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BUTISOL SODIUM® CIII (butabarbital sodium tablets)
(Butabarbitol Sodium Tablets, USP AND Butabarbitol Sodium Oral Solution, USP) TABLETS & ORAL SOLUTION
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:
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 serious side effects may be more likely to occur, such...
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...
Last reviewed on RxList: 8/3/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Butisol Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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