PITMATE Tablets (Topiramate)

Adult dosage

It is advisable 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. The recommended dose of this medicine applies equally to all adults and children, including older adults, in the absence of renal disease. This medicine may be taken with or without food. Swallow the tablet whole; do not crush it. Epilepsy monotherapy: When discontinuing another concomitant antiepileptic drug in order to use topiramate as monotherapy, the potential effect on seizure control should be considered. Unless another antiepileptic drug must be discontinued immediately for safety reasons, it should be tapered gradually by approximately 1/3 every 2 weeks (see section "5. General Precautions" under Precautions for Use). When an enzyme-inducing drug is discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentration occurs, the dose of this medicine may need to be reduced. Epilepsy monotherapy in adults (17 years and older): Start with 25㎎ in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at 1- to 2-week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating this titration schedule, extend the intervals between dose increases. The dose and rate of titration should be determined according to clinical response. The recommended dose for monotherapy in adults is 100～200mg daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses of up to 1,000㎎ daily. Epilepsy adjunctive therapy in adults (17 years and 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 to the maximum recommended dose of 800mg daily. Start 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- to 2-week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, smaller increments may be used or the intervals between dose increases may be extended. The dose should be determined according to clinical effect. Migraine prevention in adults: Start with 25mg of this medicine in the evening during the first week. Thereafter, increase the dose by 25mg/day at weekly intervals. If the patient has difficulty tolerating these increases, extend the intervals between dose increases. The recommended dose is 100mg daily, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. Doses of up to 200mg daily may be given; the dose and rate of titration should be determined according to clinical response. For patients with moderate or 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. Patients receiving hemodialysis: Since this medicine is removed from plasma by hemodialysis, the dose on dialysis days should be increased by approximately 1/2. The dose should be increased taking into account the duration of dialysis, the clearance of the dialysis system, and the patient's renal clearance, and should be administered in divided doses at the start and end of hemodialysis. Use with caution in patients with hepatic impairment, as clearance of this medicine may be reduced.

Children's dosage

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

This medication may increase the risk of suicidal thoughts or behaviors while taking it, so patients and caregivers should inform healthcare providers immediately if such symptoms occur. Patients taking this medication may experience sudden skin rashes or severe skin reactions, so if any unusual skin symptoms appear, they should stop taking it immediately and consult a doctor. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication, as it may pose risks to the fetus during pregnancy, and usage should be very cautious. Dosage adjustments are necessary for patients with impaired kidney function, and particular caution is advised in cases of kidney-related diseases. Sufficient hydration is very important while taking this medication, as it reduces the risk of kidney stone formation. This medication affects the central nervous system and may cause drowsiness, dizziness, or impaired concentration, so it is advisable to avoid driving or operating machinery during the initial treatment period. Abrupt discontinuation of this medication may result in seizures, so dosage should be gradually reduced under the guidance of a physician. Mental changes such as weight fluctuations, mood changes, depression, etc., may occur during the course of this medication, so symptoms should be closely monitored. There may be interactions with other medications taken concurrently; therefore, it's essential to inform healthcare providers of any other medications currently being taken. This medication contains lactose, so patients with lactose intolerance should not take it, and it should be avoided in cases of specific genetic metabolic anomalies. Women of childbearing potential should use effective contraception while taking this medication, and it is not administered for migraine prevention during pregnancy. Regular health check-ups, including blood tests and kidney function tests, may be necessary while taking this medication. This medication can cause various side effects, so if any abnormal symptoms occur, immediate consultation with a doctor is recommended.

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

This medication is susceptible to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is best to keep it in a cool, dry place below 25 degrees Celsius. This helps maintain the medication's effectiveness for a longer period.

Appearance

White, round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle