Butabarbital Sodium
Pronouncation: (byoo-tah-BAR-bih-tahl SO-dee-uhm)Class: Sedative and hypnotic, Barbiturate
Trade Names:
Butisol Sodium
- Tablets 30 mg
- Tablets 50 mg
- Elixir 30 mg per 5 mL
Pharmacology
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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
HypnoticAdults
PO 50 to 100 mg at bedtime.
SedativeAdults
PO Daytime sedative: 15 to 30 mg, 3 or 4 times daily. Preoperative sedative: 50 to 100 mg, 60 to 90 min before surgery.
ChildrenPO 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
Alcohol, CNS depressantsCNS depressant effects may be enhanced.
Anticoagulants (eg, warfarin), beta-blockers (eg, metoprolol), corticosteroids, doxycycline, felodipine, griseofulvin, methadone, metronidazole, nifedipine, quinidine, theophyllines, verapamilActivity of these drugs may be reduced by butabarbital.
AnticonvulsantsSerum levels of carbamazepine, valproic acid, and succinimides may be reduced. Valproic acid may increase butabarbital levels.
Estrogens, estrogen-containing oral contraceptivesMay reduce contraceptive effectiveness.
MAOIsThe effects of butabarbital may be prolonged.
MethoxyfluraneRisk of renal toxicity may be increased.
PhenytoinMay 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
MonitorEnsure CBC with differential, renal function, and hepatic function are evaluated before starting therapy and periodically thereafter during prolonged treatment. Ensure therapy periodically is reviewed to determine if it needs to be continued without change or if a dose change (eg, increase, decrease, or discontinuation) is indicated. If being used for sleep induction or maintenance, limit duration of therapy to 2 wk. |
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.
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