Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ)
Actavis Pharma, Inc.
PROPRANOLOL HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE 60 mg
ORAL
PRESCRIPTION DRUG
Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules are not indicated in the management of hypertensive emergencies. Propranolol hydrochloride extended-release capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Propranolol hydrochloride extended-release capsules are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Propranolol hydrochloride extended-release capsules improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first-degree block; 3)
Propranolol hydrochloride extended-release capsules, USP are available as follows: 60 mg – Each #3 capsule with white opaque cap and yellow opaque body printed with and 2778 on the cap and body in black ink contains 60 mg of propranolol hydrochloride, USP. Capsules are supplied in bottles of 100 (NDC 0228-2778-11) and 500 (NDC 0228-2778-50). 80 mg – Each #3 capsule with yellow opaque cap and yellow opaque body printed with and 2779 on the cap and body in black ink contains 80 mg of propranolol hydrochloride, USP. Capsules are supplied in bottles of 100 (NDC 0228-2779-11) and 500 (NDC 0228-2779-50). 120 mg – Each #2 capsule with gray opaque cap and yellow opaque body printed with and 2780 on the cap and body in black ink contains 120 mg of propranolol hydrochloride, USP. Capsules are supplied in bottles of 100 (NDC 0228-2780-11) and 500 (NDC 0228-2780-50). 160 mg – Each #1 capsule with gray opaque cap and gray opaque body printed with and 2781 on the cap and body in black ink contains 160 mg of propranolol hydrochloride, USP. Capsules are supplied in bottles of 100 (NDC 0228-2781-11) and 500 (NDC 0228-2781-50). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light, moisture, freezing, and excessive heat. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9180 Revised - December 2015
Abbreviated New Drug Application
PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ACTAVIS PHARMA, INC. ---------- PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP 40-9180 Revised - December 2015 RX ONLY DESCRIPTION Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are: C H NO ·HCl Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules are formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release capsules are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: ethylcellulose, gelatin, hydroxypropyl cellulose, povidone, sugar spheres, talc, titanium dioxide. In addition, the 60 mg and 80 mg capsule shells contain yellow iron oxide. The 120 mg capsule shells contain black iron oxide and yellow iron oxide. The 160 mg capsule shells contain black iron oxide. The ink ingredients are common for all strengths: Opacode S-1-8114 or Opacode S-1-8115 black contains: D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, pharmaceutical glaze, propylene glycol, and synthetic black iron oxide. This drug product complies with USP Drug Release Test 1. CLINICAL PHARMACOLOGY GENERAL Propranolol is a nonselective, beta-adrenergic receptor-blocking agent possessing no other autonomic nervous system activity. It specifically competes with beta-adrenergic receptor-stimulating agents for available receptor sites. When access to beta-receptor sites is blocked by propranolol, the chronotropic, inotropic, and vasodilator responses to beta-adrenergic stimulation are decreased 16 21 2 ch Læs hele dokumentet