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:

ANI Pharmaceuticals, Inc.

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 60 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Propranolol hydrochloride extended-release capsules USP 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 USP are not indicated in the management of hypertensive emergencies. Propranolol hydrochloride extended-release capsules USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Propranolol hydrochloride extended-release capsules USP 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 USP improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than

Product summary:

Propranolol Hydrochloride Extended-Release Capsules USP Each white/light-blue capsule, imprinted with three rings and reverse imprinted ‘INDERAL LA 60’, contains 60 mg of propranolol hydrochloride in bottles of 100 (NDC 62559-530-01). Each light-blue capsule, imprinted with three rings and reverse imprinted ‘INDERAL LA 80’, contains 80 mg of propranolol hydrochloride in bottles of 100 (NDC 62559-531-01). Each light-blue/dark-blue capsule, imprinted with three rings and reverse imprinted ‘INDERAL LA 120’, contains 120 mg of propranolol hydrochloride in bottles of 100 (NDC 62559-532-01). Each dark-blue capsule, imprinted with three rings and reverse imprinted ‘INDERAL LA 160’, contains 160 mg of propranolol hydrochloride in bottles of 100 (NDC 62559-533-01). 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.  For medical inquires, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755. Manufactured by: Pfizer Ireland Pharmaceuticals Little Connell, Newbridge, Co. Kildare, Ireland Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 N4626 Rev 08/19

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE ER- PROPRANOLOL HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
ANI PHARMACEUTICALS, INC.
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PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES USP
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 USP are formulated
to provide a
sustained release of propranolol hydrochloride. Propranolol
hydrochloride extended-
release capsules USP 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 USP are: microcrystalline cellulose, ethylcellulose, gelatin
capsules,
hypromellose, and titanium dioxide. In addition, propranolol
hydrochloride extended-
release 60 mg, 80 mg, and 120 mg capsules contain D&C Red No. 28 and
FD&C Blue
No. 1. Propranolol hydrochloride extended-release 160 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
16
21
2
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 ex