Topiramate 25mg Tablets (Topiramate)

Adult dosage

It is advisable to start this medicine at a low dose and increase it to the effective dose. Monitoring plasma concentrations is not necessary to optimize treatment with this medicine. The recommended dose applies to all adults and children, including older adults, provided they do not have renal disease. This medicine may be taken with or without food. Swallow the tablet whole; do not crush it. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to use topiramate as monotherapy, the potential effect on seizure control should be considered. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be gradually tapered and discontinued, reducing the dose by approximately 1/3 at 2-week intervals (see Precautions for Use, “5. General Precautions”). When enzyme-inducing drugs are discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentrations occurs, the dose of this medicine may need to be reduced. Adults (17 years of age and older): Start with 25 mg in the evening during the first week. Thereafter, increase the total daily dose by 25 or 50 mg at intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating this titration, extend the interval between dose increases. The dose and rate of titration should be determined according to clinical response. The recommended dose for adult monotherapy is 100–200 mg daily. The maximum recommended dose is 500 mg daily. Some patients with recurrent epilepsy have tolerated up to 1,000 mg daily of topiramate monotherapy. 2) Adjunctive therapy Adults (17 years of age and older) The minimum effective dose is 200 mg daily, and the usual dose is 200-400 mg daily in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800 mg daily. Start treatment with 25-50 mg in the evening during the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50 mg at intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating the increased dose, the dose increase may be smaller or the interval between increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start with 25 mg of this medicine in the evening during the first week. Thereafter, increase the dose by 25 mg/day at 1-week intervals. If the patient has difficulty tolerating this titration, extend the interval between dose increases. The recommended dose is 100 mg daily, administered in 2 divided doses. Some patients may respond to a dose of 50 mg daily. Doses up to 200 mg daily may be administered; the dose and rate of titration should be determined according to clinical response. 3. Patients with renal impairment - For patients with moderate or severe renal impairment (CLcr < 70 mL/min/1.73 m2), it is recommended to reduce the starting and maintenance doses to approximately 1/2. - Hemodialysis patients: Because this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis apparatus, and the patient's residual renal clearance, and administer the dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Use this medicine with caution in patients with hepatic impairment, as its clearance may be reduced.

Children's dosage

1. Epilepsy 1) Monotherapy Children (6-16 years): Start with 0.5-1 mg/kg in the evening during the first week. Thereafter, increase the dose by 0.5-1 mg/kg/day at intervals of 1-2 weeks and administer twice daily. If the patient has difficulty tolerating the dose increase, use smaller increments or extend the interval between increases. The dose and extent of titration should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6 mg/kg daily. Experience is available with doses up to 500 mg daily in children diagnosed with partial seizures. 1. Epilepsy 2) Adjunctive therapy Children (2-16 years): The recommended dose is approximately 5-9 mg/kg daily, administered in 2 divided doses. During the first week, administer 25 mg (or less, based on 1-3 mg/kg daily) in the evening; thereafter, increase the dose by 1-3 mg/kg/day at intervals of 1-2 weeks and administer in 2 divided doses until an appropriate clinical effect is achieved. Dose titration should be based on clinical effect. Doses up to 30 mg/kg daily have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or actions; therefore, if there are any mood changes or behavioral abnormalities while taking this medication, the prescribing physician should be consulted immediately. In patients with epilepsy, sudden unexplained deaths may occur, hence regular health check-ups are necessary. This medication may cause serious skin reactions; therefore, if there are symptoms such as rashes or blisters, the medication should be discontinued immediately and the healthcare provider should be informed. Individuals who are allergic to any of this medication's ingredients or who have certain genetic lactose problems should not take this medication. Women of childbearing potential should have a pregnancy test before taking this medication, and should use effective contraception during treatment, as it may pose risks to the fetus if taken during pregnancy. Patients with impaired kidney or liver function may experience delayed elimination of this medication, so dosage adjustments should be made according to a physician's instructions. Adequate hydration is essential during treatment to reduce the risk of kidney stones, and particular attention should be paid to this. Drowsiness, dizziness, or blurred vision may occur during treatment, so caution should be exercised while driving or operating machinery. This medication can interact with other drugs; therefore, it is important to inform the healthcare provider about any other medications being taken during treatment. Suddenly stopping this medication can worsen seizures, thus any dosage reductions should be done gradually according to the physician's advice. This medication can cause various side effects including weight loss, loss of appetite, depression, memory impairment, etc.; if any adverse symptoms persist or worsen, the treating physician should be consulted. Taking this medication during pregnancy may increase the risk of congenital malformations and low birth weight; thus, special care is needed for women who are planning to become pregnant or who are pregnant.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• paresthesia
• hyperesthesia
• ataxia

Store this medication in a tightly sealed container to prevent air and moisture ingress. It is also recommended to keep it in a cool and dry place below 25 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle