Antabuse

Disulfiram is used to treat chronic alcoholism. It causes unpleasant effects when even small amounts of alcohol are consumed. These effects include flushing of the face, headache, nausea, vomiting, chest pain, weakness, blurred vision, mental confusion, sweating, choking, breathing difficulty, and anxiety. These effects begin about 10 minutes after alcohol enters the body and last for 1 hour or more. Disulfiram is not a cure for alcoholism, but discourages drinking.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Antabuse is the brand name of the prescription drug disulfiram, which is used to treat chronic alcoholism.

The medicine blocks an enzyme that's involved in metabolizing alcohol.

Antabuse causes unpleasant symptoms when even small amounts of alcohol are consumed. People should be made aware of this when they are prescribed Antabuse.

These effects typically begin about 10 minutes after alcohol enters the body, and they last for about an hour.

Antabuse is meant to be used in combination with other forms of therapy, including behavior modification, counseling, and psychotherapy.

The Food and Drug Administration (FDA) first approved Antabuse in 1951. It's currently manufactured (as generic disulfiram) by Teva Pharmaceuticals.

Antabuse Warnings

Antabuse contains a black-box warning because the drug should never be given to someone without that person's knowledge.

Combining Antabuse with alcohol — such as by taking it while already drunk — can cause a fatal reaction.

Don't take Antabuse if you've consumed alcohol within the past 12 hours. Don't drink alcohol while taking the drug or for up to 14 days after you stop taking it.

When Antabuse is combined with alcohol, it may cause symptoms such as:

• Headache
• Nausea or vomiting
• Flushing of the face
• Chest pain
• Weakness
• Anxiety
• Blurred vision
• Confusion
• Sweating
• Difficulty breathing, or choking

Antabuse isn't a cure for alcoholism, but it may effectively discourage some people from drinking.

Before taking this medicine, tell your doctor if you have, or have ever had:

• Diabetes
• Thyroid disease
• Epilepsy
• Brain damage or a head injury
• Mental illness
• Heart disease
• A heart attack or stroke
• High blood pressure
• Kidney disease
• Liver disease
• Allergies to medications

Be sure to tell your doctor you're taking Antabuse before having any type of surgery, including a dental procedure.

You shouldn't use Antabuse if you've recently taken the drugs Flagyl (metronidazole) or paraldehyde.

Many common foods and other products may contain a small amount of alcohol that can cause a reaction with Antabuse.

These products include:

• Mouthwash
• Cough medicines
• Cooking wine or vinegar
• Certain desserts
• Cologne or perfume
• Aftershave
• Antiperspirants
• Antiseptic astringent skin products
• Hair dyes
• Paint thinners, solvents, stains, and lacquers
• Waxes, dyes, resins, and gums

Check product labels carefully to see if any foods or products you use contain alcohol, and avoid these items while taking Antabuse.

You'll need frequent blood tests to check your liver function while taking Antabuse. Be sure to keep all appointments with your doctor and laboratory.

All medical professionals who treat you should know that you're taking Antabuse.

In case of an emergency situation, it's a good idea to wear a medical alert tag or carry an ID card that says you take the drug.

Children under age 18 shouldn't take Antabuse unless a doctor recommends it.

Pregnancy and Antabuse

It's not known whether Antabuse can harm an unborn baby.

Tell your doctor if you're pregnant, or might become pregnant, before taking this medicine.

It's also not known whether the drug passes into breast milk or could hurt a breastfeeding baby.

Don't breastfeed while taking Antabuse without talking to your doctor first.

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially those listed in the Antabuse Warnings section above, and any of the following:

• Any prescription or non-prescription drugs that might contain alcohol
• Blood thinners such as Coumadin (warfarin)
• Dilantin (phenytoin)
• Elavil (amitriptyline)
• Isoniazid
• Vitamins

Antabuse and Other Interactions

Antabuse can make you drowsy.

Don't drive or operate machinery until you know how this medicine affects you.

• Disulfiram may increase the effect of warfarin (Coumadin, Jantoven) and increase the risk of bleeding. The dose of warfarin may require adjustment.
• Patients taking isoniazid and disulfiram may develop unsteady gait or significant changes in mental status. Disulfiram should be stopped if such symptoms appear.
• Disulfiram may increase blood levels of phenytoin (Dilantin), leading to high blood levels of phenytoin. Blood levels of phenytoin should be monitored and the dose of phenytoin should be adjusted as needed.
• The liquid form of ritonavir (Norvir) contains alcohol which can cause a severe reaction in people taking disulfiram.

• Odyssey Pharmaceuticals, Inc.

Tell your doctor if you are pregnant or plan to become pregnant.

Safe use of Antabuse during pregnancy has not been established. Antabuse should only be used during pregnancy when the probably benefits outweigh the risks.

Take Antabuse exactly as prescribed.

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

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Antabuse at the same time.

You should not use disulfiram if you have recently taken metronidazole or paraldehyde, or if you have consumed any foods or products that contain alcohol (mouthwash, cough medicine, cooking wine or vinegar, certain desserts, and others).

Do not take disulfiram 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.

Disulfiram should never be given to a person without his or her knowledge of taking the medicine.

Do not take disulfiram 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 disulfiram if you are allergic to it, 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 disulfiram 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 disulfiram 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.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You will need frequent blood tests to check your liver function.

Wear a medical alert tag or carry an ID card stating that you take disulfiram. Any medical care provider who treats you should know that you are using disulfiram.

When disulfiram is used as part of a treatment program for alcohol addiction or detoxification, your doctor may recommend that this medicine be given to you by a family member or other caregiver. This is to make sure you are using the medicine as it was prescribed as part of your treatment.

Additional forms of counseling and/or monitoring may be recommended during treatment with disulfiram.

For best results, keep using this medicine as directed. Disulfiram is sometimes given for up to several months or years.

Store at room temperature away from moisture, heat, and light.

General

• Initiate therapy in a hospital or physician’s office after a complete physical examination.a

• Patient must be fully aware of therapy, thoroughly understand the disulfiram-alcohol reaction, and be supervised by regular office visits and psychotherapy.a b

Disulfiram-Alcohol Test Reaction

• Considered by most clinicians to be unnecessary and may be associated with increased drug toxicity.a

• If deemed necessary, perform only under careful medical supervision (e.g., in a hospital) and with adequate facilities (including oxygen) available for treatment of a severe reaction.a b Do not perform test reaction in patients >50 years of age.a b

• After 1–2 weeks of disulfiram therapy, slowly administer 15 mL of 100-proof whiskey (or its equivalent) to the patient; dose of alcohol may be repeated once but should not exceed 30 mL of whiskey.a b Discontinue alcohol as soon as symptoms develop.a b (See Disulfiram-Alcohol Reaction under Cautions.)

Adherence to Therapy

• Assume patients on maintenance doses who report ability to drink alcoholic beverages without symptoms are disposing of disulfiram tablets without ingesting.b Observe daily intake of tablets (preferably crushed and well mixed with liquid) before concluding disulfiram is ineffective.b

Administration

Oral Administration

Administer orally once daily, usually in the morning.b If sedation occurs, may administer at bedtime.b

Do not administer until patient has abstained from alcohol for ≥12 hours.b Never administer without the patient’s knowledge.b (See Boxed Warning.)

If adherence is a problem, administer under close supervision, preferably as crushed tablets well mixed with liquid.a b

Dosage

Adults

Initially, maximum 500 mg once daily for 1–2 weeks.a b May reduce dosage if sedation occurs.b

Average maintenance dosage: 250 mg daily (range: 125–500 mg daily) until patient is fully recovered socially and a basis for permanent self-control is established.a b Treatment may be required for months or years.a b

Prescribing Limits

Adults

Maximum 500 mg daily.a b

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.a b Use with extreme caution.b (See Hepatic Effects and also Concomitant Diseases under Cautions.)

Renal Impairment

No specific dosage recommendations at this time.a b Use with extreme caution in patients with acute or chronic nephritis.b (See Concomitant Diseases under Cautions.)

Geriatric Patients

Select dosage with caution, usually starting at low end of dosing range, because of age-related decreases in hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy.b

Patients who are receiving or have recently received metronidazole, paraldehyde, alcohol, or alcohol-containing preparations, e.g., cough syrups, tonics and the like, should not be given disulfiram.

Disulfiram is contraindicated in the presence of severe myocardial disease or coronary occlusion, psychoses, and hypersensitivity to disulfiram or to other thiuram derivatives used in pesticides and rubber vulcanization.

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

Before taking this medication, tell your doctor if you have

• liver disease,
• kidney disease;
• thyroid disease;
• diabetes;
• brain damage or mental disorders;
• epilepsy or another seizure disorder.

You may not be able to take disulfiram, or you may require a lower dose or special monitoring during your therapy if you have any of these conditions.

Your doctor may want you to carry an identification card that states you are taking disulfiram. Ask your health care provider if you have any questions about this.

Disulfiram is in the FDA pregnancy category C. This means that it is not known whether disulfiram will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.

Disulfiram passes into breast milk in small amounts and may affect a nursing baby. Do not take disulfiram without first talking to your doctor if you are breast-feeding a baby.

Antabuse (disulfiram) blocks an enzyme that is involved in metabolizing alcohol intake. Disulfiram produces very unpleasant side effects when combined with alcohol in the body.

Antabuse is used in certain people with chronic alcoholism. This medicine can help keep you from drinking because of the unpleasant side effects that will occur if you consume alcohol while taking Antabuse.

Antabuse is used together with behavior modification, psychotherapy, and counseling support to help you stop drinking. This medicine is not a cure for alcoholism.

Get emergency medical help if you have any of these signs of an allergic reaction to Antabuse: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Even small amounts of alcohol can produce unpleasant symptoms while Antabuse is in your body. These symptoms include:

• flushing (warmth, redness, or tingly feeling);

• sweating, increased thirst, swelling, rapid weight gain;

• nausea, severe vomiting;

• neck pain, throbbing headache, blurred vision;

• chest pain, shortness of breath (even with mild exertion);

• fast or pounding heartbeats or fluttering in your chest;

• confusion, weakness, spinning sensation, feeling unsteady; or

• a light-headed feeling, like you might pass out.

More severe symptoms may occur when Antabuse and large amounts of alcohol are used together, such as severe chest pain spreading to your jaw or shoulder, slow heart rate, weak pulse, seizure, fainting, weak or shallow breathing, or slow breathing (breathing may stop). A disulfiram-alcohol reaction can be fatal.

Call your doctor at once if you have:

• eye pain or sudden vision loss;

• confusion, unusual thoughts or behavior; or

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Antabuse side effects may include:

• skin rash, acne;

• mild headache, tired feeling;

• impotence, loss of interest in sex; or

• metallic or garlic-like taste in the mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.