PROPRANOLOL HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hypertension Propranolol hydrochloride tablets 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 are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation Propranolol hydrochloride tablets 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 headache. The efficacy of propranolol in the treatment of a migraine attack that has started

Product summary:

Propranolol Hydrochloride Tablets, USP 20 mg are 9/32", scored, round, blue tablets imprinted DAN 5555 and 20 supplied in unit dose packages of 100 (10 x 10) NDC 60687-306-01. Propranolol Hydrochloride Tablets, USP 40 mg are 11/32", scored, round, green tablets imprinted DAN 5556 and 40 supplied in unit dose packages of 100 (10 x 10) NDC 60687-295-01. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. FOR YOUR PROTECTION: Do not use if blister is torn or broken. PACKAGING INFORMATION American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Actavis Pharma, Inc. as follows: (20 mg / 100 UD) NDC 60687-306-01 packaged from NDC 0591-5555 (40 mg / 100 UD) NDC 60687-295-01 packaged from NDC 0591-5556 Distributed by: American Health Packaging Columbus, OH 43217 8429501/0317

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE TABLET
AMERICAN HEALTH PACKAGING
----------
PROPRANOLOL HYDROCHLORIDE TABLETS, USP
8429501/0317
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
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.
16
21
2
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 kidney