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Acamprosate (Monograph)

Brand name: Campral
Drug class: Central Nervous System Agents, Miscellaneous
VA class: AD100
Chemical name: Calcium 3-(acetylamino)propane-1-sulfonate
Molecular formula: C10H20CaN2O8S2
CAS number: 77337-73-6

Introduction

Synthetic homotaurine derivative that interacts with glutamate and GABA neurotransmitter systems in the CNS.

Uses for Acamprosate

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.

Acamprosate 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

Hepatic Impairment

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

Renal Impairment

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

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

Geriatric Patients

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

Cautions for Acamprosate

Contraindications

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 Clcr 30–50 mL/minute. (See Renal Impairment under Dosage and Administration.)

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

Common Adverse Effects

Diarrhea and asthenia.

Drug Interactions

Does not induce CYP isoenzymes 1A2 or 3A4; does not inhibit CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, or 3A4.

Concomitant use with anxiolytics, hypnotics and sedatives (including benzodiazepines), or nonopiate analgesics not associated with changes in safety profile.

Specific Drugs

Drug

Interaction

Comments

Alcohol

Pharmacokinetic interaction unlikely

Antidepressants

Antidepressants: Changes in weight (i.e., loss or gain) reported

Desipramine: No change in pharmacokinetics of the antidepressant

Imipramine: No change in pharmacokinetics of the antidepressant

Diazepam

Pharmacokinetic interaction unlikely

Disulfiram

Pharmacokinetic interaction unlikely

Naltrexone

Increased concentrations of acamprosate; no change in concentrations of naltrexone or its major metabolite, 6-β-naltrexol

No dosage adjustment recommended

Acamprosate Pharmacokinetics

Absorption

Bioavailability

Absolute bioavailability is 11%.

Food

Food reduces peak plasma concentrations by 42% and AUC by 23%; effect not considered clinically important.

Distribution

Plasma Protein Binding

Negligible.

Elimination

Metabolism

Does not undergo metabolism.

Elimination Route

Excreted principally in urine as unchanged drug.

Half-life

20–33 hours.

Special Populations

In patients with moderate or severe renal impairment, peak plasma concentrations are 2-fold or 4-fold higher, respectively, than in healthy individuals. Half-life is 1.8-fold or 2.6-fold longer in patients with moderate or severe renal impairment, respectively, than in healthy individuals.

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).

Actions

Advice to Patients

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Acamprosate Calcium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, delayed-release (enteric-coated)

333 mg

Campral (with propylene glycol)

Forest

AHFS DI Essentials™. © Copyright 2024, Selected Revisions May 1, 2006. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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