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:

Preferred Pharmaceuticals 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 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 30 NDC 68788-6855-3. 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 Repackaged By: Preferred Pharmaceuticals Inc .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
PREFERRED PHARMACEUTICALS INC.
----------
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
16
21
2
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