Antabuse

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.

Antabuse is a prescription medication used to treat chronic alcoholism.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Odyssey Pharmaceuticals, Inc.

Serious side effects have been reported with Antabuse. See the “Antabuse Precautions” section.

Common side effects seen during the first 2 weeks of therapy often include:

• drowsiness
• headache
• fatigue
• acne
• changes in taste (metallic or garlic-like)
• impotence
• skin rash

These side effects tend to be mild and usually only last a short time.

Antabuse, if taken with even small amounts of alcohol,can cause unpleasant effects. These effects include:

• flushing of the face
• headache
• nausea
• vomiting
• chest pain
• weakness
• blurred vision
• mental confusion
• sweating
• choking
• breathing difficulty
• anxiety

These effects begin about 10 minutes after alcohol enters the body and last for at least an hour.Do not drink any alcoholic beverages(including wine, beer, and medications that contain alcohol such as cough syrup) while taking Antabuse, during the 12-hour period before you take your first dose, and for several weeks after stopping the drug.

This is not a complete list of Antabuse side effects.Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

• amitriptyline (Elavil)
• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• isoniazid
• metronidazole (Flagyl)
• phenytoin (Dilantin)
• any nonprescription drugs that might contain alcohol

This is not a complete list of Antabuse drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Antabuse including the following:

• Liver toxicity. Tell your healthcare provider right away if you have some or all of the following symptoms of liver toxicity:
  • excessive fatigue or weakness
  • loss of appetite
  • nausea
  • vomiting
  • yellowing of the skin or eyes
  • dark urine

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

Do not take Antabuse if you:

• are allergic to Antabuse or to any of its ingredients
• are allergic to thiuram derivatives used in pesticides and rubber vulcanization
• have recently taken metronidazole, paraldehyde, alcohol, or alcohol-containing preparations such as cough syrups and tonics
• have severe myocardial disease or coronary occlusion
• have psychoses

Patients must avoid alcohol while taking Antabuse.

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.

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.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Antabuse crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, Antabuse should not be used by nursing mothers.

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.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication

The recommended maintenance dose range of Antabuse for the treatment of chronic alcoholism is 125 to 500 mg daily. The average maintenance dose is 250 mg daily. Therapy may be continued until the patient is fully capable of permanent self-control and recovered socially from the abuse of alcohol.

If you take too much Antabuse, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Antabuse is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Antabuse at room temperature.
• Keep this and all medicines out of the reach of children.
• Do not take Antabuse within 12 hours of consuming any type or form of alcohol.

WARNING

Antabuse should never be administered to a patient when he is in a state of alcohol intoxication, or without his full knowledge.

The physician should instruct relatives accordingly.