PROPRANOLOL HYDROCHLORIDE ER 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:

American Health Packaging

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 60 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE ER- PROPRANOLOL HYDROCHLORIDE CAPSULE,
EXTENDED
RELEASE
AMERICAN HEALTH PACKAGING
----------
PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES
8250301/1214
R ONLY
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.
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Propranolol hydrochloride extended-release capsu