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:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 60 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 are not indicated in the management of hypertensive emergencies. Propranolol hydrochloride extended-release capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. 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. Propranolol hydrochloride extended-release capsules 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)

Product summary:

Propranolol Hydrochloride Extended-release Capsules USP, 60 mg are white to off-white, free flowing pellets filled in size '3' hard gelatin capsules with white colored cap printed with  "ZA-57" in black ink and light blue body printed with "60 mg" in black ink and are supplied as follows: NDC 68382-161-16 in bottle of 90 capsules NDC 68382-161-01 in bottle of 100 capsules NDC 68382-161-05 in bottle of 500 capsules NDC 68382-161-10 in bottle of 1000 capsules NDC 68382-161-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules   Propranolol Hydrochloride Extended-release Capsules USP, 80 mg are white to off-white, free flowing pellets filled in size '3' hard gelatin capsules with light blue colored cap printed with "ZA-58" in black ink and light blue body printed with "80 mg" in black ink and are supplied as follows: NDC 68382-162-16 in bottle of 90 capsules NDC 68382-162-01 in bottle of 100 capsules NDC 68382-162-05 in bottle of 500 capsules NDC 68382-162-10 in bottle of 1000 capsules NDC 68382-162-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules   Propranolol Hydrochloride Extended-release Capsules USP, 120 mg are white to off- white, free flowing pellets filled in size'2' hard gelatin capsules with dark blue colored cap printed with "ZA-59" in black ink and light blue body printed with "120 mg" in black ink and are supplied as follows: NDC 68382-163-16 in bottle of 90 capsules NDC 68382-163-01 in bottle of 100 capsules NDC 68382-163-05 in bottle of 500 capsules NDC 68382-163-10 in bottle of 1000 capsules NDC 68382-163-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules   Propranolol Hydrochloride Extended-release Capsules USP, 160 mg are white to off- white, free flowing pellets filled in size '1' hard gelatin capsules with dark blue colored cap printed with "ZA-60" in black ink and dark blue body printed with "160 mg" in black ink and are supplied as follows: NDC 68382-164-16 in bottle of 90 capsules NDC 68382-164-01 in bottle of 100 capsules NDC 68382-164-05 in bottle of 500 capsules NDC 68382-164-10 in bottle of 1000 capsules NDC 68382-164-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light, moisture, freezing, and excessive heat. Dispense in a tight, light-resistant container. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE - PROPRANOLOL HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
ZYDUS PHARMACEUTICALS USA INC.
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PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
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 formula are:
C
H
NO ·HCL
Propranolol hydrochloride, USP is white to off-white, crystalline
powder; odorless and
has a bitter taste. It melts at about 164 C. It is soluble in water
and in alcohol; slightly
soluble in chloroform and practically insoluble in ether. Its
molecular weight is 295.80.
Each propranolol hydrochloride extended-release capsule intended for
oral
administration contains 60 mg or 80 mg or 120 mg or 160 mg of
propranolol
hydrochloride. In addition, each capsule contains the following
inactive ingredients: ethyl
cellulose, FD&C blue #1, gelatin, hypromellose, microcrystalline
cellulose and titanium
dioxide. Additionally each 60 mg, 80 mg and 120 mg capsule shell
contains D&C red #
28. The capsule is printed with black pharmaceutical ink which
contains black iron oxide
as a coloring agent.
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.
16
21
2
o
Propranolol hydrochloride extended-release capsules should not