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:

Nortec Development Associates, 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 are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is 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 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)

Product summary:

The 60 mg capsules are aqua blue printed “N 60” in gray ink and the cap is white opaque printed “N 60” in blue ink. NDC 42689-011-01 Bottle of 100 NDC 42689-011-10 Bottle of 1000 The 80 mg capsules are aqua blue opaque printed “N 80” in gray ink and the cap is aqua blue opaque printed “N 80” in gray ink. NDC 42689-012-01 Bottle of 100 NDC 42689-012-10 Bottle of 1000 The 120 mg capsules are aqua blue opaque printed “N 120” in gray ink and the cap is dark blue opaque printed “N 120” in gray ink. NDC 42689-013-01 Bottle of 100 NDC 42689-013-10 Bottle of 1000 The 160 mg capsules are dark blue opaque printed “N 160” in white ink and the cap is dark blue opaque printed “N 160” in white ink. NDC 42689-014-01 Bottle of 100 NDC 42689-014-10 Bottle of 1000

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
NORTEC DEVELOPMENT ASSOCIATES, INC
----------
RX 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,(±)-. It’s molecular and structural formula 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
capsules 60 mg and 80
mg contain FD&C Blue No. 1; propranolol hydrochloride extended-release
capsules 120
mg and 160 mg contain FD&C Blue No. 1 and FD&C Red No. 40.
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 not be
considered a simple
mg-for-mg substitu