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Dilzem
(Diltiazem HCI}
DESCRIPTION
The therapeutic benefrts achieved wrth diltiazem
are believed to be related to its ability to Inhibit
the influx of calcium ions during membrane
depolarization of cardiac and vascular smooth
muscle.
Mechanism of Acllon:
Although precise mechanisms ol its anti-anginal
acting nitrates.
SPECIAL POPULATIONS
Uoeln Ronal impairment There are no avaHable
data concerning dosage reqUirements in patients
with Impaired renal function. If the drug must be
intervals.
CONTRAINDICATIONS
pecernel<er,
with hypotension (less than 90 mm Hg systolic),
wrth acute myocardoallnlarc1Jon,
transplantation.
POSOLOGY AND METHOD OF
ADMINISTRATION
lachemlc Heart Olseaae: (Exertlonal Ang1na
Pectons Due to Atherosclerotic Coronary Artery
Anesthetics: The depression of cardiac contractiiHy, conductivity, and autO<naticity as well as the
vascular dilation associated with anesthetics may
be potentiated by calcium channel blockers.
were:
MedORA System
Organ Class
Undesirable Effects
Nervous system
disorders
headache (4.5%),
diZziness (3.4%)
Cardiac dtsorders
Vascular disorders
flushing (1.7%)
Gastrointestinal
disorders
Skin and
subcutaneous tissue
nausea (1.6%)
MusculoskErietal,
joint sweMtng
connective tissue
and bone disorders
General d isorders
and administration
site conditions
Undesirable Effects
Organ ClaiS
Metabolism and
anorexia, hypergtycaemla
Psychiatric disorders
confusional state,
depressk>n, hallucination,
insomna. nervousness,
personaiHy change, sleep
disorder
Nervous system
disorders
amnesia, paresthesla,
Eye disorders
Ear and labyrinth
nutrition disorders
somnolence, syncope,
tremor
disorders
PREGNANCY AND LACTATION
Pregnancy: There are no adequate, well-controlled
studies in pregnant women; therefore, dihiazem
Should be administered to pregnant women only
if the potential benefit to the patient justifies any
risk to the patient and fetus.
lactation: Diltiazem is excreted in human breast
milk. One report suggests that concentrations in
breast milk may approximate serum levels.
Therefore, alternative methods of infant feeding
should be instituted.
MedORA System
Organ Clau
Gastrointestinal
Undeslrabte Effects
gmgiVal hyperplaSia
disorders
Skin and subcutaneous acute generalized
exanthematous pustulosts
bssue disorders
OVERDOSE
Over dosage experience with oral Oilzem has
been limited. Single oral doses of 300 mg have
been well tolerated by heanhy volunteers. In the
event of overdosage or exaggerated response,
appropriate supportive medical care should be
employed in addibon to gastric lavage.
disorders
lllsh(1.5%)
Cardiac disorders
angina pectoris,
arrhythmia, atrioventricular
block, cardiac failure
con~tiv8, e~ra systoles,
palpitations, stnus arrest,
tachycardia
Vascular disorders
hypotension
Respiratory, thoracic,
and mediastinal
dyspnoea, epistaxis,
nasal congestion
disorders
Gastrointestinal
disorders
constipation, diarrhea,
dyspepsia, vomiting,
Hepato-biliaty
granulomatous lfver
disease
disorders
Skin and
subcutaneous tissue
disorders
angioedema, el)'1hema
mulbforme, petechiae,
pruritus. photosensltMty
reaction , stevens-johnson
MedORA Syatem
Organ Class
Undesirable
Effects
Nervous system
disorders
headache (8%),
diuiness (6%)
Caroiac disorders
atrioventricular bkx:k
first degree (3%). sinus
bradycardia" (3%)
Vascular dtsorders
flushing (3%)
General disorders
and administration
asthenia (5%),
oedema (9%)
site condibons
;JJ.;}
necrotysis, urticana
UNDESIRABLE EFFECTS
Musculoskeletal.
connective tissue
and booe disorders
arthralgia, musculo9keletal
pain, myalgia
nocturia, polyuria
disorders
Reproductive system
and breast disorders
gynaecomastia, sexual
dysfunction
alanine aminotransferase
increased. aspartate
aminotransferase
increased, blood creatine
phosphoktnase increased,
btood alkaline phosphatase
increased, blood laclate
dehydrogenase increased.
weight Ulcreased
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Manufactured by:
Pfizer Pakistan ltd.
B-2, S.I.T.E., Karachi, Pakistan .