Jester Tablet 25 mg (Topiramate)

Adult dosage

It is preferable to start this medicine at a low dose and increase it to the effective dose. There is no need to monitor plasma concentrations to optimize treatment with this medicine. It may be administered with or without food. Swallow the tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy Adults (17 years of age or older): Start treatment with 25㎎ in the evening for the first week. Thereafter, increase the daily dose by 25 or 50㎎ at 1-2 week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating this rate of increase, lengthen the interval between dose increases. The dose and rate of increase should be determined according to clinical response. The recommended dose for adult monotherapy is 100～200mg daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated up to 1,000㎎ daily when receiving topiramate monotherapy. 2) Adjunctive therapy Adults (17 years of age or older) The minimum effective dose is 200mg daily, and the usual dose is 200-400mg daily in 2 divided doses. Depending on the patient, the dose may be increased up to the maximum recommended dose of 800mg daily. Initiate treatment with 25-50mg in the evening during the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50mg at 1-2 week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating an increased dose, a smaller dose increase may be made or the interval between increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start treatment with 25mg of this medicine in the evening for the first week. Thereafter, increase by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this increase, lengthen the interval between dose increases. The recommended daily dose is 100mg, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. The dose may be increased to 200mg daily; the dose and rate of increase should be determined according to clinical response. 3. Patients with renal impairment - In patients with moderate to severe renal impairment (CLcr < 70 mL/min/1.73 m2), it is recommended that the starting and maintenance doses be reduced to approximately 1/2. - Hemodialysis patients: Since 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, dialyzer clearance, and the patient's renal clearance, and administer in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution to patients with hepatic impairment because clearance of this medicine may be reduced.

Children's dosage

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

This medication may increase the risk of suicidal thoughts or actions, so if there are mood changes or unusual behaviors during treatment, it should be reported to healthcare professionals immediately. Epileptic patients taking this medication may be at risk of sudden death, thus requiring careful monitoring. Severe allergic skin reactions may occur, so if there is severe rash or blisters on the skin, use should be discontinued immediately and a doctor should be consulted. Those with hypersensitivity to this medication or specific genetic lactose intolerance should not take it. Women who are pregnant or planning to become pregnant should undergo a pregnancy test before use and should employ effective contraceptive methods. Patients with impaired kidney or liver function may be affected in terms of drug excretion and metabolism; thus, careful monitoring and dosage adjustment are necessary. This medication may increase the risk of kidney stone formation, so adequate fluid intake is important. If weight changes occur during treatment, dietary adjustments or nutritional supplementation should be considered. Central nervous system side effects such as drowsiness, dizziness, and concentration difficulties may occur, necessitating caution when driving or operating machinery. When discontinuing this medication, it should not be stopped abruptly but rather gradually reduced according to a doctor’s instructions to minimize the risk of seizures. This medication may interact with other drugs, so if any other medications are being taken, it should be reported to a healthcare professional. Especially for women taking contraceptive pills, this medication may reduce the contraceptive effect, so if there are any symptoms of bleeding or contraceptive failure, immediate consultation with a healthcare professional is necessary. When taken during pregnancy, there is a risk of fetal malformation and growth inhibition; therefore, use during pregnancy should be carefully decided only when absolutely necessary. Regular health checks including blood tests and kidney function tests are required while taking this medication. There may be problems with temperature regulation, so especially in hot weather, precautions against dehydration and heatstroke are necessary. If changes in consciousness, confusion, vomiting, and other symptoms occur, healthcare professionals should be notified immediately.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is also recommended to store it in a cool, dry place below 25 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle