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Uses

Alcohol Dependence

Maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at the time acamprosate therapy is initiated.

Should be used in conjunction with a comprehensive management program that includes psychosocial support.

Therapeutic benefit not established in patients who have not undergone detoxification and have not achieved abstinence from alcohol ingestion.

Efficacy not established for the promotion of abstinence from alcohol ingestion in patients who abuse multiple substances.

Can be used in conjunction with naltrexone or disulfiram.

Dosage and Administration

General

Initiate therapy as soon as possible after the patient has achieved abstinence from alcohol ingestion.

Therapy can be continued even if the patient relapses.

Administration

Oral Administration

Administer orally 3 times daily without regard to meals. For individuals who regularly eat 3 meals a day, administer with meals (to improve compliance).

Dosage

Available as acamprosate calcium; dosage expressed in terms of the salt.

Adults

Alcohol Dependence

Maintenance of Abstinence of Alcohol Ingestion

Oral

666 mg 3 times daily.

A lower dosage (1.3 grams daily given in 3 unequally divided doses of 666, 333, and 333 mg) also evaluated in clinical studies and may be effective in some patients.

Special Populations

Dosage in Hepatic Impairment

Dosage adjustment not required in patients with mild to moderate hepatic impairment. (See Hepatic Impairment under Cautions.)

Dosage in Renal Impairment

In patients with moderate renal impairment (Cl_cr 30–50 mL/minute), 333 mg 3 times daily. (See Renal Impairment under Cautions.)

Do not use in patients with severe renal impairment (Cl_cr<30 mL/minute). (See Contraindications under Cautions.)

Geriatric Patients

Select dosage carefully. (See Geriatric Use under Cautions.)

Cautions

Contraindications

• Known hypersensitivity to acamprosate or any ingredient in the formulation.
• Severe renal impairment (Cl_cr <30mL/minute).

Warnings/Precautions

General Precautions

Withdrawal Symptoms

Does not eliminate or diminish withdrawal symptoms.

Suicide

Increased risk of suicide in substance abusers with or without depression.

Suicidality (i.e., suicidal ideation, suicide attempt) and completed suicide reported.

Monitor for symptoms of depression and suicidal thinking.

Specific Populations

Pregnancy

Category C.

Lactation

Distributed into milk in rats; not known whether distributed into human milk. Use caution.

Pediatric Use

Safety and efficacy not established in children <18 years of age.

Evaluated in a limited number of adolescents 16–19 years of age.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution.

Increased plasma concentrations in patients with renal impairment; assess renal function periodically since geriatric patients are more likely to have decreased renal function.

Hepatic Impairment

Pharmacokinetics not altered in patients with mild to moderate hepatic impairment (Child-Pugh class A or B). Safety and pharmacokinetics not evaluated in patients with severe hepatic impairment.

Renal Impairment

Clearance decreased depending on degree of renal impairment.

Dosage adjustment necessary in patients with Cl_cr 30–50 mL/minute. (See Renal Impairment under Dosage and Administration.)

Contraindicated in severe renal impairment (Cl_cr <30 mL/minute).

Common Adverse Effects

Diarrhea and asthenia.