Topiramate Tablets

Adult dose

It is advisable to start this drug at a low dose and increase it to the effective dose. Monitoring of plasma concentrations is not necessary to optimize treatment with this drug. The recommended dose of this drug is the same for all adults and children, including elderly patients, in the absence of renal disease. It may be taken with or without food. Swallow the tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, consider the potential effect on seizure control. Unless other antiepileptic drugs need to be discontinued immediately for safety reasons, gradually reduce and discontinue the other antiepileptic drugs by approximately 1/3 every 2 weeks (see “5. General Precautions” under Precautions for Use). When enzyme-inducing drugs are discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentration occurs, the dose of this drug may need to be reduced. - Adults (17 years and 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, divided into 2 doses per day. If the patient has difficulty tolerating this titration schedule, extend the titration intervals. 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 of 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, divided into 2 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; treatment may also be started at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2-week intervals, divided into 2 doses per day. If the patient has difficulty tolerating the increased dose, smaller increments may be used 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 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 titration interval. The recommended dose is 100mg per day, divided into 2 doses. Some patients may respond to a dose of 50mg per day. Doses of up to 200mg per day 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), it is recommended that the starting and maintenance doses be reduced to approximately 1/2. - Patients on hemodialysis: Since this drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on dialysis days. Adjust the dose taking into account the duration of dialysis, the clearance of the dialysis equipment, and the patient's renal clearance, and divide the dose between the start and end of hemodialysis. 4. Patients with hepatic impairment Use this drug 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 daily dose by 0.5-1㎎/㎏ at 1-2-week intervals and administer it in 2 doses per day. If the patient has difficulty tolerating the increase, use smaller dose increments 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. - Children (2-16 years): The recommended daily dose is approximately 5-9mg/kg, 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 daily dose by 1-3mg/kg at 1-2-week intervals until an appropriate clinical effect is achieved, divided into 2 doses per day. Dose titration should be determined according to clinical effect. Doses of up to 30mg/kg per day have also been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors; therefore, changes in mood or unusual behavior should be reported to a healthcare provider immediately during treatment. Patients with epilepsy taking this medication may have an increased risk of sudden death, necessitating regular monitoring of their health status. Serious skin reactions may occur; therefore, if symptoms such as rashes or blisters appear, the medication should be discontinued immediately and medical advice should be sought. This medication should not be administered to individuals who are hypersensitive to its components or have specific genetic disorders. Women who are pregnant or planning to become pregnant must take a pregnancy test before using this medication and should use effective contraceptive methods while taking it. This medication can cause harm to the fetus during pregnancy; hence, it should be used with extreme caution during pregnancy. Patients with renal or liver dysfunction may experience delayed excretion of this medication, necessitating dosage adjustments and caution. Adequate hydration is important while taking this medication, and it is advised to drink plenty of water to reduce the risk of kidney stones. Drowsiness, dizziness, or visual disturbances may occur during treatment; thus, caution is needed while driving or operating machinery. Abrupt discontinuation of this medication may exacerbate seizures; therefore, dosage should be gradually reduced under a physician's guidance. This medication may interact with other drugs; therefore, if taking other medications, healthcare providers must be informed. In particular, if used with contraceptives, the contraceptive effect may be reduced, so additional contraceptive methods are recommended. If any unusual symptoms or discomfort arise during treatment, it is essential to consult a healthcare professional immediately.

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

This medication is sensitive to air and moisture, so it should be stored in a sealed container. It is also advised to keep it in a cool, dry place below 25 degrees Celsius. This will help maintain the drug's effectiveness for a longer duration.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle