Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ)
Physicians Total Care, Inc.
PROPRANOLOL HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE 60 mg
ORAL
PRESCRIPTION DRUG
Hypertension 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 is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride extended-release capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine 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. Hypertrophic Subaortic Stenosis Propranolol hydrochloride extended-release capsules improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Propranolol is
The 60 mg capsules are aqua blue printed “par 282” in gray ink and the cap is white opaque printed “par 282” in blue ink. The 80 mg capsules are aqua blue opaque printed “par 328” in gray ink and the cap is aqua blue opaque printed “par 328” in gray ink. The 120 mg capsules are aqua blue opaque printed “par 329” in gray ink and the cap is dark blue opaque printed “par 329” in gray ink. The 160 mg capsules are dark blue opaque printed “par 330” in white ink and the cap is dark blue opaque printed “par 330” in white ink. Store at 20°to25°C(68°to77°F);excursions permitted to 15°to30°C (59° to 86°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: PAR PHARMACEUTICAL COMPANIES, INC. Spring Valley, NY 10977 Revised: 04/2011 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146
Abbreviated New Drug Application
PROPRANOLOL HYDROCHLORIDE - PROPRANOLOL CAPSULE, EXTENDED RELEASE PHYSICIANS TOTAL CARE, INC. ---------- DESCRIPTION Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formula are: 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 is formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended release is available as 60 mg, 80 mg, 120 mg, and 160 mg capsules. Propranolol hydrochloride extended release capsules contain the following inactive ingredients: microcrystalline cellulose, methylcellulose, ethylcellulose. The capsules contain gelatin and titanium dioxide. In addition, propranolol hydrochloride extended release 60 mg and 80 mg contain FD&C Blue No. 1. Propranolol hydrochloride extended release 120 mg and 160 mg contain FD&C Blue No.1 and FD&C Red No.40. These capsules comply 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 proportionately. At dosages greater than required for beta blockade, propranolol also exerts a quinidine-like or anesthetic-like membrane action, which affects the cardiac action potential. The significance of the membrane action in the treatment of arrhythmias is uncertain. Propranolol hydrochloride extended-release capsules should not be considered a simple mg-for-mg substitute for conventional propranolol and the blood levels achieved do not matc Baca dokumen lengkap