Hanwha Topiramate Tablet 100mg

Adult dose

It is preferable to start this medicine at a low dose and increase it to an effective dose. Monitoring plasma concentrations is not necessary to optimize treatment with this medicine. The recommended dose of this medicine applies equally to all adults and children, including elderly patients, provided they do not have renal disease. It may be administered with or without food. The tablets should be swallowed whole without crushing. 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 tapered and discontinued by approximately 1/3 at 2-week intervals (see “5. General Precautions” under Precautions for Use). When enzyme-inducing drugs that affect drug metabolism are 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 with 25㎎ in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at 1-2-week intervals and administer in 2 divided doses. If the patient has difficulty tolerating this titration schedule, the interval between dose increases should be extended. The dose and rate of titration 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 topiramate monotherapy at doses up to 1,000㎎ daily. 2) Adjunctive therapy 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 for the first week; treatment may also be initiated at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2-week intervals and administer in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller dose increases may be made or the interval between increases may be extended. The dose should be determined according to clinical effect. 2. Migraine prevention Adults: Start 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 these increases, extend the interval between increases. The recommended daily dose is 100mg, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. Doses up to 200mg 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), reducing the starting and maintenance doses to approximately 1/2 is recommended. - Patients on hemodialysis: Because this medicine is removed from plasma by hemodialysis, the dose on dialysis days should be increased by approximately 1/2. Increase the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's residual renal clearance, and administer the dose in divided portions at the beginning and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment, as clearance of this medicine may be reduced.

Child dose

Children (6-16 years): Start with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the total daily dose by 0.5-1㎎/㎏ at 1-2-week intervals and administer in 2 doses daily. If the patient has difficulty tolerating the increase, reduce the size of the dose increments or extend the interval between increases. The dose and degree of titration 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): 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. Thereafter, increase by 1-3mg/kg daily 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 and behavior, so any mood changes or depressive symptoms occurring during its use should be immediately discussed with a healthcare professional. The risk of sudden death may be slightly higher in epilepsy patients taking this medication, so regular health evaluations are necessary. Severe skin reactions, such as severe rashes or skin peeling, may occur; therefore, if any unusual skin symptoms appear, the medication should be stopped immediately, and the patient should visit a hospital. Patients allergic to any ingredients in this medication or those with specific genetic lactose intolerance should not take it. Pregnant women or those planning to become pregnant must take a pregnancy test before taking this medication and should use effective contraception while on it. Since this medication may harm the fetus, it should be used cautiously during pregnancy, and using it while pregnant may increase the risks of fetal growth restriction or congenital malformations. Patients with decreased kidney or liver function may experience delayed excretion of this medication and may require dose adjustments; therefore, adequate hydration is important due to the risk of kidney stones. This medication can cause central nervous system side effects such as drowsiness, dizziness, and decreased concentration; thus, caution is advised when driving or operating machinery. While taking this medication, it should be gradually tapered down before discontinuation, as abrupt cessation may increase the risk of seizures. This medication can interact with other drugs, so patients taking other medications should inform their healthcare providers. In particular, women taking oral contraceptives should consider that this medication may reduce the contraceptive effect, thus alternative contraceptive methods should be discussed. While on this medication, various side effects including weight loss, loss of appetite, depression, cognitive impairment, and other unusual symptoms may occur; if any abnormal symptoms persist, patients should consult their healthcare provider. This medication can lead to temperature regulation issues due to decreased sweating, thus caution is necessary, especially in hot environments to prevent dehydration. Furthermore, when taken concurrently with valproate, this medication may cause serious side effects such as hyperammonemia, so any such symptoms should be reported to healthcare providers immediately. Regular blood tests and monitoring of physical conditions are advisable to check for adverse reactions.

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

This medication should be stored in a tightly closed container to protect it from exposure to air or moisture, ideally at room temperature between 1 to 30 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle