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:

Amneal Pharmaceuticals of New York LLC

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 headache. The efficacy of propranolol in the treatment of a migraine attack that ha

Product summary:

Propranolol Hydrochloride Tablets, USP 10 mg are 9/32", scored, round, orange tablets imprinted “DAN 5554” and “10” supplied in bottles of 100 and 1000. Propranolol Hydrochloride Tablets, USP 20 mg are 9/32", scored, round, blue tablets imprinted “DAN 5555” and “20” supplied in bottles of 100 and 1000. Propranolol Hydrochloride Tablets, USP 40 mg are 11/32", scored, round, green tablets imprinted “DAN 5556” and “40” supplied in bottles of 100 and 1000. Propranolol Hydrochloride Tablets, USP 80 mg are 12/32", scored, round, yellow tablets imprinted “DAN 5557” and “80” supplied in bottles of 100 and 500. Dispense in a well-closed, light-resistant container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Manufactured by: Watson Pharma Private Ltd. Verna, Salcette Goa 403 722 INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2019-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE TABLET
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
PROPRANOLOL HYDROCHLORIDE TABLETS, USP
REV. 02-2019-00
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.
MECHANISM OF ACTION
The mechanism of the antihypertensive effect of propranolol has not
been established. Factors that may
16
21
2
contribute to the antihypertensive action include: (1) decreased
cardiac output, (2) inhibition of renin
re