Campral (Acamprosate Calcium) - Indications and Dosage

INDICATIONS AND USAGE

CAMPRAL is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with CAMPRAL should be part of a comprehensive management program that includes psychosocial support.

The efficacy of CAMPRAL in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning CAMPRAL treatment. The efficacy of CAMPRAL in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.

DOSAGE AND ADMINISTRATION

The recommended dose of CAMPRAL is two 333 mg tablets (each dose should total 666 mg) taken three times daily. Although dosing may be done without regard to meals, dosing with meals was employed during clinical trials and is suggested as an aid to compliance in those patients who regularly eat three meals daily. A lower dose may be effective in some patients.

Treatment with CAMPRAL should be initiated as soon as possible after the period of alcohol withdrawal, when the patient has achieved abstinence, and should be maintained if the patient relapses. CAMPRAL should be used as part of a comprehensive psychosocial treatment program.

Dosage in Renal Impairment:    For patients with moderate renal impairment (creatinine clearance of 30-50 mL/min), a starting dose of one 333 mg tablet taken three times daily is recommended. Patients with severe renal impairment (creatinine clearance of </=30 mL/min) should not be given CAMPRAL.

HOW SUPPLIED

CAMPRAL 333 mg tablets are enteric-coated, white, round, biconvex tablets, identified with "333" debossed on one side.

Opaque HDPE bottles of 180-NDC #0456-3330-01

Dose Pak of 180-NDC #0456-3330-60

STORAGE:

Store at 25° C (77°F); excursions permitted to 15°-30°C (59°-86°F).

Manufactured by:

Merck Santé s.a.s.

Subsidiary of Merck KGaA, Darmstadt, Germany

37, rue Saint-Romain

69008 LYON FRANCE

Manufactured for FOREST PHARMACEUTICALS, Inc.

Subsidiary of Forest Laboratories, Inc.

St. Louis, MO 63045

07/04