamines and tar, in
order) with the aim of using the fewest number of treatments to control the
disease
apply sparingly in thin layers by smoothing gently into skin, preferably after
bathing
avoid tolerance by applying corticosteroid on alternate days or instituting
medication-free periods (eg 5 days on then 2 days off) during treatment of
chronic dermatoses

Nappy dermatitis
treat with a mild topical corticosteroid initially
advise parents to use highly absorbent disposable nappies and change nappy

frequently; avoid plastic pants because of occlusive effect; nappy free


periods should be maximised
use a protective agent (eg zinc cream)
often complicated by candidal infection (treat with a topical antifungal).

Products
BETAMETHASONE CREAM 0.1 % (AS VALERATE)
30 GM TUBE (BETAVAL, BETNOVATE,
VALEDERM)
BETAMETHASONE LOTION 0.1 % (AS VALERATE)
20 ML BOTTLE (BETNOVATE)
BETAMETHASONE OINTMENT 0.1 % (AS VALERATE)
30 GM TUBE (BETAVAL, BETNOVATE)
BETAMETHASONE SCALP LOTION 0.1 % (AS VALERATE)
30 ML BOTTLE (BEMETSON,
BETNOVATE SCALP APPLICATION)
CLOBETASOL (SKIN)

Mode of action
The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle
and the integrity of the epidermal barrier. Occlusive dressing with hydrocortisone for up to 24 hours has not been
demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances
penetration. Topical corticosteroids can be absorbed from normal intact skin, while inflammation and/or other
disease processes in the skin may increase percutaneous absorption. Greater absorption was observed for the
clobetasol propionate gel formulation as compared to the cream formulation in in vitro human skin penetration
studies.
Indications
Clobetasol is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and
pruritic manifestations of corticosteroid-responsive dermatoses.
Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week
because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children
under 12 years of age is not recommended.

Contraindications
Clobetasol is contraindicated in those patients with a history of hypersensitivity to any of the components of the
preparation.
Specific considerations
General: Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA
axis at doses as low as 2 g per day.
Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for
glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing's syndrome,
hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical
corticosteroids while on therapy.
Patients receiving a large dose applied to a large surface area should be evaluated periodically for evidence of HPA
axis suppression. This may be done by using the ACTH stimulation, a.m. plasma cortisol, and urinary free cortisol
tests. Patients receiving super-potent corticosteroids should not be treated for more than 2 weeks at a time, and only
small areas should be treated at any one time due to the increased risk of HPA suppression.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of
application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and
complete upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid
insufficiency may occur that require supplemental systemic corticosteroids.
Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body
mass ratios.
If irritation develops, Clobetasol should be discontinued and appropriate therapy instituted. Allergic contact
dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical
exacerbation as with most topical products not containing corticosteroids. Such an observation should be
corroborated with appropriate diagnostic patch testing.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used.
If a favorable response does not occur promptly, use of Clobetasol should be discontinued until the infection has
been adequately controlled.
Clobetasol should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face,
groin, or axillae.
Lactation: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere
with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical
administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in

human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol is
administered to a nursing woman.
Children: Safety and effectiveness of Clobetasol in children and infants have not been established; therefore, use in
children under 12 years of age is not recommended. Because of a higher ratio of skin surface area to body mass,
children are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids.
They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of
Cushing's syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use
of topical corticosteroids in infants and children.
HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving
topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed
weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of
intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Adverse effects
In a controlled trial with Clobetasol, the only reported adverse reaction that was considered to be drug related was a
report of burning sensation (1.8% of treated patients).
In larger controlled clinical trials with other clobetasol propionate formulations, the most frequently reported
adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of
the skin, numbness of the fingers, skin atrophy, and telangiectasia (all less than 2%).
Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol
propionate formulations.
Clobetasol is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive
weeks, and amounts greater than 50 g per week should not be used.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no
improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Clobetasol should not be used with occlusive dressings.

Products
CLOBETASOL BUTYRATE CREAM 0.05 %
25 GM TUBE (EUMOVATE)
CLOBETASOL BUTYRATE OINTMENT 0.05 %
25 GM TUBE (EUMOVATE)
CLOBETASOL PROPIONATE CREAM 0.05 %
25 GM TUBE (CLODERM, DELOR, DERMOVATE,
MEDODERMONE)
CLOBETASOL PROPIONATE OINTMENT 0.05 %
15-25 GM TUBE (CLODERM, DELOR,
DERMOVATE, MEDODERMONE)
DEXAMETHASONE (SKIN)

Adverse Effects, Treatment, Withdrawal, and Precautions


As for corticosteroids in general
When applied topically, particularly to large areas, when the skin is broken, or under occlusive dressings, or when
given intranasally, corticosteroids may be absorbed in sufficient amounts to cause systemic effects. Prolonged
application to the eye of preparations containing corticosteroids has caused raised intra-ocular pressure and reduced
visual function.

Products
DEXAMETHASONE 0.12 % + SALICYLIC ACID 2 % SCALP LOTION
30 ML BOTTLE
(DEXASALYL, SALIDEX)
DEXAMETHASONE 0.12 % + SALICYLIC ACID 3 % OINTMENT
20 GM TUBE (DEXASALYL)
FLUOCINOLONE ACETONIDE (SKIN)
Mode of action
Anti-inflammatory, immunosuppressive and antimitotic activity against cutaneous fibroblasts and epidermal cells.
They also cause vasoconstriction which has been used to measure their potency.
Indications
Inflammatory skin conditions, eg eczema, psoriasis.
Contraindications
Rosacea; Acne vulgaris; Allergy to corticosteroids or preservatives in vehicle; Ulcerative conditions and/or impaired
circulation; Uncontrolled infection in area to be treated.
Specific considerations

Pregnancy: Use the lowest potency for the shortest time necessary where emollients and other simple measures are
inadequate; ADEC category A.
Skin atrophy: increases systemic absorption and skin atrophy; avoid use.
Diabetes: systemic absorption increases blood glucose; avoid extensive use.
Impaired T cell function: systemic absorption results in immunosuppression; avoid extensive use.
Elderly: Skin atrophy makes cutaneous adverse effects more likely.
Children: More susceptible to systemic absorption due to higher surface area/bodyweight ratio.
Hydrocortisone is adequate initial treatment for most children with mild-to-moderate disease. Use stronger
preparations for short periods under close supervision.
Consider a corticosteroid-free period of at least 2 weeks after each 23 week period of daily use.
Lactation: Safe to use; ensure breast area is free of corticosteroid before nursing.
Adverse effects
spread and worsening of untreated infection; thinning of the skin which may be restored over a period after stopping
treatment but the original structure may never return; irreversible striae atrophicae and telangiectasia; contact
dermatitis; perioral dermatitis; acne, or worsening of acne or rosacea; mild depigmentation which may be reversible;
hypertrichosis also reported.
Dosage
Apply sparingly 12 times a day.
Practice points
use an appropriately potent preparation for the shortest time required to

control skin disorder then stop corticosteroid


therapy can be staged (eg remove precipitating factors and use a moisture care
plan, then add topical corticosteroids, sedating antihistamines and tar, in
order) with the aim of using the fewest number of treatments to control the
disease
apply sparingly in thin layers by smoothing gently into skin, preferably after
bathing
avoid tolerance by applying corticosteroid on alternate days or instituting
medication-free periods (eg 5 days on then 2 days off) during treatment of
chronic dermatoses

Nappy dermatitis
treat with a mild topical corticosteroid initially
advise parents to use highly absorbent disposable nappies and change nappy

frequently; avoid plastic pants because of occlusive effect; nappy free


periods should be maximised
use a protective agent (eg zinc cream)
often complicated by candidal infection (treat with a topical antifungal).
Products
FLUOCINOLONE ACETONIDE CREAM OR OINTMENT 0.025% (15-30)GM (PETRALAR,
SYNALAR)
HYDROCORTISONE (SKIN)
Mode of action
Anti-inflammatory, immunosuppressive and antimitotic activity against cutaneous fibroblasts and epidermal cells.
They also cause vasoconstriction which has been used to measure their potency.
Useful in a range of skin conditions including insect bite reactions, sunburn and as adjuncts to other treatments.
Indications
Inflammatory skin conditions, e.g. eczema, psoriasis.
Contraindications
Rosacea; Acne vulgaris; Allergy to corticosteroids or preservatives in vehicle; Ulcerative conditions and/or impaired
circulation; Uncontrolled infection in area to be treated.
Specific considerations
Pregnancy: Use the lowest potency for the shortest time necessary where emollients and other simple measures are
inadequate; ADEC category A.

Skin atrophy: increases systemic absorption and skin atrophy; avoid use.
Diabetes: systemic absorption increases blood glucose; avoid extensive use.
Impaired T cell function: systemic absorption results in immunosuppression; avoid extensive use.
Elderly: Skin atrophy makes cutaneous adverse effects more likely.
Children: More susceptible to systemic absorption due to higher surface area/bodyweight ratio.
Hydrocortisone is adequate initial treatment for most children with mild-to-moderate disease. Use stronger
preparations for short periods under close supervision.
Consider a corticosteroid-free period of at least 2 weeks after each 23 week period of daily use.
Lactation: Safe to use; ensure breast area is free of corticosteroid before nursing.
Adverse effects
Relative potency, patient age, site and extent of disease, preparation type, method of application and length of
treatment determine the incidence and severity of adverse effects.
Common: folliculitis, steroid rosacea, perioral dermatitis, skin atrophy, delayed wound healing, striae, purpura,
depigmentation, telangiectasia.
Infrequent: allergic contact dermatitis.
Rare: hyperaesthesia, subcutaneous tissue atrophy, systemic effects (hypothalamic-pituitary-adrenal axis
suppression, hyperglycaemia, growth retardation, Cushing's syndrome, cataract).
Dosage
Apply sparingly 12 times a day.
Practice points

Same as fluocinolone
Products
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE

ACETATE CREAM 1 % (ALFACORT, HYDROCORT)


ACETATE OINTMENT 1 % (ALFACORT)
BUTYRATE CREAM 0.1 % (LOCOID LIPO, ZONA)
BUTYRATE SKIN LOTION 0.1 %
100 ML BOTTLE (LOCOID LIPO)

METHYLPREDNISOLONE (SKIN)
Mode of action
Anti-inflammatory, immunosuppressive and antimitotic activity against cutaneous fibroblasts and epidermal cells.
They also cause vasoconstriction which has been used to measure their potency.
Useful in a range of skin conditions including insect bite reactions, sunburn and as adjuncts to other treatments.
Indications
Inflammatory skin conditions, e.g. eczema, psoriasis.
Contraindications
Rosacea; Acne vulgaris; Allergy to corticosteroids or preservatives in vehicle; Ulcerative conditions and/or impaired
circulation; Uncontrolled infection in area to be treated.
Specific considerations
Pregnancy: Use the lowest potency for the shortest time necessary where emollients and other simple measures are
inadequate; ADEC category A.
Skin atrophy: increases systemic absorption and skin atrophy; avoid use.
Diabetes: systemic absorption increases blood glucose; avoid extensive use.
Impaired T cell function: systemic absorption results in immunosuppression; avoid extensive use.
Elderly: Skin atrophy makes cutaneous adverse effects more likely.
Children: More susceptible to systemic absorption due to higher surface area/bodyweight ratio.
Hydrocortisone is adequate initial treatment for most children with mild-to-moderate disease. Use stronger
preparations for short periods under close supervision.
Consider a corticosteroid-free period of at least 2 weeks after each 23 week period of daily use.
Lactation: Safe to use; ensure breast area is free of corticosteroid before nursing.
Adverse effects
Relative potency, patient age, site and extent of disease, preparation type, method of application and length of
treatment determine the incidence and severity of adverse effects.
Common: folliculitis, steroid rosacea, perioral dermatitis, skin atrophy, delayed wound healing, striae, purpura,
depigmentation, telangiectasia.
Infrequent: allergic contact dermatitis.

Rare: hyperaesthesia, subcutaneous tissue atrophy, systemic effects (hypothalamic-pituitary-adrenal axis


suppression, hyperglycaemia, growth retardation, Cushing's syndrome, cataract).
Dosage
Apply sparingly once a day.
Practice points
use an appropriately potent preparation for the shortest time required to

control skin disorder then stop corticosteroid


therapy can be staged (eg remove precipitating factors and use a moisture care
plan, then add topical corticosteroids, sedating antihistamines and tar, in
order) with the aim of using the fewest number of treatments to control the
disease
apply sparingly in thin layers by smoothing gently into skin, preferably after
bathing
avoid tolerance by applying corticosteroid on alternate days or instituting
medication-free periods (eg 5 days on then 2 days off) during treatment of
chronic dermatoses
Products
METHYLPREDNISOLON CREAM 1 % (AS OXYPONATE)
20 GM TUBE (ADVANTAN)
METHYLPREDNISOLON OINTMENT 1 % (AS OXYPONATE)
20 GM TUBE (ADVANTAN)

