PROPRANOLOL HYDROCHLORIDE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

AvPAK

INN (Международно Name):

PROPRANOLOL HYDROCHLORIDE

Композиция:

PROPRANOLOL HYDROCHLORIDE 10 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Hypertension Propranolol hydrochloride tablets, USP 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 is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride tablets, USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation Propranolol hydrochloride tablets, USP are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction Propranolol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine Propranolol is indicated for the prophylaxis of common migraine hea

Каталог на резюме:

Propranolol Hydrochloride Tablets, USP 10 mg are 9/32", scored, round, orange tablets imprinted “DAN 5554” and “10” supplied as NDC 50268-700-15 (10 tablets per card, 2 cards per carton). Propranolol Hydrochloride Tablets, USP 20 mg are 9/32", scored, round, blue tablets imprinted “DAN 5555” and “20” supplied as NDC 50268-701-15 (10 tablets per card, 2 cards per carton). Propranolol Hydrochloride Tablets, USP 40 mg are 11/32", scored, round, green tablets imprinted “DAN 5556” and “40” supplied as NDC 50268-702-15 (10 tablets per card, 2 cards per carton). Propranolol Hydrochloride Tablets, USP 80 mg are 12/32", scored, round, yellow tablets imprinted “DAN 5557” and “80” . Dispensed in Unit Dose Package. For Institutional Use Only. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE TABLET
AVPAK
----------
PROPRANOLOL HYDROCHLORIDE TABLETS, USP
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,(±)-. 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 is available as 10 mg, 20 mg, 40 mg and 80
mg tablets for
oral administration.
Propranolol Hydrochloride Tablets, USP 10 mg, 20 mg, 40 mg, and 80 mg
contain the
following inactive ingredients: anhydrous lactose, colloidal silicon
dioxide, croscarmellose
sodium, D&C Yellow No. 10, magnesium stearate, microcrystalline
cellulose and stearic
acid.
Propranolol Hydrochloride Tablets, USP 10 mg and 80 mg also contain
FD&C Yellow No.
6.
Propranolol Hydrochloride Tablets, USP 20 mg and 40 mg also contain
FD&C Blue No. 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 agonist 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
16
21
2
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.
MECHANISM OF ACTION
The mechanism of the antihypertensive effect of propranolol has not
been established.
Factors that may contribute to the antihypertensive action include:
(1) decreased
cardiac output, (2) inhibition of renin release by the kidneys, and
(3) diminution of tonic