【藥品性質提示】 根據 2019 AGS Beers Criteria，本藥品為【潛在不適當用藥 (PIM)】，不建議用於有骨折風險之老年人(除非用於癲癇、調節情緒)。 【藥品訊息】 帝拔癲口服液 仿單

治療癲癇 Absence seizure, Simple and complex; Complex partial epileptic seizure

Anticonvulsants
Valproate sodium is an antiepileptic agent with unknown therapeutic mechanism of action, although, it is believed to exert its effect by increasing the concentrations of gamma-aminobutyric acid (GABA) in the brain.

Distribution
1. Vd: 11 L/1.73 m²
2. Protein binding: approximately 10% unbound at 40 mcg/mL and 18.5% unbound at 130 mcg/mL, concentration dependent
Metabolism
Hepatic; glucuronosyltransferase; over 40% by mitochondrial beta-oxidation, glucuronidation
Excretion
1. Renal: 30% to 50% as glucuronide conjugate, less than 3% unchanged
2. Dialyzable: yes (hemodialysis), about 20%
Elimination Half Life
1. 16 h +/- 3 h
2. Children (greater than 2 mo): 7 h to 13 h
3. Neonates (less than 10 days): 10 h to 67 h
4. Liver impairment: increased from 12 h to 18 h

1. Hepatic disease or significant hepatic dysfunction
2. Hypersensitivity to valproate sodium
3. Use in patients with mitochondrial disorders caused by mutations in mitochondrial DNA polymerase gamma (POLG; eg, Alpers-Huttenlocher syndrome) and in children younger than 2 years with a suspected POLG-related disorder
4. For prevention of migraine headaches in pregnant women
5. Urea cycle disorders

X (FDA) D (AUS)

Infant risk cannot be ruled out

Common:
Dermatologic: Injection site pain (2.6% ), Injection site reaction (2.4% )
Gastrointestinal: Nausea (3.2% )
Neurologic: Dizziness (5.2% to 7.1% ), Headache (2.7% to 4.3% ), Somnolence (1.7% to 10.7% )
Serious:
Endocrine metabolic: Hyperammonemia
Gastrointestinal: Pancreatitis
Hematologic: Myelodysplastic syndrome, Thrombocytopenia (27% )
Hepatic: Liver failure
Immunologic: Drug reaction with eosinophilia and systemic symptoms
Neurologic: Hyperammonemic encephalopathy

1. Initial: 10-15mg/kg/day, increased by 5-10mg/kg daily at one week intervals until seizures are controlled
2. Maximum recommended dosage: 60mg/kg/day

Seizures disorders: (Not recommended for ages <6 years)
1. Initial: 10-15mg/kg/day in 1 to 3 divided doses, increased by 5-10mg/kg daily at one week intervals until seizures are controlled
2. Maintenance: 30 to 60 mg/kg/day in 2 to 3 divided doses
Migraine prophylaxis: (Limited data available, for Children ≥12 years and Adolescents)
Initial 500 mg once daily for 15 days, may increase to 1,000 mg once dailiy; dose should be individualized

Mild to severe impairment: No dosage adjustment required (including patients on hemodialysis); however, protein binding is reduced in patients with renal impairment; monitoring only total valproate serum concentrations may be misleading

1. Mild to moderate impairment: Not recommended for use in hepatic disease; clearance is decreased with liver impairment.
2. Severe impairment: Use is contraindicated