PROPRANOLOL HYDROCHLORIDE- propranolol capsule, extended release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Physicians Total Care, Inc.

INN (इंटरनेशनल नाम):

PROPRANOLOL HYDROCHLORIDE

रचना:

PROPRANOLOL HYDROCHLORIDE 60 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Hypertension Propranolol hydrochloride extended-release capsules 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 extended-release capsules is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride extended-release capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine Propranolol hydrochloride extended-release capsules 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. Hypertrophic Subaortic Stenosis Propranolol hydrochloride extended-release capsules improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Propranolol is

उत्पाद समीक्षा:

The 60 mg capsules are aqua blue printed “par 282” in gray ink and the cap is white opaque printed “par 282” in blue ink. The 80 mg capsules are aqua blue opaque printed “par 328” in gray ink and the cap is aqua blue opaque printed “par 328” in gray ink. The 120 mg capsules are aqua blue opaque printed “par 329” in gray ink and the cap is dark blue opaque printed “par 329” in gray ink. The 160 mg capsules are dark blue opaque printed “par 330” in white ink and the cap is dark blue opaque printed “par 330” in white ink. Store at 20°to25°C(68°to77°F);excursions permitted to 15°to30°C (59° to 86°F). [See USP Controlled Room Temperature] Protect from light, moisture, freezing, and excessive heat. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: PAR PHARMACEUTICAL COMPANIES, INC. Spring Valley, NY 10977 Revised: 04/2011 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma         74146

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

PROPRANOLOL HYDROCHLORIDE - PROPRANOLOL CAPSULE, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
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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 formula 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 extended release is formulated to provide a
sustained release of
propranolol hydrochloride. Propranolol hydrochloride extended release
is available as 60 mg, 80 mg,
120 mg, and 160 mg capsules.
Propranolol hydrochloride extended release capsules contain the
following inactive ingredients:
microcrystalline cellulose, methylcellulose, ethylcellulose. The
capsules contain gelatin and titanium
dioxide. In addition, propranolol hydrochloride extended release 60 mg
and 80 mg contain FD&C Blue
No. 1. Propranolol hydrochloride extended release 120 mg and 160 mg
contain FD&C Blue No.1 and
FD&C Red No.40.
These capsules comply with USP Drug Release Test 1.
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-stimulating 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.
Propranolol hydrochloride extended-release capsules should not be
considered a simple mg-for-mg
substitute for conventional propranolol and the blood levels achieved
do not matc