ACAMPROSATE Drug Interactions: What You Need to Know

INTERACTIONS Acamprosate does not affect the pharmacokinetics of alcohol. The pharmacokinetics of acamprosate are not affected by alcohol, diazepam, or disulfiram, and clinically important interactions between naltrexone and acamprosate were not observed [see Clinical Pharmacology ( 12.3 )] .

4 CONTRAINDICATIONS

• Acamprosate calcium delayed-release tablets are contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components ( 4.1 ).
• Acamprosate calcium delayed-release tablets are contraindicated in patients with severe renal impairment ( 4.2 ).

4.1 Hypersensitivity to Acamprosate Calcium Acamprosate calcium delayed-release tablets are contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components.

4.2 Severe Renal Impairment Acamprosate calcium delayed-release tablets are contraindicated in patients with severe renal impairment (creatinine clearance of ≤ 30 mL/min) [ see Dosage and Administration (2.1) , Warnings and Precautions (5.1) , Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ].

AND PRECAUTIONS Contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

• Dose 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 ).

5.1 Renal Impairment Treatment with acamprosate calcium delayed-release tablets in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min) requires a dose reduction <span class="opacity-50 text-xs">[see Dosage and Administration (2.1) ]</span> . Acamprosate calcium delayed-release tablets are contraindicated in patients with severe renal impairment (creatinine clearance of ≤ 30 mL/min) <span class="opacity-50 text-xs">[see Dosage and Administration (2.1) , Contraindications (4.2) , Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ]</span> .

5.2 Suicidality and Depression In controlled clinical trials of acamprosate calcium delayed-release tablets, adverse events of a suicidal nature (suicidal ideation, suicide attempts, completed suicides) were infrequent overall, but were more common in acamprosate calcium delayed-release tablets-treated patients than in patients treated with placebo (1.4% vs. 0.5% in studies of 6 months or less; 2.4% vs. 0.8% in year-long studies). Completed suicides occurred in 3 of 2272 (0.13%) patients in the pooled acamprosate group from all controlled studies and 2 of 1962 patients (0.10%) in the placebo group. Adverse events coded as &quot;depression&quot; were reported at similar rates in acamprosate calcium delayed-release tablets-treated and placebo-treated patients. Although many of these events occurred in the context of alcohol relapse, and the interrelationship between alcohol dependence, depression and suicidality is well-recognized and complex, no consistent pattern of relationship between the clinical course of recovery from alcoholism and the emergence of suicidality was identified. Alcohol-dependent patients, including those patients being treated with acamprosate calcium delayed-release tablets, should be monitored for the development of symptoms of depression or suicidal thinking. Families and caregivers of patients being treated with acamprosate calcium delayed-release tablets should be alerted to the need to monitor patients for the emergence of symptoms of depression or suicidality, and to report such symptoms to the patient&apos;s health care provider.

5.3 Alcohol Withdrawal Use of acamprosate calcium delayed-release tablets does not eliminate or diminish withdrawal symptoms.