Topamine Tablets (Topiramate)

Adult dose

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 administration of this medicine. The recommended dose of this medicine applies to all adults and children, including older adults, in the absence of renal disease. This medicine may be taken with or without food. The tablet should be swallowed whole and should not be crushed. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer 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 reduced and discontinued by about 1/3 at 2-week intervals (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. Adults (17 years and older): Start treatment with 25㎎ in the evening for the first week. Thereafter, increase the dose by 25 or 50㎎ per day at 1-2-week intervals, administered in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the intervals between dose increases. The dose and titration rate should be determined according to clinical response. The recommended dose for adult monotherapy is 100～200mg per day. The maximum recommended dose is 500㎎ per day. Some patients with relapsed epilepsy have tolerated doses up to 1,000㎎ per day during topiramate monotherapy. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg per day, and the usual dose is 200-400mg per day in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg per day. Start treatment with 25-50mg in the evening for the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50mg at 1-2-week intervals, administered in 2 divided doses. If the patient has difficulty tolerating the increased dose, a smaller dose increase may be used or the interval between increases may be extended. The dose should be determined according to clinical response. 2. Prevention of migraine Adults: Start treatment with 25mg of this medicine in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this titration, extend the intervals between dose increases. The recommended dose is 100mg per day, administered in 2 divided doses. Some patients may respond to a dose of 50mg per day. Doses up to 200mg per day may be administered; the dose and titration rate 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 that the starting and maintenance doses be reduced to approximately 1/2. - Hemodialysis patients: Since this medicine is removed from plasma by hemodialysis, the dose should be increased 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 the additional 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.

Child dose

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

This medication may increase the risk of suicidal thoughts or behavior; therefore, it is important to closely monitor for mood changes or symptoms of depression during treatment. Patients with epilepsy taking this medication may have a slightly increased risk of sudden death, so regular health checks during treatment are necessary. Serious allergic skin reactions may occur; if skin rashes, red spots, or blisters develop, consult a doctor immediately. Patients allergic to any component or with lactose intolerance should not take this medication. Women who are pregnant or planning to become pregnant must consult a healthcare professional before taking this medication and should use effective contraception during treatment. Patients with impaired kidney function may have delayed excretion of this medication; therefore, careful management and dosage adjustment are required. Adequate hydration during treatment is important, and particular caution should be taken to reduce the risk of kidney stones. This medication can cause central nervous system side effects such as drowsiness, dizziness, and blurred vision; it is advisable to avoid driving or operating machinery initially. Weight changes may occur during treatment; therefore, proper nutrition and dietary management should be maintained. This medication may interact with other drugs, so be sure to inform healthcare providers of any other medications being taken. Do not discontinue this medication abruptly; taper off gradually as directed by a healthcare provider to reduce the risk of seizures. Taking this medication during pregnancy may lead to teratogenic effects or growth restriction in the fetus, so careful consultation and management are necessary for women who are pregnant or plan to become pregnant.

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. Also, it should be kept in a cool, dry place below 25 degrees Celsius to maintain its efficacy.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle