Pronunciation: am-oh-BAR-bih-tahl SO-dee-uhm
Class: Sedative, Hypnotic, Barbiturate
- Powder for injection 500 mg
Depresses sensory cortex; decreases motor activity; alters cerebellar function and produces drowsiness, sedation and hypnosis.
Rapidly distributed to all tissues and fluids, with high concentrations in brain, liver, and kidneys. Bound to plasma and tissue proteins.
Metabolized by hepatic microsomal enzyme system.
Plasma t ½ is about 25 h. Metabolites excreted in urine and to a lesser extent in the feces. Negligible amount eliminated unchanged in urine.
0.75 to 1 h.
6 to 8 h.
Indications and Usage
Relief of anxiety; short-term therapy for insomnia; induction of preanesthetic sedation.
Hypersensitivity to barbiturates; history of addiction to sedative-hypnotic drugs; history of porphyria; severe liver impairment; respiratory disease with dyspnea; patients with nephritis.
Dosage and AdministrationInsomnia
PO/IM/IV 65 to 200 mg at bedtime.Sedation
PO/IM/IV 30 to 50 mg twice daily or 3 times daily.Children
PO/IM 2 to 6 mg/kg/dose.
- Reconstitute solution with sterile water for injection, rotating vial to mix. Do not shake vial. Solution should clear within 5 min.
- Do not dilute with lactated Ringer's solution.
- Do not administer if solution is discolored or if precipitate is present.
- After reconstitution, inject solution within 30 min.
Store at room temperature. Do not freeze.
Drug InteractionsAlcohol, CNS depressants
Depressant effects of these drugs may be enhanced.Anticoagulants, beta-blockers, calcium-channel blockers (eg, verapamil), theophyllines
Activity of these drugs may be reduced.Anticonvulsants
Serum concentrations of carbamazepine, valproic acid and succinimides may be reduced. Valproic acid may increase barbiturate serum levels.Corticosteroids
Effectiveness may be reduced.Estrogens, estrogen-containing oral contraceptives
Effectiveness may be reduced.
Laboratory Test Interactions
Decreased serum bilirubin; false-positive phentolamine test results.
Bradycardia; hypotension; syncope.
Drowsiness; agitation; confusion; headache; hyperkinesia; ataxia; CNS depression; paradoxical excitement; nightmares; psychiatric disturbances; hallucinations; insomnia; dizziness.
Nausea; vomiting; constipation.
Blood dyscrasias (agranulocytosis, thrombocytopenia).
Hypoventilation; apnea; laryngospasm; bronchospasm.
Hypersensitivity reactions (eg, angioedema, rashes, exfoliative dermatitis); fever; injection site reactions (eg, local pain, thrombophlebitis).
Observe IV site during and after infusion. Extravasation or inadvertent intra-arterial injection may cause tissue necrosis, arterial spasm, thrombosis, or gangrene. If signs of extravasation or phlebitis appear at injection site, discontinue IV infusion and notify health care provider.
Category D .
Excreted in breast milk.
Safety and efficacy not established in children younger than 6 yr of age.
Use with caution; reduce dosage.
Use with caution; reduce dosage.
Tolerance or psychologic and physical dependence may occur with continued use.
Respiratory depression, CNS depression progressing to Cheyne-Stokes respiration, oliguria, tachycardia, hypotension, hypothermia, coma, shock, cessation of electrical activity in brain (extreme overdose).
- Advise patient not to increase dosage or stop therapy without advice of health care provider.
- Instruct patient to avoid alcohol, nicotine, and caffeine products.
- Advise patient that drug may cause drowsiness, and to use caution while driving or performing other tasks requiring mental alertness.
- Inform patient to report the following symptoms to health care provider: excessive sleepiness, fatigue, nausea, vomiting.
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