【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)。

Epilepsy (partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome); Migraine

Blocks neuronal voltage-dependent sodium channels, enhances GABA(A) activity, antagonizes AMPA/kainate glutamate receptors, and weakly inhibits carbonic anhydrase.

Absorption: Good, rapid; immediate release formulation is unaffected by food. A single Trokendi XR dose with a high-fat meal increased the Cmax by 37% and shortened the Tmax to approximately 8 hours; this effect is significantly reduced following repeat administrations. A single Qudexy XR dose with a high-fat meal delayed the Tmax by 4 hours.
Distribution: Vd: 0.6 to 0.8 L/kg
Protein binding: 15% to 41% (inversely related to plasma concentrations)
Metabolism: Not extensively metabolized. Minor amounts metabolized in liver via hydroxylation, hydrolysis, and glucuronidation; there is evidence of renal tubular reabsorption; percentage of dose metabolized in liver and clearance are increased in patients receiving enzyme inducers (eg, carbamazepine, phenytoin)
Bioavailability: ~80% (immediate release)
Half-life elimination:
Trokendi XR: ~31 hours
Time to peak, serum:
Trokendi XR: ~24 hours
Excretion: Urine (~70% as unchanged drug); may undergo renal tubular reabsorption
Clearance:
Adults: 20 to 30 mL/minute

Recent alcohol use (ie, within 6 hours prior to and 6 hours after administration)

Topiramate may cause fetal harm if administered to a pregnant woman

According to the manufacturer, the decision to breastfeed during therapy should consider the risk and benefits.

Central nervous system: Paresthesia, fatigue, drowsiness , dizziness, memory impairment
Endocrine & metabolic: Decreased serum bicarbonate, hyperammonemia, weight loss
Gastrointestinal: Abdominal pain, anorexia, dysgeusia, nausea, diarrhea
Respiratory: Upper respiratory tract infection
Miscellaneous: Fever

Epilepsy, monotherapy: Partial-onset seizure and primary generalized tonic-clonic seizure:
Initial: 50 mg daily for 1 week; may increase weekly by 50 mg daily up to 200 mg once daily (week 4 dose); thereafter, may further increase weekly by 100 mg daily up to the recommended dose of 400 mg once daily.
Epilepsy, adjunctive therapy: Partial-onset seizure, primary generalized tonic-clonic seizure, or Lennox-Gastaut syndrome: Oral: Note: Doses >1600 mg have not been studied.
Extended release: Initial: 25 to 50 mg once daily for 1 week; may increase weekly by 25 to 50 mg daily until response; usual maintenance dose: 200 to 400 mg once daily (partial-onset seizures, Lennox-Gastaut syndrome) or 400 mg once daily (primary generalized tonic-clonic seizures). Doses >400 mg daily have not shown additional benefit for treatment of partial-onset seizures.
Migraine prophylaxis: Oral:
Extended release: Initial: 25 mg once daily; increase based on response and tolerability in weekly increments of 25 mg to the recommended dose of 100 mg once daily. Increased intervals between dose adjustments may be considered.

Anticonvulsant, adjunctive therapy:
Children and Adolescents 2 to 16 years:
Trokendi XR: Children and Adolescents 6 to 16 years, able to swallow capsule whole: Initial: 25 mg once daily (approximately 1 to 3 mg/kg/day) administered nightly for 1 week; increase at 1- to 2-week intervals in increments of 1 to 3 mg/kg/day rounded to the nearest appropriate capsule size administered once daily; titrate dose to response; usual maintenance: 5 to 9 mg/kg/dose once daily
Primary generalized tonic-clonic seizures:
Trokendi XR: Children and Adolescents 6 to 16 years, able to swallow capsule whole: Initial: 25 mg once daily (approximately 1 to 3 mg/kg/day) administered nightly for 1 week; increase over 8 weeks in increments of 1 to 3 mg/kg/day rounded to the nearest appropriate capsule size to a target dose of 6 mg/kg/day once daily

CrCl ≥70 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling.
CrCl <70 mL/minute/1.73 m2: Reduce dose to 50% of normal dose and titrate more slowly.
Hemodialysis: 50 to 100 mg twice daily; administer a supplemental dose (50 to 100 mg) post-dialysis. Topiramate is cleared by hemodialysis.
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There are no dosage adjustments provided in the manufacturer's labeling. However, topiramate clearance in hepatic impairment may be reduced. Use with caution.