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

Logo VERAHEXAL ™ 240 SR

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

VERAHEXAL ™ 240 SR
(slow release film coated tablets)

COMPOSITION
Each slow release film coated tablet contains
verapamil hydrochloride 240 mg

PHARMACOLOGICAL CLASSIFICATION
7.1 Vasodilators. Hypotensive medicines.

PHARMACOLOGICAL ACTION
Verapamil is a calcium channel blocker - it decreases the flow of calcium ions across the cell membranes of cardiac and of arterial smooth muscle cells.
Verapamil reduces the oxygen demand of the heart by intervening in the energy utilizing metabolic processes of the myocardial cells and also decreasing the total peripheral resistance.
Verapamil also prolongs impulse conduction in the AV node.

INDICATIONS
1. Mild to moderate hypertension.
2. Prophylaxis of angina pectoris
3. Supraventricular tachydysrrhythmia
4. Prophylaxis of supraventricular relapses after electrocardioversion

CONTRA-INDICATIONS
1. Hypersensitivity to verapamil or any of the ingredients of this preparation.
2. Hypotension associated with cardiogenic shock.
3. Heart failure.
4. Second or third degree AV block.
5. Myocardial infarction (acute stage).
6. Sick sinus syndrome.
7. Pregnancy: Verapamil does cross the placenta and should not be administered during pregnancy.
8. Breast feeding: Verapamil is excreted in the breast milk - discontinue breast feeding while taking verapamil.

WARNINGS
Heart failure: Because verapamil is a negative inotrope, congestive cardiac failure or pulmonary oedema may occur in susceptible patients.
Verapamil should not be administered to patients with severe left ventricular dysfunction or to patients with any degree of left ventricular dysfunction, should they be receiving a beta adrenergic blocking agent
Ideally patients with mild ventricular dysfunction should be treated with digitalis and / or diuretics, before treatment with verapamil.
Hypotension: Less frequently verapamil may induce symptomatic hypotension in normotensive patients. In hypertensive patients, decreases in blood pressure below normal values are unusual.
Elevated liver enzymes: Elevation of transaminases with and without concomitant elevations in alkaline phosphatases and bilirubin have been reported. Such elevations are usually transient.
Accessory bypass tract (Wolff - Parkinson - White or Lown - Ganong - Levine): After receiving intra-venous verapamil certain patients with paroxysmal and/or chronic atrial fibrillation or atrial flutter with a co-existing accessory AV pathway have developed an increased antegrade conduction across the accessory pathway leading to ventricular fibrillation.
Such patients receiving oral verapamil may be at risk.
AV-Block: Since verapamil slows down conduction at the AV node and has an effect on the SA node, asymptomatic first degree AV block and transient bradycardia may occur. PR interval prolongation is related to verapamil plasma concentrations. Significant first degree block and progressive development to second or third degree block may require reduction of dose or less frequently discontinuation of therapy.
Hypertrophic cardiac myopathies: Pulmonary oedema and/or severe hypotension, sinus bradycardia, AV block and sinus arrest may occur in these patients. Reducing the dose often reduces these side effects.

DOSAGE AND DIRECTIONS FOR USE:
Hypertension:
One tablet daily, preferably in the morning.
Should the desired response not be achieved within 7 days, the dose may be increased to 1 tablet in the morning and half a tablet in the evening. Maximum dose 1 tablet every 12 hours.
Angina pectoris and supraventricular dysrrhythmia:
Half to one tablet every 12 hours.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Constipation, headache, fatigue, palpitations, worsening heart failure, transient asystole, first and second degree AV block, bradycardia, SA block, dizziness, urticaria and temporary skin rash may occur, hypotension, flushing.
Some cases of abnormal liver function and hepatotoxicity have been reported.
Precautions
Impaired liver and kidney function: Verapamil is highly metabolized in the liver and is almost exclusively excreted via the urine. The dose of verapamil, should therefore, either be reduced or it should be administered with caution. These patients should be monitored for abnormal prolongation of the PR interval or other signs of overdosage.
Attenuated neuromuscular transmission: Verapamil decreases neuromuscular transmission in patients with Duchene's muscular dystrophy. The recovery from the neuromuscular blocking agent, verconium, is prolonged by verapamil.
Administer with caution.
Interactions
Beta blockers: This combination may lead to cumulative effects on heart rate, AV conduction etc. Monitor this combination carefully.
Digitalis: Verapamil increases serum concentrations of digitalis which can result in digitalis toxicity. The dosage of digitalis may have to be reduced or temporarily discontinued.
Antihypertensives: Additive hypotensives effects. The dose of other hypotensives may have to be lowered.
Disopyramide: This agent should not be administered 48 hours before or 24 hours after verapamil administration.
Flecainide: Additive effects on AV node conductivity, myocardial contractility and repolarisation, as well as on the negative inotropic effect.
Quinidine: This combination may lead to significant hypotension in patients suffering from hypertrophic cardiac myopathy. Verapamil may also lead to increased quinidine plasma levels. This combination should probably be avoided in the above mentioned patients.
Lithium: this combination may result in pharmacodynamic (increased sensitivity to the effects of lithium) or pharmacokinetic (lowered lithium serum levels) interactions. Monitor patients carefully.
Carbamazepine: Concomitant administration may lead to increased carbamazepine levels. Rifampicin: Rifampicin reduces the oral bioavailability of verapamil.
Phenobarbitone: May increase verapamil clearance.
Ciclosporin: Verapamil may increase levels of this drug.
Inhalation anaesthetics: May cause excessive cardiovascular depression. Neuromuscular blocking agents: Verapamil may potentiate the effects of these agents.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Bradycardia, hypotension, atrioventricular disassociation, hyperglycaemia. Treatment is supportive and symptomatic.

IDENTIFICATION
Oblong, slightly biconvex, light green coloured, film coated tablets with a smooth intact surface and scores on both sides.
Length: 19,0 - 19,4 mm
Width: 8,0 - 8,3 mm
Height: 6,2 - 6,6 mm

PRESENTATION
The tablets are packed into white opaque polypropylene securitainers containing 30 or 100 tablets each.

STORAGE INSTRUCTIONS
Store below 25°C and protect from light.
KEEP OUT OF THE REACH OF CHILDREN.

REGISTRATION NUMBER
31/7.1/0637

NAME AND ADDRESS OF THE APPLICANT
HEXAL Pharma (SA) (Pty) Ltd
46 Mahogany Road
Mahogany Ridge
Pinetown
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT.
04/2002

VERDP3        Pro-Print

New addition to this site: December 2004
Source: Community Pharmacy
Current: June 2006

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2006