PROPRANOLOL HCL ER capsule, extended release PROPRANOLOL HYDROCHLORIDE ER capsule, extended release PROPRANOLOL HCL ER capsule

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Direct Rx

INN (International ime):

PROPRANOLOL HYDROCHLORIDE

Sastav:

PROPRANOLOL HYDROCHLORIDE 80 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Hypertension Propranolol hydrochloride extended-release capsules 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 are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride extended-release capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine 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. Hypertrophic Subaortic Stenosis Propranolol hydrochloride extended-release capsules improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Propranolol

Proizvod sažetak:

Propranolol hydrochloride extended-release capsules Each white capsule identified by 3 narrow bands, 1 wide band, and “AK 60,” contains 60 mg of propranolol hydrochloride Each white/light blue capsule identified by 3 narrow bands, 1 wide band, and “AK 80,” contains 80 mg of propranolol hydrochloride Each white/dark blue capsule identified by 3 narrow bands, 1 wide band, and “AK 120,” contains 120 mg of propranolol hydrochloride Each dark blue/light blue capsule identified by 3 narrow bands, 1 wide band, and “AK 160,” contains 160 mg of propranolol hydrochloride 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. This product’s label may have been updated. For current package insert and further product information, please call 1-877-567-0862

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

PROPRANOLOL HCL ER- PROPRANOLOL HCL ER CAPSULE, EXTENDED RELEASE
PROPRANOLOL HYDROCHLORIDE ER- PROPRANOLOL HYDROCHLORIDE ER CAPSULE,
EXTENDED
RELEASE
PROPRANOLOL HCL ER- PROPRANOLOL HCL ER CAPSULE, EXTENDED RELEASE
DIRECT RX
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PROPRANOLOL HCL ER 60MG
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:
[structural formulae]
C16H21NO2 · 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.
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