Yes

Barbiturate

Sedative; hypnotic

C-III

D

Hypersensitivity to barbiturates or any component of the formulation; porphyria

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, 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. May cause respiratory depression or hypotension. Use with caution in hemodynamically unstable patients or patients with respiratory disease.

>10%: Central nervous system: Dizziness, lightheadedness, drowsiness, "hangover" effect

1% to 10%:

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

Gastrointestinal: Constipation, nausea, vomiting

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

Symptoms of overdose include slurred speech, confusion, nystagmus, tachycardia, 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

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

Distribution: V_d: 0.8 L/kg

Protein binding: 26%

Metabolism: In the liver

Half-life: 40-140 hours

Time to peak serum concentration: Oral: Within 40-60 minutes

Elimination: In urine as metabolites

Oral:

Adults:

Sedative: 15-30 mg 3-4 times/day

Hypnotic: 50-100 mg

Preop: 50-100 mg 1-11/2 hours before surgery

Alcohol: Additive CNS effects, avoid use

Therapeutic: Not established; Toxic: 28-73 mg/mL

ammonia (B); bilirubin (S)

Drowsiness is common

Rare reports of agranulocytosis; use caution with clozapine and carbamazepine; enzyme induction effects of barbiturates may decrease effects of psychotropics; CNS depressant effects of psychotropics may be enhanced by barbiturates

No information available to require special precautions

No effects or complications reported

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 driving or engaging in tasks requiring alertness until response to drug is known); nausea or vomiting (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); constipation (increased exercise, fluids, or dietary fruit and fiber may help). Report skin rash or irritation; CNS changes (confusion, depression, increased sedation, excitation, headache, insomnia, or nightmares); difficulty breathing or shortness of breath; difficulty swallowing or feeling of tightness in throat; unusual weakness or unusual bleeding in mouth, urine, or stool; or other unanticipated adverse effects. Pregnancy/breast-feeding precautions: Do not get pregnant while taking this medication; use appropriate contraceptive measures. Do not breast-feed.

Raise bed rails; initiate safety measures; aid with ambulation; monitor for CNS depression

Capsule: 15 mg, 30 mg

Elixir, with alcohol 7%: 30 mg/5 mL (480 mL, 3780 mL); 33.3 mg/5 mL (480 mL, 3780 mL)

Tablet: 15 mg, 30 mg, 50 mg, 100 mg