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Acebutolol (Acebutolol Hydrochloride) - Indications and Dosage

 
 



INDICATIONS & USAGE

HYPERTENSION: Acebutolol hydrochloride capsules are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.

VENTRICULAR ARRHYTHMIAS: Acebutolol hydrochloride capsules are indicated in the management of ventricular premature beats; it reduces the total number of premature beats, as well as the number of paired and multiform ventricular ectopic beats, and R-on-T beats.

DOSAGE & ADMINISTRATION

HYPERTENSION: The initial dosage of acebutolol in uncomplicated mild-to-moderate hypertension is 400 mg. This can be given as a single daily dose, but in occasional patients twice daily dosing may be required for adequate 24-hour blood-pressure control. An optimal response is usually achieved with dosages of 400 to 800 mg per day, although some patients have been maintained on as little as 200 mg per day. Patients with more severe hypertension or who have demonstrated inadequate control may respond to a total of 1200 mg daily (administered b.i.d.), or to the addition of a second antihypertensive agent. Beta-1 selectivity diminishes as dosage is increased.

VENTRICULAR ARRHYTHMIA: The usual initial dose of acebutolol is 400 mg daily given as 200 mg b.i.d. Dosage should be increased gradually until an optimal clinical response is obtained, generally at 600 to 1200 mg per day. If treatment is to be discontinued, the dosage should be reduced gradually over a period of about two weeks.

USE IN OLDER PATIENTS: Older patients have an approximately 2-fold increase in bioavailability and may require lower maintenance doses. Doses above 800 mg/day should be avoided in the elderly.

HOW SUPPLIED

Acebutolol hydrochloride capsules are available as follows:



400 mg: Size “2” hard gelatin capsules with bright orange opaque body printed radially “670” with black ink and lavender opaque cap printed radially “Amneal” with black ink.

Bottles of 30
NDC 54868-4216-0

Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).

Protect from light. Keep tightly closed. Dispense in a light resistant, tight container.

Manufactured by:

Amneal Pharmaceuticals of NY

Hauppauge, NY 11788

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42164

Rev. 09-2010




Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma        74146


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