PROPRANOLOL HYDROCHLORIDE tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (इंटरनेशनल नाम):

PROPRANOLOL HYDROCHLORIDE

रचना:

PROPRANOLOL HYDROCHLORIDE 10 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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

उत्पाद समीक्षा:

Propranolol hydrochloride tablets, USP are available containing 10 mg, 20 mg, 40 mg, 60 mg and 80 mg of propranolol hydrochloride, USP. The 10 mg tablets are orange, round, scored tablets debossed with MYLAN above the score and 182 below the score on one side and 10 on the other side. They are available as follows: NDC 0615-2561-39 blistercards of 30 tablets. NDC 0615-2561-31 blistercards of 31 tablets. The 20 mg tablets are blue, round, scored tablets debossed with MYLAN above the score and 183 below the score on one side and 20 on the other side. They are available as follows: NDC 0615-2562-39 blistercards of 30 tablets NDC 0615-2562-31 blistercards of 31 tablets The 40 mg tablets are green, round, scored tablets debossed with MYLAN above the score and 184 below the score on one side and 40 on the other side. They are available as follows: NDC 0615-2563-39 blistercards of 30 tablets NDC 0615-2563-31 blistercards of 31 tablets The 60 mg tablets are light purple, round, scored tablets debossed with MYLAN above the score and PR60 below the score on one side of the tablet and 60 on the other side. The 80 mg tablets are yellow, round, scored tablets debossed with MYLAN above the score and 185 below the score on one side of the tablet and 80 on the other side. Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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PROPRANOLOL HYDROCHLORIDE
DESCRIPTION
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:
C
H NO • HCl
Propranolol hydrochloride, USP is a stable, white, crystalline solid
which is readily soluble in water
and ethanol. Its molecular weight is 295.80.
Each tablet for oral administration contains 10 mg, 20 mg, 40 mg, 60
mg or 80 mg of propranolol
hydrochloride and the following inactive ingredients: colloidal
silicon dioxide, croscarmellose
sodium, magnesium stearate, microcrystalline cellulose, pregelatinized
starch and sodium lauryl sulfate.
The coloring agents are:
10 mg: FD&C Yellow No. 6 Aluminum Lake
20 mg: FD&C Blue No. 1 Aluminum Lake
40 mg: FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake
and D&C Yellow No.
10 Aluminum Lake
60 mg: FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake
80 mg: FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum
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
16
21
2
contribute to the antihypert