MOMETASONE (SKIN)
Mode of action
Anti-inflammatory, immunosuppressive and antimitotic activity against cutaneous fibroblasts and epidermal cells.
They also cause vasoconstriction which has been used to measure their potency.
Useful in a range of skin conditions including insect bite reactions, sunburn and as adjuncts to other treatments.
Indications
Inflammatory skin conditions, eg eczema, psoriasis.
Contraindications
Rosacea; Acne vulgaris; Allergy to corticosteroids or preservatives in vehicle; Ulcerative conditions and/or impaired
circulation; Uncontrolled infection in area to be treated.
Specific considerations
Pregnancy: Use the lowest potency for the shortest time necessary where emollients and other simple measures are
inadequate. Safety data are lacking; ADEC category B3.
Skin atrophy: increases systemic absorption and skin atrophy; avoid use.
Diabetes: systemic absorption increases blood glucose; avoid extensive use.
Impaired T cell function: systemic absorption results in immunosuppression; avoid extensive use.
Elderly: Skin atrophy makes cutaneous adverse effects more likely.
Children: More susceptible to systemic absorption due to higher surface area/bodyweight ratio.
Hydrocortisone is adequate initial treatment for most children with mild-to-moderate disease. Use stronger
preparations for short periods under close supervision.
Consider a corticosteroid-free period of at least 2 weeks after each 23 week period of daily use.
Lactation: Safe to use; ensure breast area is free of corticosteroid before nursing.
Adverse effects
Relative potency, patient age, site and extent of disease, preparation type, method of application and length of
treatment determine the incidence and severity of adverse effects.
Common: folliculitis, steroid rosacea, perioral dermatitis, skin atrophy, delayed wound healing, striae, purpura,
depigmentation, telangiectasia.
Infrequent: allergic contact dermatitis.
Rare: hyperaesthesia, subcutaneous tissue atrophy, systemic effects (hypothalamic-pituitary-adrenal axis
suppression, hyperglycaemia, growth retardation, Cushing's syndrome, cataract).
Dosage
Apply sparingly once a day.
Practice points
use an appropriately potent preparation for the shortest time required to

control skin disorder then stop corticosteroid

therapy can be staged (eg remove precipitating factors and use a moisture care
plan, then add topical corticosteroids, sedating antihistamines and tar, in
order) with the aim of using the fewest number of treatments to control the
disease
apply sparingly in thin layers by smoothing gently into skin, preferably after
bathing
avoid tolerance by applying corticosteroid on alternate days or instituting
medication-free periods (eg 5 days on then 2 days off) during treatment of
chronic dermatoses
Products
MOMETASONE CREAM 0.1 % 15-30 GM TUBE (ELICA, ELISONE, ELNA, ELOCOM,
MESONE)
MOMETASONE OINTMENT 0.1 % 15-30 GM TUBE (ELICA, ELOCOM, MESONE)
TRIAMCINOLONE (SKIN)
Mode of action
Anti-inflammatory, immunosuppressive and antimitotic activity against cutaneous fibroblasts and epidermal cells.
They also cause vasoconstriction which has been used to measure their potency.
Useful in a range of skin conditions including insect bite reactions, sunburn and as adjuncts to other treatments.
Indications
Inflammatory skin conditions, e.g. eczema, psoriasis.
Contraindications
Rosacea; Acne vulgaris; Allergy to corticosteroids or preservatives in vehicle; Ulcerative conditions and/or impaired
circulation; Uncontrolled infection in area to be treated.
Specific considerations
Pregnancy: Use the lowest potency for the shortest time necessary where emollients and other simple measures are
inadequate; ADEC category A.
Skin atrophy: increases systemic absorption and skin atrophy; avoid use.
Diabetes: systemic absorption increases blood glucose; avoid extensive use.
Impaired T cell function: systemic absorption results in immunosuppression; avoid extensive use.
Elderly: Skin atrophy makes cutaneous adverse effects more likely.
Children: More susceptible to systemic absorption due to higher surface area/bodyweight ratio.
Hydrocortisone is adequate initial treatment for most children with mild-to-moderate disease. Use stronger
preparations for short periods under close supervision.
Consider a corticosteroid-free period of at least 2 weeks after each 23 week period of daily use.
Lactation: Safe to use; ensure breast area is free of corticosteroid before nursing.
Adverse effects
Relative potency, patient age, site and extent of disease, preparation type, method of application and length of
treatment determine the incidence and severity of adverse effects.
Common: folliculitis, steroid rosacea, perioral dermatitis, skin atrophy, delayed wound healing, striae, purpura,
depigmentation, telangiectasia.
Infrequent: allergic contact dermatitis.
Rare: hyperaesthesia, subcutaneous tissue atrophy, systemic effects (hypothalamic-pituitary-adrenal axis
suppression, hyperglycaemia, growth retardation, Cushing's syndrome, cataract).
Dosage
Apply sparingly 12 times day.
Practice points

Same as betamethasone.
Products
TRIAMCINOLONE OINTMENT 0.1 % (KENACIN A)

13.01.02 Coal Tar (Skin)

COAL TAR (SKIN)


Mode of action
Exact mechanism unknown. Tars suppress DNA synthesis, reduce epidermal thickness, are antipruritic and may be
weakly antiseptic.
Indications
Eczema, particularly chronic or lichenified eczema; Seborrhoeic dermatitis; Stable chronic plaque psoriasis;
Dandruff.
Contraindications
Inflamed, broken skin; Infection; Previous allergic reaction to coal tar; Conditions characterised by photosensitivity,
e.g. lupus erythematosus, polymorphic light eruption (coal tars contraindicated because of photosensitising action);
Unstable psoriasis.
Specific considerations
Treatment with photosensitising medications: increases risk of phototoxic reactions; avoid combinations.
Children: Safety and efficacy of coal tar preparations have not been established. Should not be used in children
<2 years, except under the direction and supervision of a dermatologist.
Pregnancy: Data lacking, unlikely to be a concern.
Lactation: Safe to use.
Adverse effects
Common: mild stinging.
Rare: folliculitis, irritant reactions, allergic reactions, photosensitivity, acneiform eruptions.
Others: staining of skin, hair (especially in patients with fair, bleached or grey hair) and clothing
Carcinogenicity: Conflicting evidence.
Dosage
Shampoo, once a week to once a day.
Cream, lotion, 24 times a day.
Gel, 24 times a day.
Medicated bar, use as soap.
Dose equivalence
Extemporaneous products, 1% crude coal tar is equivalent to 5% coal tar solution.
Administration instructions
Shampoo, apply to wet hair, massage vigorously into scalp and leave for 35 minutes; rinse thoroughly; repeat
application and rinse.
Cream, gel, apply enough to cover affected area and rub in gently.
Patient counselling
Do not use near eyes.
May stain skin, hair and clothes.
Avoid exposure to direct sunlight or sunlamps for at least 24 hours after application. Completely remove coal tar
preparations before exposure to sunlight.
Practice points
may be used alone in treatment of psoriasis, or combined with dithranol and/or

ultraviolet light
use low concentrations (0.51%) on face, flexures and genitals to reduce
potential for irritation
patient acceptance may be poor due to the messiness, smell and staining
properties of some preparations
salicylic acid, sulfur and allantoin have keratolytic properties and may be
used in combination with coal tar in the treatment of psoriasis, seborrhoeic
dermatitis and dandruff
pyrithione zinc has bacteriostatic and fungistatic properties and is available
with coal tar for the treatment of seborrhoeic dermatitis and dandruff
Products
COAL TAR SHAMPOO

13.01.03 Other Drugs for Eczema

DIMETINDENE (SKIN)
Dimetindene maleate, an alkylamine derivative, is a sedating antihistamine; it is mildly sedative and is reported to
have mast-cell stabilising properties. It is used for the s relief of allergic conditions including urticaria, and in
pruritic skin disorders.

Products
DIMETINDENE GEL 1 %

30 GM TUBE (FENISTIL)

PIMECROLIMUS (SKIN)
Mode of action
Anti-inflammatory, but precise mechanism unknown. Inhibits calcineurin thus blocking T-cell activation, prevents
release of inflammatory mediators from mast cells.
Indications
Short term treatment of active mild-to-moderate eczema in children >3 months and adults.
Contraindications
Cutaneous viral infection.
Specific considerations
Immunosuppression, skin cancer: avoid use, theoretical risk of toxicity.
Bacterial or fungal skin infections: treat area before starting pimecrolimus.
Pregnancy: Limited data; ADEC category B3.
Lactation: No data, seek specialist advice.
Adverse effects
Common: local irritation, burning sensation, itch, erythema, skin infections.
Infrequent: local rash, aggravation of eczema, herpes simplex dermatitis, impetigo.
Dosage
Apply twice a day in a thin film to affected areas.
Administration instructions
Apply to clean, dry skin.
Patient counselling
Avoid contact with eyes, mouth and other mucous surfaces.
Avoid exposure to sun, use an effective sunscreen.
Practice points
due to concerns about possible increased incidence of adverse effects (upper

respiratory tract infections, otitis media, diarrhoea, asthma, irritability),


pimecrolimus is not approved for use in children <2 years in the USA or the UK
stop treatment if condition deteriorates or there is no noticeable improvement
after 6 weeks
if irritation occurs, apply less frequently; if it persists or is severe, stop
treatment
data comparing pimecrolimus with topical corticosteroids is limited; it is
much more expensive than topical corticosteroid treatment and benefit over
such agents has not been confirmed
safety of long term use has not been clearly established
Products
PIMECROLIMUS CREAM 1 %
30 GM TUBE (ELIDEL)
TACROLIMUS

Mode of Action
The mechanism of action of tacrolimus in atopic dermatitis is not known. While the following have been observed,
the clinical significance of these observations in atopic dermatitis is not known. It has been demonstrated that
tacrolimus inhibits T-lymphocyte activation by first binding to an intracellular protein, FKBP-12. A complex of
tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of
calcineurin is inhibited. This effect has been shown to prevent the dephosphorylation and translocation of nuclear
factor of activated T-cells (NF-AT), a nuclear component thought to initiate gene transcription for the formation of

lymphokines (such as interleukin-2, gamma interferon). Tacrolimus also inhibits the transcription for genes which
encode IL-3, IL-4, IL-5, GM-CSF, and TNF-(alpha), all of which are involved in the early stages of T-cell activation.
Additionally, tacrolimus has been shown to inhibit the release of pre-formed mediators from skin mast cells and
basophils, and to downregulate the expression of Fc[egr ]Rl on Langerhans cells.

Indication and usage


Tacrolimus Ointment 0.1% for adults, is indicated for short-term and intermittent long-term therapy in the treatment
of patients with moderate to severe atopic dermatitis in whom the use of alternative, conventional therapies are
deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or
are intolerant of alternative, conventional therapies.

Contraindications
Contraindicated in patients with a history of hypersensitivity to tacrolimus or any other component of the
preparation.

Precautions
General
Studies have not evaluated the safety and efficacy in the treatment of clinically infected atopic dermatitis. Before
commencing treatment, clinical infections at treatment sites should be cleared.
While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum
(Kaposi's varicelliform eruption), treatment may be associated with an increased risk of varicella zoster virus
infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum. In the presence of these
infections, the balance of risks and benefits associated with Tacrolimus Ointment use should be evaluated.
In clinical studies, 33 cases of lymphadenopathy (0.8%) were reported and were usually related to infections
(particularly of the skin) and noted to resolve upon appropriate antibiotic therapy. Of these 33 cases, the majority
had either a clear etiology or were known to resolve. Transplant patients receiving immunosuppressive regimens
(e.g., systemic tacrolimus) are at increased risk for developing lymphoma; therefore, patients who develop
lymphadenopathy should have the etiology of their lymphadenopathy investigated. In the absence of a clear etiology
for the lymphadenopathy, or in the presence of acute infectious mononucleosis, discontinuation should be
considered. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy
resolves.
The enhancement of ultraviolet carcinogenicity is not necessarily dependent on phototoxic mechanisms. Despite the
absence of observed phototoxicity in humans, Tacrolimus Ointment shortened the time to skin tumor formation in an
animal photocarcinogenicity study. Therefore, it is prudent for patients to minimize or avoid natural or artificial
sunlight exposure.
The use of Tacrolimus Ointment may cause local symptoms such as skin burning (burning sensation, stinging,
soreness) or pruritus. Localized symptoms are most common during the first few days of application and typically
improve as the lesions of atopic dermatitis heal. With Tacrolimus Ointment 0.1%, 90% of the skin burning events
had a duration between 2 minutes and 3 hours (median 15 minutes). Ninety percent of the pruritus events had a
duration between 3 minutes and 10 hours (median 20 minutes).
Patients counseling
Patients using Tacrolimus Ointment should receive the following information and instructions:
Patients should use Tacrolimus Ointment as directed by the physician.
As with any topical medication, patients or caregivers should wash hands after application if hands are not an area
for treatment.
Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while
using Tacrolimus Ointment.
Patients should not use this medication for any disorder other than that for which it was prescribed.
Patients should report any signs of adverse reactions to their physician.
Pregnancy:
Teratogenic Effects: Pregnancy Category C
Pediatric Use: Tacrolimus Ointment 0.03% may be used in pediatric patients 2 years of age and older. Two phase 3
pediatric studies were conducted involving 606 patients 2-15 years of age: one 12-week randomized vehiclecontrolled study and one open-label, 1 year, long-term safety study. Three hundred and thirty (330) of these patients
were 2 to 6 years of age.
Geriatric Use: Twenty-five (25) patients >/= 65 years old received Tacrolimus Ointment in phase 3 studies. The
adverse event profile for these patients was consistent with that for other adult patients.

Adverse effects
No phototoxicity and no photoallergenicity was detected in clinical studies of 12 and 216 normal volunteers,
respectively. One out of 198 normal volunteers showed evidence of sensitization in a contact sensitization study.
In three randomized vehicle-controlled studies and two long-term safety studies, 655 and 571 patients respectively,
were treated with Tacrolimus Ointment.
The following table depicts the adjusted incidence of adverse events pooled across the 3 identically designed 12
week studies for patients in vehicle, Tacrolimus Ointment 0.03%, and Tacrolimus Ointment 0.1% treatment groups,
and the unadjusted incidence of adverse events in two one year long-term safety studies, regardless of relationship to
study drug.

Dosage and administration


Adults: Apply a thin layer to the affected skin areas twice daily and rub in gently and completely. Treatment should
be continued for one week after clearing of signs and symptoms of atopic dermatitis.
Pediatric: Apply a thin layer of Tacrolimus Ointment 0.03% to the affected skin areas twice daily and rub in gently
and completely. Treatment should be continued for one week after clearing of signs and symptoms of atopic
dermatitis.

Products
TACROLIMUS OINTMENT 0.1 % (PROTOPEC)
TACROLIMUS OINTMENT 0.03 % (PROTOPEC)

13.02 DRUGS FOR ACNE


ACNE
Acne vulgaris is a common skin disease caused by increased sebum production, abnormal follicular keratinization,
proliferation of Propionibacterium acnes and inflammation. Management is directed at these factors.
Mild acne is characterised by comedones with some papules and pustules. In moderate acne, the papules and
pustules are more widespread and there may be mild scarring.
Severe acne is characterised by nodular abscesses and cysts in addition to widespread papules and pustules and may
lead to extensive scarring.
Rationale for drug use
Improve complexion, reduce the number of lesions.
Prevent scarring.
Limit disease duration.
Reduce psychological stress (depression and low self esteem) related to acne.
Before starting treatment
Hormonal evaluation is indicated if hirsutism, alopecia or menstrual irregularities are present.
When to start treatment
Start early to prevent scarring; tailor treatment according to severity.
Choice of topical treatment
Retinoids, benzoyl peroxide or azelaic acid are used as first line treatments in mild acne and with oral antibacterials
in moderate acne. Apply to entire affected area and not just to individual lesions.
Retinoids
Tretinoin, adapalene or isotretinoin (skin) are the treatment of choice for comedonal acne. May be used with other
topical and oral (antibacterial or hormonal) treatments. Irritation may increase with use of >1 topical treatment. Do
not use during pregnancy because of potential risk of teratogenicity.
Benzoyl peroxide and azelaic acid
Benzoyl peroxide has antibacterial activity and is mildly comedolytic; first line treatment in comedonal and mild
inflammatory acne. May be used with topical or oral antibacterials; can be used on alternate days with topical
retinoids; some patients can tolerate same day applications of benzoyl peroxide and a topical retinoid.
Azelaic acid has antibacterial activity and is comedolytic; it is a less irritating alternative to benzoyl peroxide in mild
inflammatory acne. Should be used cautiously in patients with dark complexions (may cause hypopigmentation).
Hypopigmentation effects may be useful if acne has caused hyperpigmented scars.
Antibacterials
Clindamycin and erythromycin (skin) may also have indirect effects on comedogenesis; clinical efficacy is similar.
Development of antibacterial resistance by skin flora is an increasing problem. Add to topical retinoid, benzoyl
peroxide or azelaic acid in mild acne after 68 weeks if there is inadequate response.
Choice of oral treatment

Includes antibacterials, hormonal treatments and isotretinoin.


Antibacterials
Are useful in treatment of moderate acne; doxycycline and tetracycline are the drugs of choice. Minocycline,
although widely used, is less well tolerated and has been associated more commonly with CNS adverse effects,
including benign intracranial hypertension; may also cause hepatitis, a lupus-like syndrome and altered skin
pigmentation. Erythromycin may be used if tetracyclines are not tolerated or are contraindicated.
Antibacterials may be used with topical agents. Improvement may not begin until after 48 weeks of treatment.
Treatment should be changed if there is no response after 3 months. They must be taken for at least 36 months to
obtain a good response; in some patients longer term treatment may be necessary.
Hormonal treatments
Are limited to treatment of acne in females; they reduce sebum secretion which is under androgen control. Several
months of treatment are usually required before benefit occurs; prolonged treatment is needed to maintain
improvement.
Oestrogens suppress ovarian androgen production; usually prescribed as combined oral contraceptive (COC).
Beneficial effect is most apparent at doses of 50 micrograms or more of ethinyloestradiol (or equivalent), but even a
low dose COC (particularly one that contains a less androgenic progestogen, such as desogestrel) may be effective.
Consider adding to topical retinoid, benzoyl peroxide or azelaic acid in moderate acne either in addition to, or
instead of, an oral antibacterial.
Cyproterone is an antiandrogen and is used with ethinyloestradiol for the control of severe acne refractory to
prolonged oral antibacterial treatment, see Cyproterone with ethinyloestradiol. Higher doses of cyproterone are
occasionally recommended by specialists, particularly if seborrhoea or hirsutism are also present.
Spironolactone has potent antiandrogen activity and has been used by specialists to treat severe acne.
Isotretinoin
Acts primarily by reducing sebum secretion; used in severe acne or in moderate acne unresponsive to conventional
treatment.
Known teratogen; pregnancy and blood donation should be avoided during treatment and for at least 1 month after
stopping treatment.
Other drug treatments
Include abrasive agents, eg aluminium oxide; degreasing agents, eg triclosan; and preparations containing sulfur,
salicylic acid, resorcinol and allantoin. Although widely used, effectiveness is questionable.
Exfoliants may limit tolerance to other more effective agents and have no effect on sebaceous gland activity.
Special cases
Acne conglobata, acne fulminans and pyoderma faciale are severe forms of inflammatory acne that require urgent
specialist referral for treatment with isotretinoin and oral corticosteroids.
Patient counselling
Wash affected areas gently; avoid vigorous scrubbing and abrasive cleansers, which may cause more inflammation
and make acne worse.
Avoid using toners and oil-based moisturisers.
Do not squeeze or pick the acne lesions (pimples).
Eat a healthy balanced diet; there is no relationship between particular foods and acne.
Practice points
consider using 2 or 3 agents that act in different ways
avoid systemic antibiotics if a topical medication will suffice
do not switch or rotate antibiotics in patients who are responding to therapy

(response indicates efficacy and changing antibiotics may promote resistance)

13.02.01 Keratolytics
BENZOYL PEROXIDE
Mode of action
Antibacterial action probably due to oxidising effect; mild keratolytic properties.
Indications
Acne vulgaris.
Contraindications
Allergy to benzoyl peroxide.

Specific considerations
Inflamed or broken skin: increases systemic absorption.
Children: Safety and efficacy are not established in children, but problems are not expected.
Pregnancy: Safe to use.
Lactation: Safe to use.
Adverse effects
Common: skin dryness or peeling, feeling of warmth, mild stinging or erythema.
Rare: allergic contact dermatitis.
Dosage
Apply once or twice a day; begin treatment with 2.5% or 5% product, then change to 10% strength after 34 weeks,
or sooner if tolerance to the lower strengths develops.
Administration instructions
Before applying, wash affected area with mild soap or soap substitute and warm water; gently pat dry. Apply enough
medication to cover affected area and rub in gently.
Patient counselling
Avoid contact with eyes, mouth and other mucous membranes.
Avoid contact with hair and coloured fabric as bleaching or discolouration may result.
Practice points
cumulative irritant or drying effects with other topical anti-acne

preparations; combinations may be used if tolerated by patient


benzoyl peroxide inactivates topical tretinoin; apply 1224 hours apart
effective first line treatment for mild acne when used alone; may be used on
alternate days with topical retinoids and with topical or oral antibacterials
in more severe acne; however, irritation may be a problem with such
combinations
if irritation occurs, apply less frequently or use a lower strength
preparation; if it persists, is severe or is thought to be due to allergy,
stop treatment
Products
BENZOYL PEROXIDE GEL 5 %
40-60 GM TUBE (BENZAC, BENOXYPHIL, PANOXYL)

13.02.02 Antibacterials
CLINDAMYCIN (SKIN)
Mode of action
Lincosamide antibacterial; inhibits growth of Propionibacterium acnes.
Indications
Acne vulgaris, mild-to-moderate.
Specific considerations
History of antibacterial-associated colitis, regional enteritis or ulcerative colitis: small risk of systemic adverse
effects, eg colitis, following topical application.
Pregnancy: Safe to use; ADEC category A.
Lactation:Safe to use; low topical absorption.
Drug interactions
See Clindamycin.
Adverse effects
Common:dry, scaly or peeling skin.
Infrequent:contact dermatitis.
Rare: pseudomembranous colitis.
Dosage
Apply twice a day. Application to the entire face is equivalent to approximately 2 mL of liquid or lotion.
Administration instructions
Before applying, wash affected areas with mild soap or soap substitute and warm water; rinse and pat dry.
Patient counselling
Do not use near heat, open flame or if smoking (products contain alcohol).

Avoid contact with eyes, mouth and other mucous membranes.


Stop use and tell your doctor if GI symptoms such as diarrhoea occur.
Practice points
noticeable improvement is usually seen after about 6 weeks in most patients;

however, 812 weeks of treatment may be required before maximum benefit is


seen
avoid combination with topical erythromycin preparation (antagonistic mode of
action)
cumulative irritant or drying effects may occur if used with other topical
anti-acne preparations; combinations may be used if tolerated by patient
Products
CLINDAMYCIN SOLUTION 1 % 30 ML BOTTLE (CLINADERM, CLINDOX, CLINDACIN-T,
DALACIN-T, DERMOVATE, LINDASOL)
ERYTHROMYCIN (SKIN)
Mode of action
Macrolide antibacterial; inhibits growth of Propionibacterium acnes.
Indications
Marketed: Acne vulgaris, mild-to-moderate.
Accepted: Minor bacterial skin infections.
Specific considerations
Pregnancy: Safe to use; ADEC category A.
Lactation: Safe to use.
Adverse effects
Common: dry or scaly skin, itch, stinging or burning feeling.
Infrequent: desquamation, erythema.
Dosage
Apply twice a day in a thin film to affected areas.
Administration instructions
Before application, wash affected area with a mild soap or soap substitute and warm water; rinse thoroughly and pat
dry.
Patient counselling
Avoid contact with eyes, mouth and other mucous surfaces.
Do not use near heat or open flame or if smoking (contains alcohol).
Practice points
noticeable improvement may be seen in 34 weeks; however, 812 weeks of

treatment may be required before maximum benefit is seen


if irritation occurs, apply less frequently; if it persists or is severe, stop
treatment
combination treatment with benzoyl peroxide and topical erythromycin may
prevent resistance; use with caution due to cumulative irritant effects
avoid combination with topical clindamycin preparation (antagonistic mode of
action)
cumulative irritant or drying effects may occur if used with other topical
anti-acne preparations; combinations may be used if tolerated by patient
Products
ERYTHROMYCIN LOTION 40 MG/ML + ZINC ACETATE 12 MG/ML 30 GM BOTTLE (ZINYRET)
ERYTHROMYCIN SOLUTION 2 %
25 ML BOTTLE (AKNE-MYCIN, PHILAMYCIN,
STIEMYCIN)

13.02.03 Retinoids (Oral)

ACITRETIN (ORAL)
Mode of action
Reverses the epidermal proliferation and increased keratinization seen in hyperkeratotic disorders.
Indications
Psoriasis, severe; Keratinization disorders, severe.
Contraindications
Pregnancy; Breastfeeding; Hepatic impairment.
Specific considerations
Renal impairment: Avoid in endstage renal disease; use lower doses in patients with renal impairment.
Children: Because of the unknown effects of acitretin on growth and skeletal development and the risk of premature
epiphyseal closure, acitretin should be used in people <18 years only in:
life-threatening circumstances where other treatment cannot be used or is ineffective (eg widespread pustular
psoriasis), severe disorders for which there is no alternative treatment.
Growth parameters and bone development must be closely monitored by regular measurement and x-ray in all
children on long term treatment.
Pregnancy: Contraindicated; ADEC category X.
Acitretin is the active metabolite of etretinate which has been reported to cause major human fetal abnormalities if
administered during pregnancy. Acitretin may also be converted to etretinate in the body. Alcohol intake may
increase this conversion.
Breastfeeding: Contraindicated.
Hyperlipidaemia, obesity, excessive alcohol intake, diabetes: oral retinoids are associated with increased risk of
hypertriglyceridaemia and cardiovascular disease; avoid use or monitor carefully because of further risk of
triglyceride elevation.
Women of child-bearing age
Treatment with tetracyclines: increases risk of benign intracranial hypertension; avoid combination (contraindicated
by manufacturer).
Treatment with topical retinoids: increases risk of adverse effects; avoid combination.
Treatment with photosensitising medications: increases risk of phototoxic reactions; avoid combination.
Elderly: Arthralgias are more common; monitor carefully.
Children: Risk of premature epiphyseal closure; seek specialist advice.
Pregnancy: The elimination half-life for isotretinoin is 20 hours and for acitretin, 50 hours. However, due to possible
conversion of acitretin to etretinate, which has an elimination half-life of 120 days or more, the recommended
contraception period is significantly longer with acitretin.
Breastfeeding: Contraindicated.
Adverse effects
Common: nail fragility, sticky skin, taste disturbance, blurred vision and impaired night vision.
Infrequent: vertigo, somnolence.
Rare: granulomatous lesions, bullous eruptions
Most patients experience adverse effects which generally resemble excess vitamin A intake.
Dosage
Adult
Initially, 2530 mg once a day for 24 weeks.
Maintenance, based on clinical efficacy and tolerance; generally 2550 mg once a day for a further 68 weeks.
Longer courses using lower doses have been used.
Treatment may be stopped if lesions have resolved sufficiently.
Child: 0.51 mg/kg daily; maximum daily dose 35 mg.
Patient counselling
Do not donate blood during, and for at least 2 years after, treatment.
Female patients, it is important that you use adequate contraception before, during and for 2 years after, treatment,
because birth defects have occurred during this time.
Avoid alcohol during, and for 2 months after, treatment.
Psoriasis, sometimes psoriasis becomes worse for a short time after starting treatment.
Practice points
confirm a negative pregnancy test in the 2 weeks before starting treatment,

then start on the second or third day of the next normal menstrual period

ensure effective contraception before, during and after treatment; an


oestrogenprogestogen combined pill is the contraceptive method of choice;
another method of contraception may be used as well, eg condoms or diaphragm,
to minimise pregnancy risk
complete blood count, biochemical profile, liver function and fasting blood
lipids should be measured at baseline, after the first month of treatment and
then as required
blood glucose should be monitored throughout treatment in patients who either
have, or are predisposed to, type 1 diabetes
consider radiological evaluation for skeletal hyperostosis in patients
receiving long term treatment (>1 year)
Products
ACITRETIN CAPS 10 MG (NEOTIGASON)
ACITRETIN CAPS 25 MG (NEOTIGASON)
ISOTRETINOIN (ORAL)
Mode of action
Modulates cell proliferation and differentiation. Reduces sebum excretion, Propionibacterium acnes numbers,
inflammation and cyst formation.
Indications
Marketed: Cystic acne, severe.
Accepted: Neoplastic disorders, e.g. squamous cell carcinoma; Disorders of keratinization.
Contraindications
Pregnancy; Lactation; Hepatic impairment.
Specific considerations
Pregnancy: Contraindicated; ADEC category X.
Lactation: Contraindicated.
Contraindicated.
Hyperlipidaemia, obesity, excessive alcohol intake, diabetes: oral retinoids are associated with increased risk of
hypertriglyceridaemia and cardiovascular disease; avoid use or monitor carefully because of further risk of
triglyceride elevation.
Women of child-bearing age.
Treatment with tetracyclines: increases risk of benign intracranial hypertension; avoid combination (contraindicated
by manufacturer).
Treatment with topical retinoids: increases risk of adverse effects; avoid combination.
Treatment with photosensitising medications: increases risk of phototoxic reactions; avoid combination.
Elderly: Arthralgias are more common; monitor carefully.
Children: Risk of premature epiphyseal closure; seek specialist advice.
Pregnancy: ISOTRETINOIN is contraindicated; and is teratogenic; ADEC category X. Women should use effective
contraceptive measures for 1 month before starting treatment, during treatment, for 1 month after stopping
isotretinoin and for at least 2 years after stopping acitretin. Should women conceive during this period there is a high
risk of birth defects.
Lactation: Contraindicated.
Adverse effects
Common: dryness of skin, lips and mucous membranes; cheilitis, mild acne flare, conjunctivitis and epistaxis,
reduced tolerance to contact lenses, raised blood glucose (diabetics), photosensitivity.
Infrequent: depression, hair thinning, myalgias, arthralgias, fatigue, headache, severe acne flare, menstrual
disturbances, raised liver enzymes.
Rare: corneal opacities, cataracts, papilloedema, decreased night vision, optic neuritis, benign intracranial
hypertension, skeletal hyperostosis, inflammatory bowel disease, hepatitis
Hyperlipidaemia
Increases in serum triglycerides and total cholesterol and decreases in high density lipoproteins, may occur; these
effects are dose-dependent, occur early during treatment and are usually reversible within a few weeks of stopping
therapy.
Dosage

Initially, up to 0.5 mg/kg each day as a single dose or in 2 divided doses. Dosage may be increased to 1 mg/kg after
4 weeks according to response and tolerance.
Treatment should be continued until total cumulative dose is 100 mg/kg for moderate acne, or 150 mg/kg for severe
acne. A treatment course is usually 46 months.
Patients with acne primarily on the body instead of the face may require a total cumulative dose of up to 150 mg/kg.
Patient counselling
Hair removal by waxing may tear your skin during, and for 2 months after stopping, treatment because of fragile
skin.
Do not give blood during treatment or for 1 month after stopping treatment.
Use white soft paraffin, eg Vaseline, to treat dry lips; use lubricating eye drops to treat eye irritation.
Tell your doctor if you are unable to manage dry skin, dry lips or dry eyes, or if during the initial treatment period
your contact lenses become uncomfortable.
Report promptly any nausea, headaches or visual changes (including impaired night vision or blurring) to your
doctor.
Tell your doctor if you notice a change in your moods.
Avoid taking vitamin A supplements.
Protect skin from sunlight with protective clothing or sunscreen. Broad spectrum sunscreen, at least factor 15+, and
containing a physical barrier (eg titanium dioxide or zinc oxide) is recommended. Avoid sunlamps and tanning beds.
Do not share medication with others.
Practice points
a mild flare of acne commonly occurs after 24 weeks of treatment, but

improves after 12 months of continued treatment; severe flares occur


infrequently
most patients remain disease-free after a single course or have long
remissions; approximately 10% of patients relapse; repeated courses of
isotretinoin are not usually recommended unless recurrence is severe
allow at least 2 months after completing a course to see whether further
treatment is necessary, as improvement may continue for several months after
stopping
use of isotretinoin with antibacterials and antiandrogens does not markedly
improve efficacy; if concomitant antibacterial treatment is contemplated,
erythromycin is preferred, as use of isotretinoin with tetracyclines can
increase the risk of benign intracranial hypertension
Products
ISOTRETINOIN CAPS 10 MG (ISOSUPRA, ROACCUTANE)
ISOTRETINOIN CAPS 20 MG (CURANCE, ISOSUPRA, ROACCUTANE, RUATINE)

13.02.04 Retinoids (Skin)


ADAPALENE
Mode of action
Modulate cell proliferation and differentiation; decrease new comedone formation and inflammatory lesions.
Indications
Acne vulgaris, especially early comedonal acne, although may be used adjunctively in the management of
comedones associated with inflammatory acne.
Contraindications
Allergy to topical retinoids; Pregnancy; Sunburn; Unprotected sun exposure.
Specific considerations
Children: Contraindicated in neonates; may be used in young children with comedonal acne.
Eczema: severe irritation to eczematous skin may occur; use with caution.
Women of child-bearing age.
Treatment with oral retinoids: increases risk of adverse effects; avoid combination.
Treatment with photosensitising medications: increases risk of phototoxic reactions; avoid combination.
Pregnancy: Contraindicated. Although absorption via skin is minimal, in view of teratogenicity of systemic
retinoids, topical retinoids should not be used in pregnancy. ADEC category D.

Lactation: No data available but unlikely to be a concern.


Adverse effects
Common: erythema, peeling, irritation.
Infrequent: pigmentation changes, photoirritation.
Rare: allergic contact dermatitis.
Dosage
Apply once a day at bedtime.
Patient counselling
Before applying, wash with mild soap or soap substitute and warm water; rinse and gently pat dry; wait 20
30 minutes for complete drying of skin to occur. Apply enough to cover affected areas and rub in gently.
Do not apply to eyes, lips or in nostrils.
Protect treated areas from sunlight with protective clothing or sunscreen. Use broad spectrum sunscreen, at least
factor 15+ (30+ is preferable), containing a physical agent (eg titanium dioxide). Avoid sunlamps and tanning beds.
Cosmetics may be used but skin must be washed thoroughly before applying medication.
Practice points
cumulative irritant or drying effects may occur with other topical anti-acne

preparations; combinations may be used if tolerated by patient


confirm a negative pregnancy test in the 2 weeks before starting treatment,
then start treatment on the second or third day of the next normal menstrual
period
during early weeks of treatment, an apparent flare of acne may occur; this is
due to actions on deep lesions and is not a reason to stop treatment; benefit
does not generally become evident for some weeks or even months
if patients have been using keratolytics, allow sufficient time for their
effects to subside before initiating treatment with topical retinoids
adverse effects may decrease with time and can be minimised by using a
moisturiser
excessive application does not increase therapeutic effect and may produce
marked inflammation
if severe erythema, oedema, blistering or crusting occurs, apply less
frequently or stop until skin integrity is restored
Products
ADAPALENE GEL 0.1 %
30 GM (DIFFERIN GEL)

ISOTRETINOIN (SKIN)
Mode of action
Modulate cell proliferation and differentiation; decrease new comedone formation and inflammatory lesions.
Indications
Acne vulgaris, especially comedonal acne, although may be used adjunctively in the management of comedones
associated with inflammatory acne.
Contraindications
Allergy to topical retinoids; Pregnancy; Sunburn; Unprotected sun exposure.
Specific considerations
Children: Contraindicated in neonates; may be used in young children with comedonal acne.
Eczema: severe irritation to eczematous skin may occur; use with caution.
Women of child-bearing age.
Treatment with oral retinoids: increases risk of adverse effects; avoid combination.
Treatment with photosensitizing medications: increases risk of phototoxic reactions; avoid combination.
Pregnancy: Contraindicated. Although absorption via skin is minimal, in view of teratogenicity of systemic
retinoids, topical retinoids should not be used in pregnancy. ADEC category D.
Lactation: No data available but unlikely to be a concern.
Adverse effects
Common: erythema, peeling, irritation.
Infrequent: pigmentation changes, photoirritation.
Rare: allergic contact dermatitis.

Dosage
Apply once a day at bedtime.
Patient counselling
Before applying, wash with mild soap or soap substitute and warm water; rinse and gently pat dry; wait 20
30 minutes for complete drying of skin to occur. Apply enough to cover affected areas and rub in gently.
Do not apply to eyes, lips or in nostrils.
Protect treated areas from sunlight with protective clothing or sunscreen. Use broad spectrum sunscreen, at least
factor 15+ (30+ is preferable), containing a physical agent (eg titanium dioxide). Avoid sunlamps and tanning beds.
Cosmetics may be used but skin must be washed thoroughly before applying medication.
Practice points
cumulative irritant or drying effects may occur with other topical anti-acne

preparations; combinations may be used if tolerated by patient


confirm a negative pregnancy test in the 2 weeks before starting treatment,
then start treatment on the second or third day of the next normal menstrual
period
during early weeks of treatment, an apparent flare of acne may occur; this is
due to actions on deep lesions and is not a reason to stop treatment; benefit
does not generally become evident for some weeks or even months
if patients have been using keratolytics, allow sufficient time for their
effects to subside before initiating treatment with topical retinoids
adverse effects may decrease with time and can be minimised by using a
moisturiser
excessive application does not increase therapeutic effect and may produce
marked inflammation
if severe erythema, oedema, blistering or crusting occurs, apply less
frequently or stop until skin integrity is restored
Products
ISOTRETINION GEL 0.05 % + ERYTHROMYCIN 2 %
30 GM TUBE (ISOTREXIN)

TRETINOIN (SKIN)
Mode of action
Modulate cell proliferation and differentiation; decrease new comedone formation and inflammatory lesions.
Indications
Marketed: Acne vulgaris, especially comedonal acne, although may be used adjunctively in the management of
comedones associated with inflammatory acne.
Accepted: Photoageing.
Contraindications
Allergy to topical retinoids; Pregnancy; Sunburn; Unprotected sun exposure.
Specific considerations
Children: Contraindicated in neonates; may be used in young children with comedonal acne.
Eczema: severe irritation to eczematous skin may occur; use with caution.
Women of child-bearing age.
Treatment with oral retinoids: increases risk of adverse effects; avoid combination.
Treatment with photosensitising medications: increases risk of phototoxic reactions; avoid combination.
Pregnancy: Contraindicated. Although absorption via skin is minimal, in view of teratogenicity of systemic
retinoids, topical retinoids should not be used in pregnancy. ADEC category D.
Lactation: No data available but unlikely to be a concern.
Adverse effects
Common: erythema, peeling, irritation.
Infrequent: pigmentation changes, photoirritation.
Rare: allergic contact dermatitis.
Dosage
Apply once a day at bedtime.
Patient counselling
Before applying, wash with mild soap or soap substitute and warm water; rinse and gently pat dry; wait 20

30 minutes for complete drying of skin to occur. Apply enough to cover affected areas and rub in gently.
Do not apply to eyes, lips or in nostrils.
Protect treated areas from sunlight with protective clothing or sunscreen. Use broad spectrum sunscreen, at least
factor 15+ (30+ is preferable), containing a physical agent (e.g. titanium dioxide). Avoid sunlamps and tanning beds.
Cosmetics may be used but skin must be washed thoroughly before applying medication.
Practice points
start with the lowest strength cream or gel
benefit may be noticed after 23 weeks, but >6 weeks treatment is usually

required
there may be a symptomatic flare in the first 46 weeks of treatment
after achieving satisfactory response, it may be possible to maintain efficacy
with less frequent application
tretinoin and benzoyl peroxide can be applied with a 1224 hour interval
between applications
topical tretinoin may increase the systemic absorption of topical minoxidil;
avoid applying to same area of skin
Products
TRETINOIN GEL 0.025 %
30 GM TUBE (OPTIMAL, RETIN-A)

13.03 DRUGS FOR FUNGAL AND YEAST INFECTIONS


TINEA
Tinea is a superficial fungal infection of the skin, hair or nails caused by dermatophytes. It is classified according to
the area affected, eg scalp and hair (tinea capitis), trunk (tinea corporis, ringworm), groin (tinea cruris) and foot
(tinea pedis, athlete's foot). Infection involving the nail (tinea unguium) is discussed in Nail infections.
Before starting treatment
Skin scrapings from edge of lesion should be taken for microscopy and culture.
Confirmation of fungal infection is warranted as the clinical picture may be very similar to non-fungal conditions
(exclude discoid eczema when ringworm-like lesions are present; this is a common misdiagnosis).
When to start treatment
Obvious clinical picture or positive microscopy result; it is not necessary to wait for culture results.
Drug choice
Topical treatment
Mild localised skin infections usually respond to topical treatments, including azoles, terbinafine and tolnaftate.
Topical treatment is not usually successful for infections involving the nails and hair. Hyperkeratotic lesions also
respond poorly.
Azoles (eg clotrimazole, miconazole) are the treatment of choice; fungistatic; available as cream, lotion, solution,
spray and powder; well tolerated.
Terbinafine is more expensive but produces a more rapid response than azoles; fungicidal; available as gel and
cream.
Tolnaftate may irritate skin; less effective than azoles and terbinafine; available as cream, solution, ointment, powder
and spray.
Miscellaneous agents such as benzoic acid with salicylic acid (Whitfield's ointment), undecanoic acid salts, selenium
sulfide and crystal violet are less effective than azoles, terbinafine and tolnaftate.
Systemic treatment
Griseofulvin, itraconazole or terbinafine are used for tinea capitis, extensive infection, infections in heavily
keratinised areas, eg palms and soles, and disseminated disease. They may also be used for tinea pedis, tinea
corporis and tinea cruris when there is poor response to topical therapy. Fluconazole may be used but is more
commonly reserved for candidal infection.
Griseofulvin has a narrow spectrum of activity confined largely to dermatophytes, so accurate diagnosis is essential.
As tissue concentration drops quickly after stopping, it should be continued until condition is cured (typically
several weeks or months).
Other drug treatment
Drying agents and/or antibacterial agents (such as solution of Condy's crystals or Burow's solution) may be needed

for severe forms of interdigital infection.


Saline compresses/drying agents and sometimes topical corticosteroids may be necessary for acute vesicular tinea
pedis.
Treatment endpoints
Continue topical treatment for 2 weeks after clinical signs resolve. Continue oral treatment until mycological and
clinical cures are obtained.
Practice points
good personal hygiene is an important adjunct to antifungal treatment,

eg drying between toes, using a separate towel for infected area, wearing
thongs in public showers and change rooms, changing socks (preferably cotton)
daily, avoiding sharing combs, hats and towels
discard old shoes that may have a high density of fungal spores
creams are generally preferred; lotions or sprays may be applied to large
and/or hairy areas; powders may be used on feet, groin and other
intertriginous areas (also inside socks and shoes)
family members should be evaluated for asymptomatic carriage, particularly if
infection is persistent or recurrent

CUTANEOUS CANDIDIASIS
Usually caused by the yeast, C. albicans, although other Candida species are occasionally responsible. Infections
commonly occur in the groin, axillae, beneath the breasts, in abdominal folds in obese people, or in the umbilicus.
Infections involving the nail are discussed in Nail infections.
Before starting treatment
Confirm diagnosis by microscopy and culture when systemic treatment is anticipated.
Manage predisposing factors such as diabetes, obesity, use of systemic corticosteroids or antibacterials, neutropenia,
HIV, other immunocompromised states, occlusion, warm or moist environments, mechanical irritation and skin
diseases, eg psoriasis.
Drug choice
Topical treatment
Immunocompetent patients can usually be treated with topical antifungal agents, including the azoles, nystatin and
terbinafine.
Azoles (eg clotrimazole, miconazole) are the treatment of choice; are relatively broad spectrum, primarily
fungistatic, generally considered more effective than topical nystatin and well tolerated; available as cream, lotion,
solution, spray and powder.
Nystatin is available as a cream or ointment; not active against dermatophytes.
Terbinafine is fungistatic against Candida spp.; alternative to topical azoles, but more expensive; available as gel and
cream.
Systemic treatment
Systemic treatment with azole antifungals is indicated for widespread or unresponsive disease and
immunocompromised patients.
Fluconazole is the treatment of choice.
Itraconazole has similar safety profile to fluconazole; its use in candidal infections is less well studied.
Ketoconazole is highly effective, but due to its serious adverse effects, other oral azoles are preferred.
Other drug treatment
Topical corticosteroids may be used sparingly for short periods with topical and/or systemic antifungals, to reduce
inflammation.
Practice points
give advice about good hygiene, keeping the skin as clean and dry as possible

(particularly the groin, armpits and skin folds) and avoiding occlusion
creams are generally preferred; lotions or sprays may be applied to large
and/or hairy areas; powders may be used on feet, groin and other
intertriginous areas as well as inside socks and shoes
continue treatment with topical azoles or nystatin for 2 weeks after symptoms
resolve
regular application of topical drugs is essential for successful treatment

13.03.01 Imidazoles (Skin)


CLOTRIMAZOLE (SKIN)
Mode of action
Impair biosynthesis of ergosterol for cytoplasmic membrane, inhibiting fungal growth; fungistatic.
Indications
Dermatophytoses; Mucocutaneous candidiasis, including paronychia; Pityriasis versicolor.
Specific considerations
Pregnancy: Safe to use; ADEC category A.
Lactation: Safe to use.
Adverse effects
Topical imidazoles are generally well tolerated.
Infrequent: burning, stinging, itch, erythema.
Rare: allergic reactions.
Dosage
Apply sparingly twice a day.
Patient counselling
Regular application is essential for successful treatment.
Complete the full treatment course even if signs of infection have gone.
Attention to hygiene is important in the management of fungal disease of the feet; after washing, dry feet
thoroughly, especially between toes.
Practice points
continue treatment for 24 weeks in dermatophytoses
use sparingly, especially in intertriginous areas, to avoid maceration
creams are preferred; powders may be used on feet, moist lesions of the groin

and intertriginous areas with creams or to prevent reinfection


intractable candidiasis may be the presenting symptom of undiagnosed diabetes;
appropriate urine and blood tests may be indicated in patients not responding
to treatment
topical imidazoles are not usually successful in treating infections of the
nails or hair
Products
CLOTRIMAZOLE CREAM
20-30 GM TUBE (CLOTREX, CLOTRIM)

ECONAZOLE (SKIN)
Mode of action
Impair biosynthesis of ergosterol for cytoplasmic membrane, inhibiting fungal growth; fungistatic.
Indications
Dermatophytoses; Mucocutaneous candidiasis, including paronychia.
Specific considerations
Pregnancy: Safe to use; ADEC category A.
Lactation: Safe to use.
Adverse effects
Topical imidazoles are generally well tolerated.
Infrequent: burning, stinging, itch, erythema.
Rare: allergic reactions.
Dosage
Dermatophytoses and cutaneous candidiasis
Cream, apply a thin layer 23 times a day.
Pityriasis versicolor
Foaming liquid, apply to wet body on 3 consecutive nights and allow to dry. May be rinsed off the next morning. To
prevent relapse, repeat 1 and 3 months after initial course.
Patient counselling
Apply a thin layer to the affected skin and surrounding area; pay particular attention to skin folds.
For this treatment to be successful you have to use it regularly.

