Acamprosate


Generic Medicine Info
Indications and Dosage
Oral
Alcohol abstinence
Adult: For the maintenance of abstinence in alcohol-dependent patients: <60 kg: 666 mg at breakfast, 333 mg at noon and 333 mg at night; ≥60 kg: 666 mg tid. Treatment should be initiated as soon as possible after the alcohol withdrawal period and maintained if the patient relapses. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Elderly: Not recommended. Treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).
Renal Impairment
CrCl (mL/min) Dosage
<30 Contraindicated.
30-50 Initially, 333 mg tid.
Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Administration
May be taken with or without food. Swallow whole & do not chew/crush/cut. Consult product literature for specific recommendations.
Contraindications
Severe renal impairment (CrCl <30 mL/min).
Special Precautions
Patient with suicidal ideation. Moderate renal impairment (CrCl 30-50 mL/min) and severe hepatic impairment (Child-Pugh class C). Elderly. Pregnancy and lactation.
Adverse Reactions
Significant: CNS depression; suicidal thinking or behaviour.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, flatulence.
Reproductive system and breast disorders: Frigidity, impotence.
Skin and subcutaneous tissue disorders: Pruritus, maculopapular rash.
Patient Counseling Information
This drug may cause CNS depression, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor renal function and weight. Assess for signs of suicidal ideation.
Overdosage
Symptoms: Diarrhoea. Management: Symptomatic and supportive treatment.
Drug Interactions
Increased plasma concentration with naltrexone.
Food Interaction
Decreased absorption with food.
Action
Description:
Mechanism of Action: Acamprosate is a homotaurine analogue which interacts with glutamate and γ-aminobutyric acid (GABA) neurotransmitter systems in the CNS. It is believed to act by increasing the activity of the GABAergic system and decreasing the activity of glutamate within the CNS. Additionally, it restores the balance between GABA and glutamate activities which appear to be disrupted in alcohol use disorder.
Pharmacokinetics:
Absorption: Moderate, slow and sustained absorption from the gastrointestinal tract. Decreased absorption with food. Bioavailability: Approx 11%. Time to peak plasma concentration: 3-8 hours.
Distribution: Crosses the blood-brain barrier. Volume of distribution: Approx 1 L/kg.
Excretion: Via urine (as unchanged drug). Elimination half-life: 20-33 hours.
Chemical Structure

Chemical Structure Image
Acamprosate

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 71158, Acamprosate. https://pubchem.ncbi.nlm.nih.gov/compound/Acamprosate. Accessed Feb. 26, 2024.

Storage
Store between 20-25°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 Enteric-coated Tablet, Delayed Release (Mylan Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 06/11/2023.

Anon. Acamprosate Calcium. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 06/11/2023.

Anon. Acamprosate. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/11/2023.

Buckingham R (ed). Acamprosate Calcium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/11/2023.

Campral EC (Merck Serono Limited). MHRA. https://products.mhra.gov.uk. Accessed 06/11/2023.

Joint Formulary Committee. Acamprosate Calcium. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/11/2023.

Disclaimer: This information is independently developed by MIMS based on Acamprosate from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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