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

DRUG INTERACTIONS

Drug Interactions

The concomitant intake of alcohol and CAMPRAL ^® does not affect the pharmacokinetics of either alcohol or acamprosate.

Pharmacokinetic studies indicate that administration of disulfiram or diazepam does not affect the pharmacokinetics of acamprosate. Co-administration of naltrexone with CAMPRAL ^® produced a 25% increase in AUC and a 33% increase in the C_max of acamprosate. No adjustment of dosage is recommended in such patients.

The pharmacokinetics of naltrexone and its major metabolite 6-beta-naltrexol were unaffected following co-administration with CAMPRAL ^®.

Other concomitant therapies: In clinical trials, the safety profile in subjects treated with CAMPRAL ^® concomitantly with anxiolytics, hypnotics and sedatives (including benzodiazepines), or non-opioid analgesics was similar to that of subjects taking placebo with these concomitant medications. Patients taking CAMPRAL ^® concomitantly with antidepressants more commonly reported both weight gain and weight loss, compared with patients taking either medication alone.

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).