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

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Propranolol Hydrochloride Tablets USP 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 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 in

Product summary:

Propranolol Hydrochloride Tablets USP 10 mg – Orange, round, convex, debossed tablets on one side with PLIVA 467 and scored on the other side. 20 mg – Blue, round, convex, debossed tablets on one side with PLIVA 468 and scored on the other side. 40 mg – Green, round, convex, debossed tablets on one side with PLIVA 469 and scored on the other side. 55700-413-30 55700-413-60 60 mg – Pink, round, convex, debossed tablets on one side with PLIVA 470 and scored on the other side. 80 mg – Yellow, round, convex, debossed tablets on one side with PLIVA 471 and scored on the other side. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). PROTECT FROM LIGHT. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. C 1/2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
PROPRANOLOL HYDROCHLORIDE
TABLETS USP
467
468
469
470
471
RX ONLY
DESCRIPTION
Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor
blocking agent chemically
described as 2-Propanol,
1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-.
Its
structural formula is:
C
H NO •HCl M.W. 295.80
Propranolol hydrochloride, USP is a stable, white, crystalline solid
which is readily soluble in water
and in ethanol.
Propranolol Hydrochloride Tablets USP are available as tablets for
oral administration containing
either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol
hydrochloride, USP. Propranolol
Hydrochloride Tablets USP also contain lactose anhydrous, magnesium
stearate, microcrystalline
cellulose, and sodium starch glycolate. Color additives include FD&C
Yellow no. 6 aluminum lake (10
mg and 80 mg), D&C Yellow no. 10 aluminum lake (10 mg, 40 mg, and 80
mg), FD&C Blue no. 1
aluminum lake (20 mg and 40 mg) and FD&C Red no. 40 aluminum lake (60
mg).
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 b