Topak 25mg (Topiramate)

Adult dosage

It is advisable to start this medicine at a low dose and increase it to the effective dose. Monitoring of blood concentrations is not necessary to optimize treatment with this medicine. The recommended dose of this medicine applies to all adults and children, including the elderly, who do not have renal disease. This medicine may be taken with or without food. Swallow the tablets whole without crushing them. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs to administer topiramate as monotherapy, consider the potential effect on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, gradually taper and discontinue them by approximately 1/3 every 2 weeks (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 it in 2 divided doses daily. If the patient has difficulty tolerating this rate of dose escalation, lengthen the interval between increases. The dose and rate of escalation 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 topiramate monotherapy at doses up to 1,000㎎ per day. 2) Adjunctive therapy Adults (17 years and older): The minimum effective dose is 200mg per day; the usual dose is 200-400mg per day, administered 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; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50mg at 1-2 week intervals and administer it in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, smaller increments 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 this increase, lengthen the interval between increases. 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; the dose and rate of escalation 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: Because this medicine is removed from plasma by hemodialysis, increase the dose of this medicine 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 administer the dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution to patients with hepatic impairment, as clearance of this medicine may be reduced.

Children's dosage

Children (6-16 years): Start 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 it twice daily. If the patient has difficulty tolerating the increase, use smaller increments or extend the interval between increases. The dose and extent of dose escalation 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-onset 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 per day) in the evening. Thereafter, increase the dose by 1-3mg/kg per day at 1-2 week intervals and administer it in 2 divided doses until an appropriate clinical effect is achieved. Dose titration should be determined according to clinical effect. 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 behaviors; therefore, patients should consult their doctor immediately if they experience mood changes or symptoms of depression during treatment. Sudden death can occur in epilepsy patients; thus, patients on this medication should have their health status regularly checked. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur rarely; if symptoms such as skin rash or blistering occur, the medication should be stopped immediately, and medical personnel should be notified. Patients with an allergy to any components of this medication should not take it, and those with lactose intolerance should be careful. Women of childbearing potential should take a pregnancy test before using this medication and should use effective contraception during treatment. Taking this medication during pregnancy poses risks of malformations or growth delay in the fetus; therefore, pregnant women must consult a doctor. Patients with impaired kidney or liver function may have delayed excretion of this medication, necessitating dosage adjustments and careful monitoring. This medication affects the central nervous system and may cause drowsiness, dizziness, or blurred vision; thus, caution is advised when driving or operating machinery. Adequate hydration is crucial when taking this medication, and due to the risk of kidney stones, it is advisable to drink plenty of water. Sudden cessation of this medication may worsen seizures; therefore, it should be gradually reduced under medical supervision when discontinuing. This medication may interact with other drugs; therefore, patients should inform their healthcare provider of any other medications being taken. Women on contraceptive pills should be advised that this medication may reduce contraceptive efficacy, and alternative contraception methods are recommended. Weight changes, appetite changes, mood changes, and memory impairments may occur while taking this medication, so if any unusual symptoms arise, the patient should consult a doctor. This medication may cause side effects in children and the elderly, so careful dosage adjustments and monitoring are necessary. Pregnant or breastfeeding women should consult a doctor before taking this medication, taking into consideration the effects on fetuses or newborns.

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

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, ideally in a cool, dry place at temperatures below 25 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication and prevents degradation.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle