Veracal 40mg

PRESENTATION

Veracal 40: Each tablet contains Verapamil Hydrochloride USP 40 mg.

Veracal 80: Each tablet contains Verapamil Hydrochloride USP 80 mg.

Veracal SR: Each sustained release tablet contains Verapamil Hydrochloride USP 240 mg.

Veracal SR 180: Each sustained release tablet contains Verapamil Hydrochloride USP 180 mg.

Veracal Injection: Each 2 ml of injection solution contains 5 mg of Verapamil hydrochloride USP.

DESCRIPTION

Verapamil has a pronounced antiarrhythmic action particularly in supraventricular cardiac arrhythmias. It prolongs impulse

conduction in the AV node and thereby depending on the type of arrhythmia restores the sinus rhythm and / or normalizes the

ventricular rate. The calcium antagonist Verapamil reduces myocardial oxygen consumption directly by intervening in the energy

consuming metabolic processes of the myocardial cell and indirectly by diminishing the peripheral resistance ( afterload ). The

decrease of the vascular smooth muscle tone moreover prevents coronary spasms and lowers raised blood pressure.

INDICATIONS

Veracal Tablet:

- Essential hypertension

- Angina pectoris and prevention of re-infarction

- Supraventricular arrhythmias

Veracal Injection:

- Tachycardias such as:

Paroxysmal supraventricular tachycardias

- Atrial fibrillation with rapid ventricular response (except WPWS)

- Atrial flutter with rapid conduction

- Extrasystoles

- Acute hypertension

- Acute coronary insufficiency

For the prophylaxis and / or therapy of ectopic arrhythmias (predominantly ventricular extrasystoles) in halothane anaesthesia and

in the application of adrenaline in halothane anaesthesia respectively.

DOSAGE & ADMINISTRATION

Veracal Tablet

The dose of Verapamil should be individualized by titration and the drug should be administered with food.

For essential hypertension the initial dose should be given 180 mg in the morning. If

adequate response is not obtained with 180 mg of Verapamil then the dose may be titrated by following manner:

240 mg each morning.

180 mg each morning plus 180 mg each evening.

240 mg every 12 hourly.

For angina the usual dose is 80 mg to 120 mg three times a day.

For arrythmias in digitalized patients, Verapamil should be given 240 mg to 360 mg in divided doses, depending on the severity of

the condition. Divided doses up to 180 mg/day may occasionally be needed.

Veracal Injection:

Adults: 5mg slowly intravenously, in tachycardias and hypertensive crises, if necessary repeat after 5 to 10 minutes. Drip

infusion to maintain the therapeutic effect: 5-10 mg/hour in physiological saline, glucose, laevulose or similar solutions, on

average up to a total dose of 100mg/day.

Children:

Newborn 0.75-1mg (= 0.3-0.4ml)

Infants 0.75-2mg (= 0.3-0.8ml)

Children age 1-5 years: 2-3mg (= 0.8-1.2ml)

age 6-14 years: 2.5-5mg (= 1-2ml)

of Verapamil, given intravenously, depending on age and action. The injection should be made slowly under electrocardiographic

control and only until onset of the effect. Intravenous infusion in hypertensive crises: initially 0.05-0.1mg/kg/hour; if the

effect proves to be insufficient, the dose is increased at 30-60 minute intervals until twice the dose or more is reached. Average

total dose up to 1.5mg/kg/day.

SIDE EFFECTS

Verapamil is generally well tolerated. The following reaction to orally administered Verapamil appeared clearly drug related or

occurred at rates greater than 1% in clinical trials with approximately 5000 patients.

Digestive system: Constipation, nausea;

Cardiovascular system: Hypotension, edema, CHF, pulmonary edema, bradycardia, AV block;

Respiratory system: Upper respiratory tract infections;

Nervous system: Dizziness, headache, fatigue;

Skin: Rash, flashing;

Hepatic: Elevated liver enzyme.

PRECAUTIONS

Care should be taken in 1st degree AV block, bradycardia <50 beats/minutes, hypotension <90 mm Hg systolic pressure, atrial

fibrillation/flutter and simultaneous pre-excitation syndrome e.g. WPW syndrome, heart failure (previous compensation with cardiac

glycosides/diuretics required).

Verapamil may impair ability to drive or operate machinery, particularly in the initial stages of treatment and with concomitant

consumption of alcohol. Verapamil markedly slows down the elimination of alcohol and prolongs the duration of the effects of

alcohol.

Verapamil should be given as a slow intravenous injection over at least 2 minutes under continuous ECG and blood pressure

monitoring. Intravenous injection should only be given by the physician.

In atrial fibrillation and simultaneous WPW syndrome there is a risk of inducing ventricular fibrillation

USE IN PREGNANCY & LACTATION

Verapamil carries the potential to produce fetal hypoxia associated with maternal hypotension. Verapamil should not be

administered intravenously during the first six months of pregnancy. There are no data on use in the first and second trimester.

Verapamil should not be used in the final trimester unless the benefits clearly outweigh the risks. Verapamil should not be

administered intravenously during lactation. If a nursing mother requires intravenous Verapamil, breast feeding should be

discontinued for the duration of treatment.

OVER DOSE

Treatment of overdose should be supportive. Beta-adrenergic stimulation or parenteral administration of calcium solution may

increase calcium ion flux across the slow channel and have been used in the treatment of overdose with Verapamil. Verapamil cannot

be removed by haemodialysis.

COMMERCIAL PACK

Veracal 40: Each box contains 5 blister strips of 10 tablets.

Veracal 80: Each box contains 5 blister strips of 10 tablets.

Veracal SR: Each box contains 3 blister strips of 10 sustained release tablets.

Veracal SR 180: Each box contains 3 blister strips of 10 sustained release tablets.

Veracal Injection : Each box contains 5 ampoules of 2ml injection.