Yes

Barbiturate

Preanesthetic agent; short-term treatment of insomnia

C-II

D

Hypersensitivity to barbiturates or any component of the formulation; marked hepatic impairment; dyspnea or airway obstruction; porphyria

Should be used only after evaluation of potential causes of sleep disturbance. Failure of sleep disturbance to resolve after 7-10 days may indicate psychiatric or medical illness. Potential for drug dependency exists, abrupt cessation may precipitate withdrawal, including status epilepticus in epileptic patients. Do not administer to patients in acute pain. Use caution in elderly, debilitated, renally impaired, or pediatric patients. May cause paradoxical responses, including agitation and hyperactivity, particularly in acute pain and pediatric patients. Use with caution in patients with depression or suicidal tendencies, or in patients with a history of drug abuse. Tolerance, psychological and physical dependence may occur with prolonged use. Use with caution in patients with hepatic function impairment. May cause CNS depression, which may impair physical or mental abilities. Patients must be cautioned about performing tasks which require mental alertness (ie, operating machinery or driving). Effects with other sedative drugs or ethanol may be potentiated. May cause respiratory depression or hypotension, Use with caution in hemodynamically unstable patients or patients with respiratory disease.

>10%:

Central nervous system: Dizziness, lightheadedness, "hangover" effect, drowsiness, CNS depression, fever

Local: Pain at injection site

1% to 10%:

Central nervous system: Confusion, mental depression, unusual excitement, nervousness, faint feeling, headache, insomnia, nightmares

Gastrointestinal: Nausea, vomiting, constipation

<1%: Hypotension, hallucinations, rash, exfoliative dermatitis, urticaria, Stevens-Johnson syndrome, agranulocytosis, megaloblastic anemia, thrombocytopenia, thrombophlebitis, respiratory depression, apnea, laryngospasm

Symptoms of overdose include unsteady gait, slurred speech, confusion, jaundice, hypothermia, fever, hypotension, respiratory depression, and coma. Charcoal hemoperfusion or hemodialysis may be useful, especially in the presence of very high serum barbiturate levels when the patient is in shock, coma, or renal failure. Forced alkaline diuresis is of no value in the treatment of intoxications with short-acting barbiturates.

Barbiturates are enzyme inducers. Patients should be monitored when these drugs are started or stopped for a decreased or increased therapeutic effect respectively.

Increased toxicity when combined with other CNS depressants, antidepressants, benzodiazepines, chloramphenicol, or valproic acid; respiratory and CNS depression may be additive

MAOIs may prolong the effect of secobarbital

Barbiturates stimulate the metabolism of beta-blockers and decrease their serum concentrations; consider a renally-eliminated beta-blocker (atenolol, nadolol)

Barbiturates may enhance the hepatotoxic potential of acetaminophen via an increased formation of toxic metabolites

Barbiturates may increase chloramphenicol metabolism and chloramphenicol may inhibit the metabolism of barbiturates. Barbiturates may increase the metabolism of corticosteroids, cyclosporine, disopyramide, griseofulvin, nifedipine, oral contraceptives, phenytoin, propafenone, quinidine, verapamil; dosage adjustments may be useful.

Barbiturates may enhance the metabolism of methadone resulting in methadone withdrawal

Interferes with transmission of impulses from the thalamus to the cortex of the brain resulting in an imbalance in central inhibitory and facilitatory mechanisms

Onset of hypnosis:

Oral: Within 1-3 minutes

I.V. injection: Within 15-30 minutes

Duration: ~15 minutes

Absorption: Oral: Well absorbed (90%)

Serum half-life: 25 hours

Time to peak serum concentration: Within 2-4 hours

Hypnotic:

Adults:

I.M.: 100-200 mg/dose

I.V.: 50-250 mg/dose

Hemodialysis: Slightly dialyzable (5% to 20%)

No information available to require special precautions

No effects or complications reported

I.V.: Patient instruction and information is determined by patient condition and therapeutic purpose.

I.V.: Administer undiluted or diluted with sterile water for injection, normal saline, or Ringer's injection; maximum infusion rate: 50 mg/15 seconds

Stability: Do not shake vial during reconstitution, rotate ampul; aqueous solutions are not stable, reconstitute with aqueous polyethylene glycol; aqueous (sterile water) solutions should be used within 30 minutes; do not use bacteriostatic water for injection or lactated Ringer's. I.V. form is incompatible when mixed with benzquinamide (in syringe), cimetidine (same syringe), codeine, erythromycin, glycopyrrolate (same syringe), hydrocortisone, insulin, levorphanol, methadone, norepinephrine, pentazocine, phenytoin, sodium bicarbonate, tetracycline, vancomycin

Capsule, as sodium: 100 mg

Levine HL, Cohen ME, Duffner PK, et al, "Rectal Absorption and Disposition of Secobarbital in Epileptic Children," Pediatr Pharmacol (New York), 1982, 2(1):33-8.

Monteil RA, Raybaud H, Madinier I, et al, "Occurrence of Oral Mucosal Necrosis in a Patient With Barbiturate-Induced Coma," Oral Surg Oral Med Oral Pathol, 1991, 72(5):562-4.

Nahata MC, Starling S, and Edwards RC, "Prolonged Sedation Associated With Secobarbital in Newborn Infants Receiving Ventilatory Support," Am J Perinatol, 1991, 8(1):35-6.

Tracqui A, Kintz P, Mangin P, et al, "A Fatality Involving Secobarbital, Nitrazepam, and Codeine," Am J Forensic Med Pathol, 1989, 10(2):130-3.

Wolfert RR and Cox RM, "Room Temperature Stability of Drug Products Labeled for Refrigerated Storage," Am J Hosp Pharm, 1975, 32(6):585-7.