Topamine 25 mg Tablets (Topiramate)

Adult dose

It is preferable to start this drug at a low dose and increase it to an effective dose. There is no need to monitor blood concentrations to optimize the administration of this drug. The recommended dose of this drug is applicable to all adults and children, including older adults, provided they do not have renal disease. It may be taken 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 every 2 weeks (refer to “5. General Precautions” in the Precautions for Use section). When enzyme-inducing drugs are discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentrations occurs, the dose of this drug may need to be reduced. Adults (17 years and older): Start treatment with 25㎎ in the evening during the first week. Thereafter, increase the dose by 25 or 50㎎ per day at 1-2 week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating this titration schedule, extend the titration interval. The dose and rate of titration 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 recurrent epilepsy have tolerated doses of up to 1,000㎎ per day as 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 during the first week; a lower starting dose may also be used. 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 the increased dose, the dose may be increased by smaller amounts or the titration interval may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start treatment with 25mg of this drug in the evening during the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this titration, extend the titration interval. The recommended dose is 100mg per day, administered in 2 divided doses. Some patients may respond to a dose of 50mg per day. The dose may be increased to 200mg per day, and the dose and rate of titration should be determined according to clinical response. 3. Patients with renal impairment - In 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: Because this drug is removed from plasma by hemodialysis, increase the dose of this drug 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 Use with caution in patients with hepatic impairment, as clearance of this drug may be reduced.

Child dose

1. Epilepsy 1) Monotherapy Children (6-16 years): Start treatment with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at 1-2 week intervals and administer twice daily. If the patient has difficulty tolerating the increase, reduce the increment or extend the titration interval. 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 of up to 500㎎ per day have been used in children diagnosed with partial seizures. 2) Adjunctive therapy Children (2-16 years): The recommended dose is approximately 5-9mg/kg per day, administered in 2 divided doses. During 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, and administer in 2 divided doses. Dose titration should be determined according to clinical effect. Doses of up to 30mg/kg per day have been administered and were generally well tolerated.

This medication is an antiepileptic drug and may increase the risk of suicidal thoughts or behavior, so it is important to closely monitor mood changes or depressive symptoms during treatment. Patients taking this medication may have a risk of sudden unexpected death, necessitating regular health status checks. Serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so if there is a sudden rash or blisters on the skin, use should be stopped immediately and consultation with a healthcare professional is required. Patients with an allergy to this drug's components or lactose intolerance, as well as women who are pregnant or might become pregnant, should exercise particular caution and must consult with a physician before taking this medication if they are planning to become pregnant. Patients with reduced kidney or liver function may experience delayed elimination of this medication; thus, dosage adjustments and regular testing are necessary. This medication may increase the risk of kidney stones, so adequate hydration is important, and if symptoms of kidney stones appear, healthcare professionals should be informed immediately. Side effects affecting the central nervous system such as drowsiness, dizziness, or blurred vision may occur; hence, caution is advised when driving or operating machinery. Abrupt discontinuation of this medication may exacerbate seizures; therefore, the dosage should be gradually reduced under the guidance of a physician upon discontinuation. The contraceptive effect may be reduced, so women taking oral contraceptives should consult a physician if there are changes in bleeding patterns or if contraceptive failure is suspected. This medication may interact with various drugs; hence, patients must inform healthcare professionals if they are taking other medications, especially when taken with other antiepileptic drugs, lithium, antidiabetic medications, or antipsychotic medications. Taking this medication during pregnancy poses risks of congenital malformations or growth impairments in the fetus, so consulting a specialist prior to planning a pregnancy is necessary, and it should only be taken during pregnancy if absolutely required. During treatment, various side effects such as weight change, appetite change, mood change, and decline in memory may occur; hence, symptoms that are severe or persistent should be discussed with a healthcare professional.

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

Store this medication in a well-sealed container to prevent exposure to air or moisture. It is best to keep it in a cool and dry place at a temperature below 25 degrees Celsius.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle