Topiramate

DRUG INFORMATION

  ADULT
    - See Full Prescribing Information for recommended dosage, and dosing considerations
      in patients with renal impairment, geriatric patients, and patients undergoing
      hemodialysis ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) 2.1 Dosing in Monotherapy
      Epilepsy Adults and Pediatric Patients 10 Years of Age and Older The recommended
      dose for topiramate monotherapy in adults and pediatric patients 10 years of age
      and older is 400 mg/day in two divided doses.
      Source: US FDA label for topiramate (topiramate), section 'dosage and
      administration', retrieved 2026-08-29
    - The dose should be achieved by titration according to the following schedule
      (Table 1): Table 1 Monotherapy Titration Schedule for Adults and Pediatric
      Patients 10 years and older Morning Dose Evening Dose Week 1 25 mg 25 mg Week 2 50
      mg 50 mg Week 3 75 mg 75 mg Week 4 100 mg 100 mg Week 5 150 mg 150 mg Week 6 200
      mg 200 mg Pediatric Patients 2 to 9 Years of Age Dosing in patients 2 to 9 years
      of age is based on weight.
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for topiramate (topiramate),
      section 'dosage and administration', retrieved 2026-08-29
    - During the titration period, the initial dose of topiramate is 25 mg/day nightly
      for the first week.
      Source: US FDA label for topiramate (topiramate), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Adjunctive Treatment for Epilepsy Pediatric Patients 2 Years of Age and Older The
      safety and effectiveness of topiramate as adjunctive therapy for the treatment of
      partial-onset seizures, primary generalized tonic-clonic seizures, or seizures
      associated with Lennox-Gastaut syndrome have been established in pediatric
      patients 2 years of age and older [see Adverse Reactions ( 6.1 ) and Clinical
      Studies ( 14.2 )] .
      Source: US FDA label for topiramate (topiramate), section 'pediatric use',
      retrieved 2026-08-29
    - After 20 days of double-blind treatment, topiramate (at fixed doses of 5, 15, and
      25 mg/kg/day) did not demonstrate efficacy compared with placebo in controlling
      seizures.
      Source: US FDA label for topiramate (topiramate), section 'pediatric use',
      retrieved 2026-08-29
    - Creatinine was the only analyte showing a noteworthy increased incidence
      (topiramate 25 mg/kg/day 5%, placebo 0%) of a markedly abnormal increase.
      Source: US FDA label for topiramate (topiramate), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - See Full Prescribing Information for recommended dosage, and dosing considerations
      in patients with renal impairment, geriatric patients, and patients undergoing
      hemodialysis ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) 2.1 Dosing in Monotherapy
      Epilepsy Adults and Pediatric Patients 10 Years of Age and Older The recommended
      dose for topiramate monotherapy in adults and pediatric patients 10 years of age
      and older is 400 mg/day in two divided doses.
      Source: US FDA label for topiramate (topiramate), section 'dosage and
      administration', retrieved 2026-08-29
    - It should not be stored for future use. 2.5 Dosing in Patients with Renal
      Impairment In patients with renal impairment (creatinine clearance less than 70
      mL/min/1.73 m 2 ), one-half of the usual adult dose of topiramate is recommended
      [see Use in Specific Populations ( 8.5 , 8.6 ), Clinical Pharmacology ( 12.3 )] .
      Source: US FDA label for topiramate (topiramate), section 'dosage and
      administration', retrieved 2026-08-29
    - The actual adjustment should take into account 1) the duration of dialysis period,
      2) the clearance rate of the dialysis system being used, and 3) the effective
      renal clearance of topiramate in the patient being dialyzed [see Use in Specific
      Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )] .
      Source: US FDA label for topiramate (topiramate), section 'dosage and
      administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for topiramate (topiramate),
      retrieved 2026-08-29

  PREGNANCY
    - Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors
      pregnancy outcomes in women exposed to topiramate during pregnancy.
      Source: US FDA label for topiramate (topiramate), section 'pregnancy', retrieved
      2026-08-29
    - Patients should be encouraged to enroll in the North American Antiepileptic Drug
      (NAAED) Pregnancy Registry if they become pregnant.
      Source: US FDA label for topiramate (topiramate), section 'pregnancy', retrieved
      2026-08-29
    - This registry is collecting information about the safety of antiepileptic drugs
      during pregnancy.
      Source: US FDA label for topiramate (topiramate), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Contraception Women of childbearing potential who are not planning a pregnancy
      should use effective contraception because of the risk of major congenital
      malformations, including oral clefts and the risk of infants being SGA [see Drug
      Interactions ( 7.4 ) and Use in Specific Populations ( 8.1 )] .
      Source: US FDA label for topiramate (topiramate), section 'nursing mothers',
      retrieved 2026-08-29
    - When topiramate (0, 0.2, 4, 20, and 100 mg/kg/day or 0, 2, 20, and 200 mg/kg/day)
      was administered orally to female rats during the latter part of gestation and
      throughout lactation, offspring exhibited decreased viability and delayed physical
      development at 200 mg/kg/day and reductions in pre- and/or postweaning body weight
      gain at 2 mg/kg/day and above.
      Source: US FDA label for topiramate (topiramate), section 'use in specific
      populations', retrieved 2026-08-29
    - The no-effect dose (0.2 mg/kg/day) for pre- and postnatal developmental toxicity
      in rats is less than the MRHD for epilepsy or migraine on a mg/m 2 basis. 8.2
      Lactation Risk Summary Topiramate is excreted in human milk [see Data].
      Source: US FDA label for topiramate (topiramate), section 'use in specific
      populations', retrieved 2026-08-29