INDERAL LA- 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:

Inderal LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal LA is not indicated in the management of hypertensive emergencies. Inderal LA is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Inderal LA is 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. Inderal LA improves 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) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol hydrochloride.

Product summary:

Inderal® LA (propranolol hydrochloride) Long-Acting Capsules Each white/light-blue capsule, imprinted with three rings and reverse imprinted ‘INDERAL LA 60’, contains 60 mg of propranolol hydrochloride USP (equivalent to 52.60 mg of propranolol) in bottles of 100 (NDC 62559-520-01). Each light-blue capsule, imprinted with three rings and reverse imprinted ‘INDERAL LA 80’, contains 80 mg of propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol) in bottles of 100 (NDC 62559-521-01). Each light-blue/dark-blue capsule, imprinted with three rings and reverse imprinted ‘INDERAL LA 120’, contains 120 mg of propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol) in bottles of 100 (NDC 62559-522-01). Each dark-blue capsule, imprinted with three rings and reverse imprinted ‘INDERAL LA 160’, contains 160 mg of propranolol hydrochloride USP (equivalent to 140.28 mg of propranolol) in bottles of 100 (NDC 62559-523-01). 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. Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 10611 Rev 11/23

Authorization status:

New Drug Application

Summary of Product characteristics

INDERAL LA- PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
ANI PHARMACEUTICALS, INC.
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INDERAL LA
(PROPRANOLOL HYDROCHLORIDE)
LONG-ACTING CAPSULES
DESCRIPTION
Inderal
LA (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 USP is a stable, white, crystalline solid
which is readily soluble
in water and ethanol. Its molecular weight is 295.80.
Inderal LA is formulated to provide a sustained release of propranolol
hydrochloride
USP. Inderal LA is available as 60 mg, 80 mg, 120 mg, and 160 mg
capsules for oral
administration.
•
•
•
•
The inactive ingredients contained in Inderal LA capsules are: diethyl
phthalate,
hypromellose phthalate, ethylcellulose, povidone, polyethylene glycol,
corn starch,
sucrose, hypromellose, gelatin capsules and titanium dioxide. In
addition Inderal LA
60 mg capsules contain D&C Red No. 28 and FD&C Blue No. 1; Inderal LA
80 mg and
120 mg capsules contain FD&C Red No. 3 and FD&C Blue No. 1; Inderal LA
160 mg
capsules contain FD&C Blue No. 1.
FDA approved dissolution specifications differ from USP.
CLINICAL PHARMACOLOGY
®
®
16
21
2
Each Inderal LA 60 mg capsule contains 60 mg propranolol hydrochloride
USP
(equivalent to 52.60 mg of propranolol).
Each Inderal LA 80 mg capsule contains 80 mg propranolol hydrochloride
USP
(equivalent to 70.14 mg of propranolol).
Each Inderal LA 120 mg capsule contains 120 mg propranolol
hydrochloride USP
(equivalent to 105.21 mg of propranolol).
Each Inderal LA 160 mg capsule contains 160 mg propranolol
hydrochloride USP
(equivalent to 140.28 mg of propranolol).
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-recept