Acebutolol (Acebutolol Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Hypertension

Acebutolol hydrochloride capsules are indicated for the management of hypertension in adults. They 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 AND 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 dosage 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, USP are available containing 200 mg or 400 mg of acebutolol as the hydrochloride salt.

The 200 mg product is a medium orange opaque and medium orange opaque capsule imprinted with MYLAN over 1200 on both the body and cap. They are available as follows:

NDC 0378-1200-01
bottles of 100 capsules

The 400 mg product is a medium orange opaque and medium orange opaque capsule imprinted with MYLAN over 1400 on both the body and cap. They are available as follows:

NDC 0378-1400-01
bottles of 100 capsules

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

Protect from light.

Keep container tightly closed.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

REVISED MARCH 2006
ACEB:R8