International generic name

Verapamil

Drug form and composition

Film-coated tablets. One film-coated tablet contains 80 mg Verapamil hydrochloride. Solution for injection. One ampoule of 2 ml contains 5 mg Verapamil hydrochloride (2.5 mg /ml).

Indications

Isocor, solution for injection, is used in the treatment of several rhythm disorders, including: paroxysmal supraventricular tachycardia, atrial fibrillation and flutter with high-frequency ventricular response (except WPW-syndrome); in the treatment of hypertensive crisis and acute coronary artery syndromes. Isocor, tablets, is indicated in patients with stable and unstable angina, manifesting with chest pain attacks; post myocardial infarction angina pectoris; rhythm disorders (except WPW-syndrome); arterial hypertension.

Dosage and administration

In adults Isocor, ampoules, is applied intravenously - 5 mg (1 ampoule); if necessary the same dose could be repeated in 10-minutes interval. The preparation can be used as an intravenous infusion also, diluted in saline, glucose or levulose solution, with rate of infusion 5-10 mg per hour - up to 100 mg total dose. In hypertensive crisis is applied as a slow drop intravenous infusion with rate 0.05-0.1 mg /kg body weight/h; in case of lack or insufficient effect the dose could be doubled. In newborns Isocor is applied intravenously in dose 0.75-1 mg (0.3-0.4 ml); in infants - 0.75-2 mg (0.3-0.8 ml); in 1-5 years children - 2-3 mg (0.8-1.2 ml), 6-14 years - 2.5-5 mg (1-2 ml). Isocor- film-coated tablets is used orally; maximal daily dose should not exceed 480 mg. In patients with angina pectoris the usual dose is 80-120 mg, given 2-3 times daily; in arrhythmias 240-320 mg daily, divided in 3-4 takes; in essential hypertension the initial dose in monotherapy is 80 mg, 2-3 times daily.

Contraindications

Isocor should not be used in cardiogenic shock; acute myocardial infarction; low blood pressure; low heart rate (below 60 beats per minute); AV-block 2-nd and 3-rd degree; sick sinus syndrome; evident heart failure; the first three mounts of the pregnancy and during lactation; in neuro-muscular conduction disorders..

Special warnings and precautions

In children Isocor should be administered only after careful consideration of indications, as a risk of rhythm disorders exists. In patients with disturbed liver function and muscular dystrophy the dosage of Isocor should be reduced. In long-term treatment with the preparation is necessary to monitor the liver function. As Isocor is excreted in the mother milk, the treatment of the nursing women with this medicine requires discontinuation of the breast-feeding.

Drug interactions

Concomitant administration of β-adrenoreceptor blocking agents (propranolol, atenolol, etc) may cause a bradycardia. Barbiturates (phenobarbital, cyclobarbital) reduce the preparation activity. Phenytoin reduces the plasma concentration of Isocor. As the calcium salts antagonize the pharmacology action of Isocor, they could be used intravenously in order to reduce its side effects. Isocor increases blood concentrations and effectiveness of theophyllin, cyclosporin, doxorubicin, carbamazepine, and digoxin. Isocor reduces excretion of the antipyrin and enhances its effectiveness. Concomitant application of other antihypertensive medicines increases its hypotensive effect, whereas nonsteroidal anti-inflammatory agents reduce the antihypertensive effect of Isocor.

Adverse reactions

Following adverse reactions are described: cardiovascular system - heart block, heart rate decrease, hypotension; nervous system - dizziness, anxiety, fatigue, headache; gastrointestinal system - constipation, nausea, abdominal discomfort (very rare); respiratory system - bronchial and laryngeal spasm; blood tests - elevation of the enzyme level (serum transaminases and alkaline phosphatase); skin and mucous membranes - itching, allergy rash.

Pharmacological mechanisms

Isocor is a calcium channel blocker, exerting direct action on the myocardium. It blocks the calcium influx through the slow voltage-dependent calcium channels in the cell and possesses local anesthetic activity. As a result of the later it causes a peripheral and coronary vessel dilation and prominent antiarrhythmic effect. The preparation reduces the oxygen consumption in the myocardium, and in higher dose possesses antiaggregant activity.

Supplied

30 film-coated tablets of 80 mg. 10 ampoules of 2ml (5mg).

Expiry

Film-coated tablets - 3 years. Solution for injection - 2 years