PROPRANOLOL HYDROCHLORIDE- propranolol hydrochloride capsule, extended release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Unit Dose Services

INN (Nome Internazionale):

PROPRANOLOL HYDROCHLORIDE

Composizione:

PROPRANOLOL HYDROCHLORIDE 60 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 are 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 improve 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)

Dettagli prodotto:

Product: 50436-4315 NDC: 50436-4315-1 30 CAPSULE, EXTENDED RELEASE in a BOTTLE

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
UNIT DOSE SERVICES
----------
PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
40-9180
Revised - December 2015
RX ONLY
DESCRIPTION
Propranolol hydrochloride, USP 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:
ethylcellulose, gelatin, hydroxypropyl cellulose, povidone, sugar
spheres, talc, titanium dioxide. In
addition, the 60 mg and 80 mg capsule shells contain yellow iron
oxide. The 120 mg capsule shells
contain black iron oxide and yellow iron oxide. The 160 mg capsule
shells contain black iron oxide.
The ink ingredients are common for all strengths: Opacode S-1-8114 or
Opacode
S-1-8115 black contains: D&C Yellow #10 Aluminum Lake, FD&C Blue #1
Aluminum Lake, FD&C
Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, pharmaceutical
glaze, propylene glycol, and
synthetic black iron oxide.
This drug product complies with USP Drug Release 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
16
21
2
chro