PROPRANOLOL HYDROCHLORIDE ER- 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:

Blenheim Pharmacal, Inc.

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 80 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hypertension Propranolol hydrochloride extended-release capsules 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 are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride extended-release capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine 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. Hypertrophic Subaortic Stenosis Propranolol hydrochloride extended-release capsules improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Propranolol

Product summary:

Propranolol hydrochloride extended-release capsules Each white capsule identified by 3 narrow bands, 1 wide band, and "AK 60," contains 60 mg of propranolol hydrochloride in bottles of 100 (NDC 43478-900-88). Each white/light blue capsule identified by 3 narrow bands, 1 wide band, and "AK 80," contains 80 mg of propranolol hydrochloride in bottles of 100 (NDC 43478-901-88). Each white/dark blue capsule identified by 3 narrow bands, 1 wide band, and "AK 120," contains 120 mg of propranolol hydrochloride in bottles of 100 (NDC 43478-902-88). Each dark blue/light blue capsule identified by 3 narrow bands, 1 wide band, and "AK 160," contains 160 mg of propranolol hydrochloride in bottles of 100 (NDC 43478-903-88). 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. This product's label may have been updated. For current package insert and further product information, please call 1-877-567-0862

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE ER- PROPRANOLOL HYDROCHLORIDE CAPSULE,
EXTENDED
RELEASE
BLENHEIM PHARMACAL, INC.
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PROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES
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 should not be
considered a simple mg-for-mg
substitute for conventional propranolol and the blood levels achieved
do not match (are lower than)
those of two to four times daily dosing with the same dose (see DOSAGE
AND
ADMINISTRATION). When changing to propranolol hydrochloride
extended-release capsules from
conventional propranolol, a possible need for retitration upwards
should be considered, especially to
maintain effectiveness at the end of the dosing interval. In most
clinical settings, however, such as
hypertension or angina where there is little correlation between
plasma levels and clinical effect,
propranolol hydrochloride extended-release capsules have been
therapeutically equivalent to the same
mg dose of conventional propranolol hydrochloride as assessed by
24-hour effects on blood pressure
and on 24-hour exercise responses of heart rate, systolic pressure,
and rate pressure product.
MECHANISM OF ACTION
The mechanism of the antihypertensive effect of propranolol has not
been established. Among the
factors that may be involved in contributing to the antihypertensive
action include: (1) decreased card