Hypertension

Sectral is 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

Sectral is 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.

Hypertension

The initial dosage of Sectral 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 Sectral 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.

Sectral® (acebutolol HCl) is available in the following dosage strengths:

200 mg, opaque purple and orange capsule marked "RP 700" and "Sectral® 200"

NDC 67857-700-01, in bottles of 100 capsules.

400 mg, opaque brown and orange capsule marked "RP 701" and "Sectral® 400"

NDC 67857-701-01, in bottles of 100 capsules.

Keep tightly closed

Store at controlled room temperature 20° to 25°C (68° to 77°F)

Protect from light

Dispense in a light-resistant, tight container

Use carton to protect contents from light

Distributed by: Reddy Pharmaceuticals, LLC Bridgewater, NJ 08807. Manufactured by: MOVA PHARMACEUTICAL CORPORATION., Manatí, Puerto Rico 00674, USA. Revised July 2007. FDA Rev date: 9/6/2007

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