Butabarbital ElixirGeneric Name:
Butabarbital (BUE-ta-BAR-bi-tal)Brand Name:
Butabarbital Elixir is used for:
Treating sleep disorders. It may also be used for other conditions as determined by your doctor.
Butabarbital Elixir is a barbiturate. It works by depressing the central nervous system, causing mild sedation or sleep, depending on the dose.
Do NOT use Butabarbital Elixir if:
- you are allergic to any ingredient in Butabarbital 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 Butabarbital Elixir:
Some medical conditions may interact with Butabarbital 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, mental or mood problems (eg, depression), or suicidal thoughts or behavior
Some MEDICINES MAY INTERACT with Butabarbital Elixir. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Monoamine oxidase inhibitors (MAOIs) (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 decreased by Butabarbital Elixir
This may not be a complete list of all interactions that may occur. Ask your health care provider if Butabarbital 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 Butabarbital Elixir:
Use Butabarbital Elixir as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Butabarbital 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 Butabarbital Elixir, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Butabarbital Elixir.
Important safety information:
- Butabarbital Elixir may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Butabarbital Elixir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Butabarbital Elixir; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking Butabarbital Elixir for longer than prescribed may be habit-forming.
- If your symptoms do not get better within 7 to 10 days or if they get worse, check with your doctor.
- Tell your doctor or dentist that you take Butabarbital Elixir before you receive any medical or dental care, emergency care, or surgery.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using Butabarbital Elixir. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.
- Some patients taking sleep medicines have performed certain activities while they were not fully awake. These have included sleep-driving, making and eating food, making phone calls, and having sex. Patients often do not remember these events after they happen. Such an event may be more likely to occur if you use a high dose of Butabarbital Elixir. It may also be more likely if you drink alcohol or take other medicines that may cause drowsiness while you use Butabarbital Elixir. Tell your doctor right away if such an event happens to you.
- Lab tests, including complete blood cell counts and kidney and liver function tests, may be performed while you use Butabarbital Elixir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Butabarbital Elixir with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness, depression, excitement, or confusion.
- PREGNANCY and BREAST-FEEDING: Butabarbital Elixir has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Butabarbital Elixir while you are pregnant. Butabarbital Elixir is found in breast milk. If you are or will be breast-feeding while you use Butabarbital Elixir, check with your doctor. Discuss any possible 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 Butabarbital Elixir. This is known as DEPENDENCE or addiction. If you suddenly stop taking Butabarbital Elixir, you may experience WITHDRAWAL symptoms. These may include anxiety, dizziness, hallucinations, lightheadedness, nausea, muscle twitching, seizures, sleeplessness, trembling hands and fingers, weakness, or vomiting.
Possible side effects of Butabarbital 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; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts or behavior; confusion; fainting; fever; hallucinations; mental or mood changes; nausea or vomiting; new or worsening trouble sleeping; severe dizziness; shortness of breath; swelling or tightness of the throat; very slow breathing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), 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 Butabarbital Elixir:
Store Butabarbital Elixir between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Butabarbital Elixir out of the reach of children and away from pets.
- If you have any questions about Butabarbital Elixir, please talk with your doctor, pharmacist, or other health care provider.
- Butabarbital 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 Butabarbital 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.
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