Campral (Acamprosate Calcium) - Drug Interactions, Contraindications, Overdosage

DRUG-DRUG INTERACTIONS

Acamprosate had no inducing potential on the cytochrome CYP1A2 and 3A4 systems, and in vitro inhibition studies suggest that acamprosate does not inhibit in vivo metabolism mediated by cytochrome CYP1A2, 2C9, 2C19, 2D6, 2E1, or 3A4. The pharmacokinetics of CAMPRAL were unaffected when co-administered with alcohol, disulfiram or diazepam. Similarly, the pharmacokinetics of ethanol, diazepam and nordiazepam, imipramine and desipramine, naltrexone and 6-beta naltrexol were unaffected following co-administration with CAMPRAL. However, co-administration of CAMPRAL with naltrexone led to a 33% increase in the C_max and a 25% increase in the AUC of acamprosate. No adjustment of dosage is recommended in such patients.

OVERDOSAGE

In all reported cases of acute overdosage with CAMPRAL (total reported doses of up to 56 grams of acamprosate calcium), the only symptom that could be reasonably associated with CAMPRAL was diarrhea. Hypercalcemia has not been reported in cases of acute overdose. A risk of hypercalcemia should be considered in chronic overdosage only. Treatment of overdose should be symptomatic and supportive.

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 (creatinine clearance </=30 mL/min).