PROPRANOLOL HYDROCHLORIDE ER- propranolol hydrochloride capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ)

Available from:

Rouses Point Pharm

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 60 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. They 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;

Product summary:

Propranolol hydrochloride extended-release capsules Each white capsule identified by 3 narrow bands, 1 wide band, and “AK 60,” contains 60 mg of propranolol hydrochloride in bottles of 100 (NDC  43478-900-88). Each white/light blue capsule identified by 3 narrow bands, 1 wide band, and “AK 80,” contains 80 mg of propranolol hydrochloride in bottles of 100 (NDC  43478-901-88). Each white/dark blue capsule identified by 3 narrow bands, 1 wide band, and “AK 120,” contains 120 mg of propranolol hydrochloride in bottles of 100 (NDC 43478-902-88). Each dark blue/light blue capsule identified by 3 narrow bands, 1 wide band, and “AK 160,” contains 160 mg of propranolol hydrochloride in bottles of 100 (NDC 43478-903-88). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°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 for Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer Inc. Philadelphia, PA 19101   Marketed and Distributed by Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 490F004 06/12 LAB-0554-2.0 Revised  June 2012

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE ER- PROPRANOLOL HYDROCHLORIDE CAPSULE,
EXTENDED
RELEASE
ROUSES POINT PHARM
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PROPRANOLOL HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES
DESCRIPTION
Propranolol hydrochloride 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:
cellulose, ethylcellulose, gelatin capsules, hypromellose, and
titanium dioxide. In addition, propranolol
hydrochloride extended-release 80 mg, and 160 mg capsules contain D&C
Red No. 28 and FD&C Blue
No. 1. Propranolol hydrochloride extended-release 120 mg capsules
contain FD&C Blue No. 1.
These capsules comply with USP Dissolution 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