Acamprosate: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Myanmar prescribing information.

Generic Medicine Info

Indications and Dosage

Oral
Alcohol abstinence

Adult: 18-65 yr ≥60 kg: 666 mg tid; <60 kg: 666 mg at breakfast, 333 mg at midday and 333 mg at night. Treatment should be started as soon as possible after the withdrawal period; maintain even if patient relapses. Recommended duration: 1 yr.
Elderly: >65 yr Not recommended.

Renal Impairment

CrCl (mL/min)	Dosage
<30	Contraindicated.
30-50	Initially, 333 mg tid.

Hepatic Impairment

Severe: Contraindicated.

Administration

Should be taken with food. Take at meal times.

Contraindications

Severe hepatic or renal impairment (CrCl <30 mL/min). Lactation.

Special Precautions

Patient w/ suicidal ideation. Moderate renal impairment (CrCl 30-50 mL/min). Elderly (>65 yr). Pregnancy.

Adverse Reactions

Nausea, vomiting, diarrhoea, asthenia, abdominal pain, pruritus, maculopapular rash, depression, fluctuations in libido. Rarely, bullous skin reactions, hypersensitivity reactions including urticaria, angioedema and anaphylaxis.

Pregnancy Category (US FDA)

PO: C

Patient Counseling Information

This drug may cause CNS depression, if affected, do not drive or operate machinery.

Monitoring Parameters

Monitor renal function; signs of depression and/or suicidal thinking.

Overdosage

Symptoms: Diarrhoea; hypercalcaemia may be considered in chronic overdose. Management: Symptomatic and supportive treatment.

Drug Interactions

Increased plasma concentrations w/ naltrexone.

Food Interaction

Food reduces absorption.

Action

Description: Acamprosate affects the balance of GABA and glutamate neurotransmitters by decreasing glutamatergic transmission and modulation of neuronal hyperexcitability.
Pharmacokinetics:
Absorption: Slowly absorbed from the GI tract. Reduced absorption w/ food. Bioavailability: Approx 11%. Time to peak plasma concentration: 3-8 hr.
Distribution: Crosses the blood-brain barrier. Volume of distribution: Approx 1 L/kg.
Excretion: Via urine as unchanged drug. Elimination half-life: 20-33 hr.

Chemical Structure

Storage

Store at 25°C.

MIMS Class

Drugs Used in Substance Dependence

ATC Classification

N07BB03 - acamprosate ; Belongs to the class of drugs used in the management of alcohol dependence.

References

Acamprosate Calcium Tablet, Delayed Release (Glenmark Pharmaceuticals Inc., USA). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 23/11/2015.

Anon. Acamprosate. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 23/11/2015.

Buckingham R (ed). Acamprosate Calcium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/11/2015.

McEvoy GK, Snow EK, Miller J et al (eds). Acamprosate Calcium. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 23/11/2015.

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