VeraHexal 80 film coated tablets
(and dosage form):
VeraHexal 80 film coated tablets
Each film coated tablet contains 80 mg Verapamil Hydrochloride.
A 7.1 Vasodilators, hypotensive medicines.
Verapamil hydrochloride is a calcium-channel blocker with class IV anti-arrhythmic activity.
Verapamil hydrochloride may be used in the control of supraventricular tachyarrhythmias, in the management of classical and variant angina pectoris, and in the treatment of mild to moderate hypertension.
Hypersensitivity to Verapamil.
Hypotension, cardiogenic shock, marked bradycardia, second or third degree AV block in uncompensated heart failure, and sick-sinus syndrome.
Safety in pregnancy has not been established. Verapamil is excreted in breastmilk. Do not use in lactation.
Heart failure: Verapamil has a negative inotropic effect, which in most patients is compensated by its afterload reduction (decreased systemic vascular resistance) properties without a net impairment of ventricular performance.
Verapamil should be avoided in patients with severe left ventricular dysfunction (eg, ejection fraction less than 30%, pulmonary wedge pressure above 20 mm Hg, or severe symptoms of heart failure) and in patients with any degree of ventricular dysfunction if they are receiving a beta-adrenergic blocker. Patients with milder ventricular dysfunction should, if possible, be controlled with optimal doses of digitalis and/or diuretics before verapamil treatment.
Hypotension: Verapamil may produce symptomatic hypotension in normotensive patients.
Elevated liver enzymes: Elevation of transaminases with and without concomitant elevations in alkaline phosphatase and bilirubin have been reported.
Accessory bypass tract (Wolff-Parkinson-White or Lawn-Ganong-Levine): Some patients with paroxysmal and/or chronic atrial fibrillation or atrial flutter and a co-existing accessory AV pathway have developed an increased anterograde conduction across the accessory pathway bypassing the AV node, producing a very rapid ventricular response or ventricular fibrillation after receiving intravenous verapamil (or digitalis). Patients receiving oral verapamil may be at risk.
Atrioventricular block: The effect of verapamil on AV conduction and the SA node may lead to asymptomatic first degree AV block and transient bradycardia, sometimes accompanied by nodal escape rhythms. PR interval prolongation is correlated with verapamil concentrations, especially during the early titration phases of therapy. Marked first degree block or progressive development to second- or third-degree block, requires a reduction in dosage or, less frequently, discontinuation of the medicine.
Patients with hypertrophic cardiomyopathy: A variety of serious adverse effects can occur in patients with hypertrophic cardiomyopathy, - pulmonary oedema and/or severe hypotension, sinus bradycardia, AV block and sinus arrest.
DOSAGE AND DIRECTIONS FOR USE:
Supraventricular tachyarrthmias: 120 - 480 mg daily in divided doses, according to the severity of the condition and the patient's response.
Angina pectoris: 120 mg three times daily. Some patients with angina of effort may respond to 80 mg three times daily, but this lower dose is not likely to be effective in angina at rest or Prinzmetal's variant angina.
Hypertension: 160 mg twice daily, with a range of 240 - 480 mg daily.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Adverse effects related to verapamil's pharmacological effects on cardiac conduction can arise and may be particularly severe in patients with hypertrophic cardiomyopathies.
Adverse effects on the heart include bradycardia, AV block, worsening of heart failure and transient asystole.
The most troublesome non-cardiac adverse effect is constipation, with nausea being less frequently reported. Other effects include hypotension, dizziness, flushing and headaches. Some cases of abnormal liver function and hepatotoxicity have been reported.
Patients with impaired hepatic function: Verapamil is highly metabolised by the liver and should therefore be administered cautiously to patients with impaired hepatic function.
Severe hepatic dysfunction prolongs the elimination half-life of immediate-release verapamil to about 15 hours. Approximately 30% of the dose given to patients with normal liver function should be given to those patients.
Patients with attenuated neuromuscular transmission: It has been reported that verapamil decreases neuromuscular transmission in patients with Duchenne's muscular dystrophy, and that verapamil prolongs recovery from the neuromuscular blocking agent vecuronium. It may be necessary to decrease the dosage of verapamil whenit is administered to patients with attenuated neuromuscular transmission.
Patients with impaired renal function: About 70% of the administered dose of verapamil is excreted as metabolites in the urine. Verapamil is not removed by haemodialysis. It should be administered with caution to patients with impaired renal function and these patients should be monitored carefully.
Beta-blockers: Concomitant therapy with beta-adrenergic blockers and verapamil may result in additive negative effects on heart rate, AV conduction and/or cardiac contractility. The combination should only be used with caution and close monitoring.
Digitalis: Chronic verapamil can increase serum digoxin levels by 50% to 70% during the first week of therapy, and this can result in digitalis toxicity. Whenever digitalis toxicity is suspected the daily dose of digitalis should he reduced or temporarily discontinued.
Antihypertensive agents: Verapamil may intensity the blood pressure lowering effect of concomitantly administered antihypertensives and this often makes it possible to reduce the dose of the antihypertensives, particularly in patients on long term treatment with verapamil.
Disopyramide: No data is available on possible interactions between verapamil and disopyramide. It is recommended that disopyramide should not be administered 48 hours before or 24 hours after verapamil administration.
Flecainide: It has been reported that concomitant administration of flecainide and verapamil may have additive effects on myocardial contractility. AV node conduction and repolarisation. Concomitant therapy may also result in additive negative inotropic effects and prolongation of AV conduction
Quinidine: Concomitant use of verapamil and quinidine in patients with hypertrophic cardiomyopathy may result in significant hypotension.
Cimetidine: Concomitant use of verapamil and cimetidine may result in accumulation of verapamil as a result of inhibition of first pass metabolism. Caution and careful titration of verapamil is recommended on initiation of therapy.
Lithium: Pharmacodynamic and pharmacokinetic interactions between oral verapamil and lithium have been reported. Patients receiving both agents must be monitored carefully.
Carbamazepine: Verapamil may increase carbamazepine levels during combined therapy.
Rifampicin: Therapy with rifampicin may markedly reduce oral verapamil bioavailability.
Phenobarbitone: Phenobarbitone therapy may increase verapamil clearance.
Cyclosporin: Verapamil may increase serum levels of cyclosporin.
Inhalation Anaesthetics: When used concomitantly, inhalation anaesthetics and calcium antagonists should be titrated carefully to avoid excessive cardiovascular depression.
Neuromuscular Blocking Agents: Verapamil may potentiate the activity of the neuromuscular blocking agents (curare like and depolarizing). It may be necessary to decrease the dose of verapamil and/or the dose of the neuromuscular agent, when the medicines are used concomitantly.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions.
In oral overdosage the stomach should be emptied by lavage. Treatment of cardiovascular effects should be supportive and symptomatic.
White, round, biconvex film-coated tablet with score.
Polypropylene securitainers containing 100 tablets.
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
NAME AND ADDRESS OF THE APPLICANT:
Hexal Pharma (SA) (Pty) Ltd
101 Wang House
10 De Mazenod Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 1997 VERP1
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