INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ISOPTIN® 80 mg FILM-COATED TABLETS

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

ISOPTIN® 80 mg FILM-COATED TABLETS

COMPOSITION:
Each film-coated tablet contains 80 mg
verapamil hydrochloride.

PHARMACOLOGICAL CLASSIFICATION:
7.1.4 Vasodilators - Coronary and other medicines used in Angina pectoris.

PHARMACOLOGICAL ACTION:
The calcium antagonist verapamil reduces myocardial oxygen consumption in vitro directly by intervening in the energy consuming metabolic processes of the myocardial cell, and indirectly by diminishing the peripheral resistance (afterload).
It prolongs impulse conduction in the AV node.

INDICATIONS:
Angina pectoris (acute and chronic coronary insufficiency), supraventricular tachydysrhythmia.

CONTRA-INDICATIONS:
Retarded AV conduction (second and third degree AV block), acute stage of myocardial infarction, sick-sinus syndrome.

DOSAGE AND DIRECTIONS FOR USE:
The doses of ISOPTIN as prescribed by the physician are to be taken regularly, preferably half an hour before meals together with some liquid. The average daily dose is 120 mg –360 mg in three divided doses where possible.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
As ISOPTIN inhibits AV conduction, it may cause AV block, ISOPTIN may also lead to a transient decrease in blood pressure, even in normotensive patients.
Constipation, headache, fatigue, palpitations, 1st and 2nd degree AV block, SA block, epigastric pain, flush, dizziness, urticaria and temporary skin rash may occur. Reversible increase of transaminases and/or alkaline phosphatase has been observed and is most probably a response to allergic hepatitis.
Reports of individuals experiencing exacerbation of arthritis, increased urination, burning sensations of the gums, mild tremor and severe facial pain are known.
Where heart failure is present, full compensation with cardiac glycosides must be achieved before the administration of ISOPTIN.
In patients with diminished hepatic function (parenchymal loss/reduced blood supply) the effect of ISOPTIN is intensified and prolonged depending on the severity of the disease due to impaired drug metabolism. In these cases dosage should be adjusted with special care.
In atrial fibrillation and simultaneous WPW syndrome there is a risk of precipitating ventricular fibrillation.
Safety in pregnancy has not been established.
Interactions:
During the simultaneous administration of ISOPTIN and drugs with cardio-depressive effect and/or inhibiting effect on atrioventricular conduction (e.g. Beta-adrenergic blockers), the patients should be observed for additive effects.
ISOPTIN may intensify the blood pressure lowering effect of antihypertensives, and this makes it often possible to reduce the dose of antihypertensives, particularly in patients on long-term treatment with ISOPTIN.
Rises in digoxin plasma levels under concomitant administration of ISOPTIN have been reported. However, extensive experience indicates that this possible interaction is of only slight clinical relevance. Physicians should be alert for symptoms of possible digitalis intoxication.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Cardiac arrest: External cardiac massage, artificial respiration, ECG for differentiating between asystolia and ventricular fibrillation; then appropriate intensive measures, such as defibrillation or pacemaker therapy, as required.
Second and third degree AV block: Atropine, isoproterenol, if necessary pacemaker therapy.
Development of myocardial insufficiency: Dopamine, dobutamine, cardiac glycosides or calcium.
Hypotension: Proper positioning, dopamine, dobutamine, norepinephrine.

IDENTIFICATION:
White, biconvex film-coated tablets. Embossed with “Isoptin 80”on one side and “Knoll”on other side.

PRESENTATION:
50 and 250 dragées of ISOPTIN 80 mg (glass bottles).
100 Blisters

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C) dry place.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
D/7.1.4/118.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Knoll Pharmaceuticals South Africa (Pty) Ltd.
P.O. Box 3030
Halfway House
1685.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 September 1990
                                        989 003
                        Jumbo Press

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