ISOPTIN RETARD 30TAB; verapamil, cardiovascular agents .
ACTIVE-INGREDIENT OF ISOPTIN RETARD 30TAB
Each film coated tablet contains 240 mg Verapamil hydrochloride in sustained release form.
INDICATION OF ISOPTIN RETARD 30TAB
Verapamil hydrochloride is indicated for the treatment of coronary artery disease ( conditions characterized by inadequate oxygen supply to the cardiac muscle) including: chronic stable angina pectoris; unstable angina pectoris (crescendo angina, angina at rest); vasospastic angina pectoris (Prinzmetal’s angina, variant angina); post-myocardial infarction angina in patients without heart failure if beta-blockers are not indicated. It is also indicated for the treatment of disturbance of cardiac rhythm in paroxysmal supraventricular tachycardia, atrial fibrillation/atrial flutter with rapid atrioventricular conduction (except in Wolff-Parkinson-White or Lown-Ganong-Levine syndromes) and for the treatment of high blood pressure (hypertension).
DOSAGE OF ISOPTIN RETARD 30TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
The dose of Verapamil hydrochloride should be adjusted individually in accordance with the severity of disease. Long-standing clinical experience shows that the average dose in all indications is between 240 mg and 360 mg. The daily dose should not exceed 480 mg on a long-term basis, although a higher dose may be used for a short period. There is no limitation on the duration of use. Verapamil hydrochloride should not be discontinued abruptly after longterm use. It is recommended to taper the dosage. In patients with impaired liver function , metabolism of the drug is delayed to a greater or lesser extent depending on the severity of hepatic dysfunction, thus potentiating and prolonging the effects of Verapamil hydrochloride . Therefore, the dosage needs to be adjusted with special caution in patients with impaired liver function and low doses should be given initially. For patients requiring higher dosages (e.g., 240 mg to 480 mg Verapamil hydrochloride per day) , formulations with a more suitable active drug content should be used. Tablets should be taken without sucking or chewing, with sufficient liquid, preferably with or shortly after meals. Adults and adolescents weighing more than 50 kg: Dose in coronary artery disease, paroxysmal supraventicular tachycardia, arterial flutter and atrial fibrillation: Isoptin 80 mg: 80 to 480 mg in three or four divided doses. Isoptin 240 mg SR: 240 to 480 mg in one or two divided doses. Hypertension: Isoptin 80 mg: 80 to 480 mg ( 1-6 tablets) in three divided doses. Isoptin 240 mg SR: 240 to 480 mg ( 1-2 tablets ) in one or two divided doses.
OVER-DOSAGE OF ISOPTIN RETARD 30TAB
Symptoms: Hypotension, bradycardia up to high degree AV block and sinus arrest, hyperglycemia, stupor and metabolic acidosis. Fatalities have occurred as a result of overdose. Treatment: treatment of Verapamil hydrochloride overdose should be mainly supportive although administration of parenteral calcium, beta adrenergic atimulation and gastrointestinal irrigation have been used in the treatment of Verapamil hydrochloride overdose. Due to the potential for delayed absorption of the sustained release product, patients may require observation and hospitalization for up to 48 hours. Verapamil hydrochloride cannot be removed by hemodialysis.
CONTRA-INDICATION OF ISOPTIN RETARD 30TAB
Verapamil hydrochloride is contraindicated in: Hypersensitivity to the active substance or to any of the inactive ingredients. Cardiogenic shock. Acute myocardial infarction with complications. Second or third degree atrioventricular block (except in patients with a functioning artificial pacemaker). Skin sinus syndrome (except in patients with a functioning artificial pacemaker). Congestive heart failure. Atrial fibrillation/flutter and an accessory bypass tract ( e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes)
STORAGE OF ISOPTIN RETARD 30TAB
Store at room temperature not exceeding 30 °C, away from light. Keep out of reach of children.
PACK OF ISOPTIN RETARD 30TAB
Pack of 3 strips each of 10 film coated tablets inside carton box with insert.
ISOPTIN RETARD 30TAB MANUFACTURED BY
Kahira Pharma & Chem. Ind. Co. Under Licence of Abbott Laboratories – USA & its subsidiary – Germany.