Generic Name: VERAPAMIL HYDROCHLORIDE

Brand Name: VERAPAMIL HYDROCHLORIDE SR

Active ingredients: VERAPAMIL HYDROCHLORIDE

COMPOSITION: Each slow release tablet contains 240 mg verapamil hydrochloride.

IDENTIFICATION: Yellow capsule-shaped tablet scored.

PHARMACOLOGICAL ACTION:
Verapamil is a calcium ion influx inhibitor (slow, channel blocker or slow calcium ion antagonist) which exerts its pharmacological effects by modulating the influx of ionic calcium across cell membranes of the arterial smooth muscle as well as in conductile and contractile myocardial cells. 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, mild to moderate hypertension, supraventricular tachydysrhythmia.
Prophylaxis of supraventricular relapses after electrocardioversion.


WARNINGS:
Heart Failure: Verapamil has a negative inotropic effect which, in most patients, is compensated by its after load reduction (decreased systemic vascular resistance) properties without a net impairment of ventricular performance. Verapamil should be avoided in patients with severe left ventricular dysfunction 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 Lown-Ganong-Levine): Some patients with paroxysmal and/or chronic atrial fibrillation or atrial flutter and a coexisting 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. 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 plasma concentration, especially during the early titration phases of therapy. Marked first-degree block or progressive development to second or third-degree AV block requires a reduction in dosage or, in some instances, discontinuation of the medicine.
Patients with hypertrophic cardiomyopathy (HSS): 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:
The doses as prescribed by the doctor are to be taken regularly. The tablets  are to be swallowed whole with some liquid, preferable with or shortly after meals.

Angina pectoris and supraventricular dysrhythmia: Half to one tablet every 12 hours.
Hypertension: One tablet per day (preferably in the morning).
If the desired response is not obtained in 7 days, the dose may be increased to one tablet in the morning, and half a tablet at night. The maximum recommended dose is one tablet every 12 hours.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Constipation, headache, fatigue, palpitations, first and second degree AV block, SA block, epigastric pain, flush, dizziness, urticaria and temporary skin rash may occur. Reports of individuals experiencing exacerbation of arthritis, increased urination, burning sensations of the gums, mild tremor and severe facial pain are known.
Use in patients with impaired hepatic function: Since verapamil is highly metabolised by the liver, it should be administered cautiously to patients with impaired hepatic function. Severe liver dysfunction prolongs the elimination half-life of immediate-release verapamil to about 15 hours; hence, approximately 30% of the dose given to patients with normal liver function should be administered to these patients. Careful monitoring for abnormal prolongation of the PR interval or other signs of excessive pharmacological effects should be carried out.
Use in 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 when it is administered to patients with attenuated neuromuscular transmission.
Use in patients with impaired renal function: About 70 % of an administered dose of verapamil is excreted as metabolites in the urine. Verapamil is not removed by haemodialysis. Until further data are available, it should be administered cautiously to patients with impaired renal function. These patients should be carefully monitored for abnormal prolongation of the PR interval or other signs of overdosage.

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


STORAGE INSTRUCTIONS:
Store at room temperature (below 25°C) protect from light and moisture.Keep out of reach of children.

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