Continue using the treatment for 2 weeks after symptoms have gone.
Practice points
topical azoles are not usually successful in treating infections of the nails

or hair
intractable candidiasis may be the presenting symptom of undiagnosed diabetes;
consider this possibility in patients not responding to treatment
Products

ECONAZOLE NITRATE CREAM 1% + TRIAMCINOLONE ACETONIDE 0.1% (15-30) GM TUBE


(ECOREX PLUS, PEVISON)
ISOCONAZOLE (SKIN)

Antimicrobial Action
Isoconazole is an imidazole antifungal active against a wide spectrum of fungi including Candida spp.,
dermatophytes, and Malassezia furfur. It is also active against some Gram-positive bacteria.

Uses and Administration


Isoconazole nitrate is an imidazole antifungal used locally in the treatment of vaginal mycoses, particularly due to
Candida spp. and in fungal skin infections. For vaginal infections it is usually given as pessaries in a single dose of
600 mg or 300 mg daily for 3 days, or as a 1% vaginal cream daily for 7 days. For skin infections a 2% cream or
other topical formulation has been used.

Adverse Effects and Precautions


Local reactions including burning or itching may occur following the application of isoconazole.
Intravaginal preparations of azole antifungals may damage latex contraceptives and additional contraceptive
measures are therefore necessary during local administration of isoconazole.

Precautions
See Fluconazole.

Products
ISOCONAZOLE CREAM 1 %

(AS NITRATE)

20 GM TUBE (AZONIT, TRAVOGEN)

KETOCONAZOLE (SKIN)
Mode of action
Impair biosynthesis of ergosterol for cytoplasmic membrane, inhibiting fungal growth; fungistatic.
Indications
Dermatophytoses; Mucocutaneous candidiasis, including paronychia
Pityriasis versicolor; Seborrhoeic dermatitis.
Specific considerations
Pregnancy: Avoid use; use alternative imidazole; ADEC category B3.
Lactation: Safe to use.
Adverse effects
Topical imidazoles are generally well tolerated.
Infrequent: burning, stinging, itch, erythema.
Rare: allergic reactions.
Dosage
Dermatophytoses and cutaneous candidiasis
Apply sparingly twice a day.
Seborrhoeic dermatitis
Use shampoo twice a week for 4 weeks.
Patient counselling
Regular application is essential for successful treatment.
Complete the full treatment course even if signs of infection have gone.
Attention to hygiene is important in the management of fungal disease of the feet; after washing, dry feet
thoroughly, especially between toes.
Practice points
continue treatment for 24 weeks in dermatophytoses
use sparingly, especially in intertriginous areas, to avoid maceration

creams are preferred; powders may be used on feet, moist lesions of the groin
and intertriginous areas with creams or to prevent reinfection
intractable candidiasis may be the presenting symptom of undiagnosed diabetes;
appropriate urine and blood tests may be indicated in patients not responding
to treatment
topical imidazoles are not usually successful in treating infections of the
nails or hair
Products
KETOCONAZOLE SHAMPOO 0.02 %
100 ML BOTTLE (FUNGIPAN, KETODAR, NIZORAL,
PHILAZOLE)
MICONAZOLE (SKIN)
Mode of action
Impair biosynthesis of ergosterol for cytoplasmic membrane, inhibiting fungal growth; fungistatic.
Indications
Dermatophytoses; Mucocutaneous candidiasis, including paronychia; Pityriasis versicolor; Seborrhoeic dermatitis
(shampoo).
Specific considerations
Pregnancy: Safe to use; ADEC category A.
Lactation: Safe to use.
Adverse effects
Topical imidazoles are generally well tolerated.
Infrequent: burning, stinging, itch, erythema
Rare: allergic reactions
Dosage
Apply sparingly twice a day.
Patient counselling
Regular application is essential for successful treatment.
Complete the full treatment course even if signs of infection have gone.
Attention to hygiene is important in the management of fungal disease of the feet; after washing, dry feet
thoroughly, especially between toes.
Practice points
continue treatment for 24 weeks in dermatophytoses
use sparingly, especially in intertriginous areas, to avoid maceration
creams are preferred; powders may be used on feet, moist lesions of the groin

and intertriginous areas with creams or to prevent reinfection


intractable candidiasis may be the presenting symptom of undiagnosed diabetes;
appropriate urine and blood tests may be indicated in patients not responding
to treatment
topical imidazoles are not usually successful in treating infections of the
nails or hair
Products
MICONAZOLE CREAM 2 % (AS NITRATE)
15 GM TUBE (CANDIPLAS, CANDIZOL,
CYPROZOL, DAKTARIN, MECONAZOL, MICOVER, MYCODERM)
MICONAZOLE LOTION 2 % (AS NITRATE)
30 GM BOTTLE (DAKTARIN)
HYDROCORTISONE ACETATE CREAM 1 % + MICONAZOLE 2 % CREAM
15 GM TUBE
(CANDICORT, MICOVER -H, MYCOHEAL -HC)

TERBINAFINE (SKIN)
Mode of action
Inhibits fungal sterol synthesis; fungicidal against dermatophytes and some yeasts, but only fungistatic against C.
albicans.
Indications
Dermatophyte infections of the skin; Cutaneous candidiasis; Pityriasis versicolor (gel).

Contraindications
Allergy to terbinafine.
Specific considerations
Pregnancy: Safe to use; ADEC category B1.
Lactation: Data lacking, unlikely to be a concern.
Adverse effects
Infrequent: redness, itch and stinging.
Rare: allergic reactions.
Dosage
Apply once or twice a day:
Tinea corporis, tinea cruris, for 12 weeks.
Tinea pedis, interdigital, for 1 week.
Tinea pedis, plantar/moccasin type, for 24 weeks.
Cutaneous candidiasis, for 2 weeks.
Pityriasis versicolor, for 1 week.
Patient counselling
Clean and dry affected areas thoroughly before applying a thin layer to the affected skin and surrounding area. Rub
in lightly.
For this treatment to be successful you have to use it regularly.
Do not use occlusive dressings or wrappings unless you have been told by your doctor.
Continue using the treatment for the full course even if your skin looks better.
Practice points
rapid action usually allows a shorter duration of treatment than with topical

azoles, but is more expensive


symptoms are usually relieved within a few days
optimum clinical response to topical terbinafine generally is delayed for a
week or more after completing a short course of treatment
may be useful when patient compliance beyond 1 week cannot be ensured
topical treatment course generally should not exceed 4 weeks
Products
TERBINAFINE CREAM 1 % (AS HCL)
15 GM TUBE (LAMIFEN, LAMISIL, SOLVEASY
TINEA, TERFINIL, TINASIL)
TERBINAFINE SPRAY 1 % (LAMISIL)

13.04 SCABICIDES AND PEDICULICIDES


SCABIES
Rationale for drug use
Scabies eradication.
Symptom relief.
Prevent secondary infection.
Prevent transmission.
Before starting treatment
Confirm diagnosis by demonstrating the typical burrows; or definitively, the mite, an ovum or scybalum (faecal
pellet) by microscopy. Dermatoscopy may also be useful.
Drug choice
Permethrin 5%: treatment of choice (including in pregnancy and breastfeeding); pyrethroid insecticide; low toxicity
and high efficacy; may cause irritation or allergic reaction.
Benzyl benzoate: messy; irritant; dilution required if used in children.
Crotamiton: other more effective agents preferred; may be used to control itch after treatment with a more effective
scabicide; may cause irritation.
Maldison: alcohol-based lotion may cause irritation.
Special cases
Norwegian scabies is a severe crusted form that occurs rarely; immunocompromised or incapacitated patients are

more susceptible; multiple applications are needed and combination treatment with keratolytics may be required.
Resistant cases or immunocompromised, oral ivermectin may be beneficial.
Patient counselling
The affected person, all household/family members and close contacts should be treated at the same time to avoid
becoming infected again. Even contacts who don't have any symptoms need to be treated.
Treatment with permethrin requires 2 applications 1 week apart.
Soft toys, bed linen and clothing should be washed and dried on hot machine settings the morning after each
treatment or stored in tightly sealed plastic bags for 12 weeks.
Practice points
examine patients 2 weeks after start of treatment to monitor adequacy; assess

for irritant dermatitis and treat residual itch


evidence of a cure requires follow-up for about 1 month; this is the time it
takes for lesions to heal and for any eggs and mites to reach maturity if
treatment fails
improvement usually occurs within 1 or 2 days of treatment; itch generally
lasts 23 weeks and patients should be warned not to mistake this for ongoing
infection; manage the itch with moisturiser, topical corticosteroids,
crotamiton or an antihistamine; patients should see a doctor if itching
continues longer than 23 weeks

HEAD LICE
Pediculosis or infestation by the head louse, Pediculus humanus capitis, can occur at any age but is most common in
school-age children.
Before starting treatment
A living, moving louse must be found to confirm infestation. Itching or the presence of eggs (nits) does not
necessarily indicate active infestation.
Examine family members and close contacts for infestation. Family members with head lice should be treated at the
same time.
Drug choice
If using chemical treatment use only products containing the insecticides mentioned below. Chemical resistance is
common; check lice are killed the day after the first treatment and repeat successful treatment; if lice are not killed
use a different insecticide as soon as possible.
Permethrin 1%: safe and effective; short application time (10 minutes); treatment of choice in pregnancy and
breastfeeding.
Maldison: organophosphate pesticide; safe and effective when used as directed; avoid use in pregnancy and infants
<12 months; smelly; requires long application time (12 hours).
Pyrethrins with piperonyl butoxide: probably as effective as other insecticide treatments.
Other treatment
'Bug busting': meticulous wet combing (using a special fine-tooth comb) with conditioner, can be used to detect and
treat head lice. Although it provides an alternative to insecticide treatment evidence for benefit is unreliable and it
requires motivation to be effective. Repeat every 2 days until there are no head lice seen for 10 consecutive days.
Electrified comb: despite a lack of clinical evidence there is anecdotal evidence that regular use of an electrified
comb (available at most pharmacies) may be a useful non-drug alternative. This technique has the advantage of
being less time consuming, does not damage hair and avoids the smell and cosmetic problems associated with
topical preparations.
Essential oils, herbal products: there is insufficient evidence to support their use in eradicating lice.
Treatment failure
May result from inadequate or incorrect application, reinfection or pediculicide resistance.
Patient counselling
Check other family members for head lice. Only treat if a live louse is found.
Chemical treatment requires 2 applications 7 days apart. The second treatment kills the lice that have hatched since
the first application.
Wet combing (using a special fine-tooth comb and conditioner) every 2 days in between chemical treatments may
increase effectiveness, but avoid using conditioner for at least 1 day before and after chemical treatment. Wet
combing, unlike chemical treatment, also helps to remove nits.
Do not use a hair dryer following chemical treatment as heat can destroy the active ingredient.

Children can be sent back to school after the first treatment. Tell children not to share hats and hairbrushes. Long
hair should be tied back or plaited, especially while at school.
Soak combs and hairbrushes in hot water (>60C) for 30 seconds and wash pillowcases in hot water or put in a
clothes dryer for 15 minutes.
Do not overuse chemical treatments or use them to prevent head lice infestation. Overuse can cause irritation and
result in lice that are resistant to chemical treatment.
BENZYL BENZOATE
Mode of action
Unknown.
Indications
Scabies; Pediculosis.
Contraindications
Acutely inflamed skin, or raw, weeping skin; Allergy to benzyl benzoate.
Specific considerations
Elderly: Age-related dryness of skin increases susceptibility to drying effects of benzyl benzoate; irritation may be
worse in this age group.
Children: Dilute with an equal quantity of water for children <12 years and with 3 parts of water for infants.
Dilution reduces irritation, but also efficacy.
Pregnancy: Although no problems in humans have been documented with benzyl benzoate, use of permethrin is
preferred; ADEC category B2.
Lactation: Data lacking, permethrin preferred.
Adverse effects
Infrequent: burning sensation, itch and dermatitis.
Rare: CNS stimulation, eg convulsions (with excessive topical use), allergic reaction.
Dosage and administration instructions
Test on small area of skin for 10 minutes before using. If excessive stinging occurs, it should be diluted with an
equal quantity of water, then retested before using.
Scabies
Apply to cool skin (not hot after bathing) from chin down; repeat without bathing on the following day and wash off
24 hours later; a third application may be required in some cases.
In infants and young children up to 2 years, also apply to the scalp, neck, face and ears; avoid eyes, mouth and
mucous membranes.
Pediculosis: Coat affected region and leave on for 24 hours, then wash with soap and water.
Patient counselling
Do not use on face unless advised by your doctor; avoid contact with eyes, mouth and mucous membranes.
If you wash your hands or any other part of your body during the treatment period for scabies, you should reapply
the lotion to the washed areas.
Itch may persist for some months after scabies treatment (710 days after lice treatment); this may not be ongoing
infection although persisting itch could mean scabies that has not responded. Symptomatic itch treatment may be
required.
Practice points
Scabies
benzyl benzoate has been superseded by more effective products for the

treatment of scabies (50% cure rate with benzyl benzoate versus 80% with
permethrin)
improvement usually occurs within 1 or 2 days of treatment
traditionally applied after a bath, but this is unnecessary and may increase
transdermal absorption, removing drug from site of action and increasing the
risk of systemic toxicity
special attention should be given to the finger and toe webs, under nails,
umbilicus, intertriginous areas and intergluteal cleft
application to the genitals is irritant; use another insecticide
(eg permethrin) or relieve with hydrocortisone 1% cream

scalp, neck, face and ears may also need to be treated in elderly,
immunocompromised, people who have had treatment failure or those with
atypical or crusted scabies; stinging is significant; an alternative agent may
be preferable
do not use to prevent scabies
Pediculosis
efficacy is questionable; other agents are more effective
Products
BENZYL BENZOATE LOTION 25 %
100 ML BOTTLE (BENZYL BENZOATE)
CROTAMITON
Mode of action
Unknown.
Indications
Scabies (but not pediculosis); Itch from various causes, eg post-scabies and post-pediculosis itch, insect bites (claims
of drug's antipruritic activity based largely on uncontrolled studies).
Contraindications
Acutely inflamed skin or raw, weeping skin; Allergy to crotamiton.
Specific considerations
Pregnancy: Safe to use; ADEC category B2.
Lactation: Safe to use (avoid nipple region).
Adverse effects
Infrequent: irritation.
Rare: allergic reaction.
Dosage
Scabies, apply once a day for 25 days, preferably in the evening; do not wash off until next application is due.
Itch, apply 23 times a day.
Administration instructions
Scabies, after bathing and drying, allow skin to cool before applying to body from chin down.
Special attention should be given to the finger and toe webs, under nails, umbilicus, intertriginous areas and
intergluteal cleft.
Itch, rub into affected areas.
Patient counselling
Do not use on face; avoid contact with eyes, mouth and mucous membranes.
Massage into skin until dry, do not wash off for 24 hours.
If you wash your hands or any other part of your body during the treatment period for scabies, you should reapply
the lotion/cream to the washed areas.
Do not apply to entire body surface of small children more than once daily.
Practice points
other more effective agents, eg permethrin, are usually preferred in the

treatment of scabies
if used correctly, 2 applications of crotamiton may be effective in
eradicating scabies
Products
CROTAMITON CREAM 10 %
20-25 GM TUBE (CROTAPHIL, EURAX)
CROTAMITON LOTION 10 %
50 ML BOTTLE (CROTAPHIL, EURAX)

PYRETHRIN
Mode of action
Pyrethrins are absorbed through the chitinous exoskeleton of arthropods and stimulate the nervous system. Nerve
impulse transmission is blocked, resulting in paralysis and death.
Piperonyl butoxide inhibits pyrethrin metabolism in arthropods (it has little or no insecticidal activity).
Indications
Pediculosis.
Contraindications

Allergy to pyrethrins or pyrethroids; Acutely inflamed skin.


Specific considerations
Pregnancy: Permethrin preferred; ADEC category B3.
Lactation: Safe to use.
Adverse effects
Rare: allergic reaction, skin infection, skin irritation.
Dosage
Following initial treatment, a second treatment is required in 710 days to kill any newly hatched lice.
Administration instructions
Mousse: Apply to dry hair and massage in until wet; leave for 10 minutes, then wash out with shampoo.
Aerosol spray: Moisten whole scalp by spraying in short bursts (23 seconds); leave for 30 minutes (do not cover
head), then wash out with shampoo.
Patient counselling
Apply aerosol in a well ventilated room.
Avoid contact with eyes, mouth and mucous membranes.
Avoid excessive treatment, as irritation can occur.
Do not use on eyelashes or eyebrows; check with your doctor or pharmacist if they become infested.
Wash hands immediately after using medication.
Practice points
treatment should be repeated in 710 days to kill any newly hatched lice

Products
PYRETHRINE SHAMPOO 0.165 %

100 ML BOTTLE (LICESOL)

13.05 DRUGS FOR OTHER SKIN INFECTONS


13.05.01 Antibacterials (Skin)
FUSIDIC ACID (SODIUM FUSIDATE) (SKIN)
Indications
Staphylococcal skin infections
Specific considerations
Pregnancy: Avoid use during the last month of pregnancy; ADEC category C.
Adverse effects
Rare: hypersensitivity reactions including rash and irritation.
Dosage
Apply 23 times daily for 7 days. If using a protective dressing, apply once daily.
Patient counselling
Avoid contact with eyes.
Exclude child with impetigo from school until appropriate treatment is started. Sores on exposed surfaces must be
covered with a watertight dressing.
Practice points
avoid use in chronic skin conditions because of doubtful efficacy and risk of

resistance emerging during treatment


studies comparing topical sodium fusidate and mupirocin show no significant
difference in efficacy in staphylococcal skin infections; mupirocin is
preferred for mild impetigo

Products
FUSIDIC ACID CREAM 2 %
15 GM TUBE (DERMOFUCIN, FUCIDIN, FUSIDERM,
FUSIVER, TOPIDIC, UCIDERM)
FUSIDIC ACID CREAM 2 % + BETAMETHASONE (AS VALERATE) CREAM 0.1 %
15 GM TUBE
(FUCICORT)
FUSIDIC ACID GEL 2 %
15 GM TUBE (DERMOFUCIN, FUCIDIN, TOPIDIC, UCIDERM)
FUSIDIC ACID OINTMENT 2 %
15 GM TUBE (DERMOFUCIN, FUCIDIN, FUSIDERM,
FUSIVER, TOPIDIC, UCIDERM, ZETA)
METRONIDAZOLE (SKIN)
Indications
Acne rosacea.
Specific considerations
Pregnancy: Safe to use; ADEC category B2.
Lactation: Safe to use.
Adverse effects
Common: local reactions include eye irritation (watering), redness, dryness and skin irritation.
Dosage
Rub a thin film of gel or cream into affected areas twice a day.
Administration instructions
Apply to clean, dry skin. Avoid eye area.
Practice points
use with systemic treatment or alone for mild rosacea and maintenance therapy
there should be improvement within 3 weeks; continue treatment for 89 weeks
continued topical therapy after oral tetracycline is stopped lowers the

relapse rate
Products
METRONIDAZOLE GEL 0.75 % 15-25 GM TUBE (FLANIZOL, METROZA)
NEOMYCIN WITH BACITRACIN
Indications
Otitis externa.
Specific considerations
Perforated eardrum, tympanostomy tubeslight risk of inner ear damage; only use neomycin with bacitracin if
there is no appropriate alternative. Limit treatment to 57 days; refer to ENT specialist if discharge continues.
Adverse effects
Common: allergic dermatitis.
Infrequent: fungal overgrowth (with prolonged use).
Rare: inner ear damage.
Dosage
Use in the affected ear 24 times daily.
Patient Councelling
If you develop ringing in the ears, hearing loss or difficulty with balance, stop using this medication and tell your
doctor.

Products
NEOMYCIN 0.5%+BACITRACIN 250 IU/GM OINTMENT 15-30 GM TUBE (BANEOCIN, MULTICIN
Z CENTER, NEOBACIN)
NITROFURAZONE (SKIN)
Mode of action
Nitrofurazone inhibits several bacterial enzymes, especially those involved in the aerobic and anaerobic degradation
of glucose and pyruvate.
Indications
Burns (treatment)Topical nitrofurazone is indicated as an adjunctive therapy for second and third degree burns
when resistance to other agents is a real or potential problem.

Skin infections (treatment)Nitrofurazone is indicated in skin grafting when bacterial contamination may cause
graft rejection or donor site infection, especially in hospitals with a history of resistant bacteria.
Contraindications
Serious allergic reaction to nitrofurazone.
Specific considerations.
Pregnancy: Avoid use; ADEC category C.
Adverse effects
Contact dermatitis (itching; rash; swelling)
Dosage
Nitrofurazone should be applied directly to affected area or on gauze to cover affected area.
The drug should be reapplied once daily or every few days, depending on the usual dressing technique..
Practice points
The use of nitrofurazone occasionally allows overgrowth of nonsusceptible

organisms including fungi and Pseudomonas If this occurs, or if irritation,


sensitization, or superinfection develops, treatment should be discontinued
Products
NITROFURAZONE OINTMENT 0.2% (BACTAZONE)
SILVER SULFADIAZINE (SKIN)
Mode of action
Bactericidal; binds to cell membranes; effective against many Gram-positive and Gram-negative bacteria.
Indications
Prevention and treatment of infection in severe burns, leg ulcers and pressure sores; Prevention and treatment of
infection in epidermolysis bullosa.
Contraindications
Serious allergic reaction to sulfonamide or related drugs or to chlorhexidine; Neonates <4 weeks old.
Specific considerations
G6PD deficiencyincreases risk of haemolysis.
Renal impairment: Use with caution in patients with impaired renal function, particularly those receiving treatment
for extensive burns.
Pregnancy: Avoid use during last month of pregnancy if possible because of the theoretical risk of kernicterus,
jaundice and haemolytic anaemia in the neonate; ADEC category C.
Adverse effects
Common: burning, itch, rash.
Rare: skin discolouration due to deposition of silver, transient neutropenia, development of bacterial resistance,
hypersensitivity reactions.
Dosage
Rub a thin film of gel or cream into affected areas twice a day.
Administration instructions
Apply a 35 mm thick layer every 24 hours or more frequently.
Practice points
silver sulfadiazine cream is formulated with the disinfectant, chlorhexidine
chlorhexidine (cation) is inactivated by anionic agents such as soap; do not

use together
silver sulfadiazine may inactivate enzymatic debriding agents
Products
SILVER SULFADIAZINE CREAM 1% (FLAMAZINE, NO-BURN, SILVABURN, SIDILAZINE,
SILVERIN)
SILVER SULFADIAZINE CREAM 1% + CERIUM NITRATE (FLAMMACERIUM)

13.05.02 Antivirals (Skin)

ACICLOVIR (SKIN)
Indications
Labial herpes simplex (cold sores), initial and recurrent.
Specific considerations
Immunocompromised patients: oral aciclovir is more effective than topical.
Pregnancy: Safe to use; ADEC category B3.
Lactation: Safe to use.
Adverse effects
Common: dry or flaking skin, transient stinging or burning.
Infrequent: erythema, itch.
Rare: allergic dermatitis.
Dosage
Apply at first sign of lesion; apply 5 times a day (every 4 hours while awake) for 5 days.
Administration instructions
Avoid contact with eyes and mucous membranes.
Practice points
treat as early as possible in the course of infection
treatment of primary infections relieves symptoms and reduces duration of

viral shedding, but does not affect recurrence rate


more effective for primary infections than for recurrences
in genital herpes, topical antivirals are less effective than oral treatment
in immunocompromised patients, oral aciclovir is more effective than topical;
severe infections should be treated with IV aciclovir
Products
ACICLOVIR CREAM 5 %
2 GM TUBE (CYCLOHERP, CUSIVIRAL, HERPAVIR, ZOVIRAX,
SUPRAVIRAN)

TROMANTADINE (SKIN)
Indications
treatment of the initial symptoms of herpes simplex infections of the skin and mucous membrane and dermal
manifestation of herpes zoster.
Specific considerations.
Pregnancy: no data available.
Lactation: no data available.
Adverse effects
Common: contact dermatitis.
Dosage
Apply at first sign of lesion; apply 3-5 times a day.
Administration instructions
Avoid contact with eyes and mucous membranes.
Practice points
treat as early as possible in the course of infection
treatment of primary infections relieves symptoms and reduces duration of

viral shedding, but does not affect recurrence rate


more effective for primary infections than for recurrences
Products
TROMANTADINE GEL 1 % 10 GM TUBE (VIRU-MERZ)

13.06 DRUGS FOR PSORIASIS


PSORIASIS
Psoriasis is a common inflammatory and proliferative disease. Several morphological variants exist; plaque psoriasis
is the most common and classically affects elbows, knees, buttocks and scalp.

Rationale for drug use


Induce remission.
Reduce the severity and extent of psoriasis to a tolerable level.
Relieve symptoms, including itch, excessive scale, pain.
Before starting treatment
Minimise or eliminate potential trigger factors where possible, eg stress, trauma, smoking, alcohol, infection
(streptococcal throat infection may precipitate guttate psoriasis). Drugs known to exacerbate or trigger psoriasis
include lithium, quinolines, ACE inhibitors, NSAIDs and beta-blockers.
Consider referral to a dermatologist if the diagnosis is in doubt, therapy fails, or when treatment with phototherapy
or systemic agents is indicated.
When to start treatment
Troubling local symptoms, eg pain, itch, reduced manual dexterity, flexural intertrigo.
Cosmetic problems, eg prominent hand, arm, leg or facial lesions.
Drug choice
Topical treatment
Should be the initial treatment for stable plaque psoriasis, except when large areas of involvement make this
impractical or expensive. Topical agents are commonly used in combination. A patient who does not respond to a
particular agent may respond to it in the future.
Moisturisers
Moisturisers hydrate and soften the scaly, hyperkeratotic surface of psoriatic plaques and may suffice in mild disease
or in some patients with more extensive disease who prefer a treatment with minimal adverse effects.
Keratolytics
Include salicylic acid. They help to remove accumulated scale and allow other topical agents such as coal tar,
dithranol and corticosteroids to penetrate lesions. They can cause irritation.
Coal tar
Coal tar is generally preferred for limited or scalp psoriasis but can be effective in widespread psoriasis, eg guttate
psoriasis. May not clear psoriasis as quickly as other topical agents but remission may be longer. Crude tar
preparations are difficult to apply, stain clothing and smell unpleasant; newer, more refined preparations are less
messy but may be less effective. It is photosensitising and may be irritant to face, genitals, flexures and in unstable
psoriasis.
Dithranol
Dithranol may be used in increasing strength and contact duration according to patient response and tolerance.
Treatment is more feasible when plaques are large or few. Short contact treatment with higher dithranol
concentrations is as effective as overnight application of lower concentrations. It is irritant and stains clothing, skin
and hair.
Topical corticosteroids
Topical corticosteroids have quicker onset of action than coal tar and dithranol. May be useful when treating face,
flexures and genitals (where coal tar and dithranol are contraindicated), in localised disease and in scalp psoriasis.
Tachyphylaxis develops with continued use and relapse occurs faster than with other topical treatments. There is a
risk of local and systemic adverse effects; should not be used in extensive disease or in large amounts for periods
>46 weeks (trunk), >4 weeks (palms or soles) or >few days to 1 week (face or flexures). Potent topical
corticosteroids should be used with caution. Systemic corticosteroids are not prescribed due to the risk of rebound
flare.
Calcipotriol
Calcipotriol is useful in the treatment of resistant plaque psoriasis; similar efficacy to moderate potency
corticosteroids and coal tar; tolerance does not occur; continuous use beyond 12 months has not been studied. Can
cause irritation particularly if applied to face or skin folds.
Phototherapy
UVB light
Narrow band UVB is the preferred form of phototherapy for psoriasis. Safer, simpler and cheaper than
photochemotherapy. UVB may be used alone or with topical treatments, eg coal tar, dithranol or calcipotriol.
Particularly effective in guttate psoriasis when used alone.
Photochemotherapy (PUVA)
Combines topical or oral methoxsalen with UVA; probably the least toxic of all systemic agents. Its advantages are a
high likelihood of response and no need for topical medication between treatments. There is a potential risk of nonmelanoma skin cancer with PUVA. It is reserved for severe psoriasis unresponsive to other treatments.

Systemic treatment
Acitretin and immunomodulators have potentially serious adverse effects and drug interactions; they should not be
used in pregnancy and their use should be overseen by a dermatologist.
Acitretin
Acitretin is most effective in treating pustular and erythrodermic psoriasis; less effective in treating plaque psoriasis.
1020% discontinuation rate due to adverse effects and risk of teratogenicity make acitretin less acceptable to
women who may become pregnant. May be combined with phototherapy or calcipotriol, providing increased
efficacy and an acitretin-sparing effect.
Immunomodulators
Methotrexate and cyclosporin are used most frequently; they are indicated in extensive plaque psoriasis and
psoriasis refractory to topical treatment, generalised pustular or erythrodermic psoriasis and severe psoriatic arthritis.
Mycophenolate mofetil and tacrolimus are newer agents that may be useful in selected patients, seek specialist
advice.
Hydroxyurea is used occasionally but is less effective than methotrexate or cyclosporin.
Alefacept and efalizumab have recently been approved for the treatment of moderate-to-severe psoriasis. They have
not been directly compared with other systemic agents and long term safety and efficacy have not been established.
Reserve for patients with contraindications to, or who are unresponsive to, phototherapy or systemic therapy.
Other treatments
Antimicrobials
Indications include secondary skin infections and psoriasis precipitated by infection.
Combination therapy
Useful when monotherapy has failed, to limit toxicities of individual agents (lower dosages can be used) and to
improve therapeutic outcome (combination more effective than either agent alone). Usually one agent is stopped
after psoriasis has cleared and the safer agent is continued as maintenance treatment.
Examples of combinations include coal tar or dithranol with UVB, acitretin with UVB or PUVA, methotrexate with
UVB or cyclosporin.
Rotational therapy
Rotating treatment regimens, before significant individual drug toxicities occur, minimizes chronic toxicity and
facilitates long term treatment.
Primary agents include PUVA, methotrexate, acitretin, UVB (with or without coal tar or dithranol) and cyclosporin.
Secondary agents such as hydroxyurea may be tried when the primary agents are no longer effective or have
unacceptable side effects.
Special cases
Unstable psoriasis: Trigger factors include intensive systemic and topical corticosteroids, infection and
overtreatment with tar, dithranol or ultraviolet irradiation. It often warrants hospitalisation for systemic treatment
with retinoids or immunosuppressants and skilled nursing.
Scalp psoriasis: Coal tar and dithranol preparations with or without salicylic acid and/or sulfur, calcipotriol or
corticosteroid scalp lotions may be used.
CALCIPOTRIOL
Vitamin D analogue
Also known as calcipotriene.
Mode of action
Vitamin D analogue. Induces differentiation and suppresses proliferation of keratinocytes, reversing the abnormal
keratinocyte changes in psoriasis.
Indications
Psoriasis vulgaris, chronic stable plaque type.
Contraindications
Disorders of calcium metabolism; Previous allergic reaction to calcipotriol; Severe, extensive psoriasis (in view of
the risk of hypercalcaemia secondary to excessive absorption)
Specific considerations
Renal impairment: Data lacking, unlikely to be of concern; monitor plasma concentrations.
Hepatic impairment: Safety not established.
Pregnancy: Data lacking; contact specialised information service.
Lactation: Ensure chest area is free from calcipotriol for breastfeeding, to avoid possible transfer to infant.
Adverse effects

Common: skin irritation (usually mild burning or stinging).


Infrequent: erythema and scaling.
Rare: allergic contact dermatitis, hypercalcaemia, photosensitivity, changes in pigmentation.
Dosage
Apply to affected area twice a day. Less frequent application may be adequate after initial period. Stop treatment
after satisfactory improvement; reinstate if disease recurs.
Maximum
Adult
Cream or ointment, 5 mg calcipotriol (100 g) each week.
Liquid, 3 mg calcipotriol (60 mL) each week. >1 formulation, 5 mg calcipotriol each week.
Child
612 years, ointment, 50 g each week for up to 8 weeks.
>12 years, ointment, 75 g each week for up to 8 weeks.
Combination with betamethasone
For additional information see BETAMETHASONE (skin)
Adult, apply to the affected area once daily. Maximum of 100 g each week. Do not apply to >30% of body surface.
Patient counselling
Do not mix with other preparations unless instructed; mixing can destroy the calcipotriol.
Wash hands thoroughly after applying to avoid unintentional transfer to other body areas.
Do not apply to face; itch and redness occurs.
Protect treated areas from sunlight with protective clothing or sunscreen. Broad spectrum sunscreen, at least factor
15+, containing a physical agent (eg titanium dioxide) is recommended. Avoid sunlamps and tanning beds.
Practice points
calcipotriol is unstable in the presence of salicylic acid or UVA; to avoid

loss of efficacy:
apply salicylic acid at a different time of day
apply calcipotriol after UVA treatment
may need to use calcipotriol for 46 weeks for maximum improvement
avoid use on skin folds, face and scalp, which are especially susceptible to
irritation
avoid use with calcium or vitamin D supplements or drugs that increase the
systemic availability of calcium (eg calcium-containing antacids, thiazide
diuretics)
monitor plasma calcium and renal function every 3 months; if calcium is
elevated, stop treatment and monitor calcium level each week until normal; may
continue treatment with regular monitoring if the elevation is marginal
plasma calcium monitoring may not be required if patients are applying <30 g
each week
to minimise risk of hypercalcaemia, use <100 g each week
calcipotriol may be used with UVB, PUVA, retinoids and immunosuppressants,
allowing less frequent and lower dosing of these agents, thus minimising their
adverse effects
there are limited data on the use of calcipotriol with betamethasone beyond a
month; change to a single ingredient product after 4 weeks of treatment
Products
CALCIPOTRIOL CREAM 50 MCG
30 GM TUBE (DAIVONEX)
CALCIPOTRIOL OINTMENT 50 MCG
30 GM TUBE (DAIVONEX)
CALCIPOTRIOL OINTMENT 50 MCG + BETAMETHASONE
30 GM TUBE (DAIVOBET)
CALCIPOTRIOL SCALP SOLUTION 50 MCG/ML
30 ML BOTTLE (DAIVONEX)

HYDROQUINONE

Adverse Effects, Treatment, and Precautions


Topical hydroquinone may cause transient erythema and a mild burning sensation. High concentrations or prolonged
use may produce hyperpigmentation especially on areas of skin exposed to sunlight. Occasionally hypersensitivity

has occurred and some recommend skin testing before use. Hydroquinone should not be applied to abraded or
sunburnt skin. It should not be used to bleach eyelashes or eyebrows and contact with the eyes should be avoided as
it may produce staining and corneal opacities. The systemic effects of hydroquinone and their treatment are similar
to those of phenol but tremors and convulsions may also occur.

Uses and Administration


Hydroquinone increases melanin excretion from melanocytes and may also prevent its production. Hydroquinone is
used topically as a depigmenting agent for the skin in hyperpigmentation conditions such as chloasma (melasma),
freckles, and lentigines (small macules that resemble freckles). Concentrations of 2 to 4% are commonly used;
higher concentrations may be very irritant and increase the risk of ochronosis. It may be several weeks before any
effect is apparent but depigmentation may last for 2 to 6 months after discontinuation. Application of hydroquinone
should be discontinued if there is no improvement after 2 months. Hydroquinone should be applied twice daily only
to intact skin which should be protected from sunlight to reduce repigmentation. Hydroquinone preparations often
include a sunscreen or a sunblocking basis.
Hydroquinone is also used as an antoxidant for ether and in photographic developers.

Products
HYDROQUINONE CREAM 4 %
PHILAQUIN)

30 GM TUBE (ECLADERM, ELDOQUIN, FEDIQUIN,

METHOXSALEN
Psoralens
Mode of action
The therapeutic effect of UVA-activated psoralens for psoriasis probably involves binding to DNA and inhibition of
DNA synthesis, resulting in decreased cell proliferation. In the absence of UV light, psoralens are inert.
Indications
Photosensitizers before UVA phototherapy in the following conditions:
Marketed: Vitiligo
Accepted: Psoriasis, severe, refractory, disabling
Atopic eczema: Polymorphic light eruption
T cell lymphomas, e.g. mycosis fungoides
Contraindications
Conditions associated with photosensitivity, eg porphyria, xeroderma pigmentosum, lupus erythematosus; Aphakia
(increased risk of retinal damage due to lack of lenses); Cataracts; Melanoma, invasive squamous cell carcinoma.
Specific considerations
Treatment with photosensitising medications: increases risk of phototoxic and photoallergic reactions; avoid
combination.
Hepatic impairment: Use cautiously.
Children: Should not be used in children; safety not established.
Pregnancy: Avoid use; ADEC category B2.
Lactation: Avoid use; safety not established.
Adverse effects
Common: Oral psoralens, itch, nausea, erythema.
Infrequent: Oral, CNS effects (including nervousness, insomnia, depression).
Topical, contact allergy.
PUVA therapy
itch, mild transient erythema, oedema, vesiculation, bullae formation, onycholysis, acneiform eruptions,
hypertrichosis, pigmentation alterations, exacerbation of systemic lupus erythematosus
Long term effects, premature skin ageing, cutaneous carcinogenesis, cataract formation
Severe burns may result from overexposure to sunlight or UVA radiation.
Dosage
Oral, 0.6 mg/kg taken with milk or after food, 2 hours before UV light exposure.
Lotion, apply a 1:10 dilution of the 1% lotion (resulting in a 0.1% preparation) to affected areas 30 minutes before
UV light exposure.
Patient counselling
Do not sunbathe for 24 hours before and 48 hours after, PUVA therapy.
Most people have 2030 PUVA treatments.
After taking methoxsalen, avoid exposure to sunlight, even through glass and cloud cover, for at least 8 hours. After

application to the skin, exposure to sunlight should be avoided for at least 1248 hours. If exposure to sunlight
cannot be avoided, protective clothing should be worn and sunscreens applied to all areas that may be exposed,
including lips.
Wear wrap-around sunglasses with 100% UVA-absorbing properties during daylight for 24 hours after taking
methoxsalen, and after methoxsalen with UVA treatment, to avoid cataracts.
Certain foods contain natural photosensitisers, eg limes, figs, parsley, parsnips, mustard, carrots and celery; these
must be eaten sparingly, or avoided, while taking methoxsalen.
Practice points
PUVA treatments may be given 2 or 3 times a week, but must be at least

48 hours apart
never dispense the lotion for home use
if nausea occurs divide the oral dose in two and give 15 minutes apart
cataracts may occur in patients who fail to wear suitable eye protection for
24 hours after oral treatment
overexposure to sunlight or artificial UV emission after taking methoxsalen
may result in serious burning
ophthalmic examination, measurement of antinuclear antibody titre and hepatic
function should be performed before and every 12 months after, beginning of
treatment
examine skin for malignancy every 6 months, depending on dose and duration of
treatment
topical treatment results in more prolonged photosensitivity, greater
incidence of adverse effects and is less cosmetically acceptable than systemic
treatment
use of topical methoxsalen in psoriasis has largely been abandoned, except for
psoriasis of the hands and feet or localised chronic plaques
Products
METHOXSALEN CAPS 10 MG (OXSORALEN)
METHOXSALEN PAINT 0.03G/15ML (ULTRAMELADININE)

13.07 DRUGS FOR WARTS AND CALLUSES


WARTS
Warts are caused by human papilloma virus (HPV). Different HPV genotypes infect particular locations and only
some are associated with neoplasia. Warts are commonly classified according to location and morphology.
Cutaneous warts include common, flat, mosaic, plantar and palmar warts. Anogenital warts involve the vulva,
vagina, cervix, penis, scrotum, urethra and rectum. Extracutaneous warts include oral and laryngeal lesions.
Rationale for drug use
Eradicate warts.
Stop spread to other sites or people.
Reduce unwanted local effects.
Before starting treatment
Discuss the need to remove cutaneous warts only when they are a cosmetic problem or causing unwanted effects as
treatments are destructive and an immune response usually will remove the wart (30% disappear within 6 months
and most disappear within 3 years without treatment in immunocompetent individuals).
Note current and past treatments, both successful and unsuccessful, and complications including pain, scarring,
changes in pigmentation and extension of warts.
Consider possibility of adjacent mucous membrane involvement in patients with external anogenital warts; specialist
referral for anoscopy or colposcopy may be indicated.
Consider factors that may predispose to HPV infection, eg immunosuppression.
Assess pregnancy status; podophyllotoxin and podophyllum resin are contraindicated in pregnancy and imiquimod
should be avoided.
Encourage patients with anogenital warts to tell sexual partners and suggest they seek medical advice. Screening for
other STIs may also be appropriate.
When to start treatment

Unwanted local effects, eg itch, burning, bleeding or painful coitus associated with genital warts; tenderness
precluding weight bearing with plantar warts.
Cosmetic and psychosocial considerations.
Numerous and/or large warts.
Warts in immunocompromised patients, as may develop into squamous cell carcinomas.
Drug choice
There is no specific HPV antiviral and treatment relies on local tissue destruction or immune modification.
Cutaneous warts
Salicylic acid: treatment of choice; inexpensive and may be used at home; relatively safe with few complications. It
is irritant and not suitable for application to the face or broken skin; reduce frequency of application if discomfort
occurs. Use caution in diabetes and peripheral vascular disease.
Also available in combination with trichloracetic acid (Upton's paste) and lactic acid. The combination with lactic
acid has not been shown to be more effective than salicylic acid alone.
Glutaraldehyde: reserve for plantar warts; irritant and not suitable for application to face or broken skin; stains skin
brown; rarely used.
Podophyllum resin: available alone or in combination with salicylic acid; may cause severe systemic toxicity; use
under close supervision.
Anogenital warts
Podophyllotoxin: treatment of choice; available as a paint for self-treatment of external genital warts; irritant but low
systemic toxicity; compliance is important.
Imiquimod: modifies immune response; use for self-treatment of external genital warts; has the advantage of less
frequent application and few adverse effects; clearance rates similar to established treatments.
Other drug treatment
Monochloroacetic acid, formaldehyde, nitric acid and silver nitrate are rarely used for cutaneous warts. Retinoids,
intralesional bleomycin, interferon alfa or beta, contact immunotherapy, oral colchicine and cimetidine have been
used in the treatment of cutaneous and anogenital warts but there is insufficient evidence of efficacy. There is some
evidence of efficacy for topical fluorouracil but it is not superior to simpler treatments.
Non-drug treatment
Cryotherapy may be used for cutaneous and anogenital warts; multiple treatments required; painful (essentially
preventing use in children); contraindicated in patients with cold intolerance; may cause scarring, dyspigmentation,
infection and rarely, damage to underlying nerves.
Electrosurgery and curettage, blunt dissection, carbon dioxide laser are costly options for cutaneous and anogenital
warts without distinct advantages; may be tried if topical agents or cryotherapy fail.
Practice points
as some warts may regress spontaneously, no treatment may be an option
HPV persists after treatment and a degree of infectivity may remain even in

the absence of clinical lesions


patients with cutaneous warts should be advised about ways to reduce the
chance of spreading the infection (individual towels and avoiding skin
maceration)
plantar warts at pressure points should be treated with non-surgical methods
to reduce risk of painful scarring
in patients with diabetes, lesions may be best left untreated since poor
circulation may result in infection
specialist referral is required for oral, laryngeal, urethral, anorectal,
vaginal and cervical (especially if cervical dysplasia present on Pap smear)
warts
Anogenital warts
patients with warts should use condoms particularly with new sexual partners
as they protect against other STIs; however, condoms may only reduce the risk
of HPV transmission
HPV types that cause external visible warts are rarely associated with
cervical abnormalities that can cause cancer; women should have regular
cervical smears as part of the usual cervical screening program

SALICYLIC ACID
Mode of action
Keratolytic, weak antifungal and antibacterial actions.
Indications
Dandruff; Dermatitis; seborrhoeic; Ichthyosis; Psoriasis, Acne; Warts (cutaneous), corns and calluses; Fungal
infections.
Contraindications
Allergy to salicylic acid; Use on facial and anogenital warts, moles, birthmarks; Use on inflamed, broken or infected
skin; Use in intertriginous areas.
Specific considerations
Diabetes, peripheral vascular disease: acute inflammation or ulceration may occur, especially on feet.
Elderly: Age-related peripheral vascular disease makes acute inflammation and ulceration of the extremities more
likely.
Children: At increased risk of toxicity because of increased absorption and increased ratio of treated area to total
body surface area; lower threshold for skin irritation; do not use in neonates.
Pregnancy: Safe to use for warts; for other uses, contact specialised information service
Lactation: Safe to use for warts.
Adverse effects
Salicylate intoxication and death have resulted from the topical use of salicylic acid.
Factors that increase the risk of salicylate intoxication include age of patient, amount applied, frequency of
application and occlusion (either naturally in skin folds or as occlusive dressings).
Infrequent: skin irritation.
Rare: skin ulceration, erosion, salicylism (intoxication due to absorption; symptoms include confusion, dizziness,
headaches, rapid breathing, tinnitus).
Dosage
Psoriasis, seborrhoeic dermatitis affecting body: Apply cream or lotion in a thin layer to affected areas 23 times a
day.
Scalp psoriasis, dandruff, seborrhoeic dermatitis: Apply shampoo to wet hair and massage vigorously into scalp and
leave for at least 35 minutes; rinse hair thoroughly after shampooing; repeat twice a week.
Warts, corns, calluses: Before application, clean affected area, soak wart in warm water for 5 minutes, remove loose
tissue with a blade, pumice stone, cloth or emery board and dry thoroughly. Apply preparation to lesion only; contact
with adjacent tissue may be reduced by encircling lesion with soft paraffin or a bandage.
Apply solution or cream 12 times a day.
Acne: Cleansing bar, lotion, lather with warm water and rinse off 23 times a day.
Wipes, wipe pad over affected area 23 times a day; do not rinse after treatment.
Patient counselling
Avoid contact with eyes, mouth and other mucous membranes.
Wash hands immediately after applying medication, unless hands are being treated.
Solutions for the removal of warts should not be used near heat or open flame or while smoking; avoid inhalation of
vapours.
Practice points
keratolytic activity of salicylic acid potentiates effects of topical

corticosteroids, dithranol and tar by increasing their dermal penetration


cumulative irritant or drying effect with abrasive or medicated soaps or
cleansers, acne products, alcohol-containing preparations and medicated
cosmetics; avoid combinations if possible
to minimise systemic absorption following application, do not use for
prolonged periods, in high concentrations, on large areas of the body, or on
inflamed or broken skin
to remove thick, adherent scales in psoriasis, creams or lotions may be used
under occlusion overnight, eg using a plastic shower cap
to avoid excessive drying, begin acne treatment with a single application
daily and then, if necessary, increase frequency gradually; use cautiously
with other topical acne preparations

may be used with other agents such as coal tar (in eczema and psoriasis),
dithranol (in psoriasis), lactic acid, trichloracetic acid and podophyllum
resin (removal of warts)
there is a lack of substantial evidence that the combination of lactic acid
and salicylic acid is any more effective than salicylic acid alone in treating
warts
Products
SALICYLIC ACID 20 % + LACTIC ACID 5 % + POLIDOCANOL 2 % TOPICAL LOTION 10 ML
(COLLOMACK)

13.08 MISCELLANEOUS
B-SITOSTEROL
Indications
burns; chronic wounds (bed ulcers, diabetic foot, leg ulcers), surgical wounds; cracked heels, cracked nipples.

Products
B-SITOSTEROLE CREAM (30-75) GM TUBE (AVOMEB, MEBO)
CALAMINE
Calamine has mild astringent and antipruritic actions and is used as a dusting powder, cream, lotion, or ointment in a
variety of skin conditions although its value is uncertain.

Products
CALAMINE 15 %+ZINC OXIDE 5 % CREAM (VASOGEN)
CALAMINE 15 %+ZINC OXIDE 5 % LOTION
200 ML BOTTLE (AL RAZI CALAMIN)
DEPROTEINIZED DYALICATE
Mode of action
concentrated deproteinized calf blood extract with trophic and healing action. Containes nucleotides, nucleozides,
glycolipides, oligopeptides, aminoacids, essential microelements, electrolits and intermediar glucidic and lipidic
metabolism products. Stimulates ATP synthesis through the glucose and oxygen caption growth by special cells in
conditions of tissular hypoxia, accelerates regeneration of cut tissues, angiogenesis, revascularisation of
ischemizated tissues, colagen synthesis and plagues reepitelization.
Indications
atherosclerotic or diabetic angiopathy; cerebral, ischemic or haemorrhagic ictus, myocardium infarct, trophic ulcers,
decubitus, spread chemical and termic burns.
For ointment and gel - treatment of trenant plagues, burns, ulcers and venous insufficiency. It is applied around the
plague and on the newly formed epithelium at its boundaries. If the plague doesnt ooze anymore it is totally
covered with the ointment. On the ozeing part gel is applied.
For dental forms for topical treatment of mucosal lesions and denture pressure sores.
Contraindications
Hyper sensibility to the drug. Congestive cardiac insufficiency, lung edema, oliguria, anuria or hyper hydration.
Side effects
Allergic reaction (rash, pruritus, anaphylactic shock).
Dosage
250-500 ml i.v. or i.a. dayly or several times per week with the speed of 20-40 drops/min, in sum 10-20 perfusions.
For skin gel or ointment it is applied in a thin layer 2-3 times per day.
Patient counselling
In cases of bedsores apply gel until a scab emerges and then use ointment until the new skin surface appears. For
burns use either gel or ointment. Normal course of treatment depends on the body's healing process, but usually lasts
from 4 to 8 weeks. Use of the gel may irritate or burn the skin, but these side effects do not require interruption of
therapy.

Products
DEPROTEINIZED
DEPROTEINIZED
DEPROTEINIZED
DEPROTEINIZED

DYALICATE
DYALICATE
DYALICATE
DYALICATE

AMP 2-10 ML (SOLCOSERYL)


DENTAL PASTE 5 GM (SOLCOSERYL)
GEL (20-30) GM (SOLCOSERYL)
OINTMENT (20-30) GM (SOLCOSERYL)

EMOLLIENT CREAM AND OINTMENT

Products
EMOLLIENT CREAM
EMOLLIENT OINTMENT
HEPARIN + CEPAE EXTRACT + ALLENTOIN
Heparin: loosens the tissue structure. It has an anti-inflammatory effect and helps to bind water to the scar tissue.
Cepae extract: is obtained from onions. It generates an anti-inflammatory, bactericidal effect. And it reduces
swelling while preventing excessive growth of the connective tissue.
Allantoin: encourages wound healing and has a soothing effect. In older scars its most important effect is to
replenish and regulate the extreme lack of water in the scar tissue and to promote blood flow.
Indications
burns; chronic wounds, scars, surgical wounds.

Products
HEPARIN + CEPAE EXTRACT + ALLENTOIN GEL

50GM (CONTRATUBEX)

SODIUM STIBOGLUCONATE

Pharmacokinetics
The pentavalent antimony compounds are poorly absorbed from the gastrointestinal tract. After intravenous doses an
initial distribution phase is followed by biexponential elimination by the kidneys. The elimination half-life of the
initial phase is about 1.7 hours and that of the slow terminal phase is about 33 hours. The corresponding half-lives
after intramuscular doses are reported to be 2 hours and 766 hours respectively.Antimony has been detected in breast
milk

Uses and Administration


Pentavalent antimony, as sodium stibogluconate or meglumine antimonate, is used as first-line treatment for all
forms of leishmaniasis except Leishmania aethiopica infections.
For systemic use, sodium stibogluconate is given by intramuscular or intravenous injection as a solution containing
the equivalent of 100 mg of pentavalent antimony per mL. Intramuscular injection is generally preferable.
Intravenous injections must be administered very slowly (over at least 5 minutes) and preferably through a fine
needle to avoid thrombophlebitis; as with trivalent antimony compounds, they should be stopped immediately if
coughing, vomiting, or substernal pain occurs. Meglumine antimonate is given by deep intramuscular injection as a
solution containing the equivalent of 85 mg of pentavalent antimony per mL. Doses are expressed in terms of the
equivalent amount of pentavalent antimony.
Local variations exist in treatment schedules but WHO recommends the following regimens:
In visceral leishmaniasis, initial treatment is based on daily injection of pentavalent antimony 20 mg/kg to a
maximum of 850 mg for at least 20 days. The length of treatment varies from one endemic area to another, but is
continued until no parasites are detected in consecutive splenic aspirates taken at 14-day intervals. Patients who
relapse are re-treated at the same dose
Early non-inflamed lesions of cutaneous leishmaniasis due to all forms of Leishmania except L. aethiopica, L.
amazonensis, and L. braziliensis may be treated by infiltration with intralesional injections of 1 to 3 mL of sodium
stibogluconate or meglumine antimonate (approximately 100 to 300 mg of pentavalent antimony), repeated once or
twice if necessary at intervals of 1 to 2 days. Systemic therapy with pentavalent antimony 10 to 20 mg/kg daily is
given if the lesions are more severe and continued until a few days after clinical and parasitological cure is achieved.
Cutaneous leishmaniasis due to L. aethiopica is not responsive to antimonials at conventional doses. In cutaneous
leishmaniasis due to L. braziliensis, prolonged systemic treatment with pentavalent antimony 20 mg/kg daily for a
minimum of 4 weeks is indicated. Similar doses are required for diffuse cutaneous leishmaniasis due to L.
amazonensis and are continued for several months after clinical improvement occurs. Relapses should be expected
until immunity develops.

In mucocutaneous leishmaniasis, daily doses of pentavalent antimony 20 mg/kg are given for a minimum of 4
weeks; if the response is poor, 10 to 15 mg/kg may be given every 12 hours. Relapses are well known and have
generally been associated with inadequate or interrupted treatment; they are treated with the same drug given for at
least twice as long as the original treatment. Only when that fails should alternative treatment be given.

Contraindications
Allergy to sodium stibogluconate
Significant impairment of renal function

Adverse Effects, Treatment, and Precautions


Adverse effects are generally less frequent and less severe with the pentavalent antimony compounds sodium
stibogluconate and meglumine antimonate than with trivalent compounds such as antimony sodium tartrate.
Nevertheless, similar precautions should be observed, especially in patients on high-dose therapy.
Intramuscular injections of sodium stibogluconate can be painful and intravenous use has been associated with
thrombophlebitis.
Common side-effects of pentavalent antimony are anorexia, vomiting, nausea, malaise, arthralgia and myalgia,
headache, lethargy, and pancreatitis. ECG changes are dose-dependent and most commonly include T-wave
inversion and prolonged QT interval. Renal damage is a rarely reported toxic effect. Pentavalent antimony is usually
well tolerated. Serious side-effects when they occur usually involve the liver or the heart when it is prudent to
interrupt the course temporarily.
Breast feeding: The amount of antimony distributed into the breast milk of a patient given sodium stibogluconate
was considered not to constitute a hazard and oral absorption was not detected in an animal study.1 The American
Academy of Pediatrics also considers that the use of antimony is usually compatible with breast feeding. 2 Others,
however, have felt that more safety evaluation was required before antimony could be considered completely safe
during breast feeding

Table 1301 Comparison of Vehicles


Vehicle

Effect

Indications

Comments

Examples

ointments

occlusive
and
lubricating

dry, scaly skin

better topical penetration of


incorporated drugs than
creams and lotions; greasy,
difficult to wash off; may
cause folliculitis

soft paraffin, lanolin

creams

cooling and
lubricating

moist or dry skin; use


where a washable (nongreasy) and cosmetically
elegant vehicle is needed

preservatives can cause


sensitisation

cetomacrogol cream,
aqueous cream

lotions and drying and


solutions
cooling

hairy and intertriginous


regions; acute exudation

can be applied without friction calamine lotion, potassium


permanganate solution

pastes

drying and
protective

psoriasis, warts

more occlusive and


absorptive, less greasy than
ointments, reducing spreading
of active ingredient

Lassar's paste (zinc oxide


and salicylic acid), Upton's
paste (salicylic acid and
trichloracetic acid)

aerosols
and sprays

cooling

conditions in which direct


application is difficult or
painful

allow application without


touching skin

antifungals, eg miconazole
sprays, sunscreen spray for
hairy areas

Table 1302 Suggested Weekly Quantities of Topical Preparations


Age

Face &
neck

Arm &
hand

Leg &
foot

Trunk
(front)

Trunk (back incl.


buttocks)

36 months

7g

7g

10 g

7g

10 g

12 years

10 g

10 g

15 g

15 g

20 g

35 years

10 g

15 g

20 g

20 g

25 g

610 years

15 g

20 g

30 g

25 g

35 g

Adult & child


>10 years

20 g

30 g

55 g

50 g

50 g

Based on twice a day application for 1 week; for corticosteroids, calcipotriol and pimecrolimus do not exceed the
suggestions without specialist recommendation

Table 1303 Comparison Of Potency and Uses of Topical Corticosteroids


Corticosteroid

Examples of indications

mild
hydrocortisone (0.51%)

facial and flexural dermatitis and psoriasis; nappy dermatitis

hydrocortisone acetate (0.51%)


moderate
betamethasone valerate (0.02 &
0.05%)

mild-to-moderate atopic dermatitis, adjunctive treatment in extensive


psoriasis

triamcinolone acetonide (0.02%)


desonide (0.05%)
potent
betamethasone dipropionate (0.05%)

short term use in severe inflammatory dermatoses

betamethasone valerate (0.1%)


mometasone furoate (0.1%)

more severe conditions, eg discoid eczema

methylprednisolone aceponate (0.1%)


very potent
betamethasone dipropionate in an
optimised vehicle (0.05%)

severe eczema and psoriasis, eg refractory lichen simplex chronicus; also


useful for eczema of hands and feet, occlusion may be used but atrophy may
occur

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