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MONOSULFIRAM

FDA/SD.255-020252 5% INN generic

What it does

Monosulfiram is a medication used to help people with alcohol dependence by discouraging drinking.

Commonly used for: alcohol dependence (alcoholism)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/SD.255-020252
Registration date
2025-02-19
Expiry date
2030-02-01
Status
Valid
Active ingredient
MONOSULFIRAM
Dosage form
-
Strength
5%
Pack size
-
Therapeutic class
-
RxNorm RxCUI
30206
Manufacturer / MAH
Vimson Derma
Applicant / LTR
ERNEST CHEMIST LIMITED
Country of origin
-
Manufacturer location
816/3 Kothari Industrial Estate, Opp Khodal Lodge, Santej, Ta :, Kalol, Santej, Gujarat 382722, India

Source: Food and Drugs Authority · fetched 2026-04-18 08:37:30 · updated 2026-10-20 04:00:09

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Monosulfiram is a medication used to help people with alcohol dependence by discouraging drinking.

What it treats

  • alcohol dependence (alcoholism)

How it works

Monosulfiram works by blocking the way your body processes alcohol, leading to unpleasant effects if alcohol is consumed.

Who it's for

This medication is for adults who are trying to stop drinking alcohol.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: monosulfiram

BNF-referenced

Monosulfiram is a compound primarily used in the treatment of alcohol dependence. It acts by inhibiting aldehyde dehydrogenase, an enzyme involved in the metabolism of alcohol, leading to the accumulation of acetaldehyde when alcohol is consumed. This accumulation causes unpleasant reactions, thus deterring the patient from drinking alcohol. Monosulfiram's unique structure includes a sulfur atom, which contributes to its pharmacological activity.

Indications

  • Alcohol dependence
  • Support in alcohol abstinence

Dosage

Children: Refer to the BNF for Children for paediatric dosing recommendations, as specific dosing information is not provided.

Adults: Refer to the BNF for specific adult dosing guidelines, as they may vary based on individual circumstances and treatment goals.

Mechanism of action

Monosulfiram is believed to exert its effects by acting as an inhibitor of aldehyde dehydrogenase, specifically targeting the mitochondrial enzyme. This inhibition prevents the conversion of acetaldehyde to acetic acid, resulting in elevated levels of acetaldehyde when alcohol is ingested. The increased acetaldehyde concentration leads to various adverse effects, including flushing, nausea, and palpitations, which serve as a deterrent to alcohol consumption.

Pharmacodynamics

The pharmacodynamics of monosulfiram relate to its role as an alcohol deterrent. By inhibiting the metabolism of alcohol, it induces unpleasant physiological effects that discourage drinking behavior. The severity of reactions can vary among individuals based on their metabolism and baseline activity of aldehyde dehydrogenase. Monosulfiram does not have significant effects on the central nervous system directly, but rather functions through its metabolic interactions.

Pharmacokinetics

Monosulfiram is absorbed following administration, with its effects lasting as long as the drug is present in the system. The metabolism of monosulfiram is complex and likely involves liver enzymes, with excretion primarily occurring via the urine. The half-life of the drug can vary considerably based on individual metabolic rates and liver function.

Contra-indications

  • Hypersensitivity to monosulfiram or any of its components
  • Severe liver impairment
  • Concurrent use with alcohol

Adverse effects

  • Drowsiness
  • Headache
  • Nausea
  • Vomiting
  • Diarrhea
  • Skin rash
  • Hepatotoxicity
  • Peripheral neuropathy

Interactions

  • Alcohol - can cause disulfiram-like reactions, including flushing, nausea, vomiting, and palpitations
  • Warfarin - may increase the anticoagulant effect of warfarin
  • Isoniazid - may increase the risk of peripheral neuropathy
  • Phenytoin - may alter phenytoin levels

Precautions

  • Use with caution in patients with a history of liver disease
  • Monitor liver function tests during treatment
  • Inform patients about the potential for disulfiram-alcohol reactions
  • Caution in patients with a history of seizures

Pregnancy

There is insufficient data on the use of monosulfiram in pregnancy. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether monosulfiram is excreted in human milk. Caution should be exercised when administering to nursing mothers.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Tablets

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: monosulfiram

PubChem CID 7215

Molecular formula: C10H20N2S3

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.