Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ)
DIRECT RX
PROPRANOLOL HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE 40 mg
ORAL
PRESCRIPTION DRUG
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
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: Bottles of 30 tablets NDC 23155-110-03 Bottles of 60 tablets NDC 23155-110-06 Bottles of 100 tablets NDC 23155-110-01 Bottles of 500 tablets NDC 23155-110-05 Bottles of 1000 tablets NDC 23155-110-10 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: Bottles of 30 tablets NDC 23155-111-03 Bottles of 60 tablets NDC 23155-111-06 Bottles of 100 tablets NDC 23155-111-01 Bottles of 500 tablets NDC 23155-111-05 Bottles of 1000 tablets NDC 23155-111-10 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: Bottles of 30 tablets NDC 23155-112-03 Bottles of 60 tablets NDC 23155-112-06 Bottles of 100 tablets NDC 23155-112-01 Bottles of 500 tablets NDC 23155-112-05 Bottles of 1000 tablets NDC 23155-112-10 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: Bottles of 30 tablets NDC 23155-113-03 Bottles of 60 tablets NDC 23155-113-06 Bottles of 100 tablets NDC 23155-113-01 Bottles of 500 tablets NDC 23155-113-05 Bottles of 1000 tablets NDC 23155-113-10 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: Bottles of 30 tablets NDC 23155-114-03 Bottles of 60 tablets NDC 23155-114-06 Bottles of 100 tablets NDC 23155-114-01 Bottles of 500 tablets NDC 23155-114-05 Bottles of 1000 tablets NDC 23155-114-10 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
Abbreviated New Drug Application
PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE TABLET DIRECT RX ---------- PROPRANOLOL HYDROCHLORIDE DESCRIPTION SECTION Propranolol hydrochloride 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: [propranololhclusp] C16H21NO2.HCl 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 SECTION 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) Citiți documentul complet