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:

Physicians Total Care, Inc.

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 80 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 are available as follows: 60 mg – Each #3 capsule with white opaque cap and yellow opaque body printed with  and 2778 on the cap and body in black ink contains 60 mg of propranolol hydrochloride, USP.  Capsules are supplied in bottles of 100 with a child-resistant closure and 500 without a child-resistant closure. 80 mg – Each #3 capsule with yellow opaque cap and yellow opaque body printed with  and 2779 on the cap and body in black ink contains 80 mg of propranolol hydrochloride, USP.  Capsules are supplied in bottles of 30 (NDC 54868-1078-1 ) with a child-resistant closure. 120 mg – Each #2 capsule with gray opaque cap and yellow opaque body printed with  and 2780 on the cap and body in black ink contains 120 mg of propranolol hydrochloride, USP.  Capsules are supplied in bottles of 100 with a child-resistant closure and 500 without a child-resistant closure. 160 mg – Each #1 capsule with gray opaque cap and gray opaque body printed with  and 2781 on the cap and body in black ink contains 160 mg of propranolol hydrochloride, USP.  Capsules are supplied in bottles of 100 with a child-resistant closure and 500 without a child-resistant closure. 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 as defined in the USP. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA 40-9180 Revised - June 2012 Distributed by: Physicians Total Care, Inc. Tulsa, OK  74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE - PROPRANOLOL HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
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PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP
40-9180
Revised - June 2012
RX ONLY
DESCRIPTION
Propranolol hydrochloride, USP 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 are formulated to
provide a sustained release of
propranolol hydrochloride. Propranolol hydrochloride extended-release
capsules are available as 60
mg, 80 mg, 120 mg, and 160 mg capsules for oral administration.
The inactive ingredients contained in propranolol hydrochloride
extended-release capsules are:
ethylcellulose, gelatin, hydroxypropyl cellulose, povidone, sugar
spheres, talc, titanium dioxide. In
addition, the 60 mg and 80 mg capsule shells contain yellow iron
oxide. The 120 mg capsule shells
contain black iron oxide and yellow iron oxide. The 160 mg capsule
shells contain black iron oxide.
The ink ingredients are common for all strengths: Opacode S-1-8114 or
Opacode
S-1-8115 black contains: D&C Yellow #10 Aluminum Lake, FD&C Blue #1
Aluminum Lake, FD&C
Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, pharmaceutical
glaze, propylene glycol, and
synthetic black iron oxide.
This drug product complies 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
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