Topamed 25 mg Tablet (Topiramate)

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring plasma concentrations is not necessary to optimize the dose of this medicine. The recommended dose of this medicine is the same for all adults and children, including the elderly, in the absence of renal disease. It may be administered with or without food. Swallow the tablets whole; do not crush them. Epilepsy 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 must be discontinued immediately for safety reasons, gradually reduce and discontinue the other antiepileptic drugs by approximately 1/3 at 2-week intervals (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. Epilepsy monotherapy, 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 intervals of 1-2 weeks and administer in 2 divided doses per day; if the patient cannot tolerate this rate of increase, lengthen the interval between increases. The dose and rate of increase should be determined according to clinical response. The recommended dose for monotherapy in adults is 100～200mg per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated up to 1,000㎎ per day of topiramate monotherapy. Adjunctive therapy for epilepsy, 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 up 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 intervals of 1-2 weeks and administer in 2 divided doses per day. If the patient cannot tolerate the increased dose, the dose increments may be smaller or the interval between increases may be extended. The dose should be determined according to clinical effect. Prevention of migraine, adults: Start treatment 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 cannot tolerate these increases, 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. Doses up to 200mg per day may be administered; the dose and rate of increase should be determined according to clinical response. Patients with renal impairment: For patients with moderate or severe renal impairment (CLcr < 70 mL/min/1.73 m2), it is recommended that the initial and maintenance doses be reduced to approximately 1/2. Patients on hemodialysis: Because this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on the day of dialysis. Adjust the dose taking into account the duration of dialysis, the clearance of the dialysis system, and the patient's renal clearance, and administer divided doses at the start and end of hemodialysis. Patients with hepatic impairment: Use with caution in patients with hepatic impairment, as clearance of this medicine may be reduced.

Child dose

Epilepsy 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 intervals of 1-2 weeks and administer twice daily. If the patient cannot tolerate the increase, reduce the dose increment or lengthen the interval between increases. The dose and extent of increase should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. In children diagnosed with partial seizures, doses up to 500㎎ per day have been used. Adjunctive therapy for epilepsy, 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 intervals of 1-2 weeks until an appropriate clinical effect is achieved, administering it in 2 divided doses. 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 behavior, so if mood changes or abnormal behaviors occur during treatment, it is essential to consult a physician immediately. Caution is necessary when administering this medication to epilepsy patients due to the risk of sudden death. Severe skin reactions may occur during treatment; if any rash or blisters develop on the skin, discontinue use immediately and inform a healthcare professional. Do not take this medication if allergic to its ingredients, and patients with lactose intolerance should exercise caution. Women who are pregnant or planning to become pregnant should take a pregnancy test before using this medication and must use effective contraception, as there may be risks to the fetus. Patients with impaired kidney or liver function may need dosage adjustments due to delayed excretion of the medication. This medication may increase the risk of kidney stone formation, so adequate fluid intake is essential. Drowsiness, dizziness, and blurred vision may occur; caution is advised when driving or operating machinery. Abrupt discontinuation of this medication may worsen seizures; therefore, dosage should be reduced gradually according to the physician's instructions. There may be interactions with other medications, so all medications being taken should be disclosed to healthcare providers, especially contraceptives, lithium, and antiepileptic drugs. Lastly, this medication can cause various side effects such as weight loss, loss of appetite, depression, and cognitive disorders, so any unusual symptoms should be reported to a physician immediately. Pregnant and breastfeeding women should carefully consider whether to take this medication, weighing the risks to the fetus and newborn.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius at room temperature. This helps maintain the effectiveness and safety of the medication.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle