INDERAL LA propranolol hydrochloride capsule extended release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Akrimax Pharmaceuticals, LLC

INN (Internationale Bezeichnung):

PROPRANOLOL HYDROCHLORIDE

Zusammensetzung:

PROPRANOLOL HYDROCHLORIDE 60 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

New Drug Application

Fachinformation

INDERAL LA- PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
AKRIMAX PHARMACEUTICALS, LLC
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INDERAL LA
INDERAL LA
(PROPRANOLOL HYDROCHLORIDE)
LONG-ACTING CAPSULES
DESCRIPTION
Inderal
(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.
Inderal LA is formulated to provide a sustained release of propranolol
hydrochloride. 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:
cellulose, ethylcellulose, gelatin
capsules, hypromellose, and titanium dioxide. In addition, Inderal LA
60 mg, 80 mg, and 120 mg
capsules contain D&C Red No. 28 and FD&C Blue No. 1; Inderal LA 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 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.
Inderal LA should not be considered a simple mg-for-mg substitute for
conventional propranolol and
the blood levels achieved do not match (are lower than) those of two
to four times daily dosing with the
same dose (see DOSAGE AND ADMINIS