PROPRANOLOL HYDROCHLORIDE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 60 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 greater than first-degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol hydrochloride.

Product summary:

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 (NDC 42291-522-01) and bottles of 1000 (NDC 42291-522-10) 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 (NDC 42291-523-01) and bottles of 1000 (NDC 42291-523-10) Each orange/opaque capsule, imprinted with "120"on cap and "RD203" on body contains 120 mg of propranolol hydrochloride in bottles of 100 (NDC 42291-524-01) and bottles of 1000 (NDC 42291-524-10). Each light brown/opaque capsule, imprinted with "160"on cap and "RD203" on body contains 160 mg of propranolol hydrochloride in bottles of 100 (NDC 42291-525-01) and bottles of 1000 (NDC 42291-525-10). 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 1-855-361-3993 or go to www.avkare.com.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
AVKARE
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PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
RX ONLY
PRESCRIBING INFORMATION
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:
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
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 consid