DrugindexOnline^{2nd edition}

Generic Name: Butabarbital Elixir (byoo-tah-BAR-bih-tal)
Brand Name: Butisol Sodium

Butisol Sodium Elixir is used for:

Treating sleep disorders. It may also be used for other conditions as determined by your doctor.

Butisol Sodium Elixir is a barbiturate. It works by depressing the central nervous system, causing mild sedation or sleep, depending on the dose.

Do NOT use Butisol Sodium Elixir if:

• you are allergic to any ingredient in Butisol Sodium Elixir
• you have the blood disease porphyria
• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Butisol Sodium Elixir:

Some medical conditions may interact with Butisol Sodium Elixir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver problems, lung or respiratory tract disease, or a painful condition
• if you are in shock
• if you have a history of substance abuse or dependence, depression, or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Butisol Sodium Elixir. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Monoamine oxidase (MAO) inhibitors (eg, phenelzine) or sodium oxybate (GHB) because the risk of severe drowsiness may be increased
• Beta-blockers (eg, atenolol), clozapine, corticosteroids (eg, prednisone), doxycycline, estrogens (eg, micronized estradiol), griseofulvin, metronidazole, oral contraceptives (birth control pills), phenytoin, quinidine, theophylline, or valproic acid because their effectiveness may be reduced by Butisol Sodium Elixir

This may not be a complete list of all interactions that may occur. Ask your health care provider if Butisol Sodium Elixir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Butisol Sodium Elixir:

Use Butisol Sodium Elixir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Butisol Sodium Elixir may be taken with or without food.
• Use a measuring device marked for medicine dosing. Ask your pharmacist if you are unsure of how to measure your dose.
• If you miss a dose of Butisol Sodium Elixir and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Butisol Sodium Elixir.

Important safety information:

• Butisol Sodium Elixir may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Butisol Sodium Elixir. Using Butisol Sodium Elixir alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Butisol Sodium Elixir. Butisol Sodium Elixir will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Do not exceed the recommended dose or take Butisol Sodium Elixir for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking Butisol Sodium Elixir for longer than prescribed may be habit-forming.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Butisol Sodium Elixir.
• Butisol Sodium Elixir may decrease the effectiveness of your birth control pill. To prevent pregnancy, be sure to use an additional form of birth control while using Butisol Sodium Elixir.
• Butisol Sodium Elixir may contain tartrazine dye (FD&C Yellow No. 5), which can cause allergic reactions in certain patients. If you have previously had an allergic reaction to tartrazine, contact your pharmacist to determine if the medicine you are taking contains tartrazine.
• LAB TESTS, such as complete blood cell counts, and kidney and liver function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Butisol Sodium Elixir with caution in the ELDERLY because they may be more sensitive to its effects, especially drowsiness, depression, or confusion.
• PREGNANCY and BREAST-FEEDING: Butisol Sodium Elixir has been shown to cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Butisol Sodium Elixir during pregnancy. Butisol Sodium Elixir is excreted in breast milk. If you are or will be breast-feeding while you are using Butisol Sodium Elixir, check with your doctor or pharmacist to discuss the risks to your baby.

When sleep medicines are used every night for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as TOLERANCE. Sleep medicines should usually be used only for short periods of time, such as a few days and generally no longer than 1 or 2 weeks. If your sleep problems continue, contact your doctor.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Butisol Sodium Elixir. This is known as DEPENDENCE or addiction. If you suddenly stop taking Butisol Sodium Elixir, you may experience WITHDRAWAL symptoms, including anxiety, muscle twitching, trembling hands and fingers, weakness, dizziness, hallucinations, nausea, vomiting, sleeplessness, lightheadedness, or seizures.

Possible side effects of Butisol Sodium Elixir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Clumsiness; dizziness; excessive daytime drowsiness; lightheadedness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty sleeping; fainting; fever; hallucinations; severe dizziness; trouble sleeping; very slow breathing.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include change in size of pupil; cold, clammy skin; deep sleep; incoordination; loss of consciousness; slowed or fast breathing; slurred speech; trouble walking; unusual eye movements.

Proper storage of Butisol Sodium Elixir:

Store Butisol Sodium Elixir between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Butisol Sodium Elixir out of the reach of children and away from pets.

General information:

• If you have any questions about Butisol Sodium Elixir, please talk with your doctor, pharmacist, or other health care provider.
• Butisol Sodium Elixir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Butisol Sodium Elixir. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.