PROPRANOLOL HYDROCHLORIDE- 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:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hypertension Propranolol hydrochloride tablets are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are 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 hydrochloride tablets are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine Propranolol hydrochloride tablets are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment o

Product summary:

Propranolol hydrochloride tablets, USP are supplied as follows: 10mg: Each tablet is an orange colored, round, biconvex tablet, embossed with "P" and "10" on either side of the breakline on one side and plain on the other side. Each 10 mg tablet contains 10 mg propranolol hydrochloride USP and is supplied in the following packages sizes: 20mg: Each tablet is a blue colored, round, biconvex tablet, embossed with "P" and "20" on either side of the breakline on one side and plain on the other side. Each 20 mg tablet contains 20 mg of propranolol hydrochloride USP and is supplied in the following package sizes: 40mg: Each tablet is a green colored, round, biconvex tablet, embossed with "P" and "40"on either side of the breakline on one side and plain on the other side. Each 40 mg tablet contains 40 mg of propranolol hydrochloride USP and is supplied in the following package sizes: 49999-286-30 49999-286-60 49999-286-90 60mg: Each tablet is a pink colored, round, biconvex tablet, embossed with "P" and "60" on either side of the breakline on one side and plain on the other side. Each 60 mg tablet contains 60 mg of propranolol hydrochloride USP and is supplied in the following package sizes: 80mg: Each tablet is a yellow colored, round, biconvex tablet, embossed with "P" and "80" on either side of the breakline on one side and plain on the other side. Each 80 mg tablet contains 80 mg of propranolol hydrochloride USP and is supplied in the following package sizes: Storage: Store at 20°-25 °C (68 -(°77 (°F); excursions permitted to 15°-30 (°C (59(°-86 (°F) [see USP Controlled Room Temperature] Protect from light. Dispense in a well closed, light-resistant container as defined in USP. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Heritage Pharmaceuticals Inc. Edison, NJ 08837 1.866.901.DRUG (3784) Manufactured by: Ipca Laboratories Limited 48, Kandivli Ind. Estate, Mumbai 400 067, India. Iss. 0109 Repackaging and Relabeling by: Quality Care Products, LLC

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
RX ONLY
DESCRIPTION
hydrochloride(Propranolol is a synthetic beta-adrenergic receptor
blocking agent chemically described
as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-,
hydrochloride,(±)-. It’s molecular and
structural formulae are:
Propranolol hydrochloride is a stable, white, crystalline solid which
is readily soluble in water and in
ethanol. Its molecular weight is 295.80.
Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg,
40 mg, 60 mg, and 80 mg tablets
for oral administration.
The inactive ingredients contained in propranolol hydrochloride
tablets, USP are: lactose monohydrate,
corn starch, sodium starch glycolate, magnesium stearate, and
povidone. In addition, propranolol
hydrochloride tablets, USP 10 mg, 40 mg and 80 mg contain FD &C yellow
No.6 Aluminium Lake and
Color D&C Yellow No. 10; propranolol hydrochloride tablets, USP 20 mg
and 40mg contain FD&C
Blue No.1 and propranolol hydrochloride tablets, USP 60 mg contain D&C
Red No. 30 Lake.
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
contribute to the antihypertensive action include: (1) decreased
cardiac output, (2) inhibition of renin
release