Trade Names:Butisol Sodium- Tablets 30 mg- Tablets 50 mg- Elixir 30 mg per 5 mL
Depresses sensory cortex, decreases motor activity, alters cerebellar function, and produces drowsiness, sedation, and hypnosis.
Absorption is increased if taken on an empty stomach.
Rapidly distributed to all tissues and fluids with high concentration in the brain, liver, and kidneys. Bound to plasma and tissue proteins.
Metabolized by liver.
Excreted in urine; plasma t ½ is 100 h.
¾ to 1 h.
6 to 8 h.
Short-term use (2 wk) as a sedative or hypnotic.
Hypersensitivity to barbiturates; history of manifest or latent porphyria.
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.Children
PO Preoperative sedative: 2 to 6 mg/kg (max, 100 mg).
Store tablets and elixir at controlled room temperature (68° to 77°F).
CNS depressant effects may be enhanced.Anticoagulants (eg, warfarin), beta-blockers (eg, metoprolol), corticosteroids, doxycycline, felodipine, griseofulvin, methadone, metronidazole, nifedipine, quinidine, theophyllines, verapamil
Activity of these drugs may be reduced by butabarbital.Anticonvulsants
Serum levels of carbamazepine, valproic acid, and succinimides may be reduced. Valproic acid may increase butabarbital levels.Estrogens, estrogen-containing oral contraceptives
May reduce contraceptive effectiveness.MAOIs
The effects of butabarbital may be prolonged.Methoxyflurane
Risk of renal toxicity may be increased.Phenytoin
May increase butabarbital levels while phenytoin levels may increase or decrease.
Decreased serum bilirubin; false-positive phentolamine test results; decreased response to metyrapone.
Bradycardia, hypotension, syncope (less than 1%).
Somnolence (1% to 3%); agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, abnormal thinking, headache (less then 1%).
Nausea, vomiting, constipation (less than 1%).
Liver damage (less than 1%).
Hypoventilation, apnea (less than 1%).
Hypersensitivity (angioedema, skin rashes, exfoliative dermatitis), fever (less than 1%).
Ensure 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.
Category D .
Excreted in breast milk.
May respond with excitement rather than depression.
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.
Use with caution and in reduced dosage.
Use with caution and in reduced dosage.
Use with caution in patients with a history of drug abuse, who are mentally depressed, or who have suicidal tendencies.
Because paradoxical excitement may be induced, use with caution.
May be habit forming; tolerance or psychological and physical dependence may occur with continued use.
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.
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.
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