PROPRANOLOL HYDROCHLORIDE 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:

American Health Packaging

INN (इंटरनेशनल नाम):

PROPRANOLOL HYDROCHLORIDE

रचना:

PROPRANOLOL HYDROCHLORIDE 60 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Propranolol Hydrochloride Extended-Release Capsules, 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 Extended-Release Capsules, USP, are not indicated in the management of hypertensive emergencies. Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Propranolol Hydrochloride Extended-Release Capsules, 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 indicated for such use. Propranolol Hydrochloride Extended-Release Capsules, USP, improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and gre

उत्पाद समीक्षा:

Propranolol Hydrochloride Extended-Release Capsules, USP. Each white/opaque capsule, imprinted with "60"on cap and "RD203" on body contains 60 mg of propranolol hydrochloride in unit dose packages of 100 (10 x 10) NDC 60687-215-01. Each capsule with white/opaque body and orange/opaque cap, imprinted with "80"on cap and "RD203" on body contains 80 mg of propranolol hydrochloride in unit dose packages of 100 (10 x 10) NDC 60687-226-01. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light, moisture, freezing, and excessive heat. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Propranolol Hydrochloride Extended-Release Capsules, USP, a DIFFUCAPS ® drug delivery product, manufactured by Adare Pharmaceuticals, Inc. You can also ask your doctor or pharmacist for information about Propranolol Hydrochloride Extended-Release Capsules, USP that is written for healthcare professionals. For more information about the drug product, call 1-800-367-3395 or go to www.bpirx.com. For more information about the packaging or labeling, call American Health Packaging at 1‐800‐707‐4621.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
AMERICAN HEALTH PACKAGING
----------
PROPRANOLOL HYDROCHLORIDE
EXTENDED-RELEASE CAPSULES, USP
8421501/0623F
RX ONLY
DESCRIPTION
Propranolol hydrochloride is a synthetic beta-adrenergic
receptor-blocking agent
chemically described as 2-Propanol,
1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-,
hydrochloride,(±)-. Its molecular and structural formulae are:
C
H
NO
· HCl
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 Capsules, USP, are
formulated to provide a
sustained release of propranolol hydrochloride.
Propranolol Hydrochloride Extended-Release Capsules, USP, are
available as 60 mg, 80
mg, 120 mg, and 160 mg capsules for oral administration.
Each capsule for oral administration contains sugar spheres,
ethylcellulose,
hypromellose phthalate, povidone, diethyl phthalate, polyethylene
glycol, titanium
dioxide, ammonium hydroxide, potassium hydroxide, black iron oxide,
and gelatin. The
80 mg, 120 mg, and 160 mg capsules contain red and yellow iron oxide.
In addition, the
160 mg capsules contain FD&C Blue No. 2.
These capsules comply with USP Dissolution 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
16
21
2
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 Capsu