Active ingredient(s) and Contents

• Effective components

  • Topiramate 25mg, 50mg, 100mg, 200mg

• Other

  • - Qudexy 25 mg: Microcrystalline Cellulose, Ethylcellulose, Diethyl Phthalate, Hypromellose, Hard capsule (Size4)
    
    - Qudexy 50 mg: Hard capsule (Size 3), Microcrystalline Cellulose, Ethylcellulose, Diethyl Phthalate, Hypromellose
    
    - Qudexy 100 mg: Microcrystalline Cellulose, Hard capsule (Size 1), Ethylcellulose, Diethyl Phthalate, Hypromellose
    
    - Qudexy 200 mg: Microcrystalline Cellulose, Ethylcellulose, Hard capsule (Size 0), Diethyl Phthalate, Hypromellose

Dosage and administration

• It is recommended that therapy be initiated at a low dose followed by titration to an effective dose.
  This drug can be taken with or without food.
  Capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food. This drug/food mixture is to be swallowed immediately and not chewed. It must not be stored for future use.
  
  
  • 1. Monotherapy
    When concomitant antiepileptic drugs (AEDs) are withdrawn to achieve monotherapy with topiramate, The possible impact on seizure control should be considered. Unless other antiepileptic drugs are to be stopped immediately due to safety concerns, a gradual discontinuation at the rate of approximately one-third of the concomitant AED dose every two weeks is recommended.
    • 1) Adults (above 17 years of age)
      Treatment should begin with 25 mg administered every night for one week. The dose should then be increased at one- or two-week intervals by increments of 25 or 50 mg daily, and if the patient is unable to tolerate the titration regimen, longer intervals between increments can be used. Dose and titration rate should be guided by clinical outcome. The recommended initial target dose for monotherapy in adults is 100 to 200 mg daily. The maximum recommended dose is 500 mg daily.
    • 2) pediatric use (over 6 years of age)
      Treatment should begin at 0.5 to 1 mg/kg every night for the first week. The dose should then be increased at one or two-week intervals by increments of 0.5 to 1 mg/kg daily, and if the pediatric patient is unable to tolerate the titration regimen, smaller increments or longer dosing intervals can be used. Dose and titration rate in pediatric patients should be guided by clinical outcome.
      The recommended dose range for monotherapy in pediatric patients is 3 to 6 mg/kg daily.
  • 2. Adjunctive therapy
    
    • 1) Adults (above 17 years of age)
      the lowest effective dose was 200 mg, and the usual daily dose is 200 to 400 mg once. Depending on the patient, the maximum recommended dose of 800 mg daily can be administered. Therapy should begin at 25 to 50 mg nightly for first week, and it can begin at lower initial doses. Subsequently, at weekly or bi-weekly intervals, the dose should be increased by 25 to 50 mg once daily. If the patient is unable to tolerate the titration regimen, smaller increments or longer intervals between dose increments can be used. The dose should be determined according to the clinical effect.
    • 2) pediatric use (aged 2 to 16)
      The recommended total daily dose as adjunctive therapy is approximately 5 to 9 mg/kg once daily. Treatment should begin at 25 mg (or less, based on a range of 1 to 3 mg/kg daily) every night for the first week, and dose should then subsequently increase at one or two-week intervals in increments of 1 to 3 mg/kg daily to achieve the optimal clinical response. Dose titration should be guided by clinical outcome. Daily doses up to 30 mg/kg daily have been studied and were generally well tolerated.
  • 3. Patients with renal impairment
    
    • 1) In patients with moderate to severe renal impairment (CLcr < 70 mL/min/1.73 m2) half of the usual starting and maintenance dose is recommended.
    • 2) hemodialysis patients: Since this drug is removed from plasma by hemodialysis, for all patients receiving hemodialysis are recommended to administer an additional dose of up to 50% of a single dose on the day of hemodialysis. The supplemental dose should be increased based on the dialysis time, clearing rate of dialysis equipment and renal clearance of, etc., The supplemental dose should be administered in divided doses at the beginning and completion of the hemodialysis.
  • 4. Patients with hepatic impairment
    patients with hepatic impairment should be administered with caution as the clearance of this drug can be decreased.

Storage and handling

• Airtight container, keep at room temperature (1~30°C) and out of humidity