Yes: Capsule

Barbiturate

Oral: Hypnotic in short-term treatment of insomnia; to reduce anxiety and provide sedation preoperatively

I.M., I.V.: Control status epilepticus or acute seizure episodes. Also used to control acute episodes of agitated behavior in psychosis and in "Amytal® Interviewing" for narcoanalysis

C-II

D

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

Safety has not been established in children <6 years of age. Use with caution in patients with CHF, hepatic or renal impairment, hypovolemic shock; when administered I.V., respiratory depression and hypotension are possible, have equipment and personnel available; this I.V. medication should be given only to hospitalized patients. Do not administer to patients in acute pain. Use caution in elderly, debilitated, renally impaired, hepatic impairment, 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. 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. Use with caution in patients with hypoadrenalism.

>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

If hypotension occurs, administer I.V. fluids and place the patient in the Trendelenburg position. If unresponsive, an I.V. vasopressor (eg, dopamine, epinephrine) may be required. Forced alkaline diuresis is of no value in the treatment of intoxications with short-acting barbiturates. Charcoal hemoperfusion or hemodialysis may be useful in the harder to treat intoxications, especially in the presence of very high serum barbiturate levels.

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

Barbiturates may enhance the hepatotoxic potential of overdoses of acetaminophen

Acetazolamide may decrease absorption of primidone (metabolized to phenobarbital) and reduce clinical effects

Barbiturates may increase the metabolism of some beta-blockers and decrease their clinical effect (atenolol and nadolol unlikely to interact given their renal elimination)

Barbiturates may increase the metabolism of chloramphenicol and chloramphenicol may inhibit barbiturate metabolism; monitor for altered response

Barbiturates may enhance the metabolism (decrease the efficacy) of antipsychotics; monitor for altered response; dose adjustment may be needed

Barbiturates may enhance the metabolism of calcium channel blockers, cimetidine, corticosteroids, cyclosporine, disopyramide, doxycycline, ethosuximide, furosemide, griseofulvin, lamotrigine, phenytoin, propafenone, quinidine, tacrolimus, TCAs, theophylline; dose adjustment may be needed

Barbiturates may increase the metabolism of estrogens and reduce the efficacy of oral contraceptives; an alternative method of contraception should be considered

Barbiturates, ethanol, and narcotic analgesics have additive CNS depressant effects

Felbamate may inhibit the metabolism of barbiturates and barbiturates may increase the metabolism of felbamate

Barbiturates may impair the absorption of griseofulvin

MAOIs may inhibit the metabolism of barbiturates

Barbiturates may enhance the nephrotoxic effects of methoxyflurane

Valproic acid inhibits the metabolism of barbiturates; monitor for excessive sedation; a dose reduction may be needed

Barbiturates inhibit the hypoprothrombinemic effects of oral anticoagulants via increased metabolism; this combination should generally be avoided

Barbiturates may enhance the metabolism of methadone resulting in methadone withdrawal

Hydrolyzes when exposed to air; use contents of vial within 30 minutes after constitution; use only clear solution

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 action: Oral: Within 1 hour; I.V.: Within 5 minutes

Distribution: Readily crosses the placenta; small amounts appear in breast milk

Metabolism: Chiefly in the liver by microsomal enzymes

Half-life, biphasic: Initial: 40 minutes; Terminal: 20 hours

Children: Oral:

Sedation: 6 mg/kg/day divided every 6-8 hours

Insomnia: 2 mg/kg or 70 mg/m²/day in 4 equally divided doses

Hypnotic: 2-3 mg/kg

Adults:

Insomnia: Oral: 65-200 mg at bedtime

Sedation: Oral: 30-50 mg 2-3 times/day

Preanesthetic: Oral: 200 mg 1-2 hours before surgery

Hypnotic:

Oral: 65-200 mg at bedtime

I.M., I.V.: 65-500 mg, should not exceed 500 mg I.M. or 1000 mg I.V.

Amobarbital interview: I.V.: 50 mg/minute for total dose up to 300 mg

Alcohol: Avoid use

Vital signs should be monitored during injection and for several hours after administration

Therapeutic: 1-5 mg/mL (SI: 4-22 mmol/L)

Toxic: >10 mg/mL (SI: >44 mmol/L)

Lethal: >50 mg/mL

ammonia (B); bilirubin (S)

No information available to require special precautions

No effects or complications reported

I.V./I.M.: Patient instructions and information are determined by patient condition and therapeutic purpose. If self-administered, use exactly as directed (do not increase dose or frequency or discontinue without consulting prescriber); may cause physical and/or psychological dependence. While using this medication, do not use alcohol or other prescription or OTC medications (especially pain medications, sedatives, antihistamines, or hypnotics) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). You may experience drowsiness, dizziness, or blurred vision (use caution when driving or engaging in tasks requiring alertness until response to drug is known); nausea, vomiting, or loss of appetite (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); constipation (increased exercise, fluids, or dietary fruit and fiber may help). If medication is used to control seizures, wear identification of epileptic status and medication. Report skin rash or irritation; CNS changes (confusion, depression, increased sedation, excitation, headache, insomnia, or nightmares); difficulty breathing or shortness of breath; changes in urinary pattern or menstrual pattern; muscle weakness or tremors; or difficulty swallowing or feeling of tightness in throat. Pregnancy/breast-feeding precautions: Do not get pregnant while taking this medication; use appropriate barrier contraceptive measures. Breast-feeding is not recommended.

Raise bed rails at night

Capsule, as sodium: 65 mg, 200 mg

Injection, as sodium: 500 mg

Tablet: 30 mg, 50 mg, 100 mg