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HOME >> API >> API List1 >> Acamprosate Calcium >> Acamprosate Calcium Pharmacology

PI-21684 Acamprosate calcium (77337-73-6)
Acamprosate Calcium Pharmacology

Pharmacology

Chronic alcohol exposure may alter normal balance between neuronal and excitation and inhibition. In vitro and in vivo animal data suggest acamprosate interacts with glutamate and GABA neurotransmitter systems, restoring this balance.

Pharmacokinetics

Absorption

Bioavailability about 11%. Steady state reached within 5 days. Steady-state concentrations average 350 ng/mL and occur 3 to 8 h postdose. C _max and AUC approximately 42% and 23%, respectively.

Distribution

Vd estimated to be 72 to 109 L (1 L/kg). Protein binding is negligible.

Metabolism

Does not undergo metabolism.

Elimination

Terminal t _½ ranges from about 20 to 33 h. Major route of excretion is via kidneys.

Special Populations

Renal function impairment

C _max in patients with moderate or severe renal function impairment were 2- and 4-fold higher, respectively. Elimination t _½ were 1.8- and 2.6-fold longer, respectively.

Indications and Usage

Maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.

Contraindications

Severe renal function impairment (Ccr 30 mL/min or less); hypersensitivity to any component of product.

Dosage and Administration

Adults

PO Two 333 mg tablets 3 times daily.

Renal Function Impairment
Adults

PO Start with 333 mg 3 times daily in patients with moderate renal function impairment (Ccr 30 to 50 mL/min). Do not administer to patients with severe renal function impairment (Ccr 30 mL/min or less).

Storage/Stability

Store tablets at controlled room temperature (59° to 86°F).

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