Butabarbital Sodium Oral solution

What is this medicine?

BUTABARBITAL (byoo ta BAR bi tal) is a barbiturate. It is used to help you relax for sleep.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• acute or chronic pain
• attempted suicide
• drug abuse or addiction
• if you frequently drink alcohol containing drinks
• liver disease
• lung or breathing disease
• mental depression
• porphyria
• an unusual or allergic reaction to butabarbital, other barbiturates, tartrazine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• other barbituates
• voriconazole

This medicine may also interact with the following medications:

• alcohol or medicines that contain alcohol
• antihistamines
• doxycycline
• female hormones, like estrogens or progestins and birth control pills
• griseofulvin
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• medicines for depression, anxiety, or psychotic disturbances
• medicines for sleep
• muscle relaxants
• narcotic medicines for pain
• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• steroid medicines like prednisone or cortisone
• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups.

Do not take this medicine unless you are able to get a full night's sleep before you must be active again. You may not be able to remember things that you do in the hours after you take this medicine. Some people have reported driving, making phone calls, or preparing and eating food while asleep after taking sleep medicine. Take this medicine right before going to sleep. Tell your doctor if you are have any problems with your memory.

If you have been taking this medicine for a long time, do not suddenly stop taking it because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a nonmedical reason. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• agitation, confusion, irritability
• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in vision
• feeling faint, lightheaded
• fever
• hallucinations
• low blood pressure
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• unusual activities while asleep like driving, eating, making phone calls
• unusual bleeding, bruising
• unusually weak or tired
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation
• dizziness
• drowsiness
• headache
• nausea, vomiting
• nightmares, trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep closed tightly. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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.