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:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 tablets USP are not indicated in the management of hypertensive emergencies. Propranolol hydrochloride tablets USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Propranolol hydrochloride tablets USP are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Propranolol hydrochloride tablets USP are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Propranolol hydrochloride tablets USP 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 indi

Product summary:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Propranolol Hydrochloride Tablets USP, 10 mg are orange, round, convex, scored tablets, debossed “54” bisect “82” on one side and debossed “V” on the reverse side. They are available in bottles of 100 and 1000. Propranolol Hydrochloride Tablets USP, 20 mg are blue, round, flat faced, beveled edge, scored tablets, debossed “54” bisect “83” on one side and debossed “V” on the reverse side. They are available in bottles of 90, 100 and 1000. Propranolol Hydrochloride Tablets USP, 40 mg are green, round, convex, scored tablets, debossed “54” bisect “84” on one side and debossed “V” on the reverse side. They are available in bottles of 100 and 1000. Propranolol Hydrochloride Tablets USP, 60 mg are pink, round, convex, scored tablets, debossed “54” bisect “85” on one side and debossed “V” on the reverse side. They are available in bottles of 100. Propranolol Hydrochloride Tablets USP, 80 mg are yellow, round, convex, scored tablets, debossed “54” bisect “86” on one side and debossed “V” on the reverse side. They are available in bottles of 100 and 500. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a well-closed, light-resistant container as defined in the USP. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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:
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, 60 mg,
and 80 mg tablets for oral
administration.
The inactive ingredients contained in Propranolol Hydrochloride
Tablets USP are: anhydrous lactose,
colloidal silicon dioxide, croscarmellose sodium, D&C Yellow #10 (10
mg, 40 mg and 80 mg tablets),
FD&C Blue #1 (20 mg tablet), FD&C Blue #2 (40 mg tablet), FD&C Red #40
(60 mg tablet), FD&C
Yellow #6 (10 mg and 80 mg tablets), magnesium stearate, and
microcrystalline cellulose.
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 by the kidneys, and (3) diminution of tonic sympathetic nerve
outflow from vasomoto