Antabuse

Name: Antabuse

What special precautions should I follow?

Before taking disulfiram,

  • tell your doctor and pharmacist if you are allergic to disulfiram or any other drugs.
  • tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially amitriptyline (Elavil), anticoagulants ('blood thinners') such as warfarin (Coumadin), isoniazid, metronidazole (Flagyl), phenytoin (Dilantin), any nonprescription drugs that might contain alcohol, and vitamins.
  • tell your doctor if you have or have ever had diabetes, thyroid disease, epilepsy, brain damage, or kidney or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking disulfiram, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking disulfiram.
  • you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.

What special dietary instructions should I follow?

Do not drink any alcoholic beverages (including wine, beer, and medications that contain alcohol such as cough syrup) while taking disulfiram, during the 12-hour period before you take your first dose, and for several weeks after stopping the drug.

Avoid sauces, vinegars, and all foods and beverages containing alcohol.

What else should I know about this drug?

What preparations of are available?

  • This medication is available as tablets of 250 mg and 500 mg.

How should I keep this medication stored?

  • This drug should be stored at room temperature, 20 C to 25 C (68 F to 77 F).

When was it approved by the FDA?

  • The FDA approved disulfiram in August, 1951.

Overdose

No specific information is available on the treatment of overdosage with disulfiram. It is recommended that the physician contact the local Poison Control Center.

Antabuse Overview

Antabuse is a prescription medication used to treat chronic alcoholism.

Antabuse is an alcohol antagonist. This drug produces sensitivity to alcohol and causes an unpleasant reaction when alcohol is consumed. Symptoms of an Antabuse-alcohol reaction include flushing, throbbing of the head and neck, throbbing headache, respiratory difficulty, nausea, copious vomiting, sweating, thirst, chest pain, palpitations, shortness of breath, hyperventilation, increased heartrate, decreased blood pressure, uneasiness, weakness, vertigo, blurred vision, and confusion.

This medication comes in tablet form and is taken once a day.

Common side effects of Antabuse include skin rash, acne, headache, tiredness, impotence, and a metallic or garlic-like taste in the mouth.

Antabuse can also cause blurred vision and drowsiness. Do not drive or operate heavy machinery until you know how Antabuse affects you.

Inform MD

Before taking Antabuse, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to Antabuse or to any of its ingredients
  • are allergic to thiuram derivatives used in pesticides and rubber vulcanization
  • have diabetes
  • have thyroid disease
  • have epilepsy
  • have or have had brain damage
  • have or have had kidney disease
  • have or have had liver disease
  • are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Introduction

Alcohol deterrent; an aldehyde dehydrogenase inhibitor.a b

Uses for Antabuse

Alcohol Dependence

Management of alcohol dependence in selected, highly motivated patients; use in conjunction with supportive and psychotherapeutic treatment.a b

Not a cure for alcohol dependence; unlikely to have substantive effect when used without proper motivation and supportive therapy.b

Actions

  • Produces hypersensitivity to alcohol; irreversibly inhibits the enzymatic oxidation of acetaldehyde to acetate, which occurs in the liver during normal alcohol catabolism.a b

  • When small amounts of alcohol are ingested after administration of disulfiram, the acetaldehyde concentration in blood may increase 5–10 times the concentration found during metabolism of the same amount of alcohol alone.a b

  • Unpleasant symptoms of the disulfiram-alcohol reaction probably caused by high blood concentrations of acetaldehyde,b or possibly from formation of a toxic quaternary ammonium compound or carbon disulfide metabolite of disulfiram.a (See Disulfiram-Alcohol Reaction under Cautions.)

  • Does not interfere with rate of alcohol elimination from the body.a b

  • Tolerance does not occur; increased sensitivity to alcohol following prolonged administration.a b

Before Using Antabuse

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of disulfiram in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of disulfiram in the elderly with use in other age groups.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amprenavir
  • Dronabinol
  • Metronidazole
  • Paraldehyde

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Secnidazole
  • Tinidazole
  • Tranylcypromine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Anisindione
  • Diazepam
  • Dicumarol
  • Fosphenytoin
  • Isoniazid
  • Omeprazole
  • Phenprocoumon
  • Phenytoin
  • Theophylline
  • Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma or other lung disease, severe, or
  • Diabetes mellitus (sugar diabetes) or
  • Epilepsy or other seizure disorder or
  • Heart or blood vessel disease or
  • Kidney disease or
  • Liver disease or cirrhosis of the liver or
  • Underactive thyroid—A disulfiram-alcohol reaction may make the condition worse
  • Depression or
  • Severe mental illness—Disulfiram may make the condition worse
  • Skin allergy—Disulfiram may cause an allergic reaction

What are some things I need to know or do while I take Antabuse?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Avoid alcohol and drugs or food with alcohol in them. This also includes alcohol in hidden forms like some sauces, vinegars, and topical products like aftershaves and back rubs. Avoid alcohol for 2 weeks after disulfiram is stopped.
  • Very bad and sometimes deadly reactions can happen if Antabuse is taken with alcohol or drugs or food with alcohol in them. Talk with your doctor.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Antabuse while you are pregnant.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Antabuse - Clinical Pharmacology

Disulfiram produces a sensitivity to alcohol which results in a highly unpleasant reaction when the patient under treatment ingests even small amounts of alcohol.

Disulfiram blocks the oxidation of alcohol at the acetaldehyde stage. During alcohol metabolism following disulfiram intake, the concentration of acetaldehyde occurring in the blood may be 5 to 10 times higher than that found during metabolism of the same amount of alcohol alone.

Accumulation of acetaldehyde in the blood produces a complex of highly unpleasant symptoms referred to hereinafter as the disulfiram-alcohol reaction. This reaction, which is proportional to the dosage of both disulfiram and alcohol, will persist as long as alcohol is being metabolized. Disulfiram does not appear to influence the rate of alcohol elimination from the body.

Disulfiram is absorbed slowly from the gastrointestinal tract and is eliminated slowly from the body. One (or even two) weeks after a patient has taken his last dose of disulfiram, ingestion of alcohol may produce unpleasant symptoms.

Prolonged administration of disulfiram does not produce tolerance; the longer a patient remains on therapy, the more exquisitely sensitive he becomes to alcohol.

Package/Label Display Panel

Antabuse® (disulfiram tablets USP) 250 mg 100s Label Text

NDC 51285-523-02

Antabuse®

(disulfiram

tablets USP)

250 mg

See Side Panel for Warnings

Rx only

100 TABLETS

TEVA

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

What is disulfiram (antabuse)?

Disulfiram interferes with the metabolism of alcohol resulting in unpleasant effects when alcohol is consumed.

Disulfiram is used to treat chronic alcoholism.

Disulfiram may also be used for purposes other than those listed in this medication guide.

What should i avoid while taking disulfiram (antabuse)?

Do not drink alcohol while taking disulfiram. Flushing, fast heartbeats, nausea, thirst, chest pain, vertigo, and low blood pressure may occur when alcohol is ingested during disulfiram therapy.

Do not take disulfiram for at least 12 hours after drinking alcohol.

Reactions may occur from drinking alcohol for several weeks after you have stopped taking disulfiram.

Be aware of the alcohol content of other common products such as cough and cold medicines and food products. Alcohol in these products can also cause a reaction.

Tell your doctor (or dentist) that you are taking disulfiram before taking an antibiotic or before having surgery.

Do not come in contact or breathe the fumes of products that may contain alcohol including paint thinners, solvents, stains, lacquers and others. Use caution when applying or using products that may contain alcohol including aftershaves, mouthwashes, colognes, perfumes, antiseptics and others. Talk to your doctor or phaarmacist if you have questions regarding product alcohol content.

Where can i get more information?

Your pharmacist has additional information about disulfiram written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Before taking this medicine

Do not take Antabuse if you have consumed alcohol within the past 12 hours. Do not drink alcohol while taking disulfiram and for up to 14 days after you stop taking this medicine.

You should not use Antabuse if you are allergic to disulfiram, or if:

  • you have recently taken metronidazole (Flagyl) or paraldehyde; or

  • you have consumed any foods or products that contain alcohol (mouthwash, cough medicine, cooking wine or vinegar, certain desserts, and others).

To make sure Antabuse is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • heart disease, high blood pressure, history of heart attack or stroke;

  • underactive thyroid;

  • diabetes;

  • seizures or epilepsy;

  • head injury or brain damage;

  • a history of mental illness or psychosis;

  • an allergy to rubber; or

  • if you take phenytoin (Dilantin), tuberculosis medicine, or a blood thinner (warfarin, Coumadin, Jantoven).

FDA pregnancy category C. It is not known whether Antabuse will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether disulfiram passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medicine to anyone under 18 years old without medical advice.

For Healthcare Professionals

Applies to disulfiram: oral tablet

Other

Frequency not reported: Fatigue[Ref]

Hepatic

Rare (less than 0.1%): Altered liver function tests
Frequency not reported: Hepatic cell damage, hepatitis (cholestatic and fulminant), hepatic failure resulting in transplant or death, jaundice, cirrhosis[Ref]

Nervous system

Frequency not reported: Drowsiness, peripheral neuritis, encephalopathy, polyneuritis, peripheral neuropathy, headache, seizures, lethargy[Ref]

Dermatologic

Frequency not reported: Skin eruptions, acneiform eruptions, allergic dermatitis, maculopapular rash[Ref]

Gastrointestinal

Frequency not reported: Nausea, vomiting, halitosis, metallic or garlic-like aftertaste, stomach upset[Ref]

Ocular

Frequency not reported: Optic neuritis, eye pain or tenderness, changes in vision[Ref]

Genitourinary

Frequency not reported: Decreased libido[Ref]

Psychiatric

Frequency not reported: Psychotic reactions, depression, paranoia, schizophrenia, mania, confusion, personality changes, disorientation, memory impairment[Ref]

Some side effects of Antabuse may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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