Campral (acamprosate calcium) Page 1 of 11 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CAMPRAL safely an d effectively. See full prescribing information for CAMPRAL. CAMPRAL� (acamprosate calcium) Delayed-Release Ta blets Initial U.S. Approval: 2004 ----------------INDICATIONS AND USAGE-------------------- Campral� is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation (1, 14). Treatment with Campral should be part of a comprehensive management program that includes psychosocial support (1). ------------- DOSAGE AND ADMINISTRATION -------------- Recommended dose: 666 mg (two 333 mg tablets) taken three times daily (2). Dose reduction to one 333 mg tablet taken three times daily for patients with moderate renal impairment (creatinine clearance 30-50 mL/min) (2.1). Campral is contraindicated in patients with severe renal impairment (creatinine clearance of ≤ 30 mL/min) (2.1, 4.2, 5.1, 8.6, 12.3). ------------DOSAGE FORMS AND STRENGTHS------------- Enteric-coated tablets, 333 mg (3). ---------------------CONTRAINDICATIONS--------------------- Campral is contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components (4.1). Campral is contraindicated in patients with severe renal impairment (4.2). --------------WARNINGS AND PRECAUTIONS------------- Do se reduction is required for patients with moderate renal impairment (5.1). Monitor patients for depression or suicidal ideation and prompt patients, families, and caregivers to report such symptoms to the health care provider (5.2). -----------------------ADVERSE REACTIONS------------------ Comm on adverse events that occurred in any Campral treatment group at a rate of 3% or greater and greater than the placebo group in controlled clinical trials with spontaneously reported adverse events are: accidental injury, asthenia, pain, anorexia, diarrhea, flatulence, nausea, anxiety, depression, dizziness, dry mouth, insomnia, paresthesia, pruritus and sweating (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Forest Laboratories, Inc. at 1-800-678-1605, or FDA at 1- 800-FDA-1088 or www.fda.gov/medwatch . ---------------USE IN SPECIFIC POPULATIONS------------ Pregnancy: Campral should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (8.1). Nursing Mothers: Caution should be exercised when Campral is administered to a nursing woman (8.3). Renal Impairment: Dose reduction required for moderate renal impairment; contraindicated in severe renal impairment (2.1, 4.2, 5.1, 8.6, 12.3) See 17 for Patient Counseling Information. Revised: January 2012 ____________________________________________________________________________________________________________ Campral (acamprosate calcium) Page 2 of 11 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 1 Dosage in Renal Impairment 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 4. 1 Hypersensitivity to Acamprosate Calcium 4. 2 Severe Renal Impairment 5 WARNINGS AND PRECAUTIONS 5. 1 Renal Impairment 5. 2 Suicidality and Depression 5. 3 Alcohol Withdrawal 6 ADVERSE REACTIONS 6. 1 Clinical Trials Experience 6. 2 Postmarketing Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8. 1 Pregnancy 8. 2 Labor and Delivery 8. 3 Nursing Mothers 8. 4 Pediatric Use 8. 5 Geriatric Use 8. 6 Renal Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12 .2 Pharmacodynamics 12 .3 Pharmacokinetics 13 NON CLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 17.1 Information for Patients * Sections or subsections omitted from the full prescribing information are not listed.
