PROPRANOLOL HYDROCHLORIDE capsule, extended release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

A-S Medication Solutions

INN (mednarodno ime):

PROPRANOLOL HYDROCHLORIDE

Sestava:

PROPRANOLOL HYDROCHLORIDE 80 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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)

Povzetek izdelek:

Product: 50090-0420 NDC: 50090-0420-0 30 CAPSULE, EXTENDED RELEASE in a BOTTLE

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
A-S MEDICATION SOLUTIONS
----------
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.
16
21
2
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 decreas