PROPRANOLOL HYDROCHLORIDE capsule, extended release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Direct_Rx

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Hypertension 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. Angina Pectoris Due to Coronary Atherosclerosis Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine 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. Hypertrophic Subaortic Stenosis Propranolol Hydrochloride Extended-Release Capsules, USP, improve NYHA functional class in symptomatic patients with hypertrophic su

Podsumowanie produktu:

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 bottles of 100 and 500 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 bottles of 100 and 500 Each orange/opaque capsule, imprinted with "120"on cap and "RD203" on body contains 120 mg of propranolol hydrochloride in bottles of 100 and 500 Each light brown/opaque capsule, imprinted with "160"on cap and "RD203" on body contains 160 mg of propranolol hydrochloride in bottles of 100 ( and 500 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. Dispense in a tight, light-resistant container as defined in the USP. 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, call 1-800-367-3395 or go to www.bpirx.com.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
DIRECT_RX
----------
PROPRANOLOL HYDROCHLORIDE
Rx Only
PRESCRIBING INFORMATION
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:
[Chemical Structure]
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.
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, USP, should not
be considered a simple mg-
for-mg substitute for c