PROPRANOLOL HYDROCHLORIDE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Amneal Pharmaceuticals of New York LLC

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

Propranolol Hydrochloride Tablets, USP 60 mg – Pink, round, convex, debossed tablets on one side with PLIVA 470 and scored on the other side. Available in bottles of 100 (NDC: 0115-1693- 01). 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 In Czech Republic By: TEVA CZECH INDUSTRIES s.r.o. Opava-Komarov, Czech Republic Distributed By: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2019-00

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE TABLET
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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PROPRANOLOL HYDROCHLORIDE TABLETS, USP
60 MG
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 60 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 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.
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 vasomotor centers in
the brain. Although total peripheral resistance may increase
initially, it readjusts to or below the
16
21
2
pretreatment level with