TEVA-PROPRANOLOL 20 MG — DIN 00740675

What is TEVA-PROPRANOLOL?

TEVA-PROPRANOLOL 20 MG contains PROPRANOLOL HYDROCHLORIDE : 20 MG. It is listed in the Health Canada Drug Product Database under DIN 00740675, held by TEVA CANADA LIMITED, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 25-Oct-2011. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is TEVA-PROPRANOLOL used for?

TEVA-PROPRANOLOL (propranolol hydrochloride) is indicated in the treatment of mild to moderate hypertension, often in combination with other drugs, particularly a thiazide diuretic. It can be used alone or as an initial agent in certain patients. It is not recommended for the emergency treatment of hypertensive crises. It is indicated for the prophylaxis of angina pectoris. For cardiac arrhythmias, it is indicated for supraventricular arrhythmias such as paroxysmal atrial tachycardias (especially those induced by catecholamines or digitalis, or associated with Wolff-Parkinson-White syndrome), persistent sinus tachycardia that is non-compensatory and impairs patient well-being, and tachycardias and arrhythmias due to thyrotoxicosis when causing distress or increased hazard and when immediate effect is necessary as adjunctive, short-term therapy. It is also used for persistent atrial extrasystoles that impair well-being and do not respond to conventional measures, and for atrial flutter and fibrillation when ventricular rate cannot be controlled by digitalis alone or when digitalis is contraindicated. It is also indicated for tachyarrhythmias of digitalis intoxication if they persist after discontinuing digitalis and correcting electrolyte abnormalities. TEVA-PROPRANOLOL is indicated for the prophylaxis of migraine headache, but not for the treatment of acute migraine attacks. It is useful in the management of hypertrophic subaortic stenosis, particularly for exertional or other stress-induced angina, palpitations, and syncope, and may improve exercise performance. For pheochromocytoma, after primary treatment with an alpha-adrenergic blocking agent has been instituted, TEVA-PROPRANOLOL may be useful as adjunctive therapy if the control of tachycardia becomes necessary before or during surgery.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

HYPERTENSION: Dosage must be individually titrated and carefully monitored. Initial dose: 40 mg twice daily. May be increased to 80 mg twice daily after one week, then to 160 mg twice daily if necessary. Most patients respond to 160-320 mg daily. Some resistant patients may benefit from doses above 320 mg/day, given on a t.i.d. or q.i.d. regimen. Full blood pressure response usually occurs within 3 to 7 days of reaching effective dose, with maximum decrease in 2 to 4 weeks. ANGINA PECTORIS: Dosage must be individualized. Start with 10-20 mg three or four times daily, before meals and at bedtime. Gradually increase at 3 to 7 day intervals until optimum response. Average optimum dosage is 160 mg/day. In resistant patients, 320-400 mg/day may be administered. If discontinuing, reduce dosage gradually over two weeks. In urgent situations, reduce stepwise over four days under close observation. If angina worsens, reinstitute treatment promptly. ARRHYTHMIAS: 10-30 mg three or four times daily, before meals and at bedtime. MIGRAINE: Dosage must be individualized. Initial dose: 40 mg twice daily. Gradually increase until optimum migraine prophylaxis is achieved. Usual effective dose range: 80-160 mg/day. HYPERTROPHIC SUBAORTIC STENOSIS: 20-40 mg three or four times daily, before meals and at bedtime. PHEOCHROMOCYTOMA: Pre-operatively: 60 mg daily, in divided doses, for three days before surgery, concomitantly with an alpha-receptor blocking agent. Malignant cases: 30 mg daily, in divided doses.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

TEVA-PROPRANOLOL (Propranolol hydrochloride) is contraindicated in: 1) bronchospasm including bronchial asthma; 2) allergic rhinitis during the pollen season; 3) sinus bradycardia and greater than first degree block; 4) cardiogenic shock; 5) right ventricular failure secondary to pulmonary hypertension; 6) congestive heart failure (See WARNINGS) unless the failure is secondary to a tachyarrhythmia treatable with TEVA-PROPRANOLOL.

Warnings and precautions

CARDIAC FAILURE: Sympathetic stimulation is vital for circulatory function in congestive heart failure. Beta-adrenergic blockade can depress myocardial contractility and precipitate cardiac failure. In patients without a history of cardiac failure, continued myocardial depression can lead to cardiac failure. If symptoms of impending cardiac failure appear, patients should be fully digitalized and/or given a diuretic. If cardiac failure persists, TEVA-PROPRANOLOL should be withdrawn. If tachyarrhythmia is controlled, maintain combined therapy and monitor closely. ABRUPT CESSATION OF THERAPY IN ANGINA PECTORIS: Severe exacerbation of angina and myocardial infarction have been reported after abrupt discontinuation. Dosage should be gradually reduced over two weeks. In urgent situations, reduce stepwise over four days. If angina worsens, reinstitute treatment promptly. Patients should be warned against abrupt discontinuation. OCULOMUCOCUTANEOUS SYNDROME: Skin rashes and conjunctival xerosis have been reported with beta-blockers. A severe oculomucocutaneous syndrome has occurred with long-term use of one beta-adrenergic blocking agent. Physicians should be alert to such reactions and discontinue treatment if they occur. THYROTOXICOSIS: Long-term use effects are not fully appraised. TEVA-PROPRANOLOL may aggravate congestive heart failure and mask clinical signs of hyperthyroidism. Abrupt withdrawal may lead to exacerbation of hyperthyroidism, including thyroid storm. Withdraw slowly by reducing dosage. Propranolol hydrochloride does not distort thyroid function tests. WOLFF-PARKINSON-WHITE SYNDROME: Use with caution. Cases of severe bradycardia requiring a pacemaker have been reported after propranolol hydrochloride treatment. ELECTIVE OR EMERGENCY SURGERY: Management is controversial. Beta-adrenergic blockade impairs the heart's ability to respond to reflex stimuli. Abrupt discontinuation may lead to severe complications. Patients receiving beta-adrenergic blocking agents have experienced protracted severe hypotension during anesthesia. For elective surgery, withdraw TEVA-PROPRANOLOL gradually. In emergency surgery, effects can be reversed with isoproterenol or levarterenol. Avoid anesthesia with agents that maintain cardiac contractility via catecholamine release (e.g., ether). NON-ALLERGIC BRONCHOSPASM: Administer with caution as it may block bronchodilation. DIABETES AND HYPOGLYCEMIA: May block premonitory signs of acute hypoglycemia. Hypoglycemic attacks may be accompanied by a precipitous elevation of blood pressure.