Acamprosate

What it is and how it works

Mechanism of Action The mechanism of action of acamprosate in maintenance of alcohol abstinence is not completely understood. Chronic alcohol exposure is hypothesized to alter the normal balance between neuronal excitation and inhibition. In vitro and in vivo studies in animals have provided evidence to suggest acamprosate may interact with glutamate and GABA neurotransmitter systems centrally, and has led to the hypothesis that acamprosate restores this balance.

Indications

Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium delayed-release tablets treatment. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed. • Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation ( 1 , 14 ).

Dosage and administration (summary)

The recommended dose of acamprosate calcium delayed-release tablets is two 333 mg tablets (each dose should total 666 mg) taken three times daily. A lower dose may be effective in some patients. Although dosing may be done without regard to meals, dosing with meals was employed during clinical trials and is suggested in those patients who regularly eat three meals daily. Treatment with acamprosate calcium delayed-release tablets should be initiated as soon as possible after the period of alcohol withdrawal, when the patient has achieved abstinence, and should be maintained if the patient relapses.

Contraindications

• Acamprosate calcium is contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components . • Acamprosate calcium is contraindicated in patients with severe renal impairment . Hypersensitivity to Acamprosate Calcium Acamprosate calcium is contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components.

Warnings and precautions

• Dose 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 . Renal Impairment Treatment with acamprosate calcium in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min) requires a dose reduction . Acamprosate calcium is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) .

Pregnancy

Pregnancy Teratogenic effects: Acamprosate calcium has been shown to be teratogenic in rats when given in doses that are approximately equal to the human dose (on a mg/m 2 basis) and in rabbits when given in doses that are approximately 3 times the human dose (on a mg/m 2 basis).

Storage and supply

Acamprosate calcium delayed-release tablets, 333 mg are white to off-white, round, biconvex, enteric-coated tablets debossed with ‘435’ on one side and plain on the other side. Bottle of 180, NDC 68462-435-18 Carton of 100 (10 x 10 Unit-Dose Blisters), NDC 68462-435-11 Storage and Handling Store at 20ºC to 25°C(68° F to 77ºF).

Source: Acamprosate Calcium (Acamprosate Calcium) — US FDA prescribing information, 2026-01-23, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.