Acamprosate 333Mg 50 Tab By Mylan Institutional/Gen Campral

M AC tablet , enteric-coated , white , round round Black ink Campral (acamprosate calcium) Page of 11 Item info. These highlights do not include all the info. needed to use CAMPRAL safely an effectively. See full prescribing info. 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 comprehensive management program that includes psychosocial support . - DOSAGE AND ADMINISTRATION Recommended dose: 666 mg (two 333 mg tablets) taken three times daily . Dose reduction to one 333 mg tablet taken three times daily for patients with moderate renal impairment (creatinine clearance 30-50 mL/min) . 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 . -CONTRAINDICATIONS Campral is contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components . Campral is contraindicated in patients with severe renal impairment . WARNINGS AND PRECAUTIONS Do se reduction is required for patients with moderate renal impairment . Monitor patients for depression or suicidal ideation and prompt patients, families, and caregivers to report such symptoms to the health care provider . -ADVERSE REACTIONS - Comm on adverse events that occurred in any Campral treatment group at 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 . 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 . Nursing Mothers: Caution should be exercised when Campral is administered to nursing woman . 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 info.. Revised: January 2012 ____________________________________________________________________________________________________________ Campral (acamprosate calcium) Page of 11 FULL Item info.: CONTENTS* INDICATIONS AND USAGE DOSAGE AND ADMINISTRATION 2. Dosage in Renal Impairment DOSAGE FORMS AND STRENGTHS CONTRAINDICATIONS 4. Hypersensitivity to Acamprosate Calcium 4. Severe Renal Impairment WARNINGS AND PRECAUTIONS 5. Renal Impairment 5. Suicidality and Depression 5. Alcohol Withdrawal ADVERSE REACTIONS 6. Clinical Trials Experience 6. Postmarketing Experience DRUG INTERACTIONS USE IN SPECIFIC POPULATIONS 8. Pregnancy 8. Labor and Delivery 8. Nursing Mothers 8. Pediatric Use 8. Geriatric Use 8. 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 info. 17.1 info. for Patients Sections or subsections omitted from the full prescribing info. are not listed.