Topiramate 25 mg Tablets

Adult dose

It is advisable to start this medicine at a low dose and increase it to the effective dose. There is no need to monitor blood concentrations 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. It may be taken with or without food. The tablets should be swallowed whole and not crushed. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, the possible effects 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 approximately 1/3 every 2 weeks (see section “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 medicine may need to be reduced. Adults (17 years of age or older): Start with 25㎎ in the evening for the first week. Thereafter, increase the daily dose by 25 or 50㎎ at intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating this rate of increase, lengthen the intervals between increases. The dose and rate of increase 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 relapsed epilepsy have tolerated topiramate monotherapy at doses up to 1,000㎎ daily. 2) Adjunctive therapy Adults (17 years of age or 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; treatment may also be started at a lower dose. Thereafter, increase the dose by 25-50mg at intervals of 1-2 weeks and administer 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 effect. 2. Prevention of migraine Adults: Start with 25mg of this medicine in the evening during the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, lengthen the intervals between increases. The recommended dose is 100mg daily, 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 increase 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: 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 renal clearance, and administer the dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment because clearance of this medicine may be reduced.

Child dose

Children (6-16 years): Start with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the daily dose by 0.5-1㎎/㎏ at intervals of 1-2 weeks and administer in 2 doses daily. If the patient has difficulty tolerating the increase, reduce the size of the dose increments or lengthen the intervals between increases. The dose and extent of dose increase 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 the daily dose by 1-3mg/kg at intervals of 1-2 weeks and administer in 2 divided doses until an appropriate clinical effect is achieved. Dose titration should be based on clinical effect. Doses up to 30mg/kg daily have been used and were generally well tolerated.

This drug is used for the preventive treatment of epilepsy and migraines, and the risk of suicidal thoughts or behaviors may increase during use. Patients or caregivers should notify healthcare professionals immediately if symptoms like depression, mood changes, or suicidal impulses occur. If this drug is abruptly discontinued, seizures may occur more frequently, so dosage should be gradually reduced according to physician instructions. Due to central nervous system side effects such as drowsiness, dizziness, and blurred vision, caution is needed when driving or operating machinery. For patients with impaired kidney function, dosage adjustments are necessary as the drug is eliminated from the body more slowly, and patients on dialysis should adjust dosage according to dialysis conditions. This drug can cause severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so if a skin rash or blisters develop, it should be discontinued immediately. Due to the risk of kidney stones, adequate fluid intake is important, and patients with a history of kidney stones should exercise extra caution. During pregnancy, there is a risk of fetal malformations, growth retardation, and low birth weight, therefore women of childbearing age should take a pregnancy test before getting pregnant and employ effective contraceptive methods. This drug can interact with other medications, so inform healthcare professionals if other medications are being taken, especially when used with central nervous system depressants, anti-epileptics, or contraceptives. While on this medication, various side effects including weight changes, depression, and memory impairment may occur, thus regular monitoring of the condition is recommended. Sudden vision loss or eye pain may occur during the use of this medication; if visual abnormalities appear, consult a healthcare professional immediately. Moreover, this drug can affect temperature regulation, so care should be taken to avoid decreased sweating and elevated body temperature in hot environments.

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

Store this medicine in a tightly sealed container to prevent exposure to air and moisture. It is also recommended to keep it in a cool, dry place below 25 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle