Butabarbital Sodium

Trade Names:Butisol Sodium- Tablets 30 mg- Tablets 50 mg- Elixir 30 mg per 5 mL

Pharmacology

Depresses sensory cortex, decreases motor activity, alters cerebellar function, and produces drowsiness, sedation, and hypnosis.

Pharmacokinetics

Absorption

Absorption is increased if taken on an empty stomach.

Distribution

Rapidly distributed to all tissues and fluids with high concentration in the brain, liver, and kidneys. Bound to plasma and tissue proteins.

Metabolism

Metabolized by liver.

Elimination

Excreted in urine; plasma t _½ is 100 h.

Onset

¾ to 1 h.

Duration

6 to 8 h.

Indications and Usage

Short-term use (2 wk) as a sedative or hypnotic.

Contraindications

Hypersensitivity to barbiturates; history of manifest or latent porphyria.

Dosage and Administration

PO 50 to 100 mg at bedtime.

PO Daytime sedative: 15 to 30 mg, 3 or 4 times daily. Preoperative sedative: 50  to 100 mg, 60 to 90 min before surgery.

PO Preoperative sedative: 2 to 6 mg/kg (max, 100 mg).

Storage/Stability

Store tablets and elixir at controlled room temperature (68° to 77°F).

Drug Interactions

CNS depressant effects may be enhanced.

Activity of these drugs may be reduced by butabarbital.

Serum levels of carbamazepine, valproic acid, and succinimides may be reduced. Valproic acid may increase butabarbital levels.

May reduce contraceptive effectiveness.

The effects of butabarbital may be prolonged.

Risk of renal toxicity may be increased.

May increase butabarbital levels while phenytoin levels may increase or decrease.

Laboratory Test Interactions

Decreased serum bilirubin; false-positive phentolamine test results; decreased response to metyrapone.

Adverse Reactions

Cardiovascular

Bradycardia, hypotension, syncope (less than 1%).

CNS

Somnolence (1% to 3%); agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, abnormal thinking, headache (less then 1%).

GI

Nausea, vomiting, constipation (less than 1%).

Hepatic

Liver damage (less than 1%).

Respiratory

Hypoventilation, apnea (less than 1%).

Miscellaneous

Hypersensitivity (angioedema, skin rashes, exfoliative dermatitis), fever (less than 1%).

Precautions

Pregnancy

Category D .

Lactation

Excreted in breast milk.

Children

May respond with excitement rather than depression.

Elderly

Use with caution because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy. May react to barbiturates with marked excitement, depression, and confusion.

Renal Function

Use with caution and in reduced dosage.

Hepatic Function

Use with caution and in reduced dosage.

Special Risk Patients

Use with caution in patients with a history of drug abuse, who are mentally depressed, or who have suicidal tendencies.

Acute or chronic pain

Because paradoxical excitement may be induced, use with caution.

Dependence

May be habit forming; tolerance or psychological and physical dependence may occur with continued use.

Discontinuation

If treatment needs to be discontinued, attempt to gradually taper the dose over at least a 1-wk interval in patient who has been on prolonged therapy. Monitor patient for withdrawal symptoms (eg, increased anxiety, tremor, muscle or abdominal cramps, sweating). If significant withdrawal symptoms develop, reinstitute previous dosing schedule and attempt a less rapid tapering regimen after patient has stabilized.

Overdosage

Symptoms

Unsteady gait, slurred speech, sustained nystagmus, CNS and respiratory depression, Cheyne-Stokes respiration, areflexia, constriction of pupils, oliguria, tachycardia, hypotension, lowered body temperature, coma, shock syndrome (apnea, circulatory collapse, respiratory arrest, and death may occur), pneumonia, pulmonary edema, cardiac arrhythmia, CHF, renal failure, death.

Patient Information

• Advise patients or caregiver to read the patient information leaflet before starting therapy and with each refill.
• Advise patient with anxiety to take as needed and to seek alternative methods for controlling or preventing anxiety (eg, stress, reduction, counseling).
• Advise patient medication usually is started at a low dose and then gradually increased as tolerated until max benefit is obtained.
• Advise patient medication may be habit forming and to take as prescribed and not to stop taking or change dose unless advised by health care provider.
• Advise patient to take each dose without regard to meals but to take with food if stomach upset occurs.
• Advise patient using elixir to measure and administer prescribed dose using dosing syringe, dosing spoon, or dosing cup.
• Advise patient if a dose is missed to skip that dose and take the next dose at the regularly scheduled time. Caution patient never to take 2 doses at same time.
• Advise patient if medication needs to be discontinued after long-term use, it usually will be slowly withdrawn over 1 wk or more unless safety concerns (eg, rash) require a more rapid withdrawal.
• Instruct patient to avoid alcoholic beverages and other depressants while taking this medication.
• Advise patient that drug may impair judgement, thinking, or motor skills, or cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.

Copyright © 2009 Wolters Kluwer Health.