Butisol

DRUG DESCRIPTION

BUTISOL SODIUM® (butabarbital sodium tablets, USP and butabarbital sodium oral solution, USP) is a non-selective central nervous system depressant which is used as a sedative or hypnotic. It is available for oral administration as Tablets containing 30 mg or 50 mg butabarbital sodium; and as Oral Solution containing 30 mg/5 mL, with alcohol (by volume) 7%. Other ingredients in the Tablets are: calcium stearate, corn starch, dibasic calcium phosphate, FD&C Blue No. 1 (30 mg only), FD&C Yellow No. 5 (30 mg and 50 mg — see PRECAUTIONS), FD&C Yellow No. 6 (50 mg only). Other ingredients in the Oral Solution are: D&C Green No. 5, edetate disodium, FD&C Yellow No. 5 (see PRECAUTIONS), flavors (natural and artificial), propylene glycol, purified water, saccharin sodium, sodium benzoate. Butabarbital sodium occurs as a white, bitter powder which is freely soluble in water and alcohol, but practically insoluble in benzene and ether.

The structural formula for butabarbital sodium is:

Butisol sodium (butabarbital sodium) structural formula illustration

What are the possible side effects of butabarbital (Butisol Sodium)?

Butabarbital may cause a severe allergic reaction. Stop taking butabarbital and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling like you might pass out;
  • a fever or a sore throat;
  • sores in your mouth;
  • easy bruising or bleeding; or
  • trouble breathing or swallowing.

Less...

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What are the precautions when taking butabarbital sodium tablets (Butisol)?

Before taking butabarbital, tell your doctor or pharmacist if you are allergic to it; or to other barbiturates (such as phenobarbital); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain hormone problems (adrenal disease such as Addison's disease), liver problems, kidney problems, lung disease (such as sleep apnea, chronic obstructive pulmonary disease-COPD), mental/mood disorders (such as depression, thoughts of suicide), history of alcohol/substance abuse, personal/family history of a certain blood disorder (porphyria).

This drug may make...

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Butisol Consumer (continued)

SIDE EFFECTS: Unwanted sleepiness, trouble waking up, dizziness, excitation, headache, tiredness, loss of appetite, nausea, or vomiting may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, depression, hallucinations, thoughts of suicide, nightmares), slurred speech, staggering walk/clumsiness, double vision, memory problems.

Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, or have prepared/eaten food, made phone calls, or had sex while not fully awake. Often these people do not remember these events. If you discover that you have done any of these things, tell your doctor immediately. Drinking alcohol, taking other medications that cause drowsiness, or taking higher doses of butabarbital may increase your risk for this effect. Do not drink alcohol while using this medication.

Tell your doctor immediately if any of these rare but very serious side effects occur: slow/shallow breathing, fainting, slow heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking butabarbital, tell your doctor or pharmacist if you are allergic to it; or to other barbiturates (such as phenobarbital); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain hormone problems (adrenal disease such as Addison's disease), liver problems, kidney problems, lung disease (such as sleep apnea, chronic obstructive pulmonary disease-COPD), mental/mood disorders (such as depression, thoughts of suicide), history of alcohol/substance abuse, personal/family history of a certain blood disorder (porphyria).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

The liquid form of this product may contain alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, or any other condition that requires you to limit/avoid alcohol in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially drowsiness and dizziness. However, this drug can often cause excitement or confusion instead of drowsiness in older adults.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. Since birth control pills may not be effective if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor. If you become pregnant while taking this medication, notify your doctor immediately.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Butisol Patient Information Including Side Effects

Brand Names: Butisol Sodium

Generic Name: butabarbital (Pronunciation: byoo ta BAR bi tal)

  • What is butabarbital (Butisol)?
  • What are the possible side effects of butabarbital (Butisol)?
  • What is the most important information I should know about butabarbital (Butisol)?
  • What should I discuss with my healthcare provider before taking butabarbital (Butisol)?
  • How should I take butabarbital (Butisol)?
  • What happens if I miss a dose (Butisol)?
  • What happens if I overdose (Butisol)?
  • What should I avoid while taking butabarbital (Butisol)?
  • What other drugs will affect butabarbital (Butisol)?
  • Where can I get more information?

What is butabarbital (Butisol)?

Butabarbital is in a group of drugs called barbiturates (bar-BIT-chur-ates). Butabarbital slows the activity of your brain and nervous system.

Butabarbital is used short-term to treat insomnia, or as a sedative before surgery.

Butabarbital may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of butabarbital (Butisol)?

Butabarbital may cause a severe allergic reaction. Stop taking butabarbital and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling like you might pass out;
  • a fever or a sore throat;
  • sores in your mouth;
  • easy bruising or bleeding; or
  • trouble breathing or swallowing.

Less serious side effects may be more likely to occur, such as:

  • drowsiness or dizziness;
  • problems with memory or concentration;
  • excitement (especially in children or older adults);
  • joint or muscle pain;
  • nausea, vomiting, upset stomach, constipation; or
  • nightmares or increased dreaming.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about butabarbital (Butisol)?

Butabarbital may cause a severe allergic reaction. Stop taking butabarbital and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Take butabarbital only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking butabarbital and talk with your doctor about another treatment for your sleep disorder.

Do not use butabarbital without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Butabarbital can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking butabarbital.

Butabarbital may be habit-forming and should be used only by the person it was prescribed for. Butabarbital should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

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