Topiramate Tablets 25mg (Topiramate)

Adult dosage

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 treatment with this medicine. The recommended dosage applies to all adults, including the elderly, provided they do not have renal disease. This medicine may be taken with or without food. Tablets should be swallowed whole and not crushed. 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, they should be gradually reduced by approximately 1/3 every 2 weeks before discontinuation (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 medicine may need to be reduced. Adults (17 years and older): Start with 25㎎ in the evening for the first week. Thereafter, increase 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 rate of dose escalation, extend the interval between increases. The dose and rate of increase should be determined by clinical response. The recommended dose for adult monotherapy is 100～200mg daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated doses of up to 1,000㎎ daily as topiramate monotherapy. 2) Adjunctive therapy Adults (17 years and 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 for 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 in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, smaller increments may be used or the intervals between increases may be extended. The dose should be determined according to clinical response. 2. Prevention of migraine Adults: Start with 25mg of this medicine in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, extend the interval between increases. The recommended dose is 100mg daily, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. Doses of 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, increase the dose of this medicine by approximately 1/2 on dialysis days. The dose should be increased taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and should be administered 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), epilepsy monotherapy: Start with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase by 0.5-1㎎/㎏ per day at 1-2 week intervals and administer twice daily. If the patient has difficulty tolerating the increase, use smaller increments or extend the intervals 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 daily. Doses of up to 500㎎ daily have been used in children diagnosed with partial seizures. Children (2-16 years), epilepsy adjunctive therapy: The recommended dose is approximately 5-9mg/kg daily, administered in 2 divided doses. For the first week, administer 25mg (or less, based on 1-3mg/kg daily) in the evening. Thereafter, increase by 1-3mg/kg daily 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 daily have been administered and were generally well tolerated.

This drug is used as an antiepileptic medication for the prevention of epilepsy or migraines. The risk of suicidal thoughts or intentions, and mental health issues such as depression may increase while taking this medication, so the patient and caregiver should immediately inform healthcare professionals if these symptoms occur. This drug may cause serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so if symptoms such as rash, blisters, or fever occur, stop taking the medication immediately and consult a doctor. Taking this medication during pregnancy may carry risks of birth defects or growth impairments to the fetus, so women of childbearing age should check for pregnancy before taking this medication and use very effective contraceptive methods. Patients with reduced renal function may find it difficult to control the concentration of this medication in the body, so healthcare professionals should carefully adjust the dosage. This medication can cause central nervous system side effects such as drowsiness, dizziness, and blurred vision, so it is advised to avoid driving or operating machinery while starting the treatment. It is important to maintain adequate hydration to reduce the risk of kidney stones, especially in patients with a history of kidney stones who should be more cautious. Stopping this medication abruptly may worsen seizures, so it must be tapered off gradually according to medical advice when discontinuing. As this drug can interact with other medications, inform healthcare professionals about any other medications currently being taken, especially when used in combination with other antiepileptic drugs, contraceptives, lithium, antihypertensives, etc. While taking this medication, side effects such as weight loss, decreased appetite, fatigue, depression, and memory impairment may occur. If any unusual symptoms persist, consult with healthcare professionals.

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

This medication should be stored in a tightly closed container to prevent air or moisture from entering, and it is preferable to keep it in a cool, dry place below 25 degrees.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle