CELIN

Manufacturer Distributor Contents Indications Pediatrica United Lab Vitamin C, zinc. Syrup: Prevention and treatment of deficiencies of vitamin C and zinc. Oral Drops: As a food supplement. Syrup: Children 9-13 years: Recommended Dose: 5-10 mL (1-2 teaspoon).4-8 years: Recommended Dose: 5 mL (1 teaspoon). 1-3 years:Recommended Dose: 2.5 mL ( teaspoon). Oral Drops: Children 1-2 years: Recommended Dose: 1 mL. 6-11 months:Recommended Dose: 0.5-1 mL. All doses to be taken orally, once daily. Missed Dose: In case of a missed dose, just give the next dose and the subsequent doses at the usual recommended schedule ie, once daily. Do not double the dose unless recommended by a physician. Syrup: Vitamin C: There is no information regarding overdosage of vitamin C. Oral Drops: Vitamin C: Prolonged intake of ascorbic acid (vitamin C) in excess of 2 g/day may lead to nausea, abdominal cramps, diarrhea and nose bleeds. Zinc: Rare occurrences of acute zinc poisoning has been reported. The toxicity signs observed after ingestion of high zinc doses (4-8 g) include nausea, vomiting, diarrhea, fever, metallic taste and lethargy (sleepiness). If the patient has taken more than the recommended dosage, consult a physician or contact a poison center right away.

Dosage & Administration

Overdosage

Contraindications Hypersensitivity to any of the excipients of Ceelin Plus. Adverse Drug Reactions Syrup: Vitamin C: Prolonged intake of ascorbic acid (vitamin C) in excess of 2 g/day may lead to nausea, abdominal cramps, diarrhea and nose bleeds. Oral Drops: Vitamin C: Vitamin C is usually well-tolerated. However, nausea, vomiting, heartburn, abdominal cramps, fatigue, flushing, insomnia and sleepiness have been reported with high doses (ie, 1 g daily). Zinc: Gastrointestinal adverse reactions eg, nausea and vomiting are seen with doses of elemental zinc >30 mg. Consult physician if any adverse reaction occurs. View ADR Monitoring Website

Drug Interactions The amounts of nutrients in Ceelin Plus are not expected to interact with food or medicines. Storage Description Store at temperatures not exceeding 25C. Keep container tightly closed. Syrup: Each 5 mL contains ascorbic acid (vitamin C) 100 mg and zinc sulfate monohydrate (equivalent to elemental zinc 10 mg) 27.44 mg. Oral Drops: Each mL contains the following ingredients: Sweetening agents, ascorbic acid, preservatives, zinc sulfate monohydrate, pH adjuster, thickener, flavor, colors and purified water. For nutrient information, see table as follows. Young children are growing rapidly and their immune system may not be fully developed. Hence, supplementation with vitamin C and zinc may be beneficial. Vitamin C and zinc together help the body's natural defense against damaging free radicals (antioxidant effect) and help boost immune function. Free radicals are highly reactive and unstable chemicals generated during normal body activities that require oxygen (eg, respiration, digestion, blood circulation, immune system response, increased physical activity, etc) and after exposure to ultraviolet light, cigarette smoke and various pollutants. One major effect of zinc is on the ability of cells to properly replicate the deoxyribonucleic acid (DNA), which is required for cells to multiply. Hence, zinc is needed for normal growth of infants and young children, cell renewal and cell repair.

Mechanism of Action

Vitamin C and zinc have other important functions particularly during the period of rapid growth. Vitamin C: The body's major water-soluble antioxidant which acts as 1st defense against free radicals in the aqueous (water) phase including blood, plasma and other intracellular and extracellular fluids. A cofactor of enzymes involved in the formation of collagen, the most abundant protein essential in the formation of bones, teeth, cartilage and skin. Collagen provides strength and elasticity to the skin and helps promote faster wound healing. Forms part of the body's natural immune system; it stimulates the activity of antibodies and immune cells which inhibit foreign antigens eg, bacteria and viruses that are harmful to the body. Zinc: Cofactor of various enzymes involved in cell division and growth. Required for the normal development and maintenance of the immune system; helps regulate the activity of cells involved in immune function. Functions as an antioxidant by being a cofactor of the enzyme superoxide dismutase which is involved in the removal of harmful free radicals. Oral Drops: Essential for skin integrity and wound healing; it promotes tissue repair by stimulating cell division through proper connective tissue formation. Vitamins &/or Minerals A11GB - Ascorbic acid (vitamin C), combinations ; Used as dietary supplements.

MIMS Class ATC Classification Regulatory Classification

Non-Rx

Presentation/Pac Syrup (yellow-colored, apple-flavored) 60 mL, 120 mL, 250 mL. Oral drops (yellow-green to yellow-orange, king apple-flavored) 15 mL, 30 mL.

Amoxicillin
Manufacturer Pediatrica Distributor Contents Indications United Lab Amoxicillin, clavulanic acid. For short-term treatment of bacterial infections at the following sites: Upper Respiratory Tract Infections (Including ENT): Tonsillitis, sinusitis, otitis media. Lower Respiratory Tract Infections: Acute and chronic bronchitis, pneumonia and lung abscess. Genitourinary Tract Infections: Cystitis, urethritis, pyelonephritis, female genital infections, septic abortion, pelvic or puerperal sepsis and intra-abdominal sepsis. Skin and Soft Tissue Infections: Furuncle, abscesses, cellulitis, wound infections. Dental Infection: Dentoalveolar abscess. Bone and Joint Infections: Osteomyelitis. Others: Septicemia, peritonitis, postsurgical infections.

Dosage & Susp 200 mg/28.5 mg/5 mL: Children >6 years with body weight 18-40 kg:Mild to Moderate Infections: 5-10 Administratio mL. Severe Infections: 10-20 mL. Children 1-6 years with body weight 10-18 kg: Mild to Moderate Infections: 2.5-5 n mL.Severe Infections: 5-10 mL. Children <1 year with body weight <10 kg: Mild, Moderate, Severe Infections: 2.5 mL. Susp 400 mg/57 mg/5 mL: Children >6 years with body weight 18-40 kg:Mild to Moderate Infections: 2.5-5 mL. Severe Infections: 5-10 mL. Children 1-6 years with body weight 10-18 kg: Mild to Moderate Infections: 2.5 mL.Severe Infections: 2.5-5 mL. Overdosage Problems of overdosage with Amoclav are unlikely to occur; if encountered, GI symptoms and disturbance of the fluid and electrolyte balances may be evident. They may be treated symptomatically with attention to the water electrolyte

balance. Amoclav may be removed from the circulation by hemodialysis. Contraindicat Penicillin hypersensitivity. ions Attention should be paid to possible cross-sensitivity with other -lactam antibiotics eg, cephalosporins. A previous history of Amoclav- or penicillin-associated jaundice/hepatic dysfunction. Special Precautions Changes in the liver function tests have been observed in some patients receiving Amoclav. The clinical significance of these changes is uncertain but Amoclav should be used with caution in patients with evidence of hepatic dysfunction. Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely. Signs and symptoms may not become apparent for up to 6 weeks after treatment has ceased. In patients with moderate or severe renal impairment, Amoclav dosage should be adjusted as recommended in the Dosage & Administration section. Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with history of penicillin hypersensitivity (see Contraindications). Erythematous rashes have been associated with glandular fever in patients receiving amoxicillin. Prolonged use may also occasionally result in overgrowth of nonsusceptible organisms. Amoclav suspensions contain 12.5 mg aspartame per 5-mL dose and therefore care should be taken in patients with phenylketonuria. During the administration of high doses of Amoclav, adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria. When present at high concentrations in urine at room temperature, amoxicillin may precipitate in bladder catheters. A regular check on patency should be maintained. Use in pregnancy & lactation: Reproduction studies in animals (mice and rats) with orally and parenterally administered Amoclav have shown no teratogenic effects. There is limited experience of the use of Amoclav in human pregnancy. As with all medicines, use should be avoided in pregnancy, especially during the 1st trimester, unless considered essential by the physician. Amoclav may be administered during the period of lactation. With the exception of the risk of sensitization, associated with the excretion of trace quantities in breast milk, there are no detrimental effects for the infant. Side effects, as with amoxicillin, are uncommon and mainly of mild and transitory nature. Diarrhea, indigestion, nausea, vomiting, pseudomembranous colitis and candidiasis have been reported. Nausea, although uncommon, is more often associated with higher oral dosages. If GI side effects occur with oral therapy, they may be reduced by taking Amoclav at the start of meals. A moderate rise in AST and/or ALT has been noted in patients in semisynthetic penicillins but the significance of these findings is unknown. Hepatitis and cholestatic jaundice have been reported rarely with Amoclav. They may, however, be severe and continue for several months. They are reported as occurring predominantly in adult or elderly patients and slight more frequently in males. Signs and symptoms may occur during treatment but are more frequently reported after cessation of therapy with a delay of up to 6 weeks. The hepatic events are usually reversible. However, in extremely rare circumstances, deaths have been reported. These have almost always been cases associated with serious underlying disease or concomitant medications. Phlebitis at the site of injection has also been reported. Urticarial and erythematous rashes sometimes occur. Rarely, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and exfoliative dermatitis have been reported. Treatment should be discontinued if one of these types of rashes appears. In common with other -lactam antibiotics, angioedema and anaphylaxis have been reported. Interstitial nephritis can occur rarely. As with other antibiotics, the incidence of gastrointestinal side effects may be raised in children <2 years. In clinical trials, however, only 4% of children <2 years were withdrawn from treatment. As with other -lactams, transient leukopenia, thrombocytopenia and hemolytic anemia have been reported rarely. Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Amoclav. Amoclav should be used with care in patients on anticoagulant therapy. In common with other broad-spectrum antibiotics, Amoclav may reduce the efficacy of oral contraceptives and patients should be warned accordingly. Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility)

Side Effects

Drug Interactions

Pregnancy Category

(US FDA)

that was not confirmed in controlled studies in women in the 1 trimester (and there is no evidence of a risk in later trimesters). Store in a dry place at or below 25C. Once reconstituted, Amoclav suspension must be stored in a refrigerator (but not frozen) and used within 7 days. Each 5 mL of the 228.5- and 457-mg suspension contains amoxicillin 200 and 400 mg and clavulanic acid 28.5 and 57 mg, respectively. Amoclav do not contain sucrose, tartrazine or any other azo dyes. Amoclav is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. Resistance to many antibiotics is caused by bacterial enzymes which destroy the antibiotic before it can act on the pathogen. The clavulanate in Amoclav anticipates the defense mechanism by blocking the -lactamase enzymes, thus rendering the organisms sensitive to amoxicillin's rapid bactericidal effect at concentrations readily attainable in the body. The -lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms, including many resistant to other -lactam antibiotics. Microbiology: Amoclav is bactericidal to a wide range of organisms, including: Gram-Positive Aerobes: Enterococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, *Staphylococcus aureus, *coagulase-negative staphylococci (including Staphylococcus epidermidis),Corynebacterium sp, Bacillus anthracis, Listeria monocytogenes. Gram-Positive Anaerobes: Clostridium and Peptococcus spp, Peptostreptococcus. Gram-Negative Aerobes: *Haemophilus influenzae, *Escherichia coli, *Proteus mirabilis, *Proteus vulgaris, *Klebsiella sp, *Moraxella catarrhalis, *Salmonella and *Shigella spp, Bordetella pertussis, Brucella sp, *Neisseria gonorrhoeae, Neisseria meningitidis, Vibrio cholerae, Pasteurella multocida. Gram-Negative Anaerobes: *Bacteroides sp, including B. fragilis. *Including -lactamase-producing strains resistant to ampicillin and amoxicillin. Pharmacokinetics: The pharmacokinetics of the 2 components of Amoclav are closely matched. Peak serum levels of both occur about 1-2.5 hrs after oral administration. Absorption of oral Amoclav is optimized at the start of meal. Both clavulanate and amoxicillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage of Amoclav approximately doubles the serum levels achieved. Penicillins

st

Storage

Description

Mechanism of Action

MIMS Class

ATC J01CR02 - amoxicillin and enzyme inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase Classification inhibitors. Used in the systemic treatment of infections. Regulatory Rx Classification Presentation/ Oral susp 200 mg/28.5 mg/5 mL x 70 mL. 400 mg/57 mg/5 mL x 35 mL, 70 mL. Packing

SALBUTAMOL
Manufacturer Pediatrica

Distributor

Pediatrica

Contents

Salbutamol sulfate.

Indications

Prevention and relief of bronchospasm associated with reversible obstructive airway diseases eg, bronchial asthma. Pulmoneb: Treatment of acute exacerbations of asthma.

Dosage & Administration

Syrup: Adults and Children >12 years: 5-10 mL (1-2 tsp). Children 7-12 years: 5 mL (1 tsp); 2-6 years: 2.5-5 mL (1 tsp); <2 years: As prescribed by a physician. To be taken orally every 6 or 8 hrs. Pulmoneb: Adults and Children: 2.5-5 mg as needed every 6-8 hrs. To be administered via a nebulizer.

Overdosage

Symptoms: Hypokalemia has also been reported; thus, plasma potassium concentrations should be monitored. Syrup: Extensions of the common adverse effects (eg, angina, arrhythmias, palpitation, tachycardia, nervousness, dizziness, tremor, seizures, insomnias/sleeplessness, headache, fatigue, malaise, dry mouth and nausea). Pulmoneb: Extensions of the common adverse effects (eg, tremors, seizure, nervousness, dizziness, headache, sleeplessness/insomnia, hypertension or hypotension, palpitation, tachycardia, arrhythmia, angina, dry mouth, nausea, fatigue, and malaise). Excessive use of oral sympathomimetic inhalations may result in cardiac arrest and even fatalities. Treatment: Discontinue salbutamol and institute appropriate symptomatic therapy in cases of salbutamol overdosage. Administration of a -adrenergic blocking agent may be appropriate, but use with caution if the patient is asthmatic. Pulmoneb: There is no adequate evidence to support the use of dialysis in the treatment of salbutamol overdose.

Contraindicatio Hypersensitivity to salbutamol or to any of the ingredients of Asmalin. ns

Warnings

Syrup: The bronchodilator effect of each administration of salbutamol syrup lasts for at least 6 hrs. If a previously effective dose fails to provide the usual relief or the usual duration of action is reduced, consult a physician for medical advice as this is a sign of worsening of asthma that would require reassessment of therapy. Pulmoneb: If a previously effective dose fails to provide the usual relief or the usual duration of action is reduced, consult a physician for medical advice as this is a sign of worsening of asthma that would require re-assessment of therapy. Excessive use of sympathomimetic oral inhalations has been associated with fatalities in asthmatic patients. The exact cause of death is unknown but cardiac arrest following severe, acute asthmatic crisis and hypoxia is suspected. Paradoxical bronchospasm, a potentially life-threatening event, may occur with the 1st use of a new ampule. If it occurs, discontinue salbutamol immediately and institute alternative therapy. Immediate hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis and oropharyngeal edema may occur rarely after administration of Asmalin.

Special Precautions

Use with caution in patients with the following conditions: Cardiovascular disorders including coronary insufficiency, cardiac arrhythmias or hypertension; convulsive disorders; hyperthyroidism; diabetes mellitus; patients who are unusually responsive to sympathomimetic amines. Use with caution in acute severe asthma where concomitant therapy with steroid, xanthine derivatives or diuretics, and by hypoxia may result in hypokalemia; plasma potassium concentrations should be monitored in severe asthma. Pulmoneb: Patients should be advised that increased blood glucose has occurred after inhalation of salbutamol via nebulization of higher than recommended (ie, 5-10 mg) doses of salbutamol. Therapy with salbutamol and other 2-agonists may decrease plasma potassium concentration possibly through intracellular shunting resulting in cardiovascular adverse effects eg, palpitation. Use in pregnancy: There have been reports of congenital anomalies (eg, cleft palate and limb defects) in children of patients treated with salbutamol. Some of the mothers, however, were receiving various medications in the course of their pregnancies. Since there is no consistent pattern of congenital abnormality development, a relationship

between the use of salbutamol and the development of congenital anomalies cannot be established. Therefore, salbutamol should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Use in lactation: Salbutamol may be secreted in breast milk. Therefore, do not administer to breastfeeding women unless, in the opinion of a physician, the potential benefits of salbutamol justify the possible risk.

Adverse Drug Reactions

Syrup: The most frequent adverse reactions of salbutamol in adults and older children are tremors (particularly the hands), nervousness and shakiness. Other reported reactions are headache, dizziness, hyperactivity and excitement, tachycardia, palpitation, peripheral vasodilation, epistaxis, cough, increased appetite, epigastric pain or stomachache, insomnia/sleeplessness, weakness, and rarely muscle cramps. The following adverse effects are noted in young children: Excitement, nervousness, hyperkinesia, sleeplessness, emotional lability, fatigue, tachycardia, pallor, gastrointestinal symptoms and conjunctivitis. Erythema multiforme or Stevens-Johnson syndrome has been reported rarely with administration of oral salbutamol in children. Potentially serious hypokalemia has also been reported. Cases of urticaria, angioedema, rash, anaphylaxis, paradoxical bronchospasm, oropharyngeal edema and arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) have also been noted after the use of oral salbutamol. Salbutamol, like other sympathomimetic agents, can also cause CNS stimulation, angina, nausea, unusual taste, and drying or irritation of the oropharynx. Pulmoneb: Tremors (particularly the hands), nervousness, dizziness, headache, sleeplessness/insomnia, tachycardia, palpitations, chest pain, hypertension, peripheral vasodilation, increased coughing, wheezing, asthma exacerbation, bronchitis, nasal congestion, rhinitis, pharyngitis, sinusitis, viral infection, increased hemoptysis in patients with preexisting hemoptysis, hoarseness, otitis media, nausea, vomiting, diarrhea, hypertonia, asthenia, back pain, fever, lymphadenopathy, and rarely, muscle cramps have been observed after administration of nebulized salbutamol. Potentially serious hypokalemia has also been reported. Hypersensitivity reactions (eg, urticaria, angioedema, rash, bronchospasm, anaphylaxis, oropharyngeal edema, hypotension and collapse) and arrhythmias (eg, atrial fibrillation, supraventricular tachycardia and extrasystoles) have also been noted after the use of orally inhaled salbutamol. Salbutamol, like other sympathomimetic agents, can also cause angina, vertigo, CNS stimulation, paradoxical bronchospasm and dry mouth. View ADR Monitoring Website

Drug Interactions

Do not use salbutamol together with other sympathomimetic oral/aerosol bronchodilators or epinephrine. Administer with caution additional adrenergic drugs by any route to patients using salbutamol to avoid deleterious cardiovascular effects. Concurrent administration with MAOIs (eg, phenelzine) or tricyclic antidepressants (eg, amitriptyline, imipramine, nortriptyline, doxepin) may increase the risk for cardiac arrhythmia, tachycardia, and increased or decreased blood pressure. Do not administer salbutamol and -receptor blockers (eg, propranolol, atenolol, metoprolol) at the same time since they inhibit each other's effect. Pulmoneb: The combination of nebulized salbutamol and nebulized anticholinergic has been reported to precipitate acute angle-closure glaucoma and therefore should be used with caution in patients with actual or potential glaucoma.

Pregnancy Category (US FDA)

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Caution For Usage

Pulmoneb: Directions for Use: Asmalin Pulmoneb must only be used in a nebulizer for inhalation. Read the manufacturer's instructions on how to use the nebulizer before using Asmalin Pulmoneb.

Prepare the nebulizer for use. Remove the pulmoneb from the labeled strip by twisting and pulling. Hold the pulmoneb upright and twist off the cap. Transfer the content to the reservoir of the nebulizer. If dilution is required, use only sterile normal saline as directed by the physician. Use the nebulizer, as instructed by the manufacturer. After use, discard any remaining solution. Thoroughly clean the nebulizer. Patient Information: Administer in a well-ventilated area. Do not mix the solution with other medicines, unless instructed to do so by the physician. Do not allow the solution for nebulization or the mist to come into contact with the eyes. If a dose was missed, do not take a double dose.

Storage

Syrup: Store at temperatures not exceeding 30C. Always keep the container tightly closed. Pulmoneb: Store at temperatures not exceeding 25C. Protect from light.

Description

Syrup: Each 5 mL (1 tsp) contains salbutamol sulfate 2 mg. It uses TasteRite technology which is a unique taste masking system developed specifically for liquid dosage forms. This technology significantly reduces the bitterness of medicine so that children taste the flavor and not the medicine. Pulmoneb: Each mL of solution for inhalation contains salbutamol sulfate 1 mg. Pharmacology: Pharmacodynamics: Salbutamol is a selective short-acting 2-adrenergic agonist with preferential effect on 2-adrenergic receptors found in the respiratory tract. It stimulates adenyl cyclase, the enzyme which catalyzes the conversion of adenosine triphospate (ATP) to cyclic-3',5'-adenosine monophospate (cAMP). cAMP mediates cellular responses eg, bronchial smooth muscle relaxation resulting in bronchodilation. Pharmacokinetics: Syrup: Salbutamol is readily absorbed from the GIT after oral administration. Salbutamol's onset of action is within 30 min, peaks in 2-3 hrs after the dose, and persists for 6 hrs. The plasma t of salbutamol is from 4-6 hrs. It is extensively metabolized in the liver, being converted to salbutamol 4' O-sulfate. Salbutamol and its metabolites are rapidly excreted in urine and feces. After an oral administration of salbutamol to healthy individuals, about 75% of a single dose is excreted in urine within 72 hrs, mainly as the major metabolite; about 4% of the dose is excreted in feces. Pulmoneb: Onset of bronchodilation is within 5 min after nebulization with salbutamol, peaks in 1-2 hrs, and persists for 3-4 hrs. Bronchodilation generally persist up to 6 hrs or longer. After inhalation of nebulized salbutamol, <20% of salbutamol is absorbed in the lungs. The remaining amount is retained in the nebulizer and recovered in expired air. Much of the salbutamol dose delivered by oral inhalation is deposited on the buccal mucosa and subsequently swallowed and absorbed from the GIT. Salbutamol is metabolized in the liver, being converted to salbutamol 4'-O-sulfate. This is then excreted in the urine and feces. In patients with asthma, about 70% of the inhaled dose is excreted in urine as unchanged drug and metabolites within 24 hrs, and 80-100% within 72 hrs. About 30% of the inhaled dose is excreted unchanged in the urine in 24 hrs. About 10% of the inhaled dose may be excreted in the feces. Animal studies show that salbutamol can cross the blood-brain barrier and the placenta. It may be secreted in breast milk but the concentrations are not known.

Mechanism of Action

MIMS Class

Antiasthmatic & COPD Preparations

ATC Classification

R03AC02 - salbutamol ; Belongs to the class of adrenergic inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.

Regulatory Classification

Rx

DIATAB.
Manufacturer United Lab

Distributor

Biomedis

Contents

Loperamide HCl

Indications

Symptomatic control of acute & chronic diarrhea. Ileostomy. Adult Acute diarrhea 2 cap followed by 1 cap after each unformed stool. Do not use for >5 days. Chronic diarrhea 2 cap then adjust dose until 1-2 solid stools/day are obtained. Max: 16 mg/day.

Dosage

Administration

May be taken with or without food.

Contraindications

Constipation. Acute ulcerative colitis, pseudomembranous colitis, acute dysentery.

Special Precautions Hepatic dysfunction, persistent diarrhea, patients receiving anti-infectives. Pregnancy & lactation. Childn <12 yr.

Adverse Drug Reactions

Constipation, nausea, vomiting, tiredness, drowsiness or dizziness, dry mouth. View ADR Monitoring Website

Pregnancy Category B: Either animal-reproduction studies have not demonstrated a foetal Category (US FDA) risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was st not confirmed in controlled studies in women in the 1 trimester (and there is no evidence of a risk in later trimesters).

MIMS Class

Antidiarrheals

ATC Classification

A07DA03 - loperamide ; Belongs to the class of antipropulsives. Used in the treatment of diarrhea.

Regulatory Classification

Non-Rx

MIMS Class

Antidiarrheals

ATC Classification

A07FA01 - lactic acid producing organisms ; Belongs to the class of antidiarrheal microorganisms. Used in the treatment of diarrhea.

Regulatory Classification

Rx

Presentation/Packing Oral soln 2 billion x 5 mL x 10's.

Pharex
Manufacturer Pascual

Distributor

Zuellig

Marketer

Pharex

Contents

Vit B1 100 mg, vit B12 50 mcg, vit B6 5 mg Vit B-complex deficiencies; neuritis, polyneuritis, diabetic neuritis, neuralgia, lumbalgia, sciatica, intercostal & trigeminal neuralgia, peripheral neuroparalysis, arthralgia & myalgia.

Indications

Dosage

1-2 tab daily.

Administration

May be taken with or without food: May be taken w/ meals to reduce GI discomfort.

MIMS Class

Vitamin B-Complex / with C

ATC Classification

A11DB - Vitamin B1 in combination with vitamin B6 and/or vitamin B12 ; Used as dietary supplements.

Regulatory Classification

Non-Rx