【藥品性質提示】 根據 2019 AGS Beers Criteria，本藥品為【潛在不適當用藥 (PIM)】，不建議用於老年人。

Sedation: Use as a sedative
Seizures: Management of generalized tonic-clonic, status epilepticus, and partial seizures

Long-acting barbiturate with sedative, hypnotic, and anticonvulsant properties. Barbiturates depress the sensory cortex, decrease motor activity, alter cerebellar function, and produce drowsiness, sedation, and hypnosis. In high doses, barbiturates exhibit anticonvulsant activity; barbiturates produce dose-dependent respiratory depression.(UTD)

Distribution:
Neonates and Young Infants: Vd: 0.71 to 1.71 L/kg
Older Infants and Children: Vd: 0.57 to 0.7 L/kg
Adults: Vd: 0.54 to 0.73 L/kg
Metabolism: Hepatic by oxidation via CYP2C9 and to a lesser extent via CYP2C19 and CYP2E1, and by N-glucosidation
Bioavailability: Oral: Adults: 95% to 100%
Half-life elimination:
Neonates (<48 hours old), Infants, and Children: ~110 hours (60 to 180 hours); Adults: ~79 hours (range: 53 to 118 hours)
Excretion: Urine (25% to 50% as unchanged drug)(UTD)

Hypersensitivity to phenobarbital, barbiturates or any component of the formulation; marked hepatic impairment; dyspnea or airway obstruction; porphyria (manifest and latent); intra-arterial administration, subcutaneous administration (not recommended); use in patients with a history of sedative/hypnotic addiction; nephritic patients (large doses)(UTD)

D (FDA) D (AUS)

Drugs that have been associated with significant effects on some nursing infants and should be given to nursing mothers with caution.(AAP)
Compatible with breastfeeding. Monitor infant for side effects.(WHO)
Infant risk cannot be ruled out.(MDX)

Common:
Neurologic: Somnolence (1% to 3% )
Serious:
Cardiovascular: Syncope (less than 1% ), Thrombophlebitis
Hematologic: Megaloblastic anemia (less than 1% )
Hepatic: Liver damage (less than 1% )
Immunologic: Hypersensitivity reaction (less than 1% )
Other: Angioedema.

Sedation:
IV, IM: 30 to 120 mg/day in 2 to 3 divided doses; maximum: 400 mg/day
Preoperative sedation: IM: 100 to 200 mg 60 to 90 minutes before surgery
Status epilepticus:
American Epilepsy Society recommendations: 15 mg/kg as a single dose.
Neurocritical Care Society recommendation: 20 mg/kg (infused at 50 to 100 mg/minute); if necessary, may repeat once after 10 minutes with an additional 5 to 10 mg/kg
Seizures: Maintenance dose: Note: Maintenance dose usually starts 12 hours after loading dose.(UTD)

General Dosage Information:
this drug has not been found by the US Food and Drug Administration (FDA) to be safe and effective, and the drug product labeling has not been approved by the FDA.
discontinuation dosing, decrease the daily phenobarbital dosage by 10%, if tolerated, and monitor carefully.
Status epilepticus, For emergency use:
loading dose, 20 mg/kg IV infused no faster than 60 to 100 mg/min, followed by a maintenance dose of 5 mg/kg IV given at 12 and 24 hours after the loading dose was used in a clinical trial (n=60).

severe renal failure (GFR (glomerular filtration rate) less than 10 mL/min): dosing interval every 12 to 16 hours.

hepatic impairment: initial doses should be reduced