Topiramate 25 mg Tablet

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 applies to all adults and children, including older adults, provided they do not have renal disease. It 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 in order to administer topiramate as monotherapy, the potential effects on seizure control should be considered. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be tapered 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 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 intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the intervals between dose 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 recurrent epilepsy have tolerated topiramate monotherapy at doses up to 1,000㎎ daily. 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. Initiate 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 intervals of 1-2 weeks and administer in 2 divided doses. 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 effect. 2. Prevention of migraine Adults: Start with 25mg of this medicine in the evening for the first week. Thereafter, increase the daily dose by 25mg at weekly intervals. If the patient has difficulty tolerating these increases, extend 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 initial and maintenance doses be reduced to approximately 1/2. - Patients receiving hemodialysis: Because this medicine is removed from plasma by hemodialysis, increase the dose by approximately 1/2 on dialysis days. Adjust the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and administer the increased dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment, as clearance of this medicine may be reduced.

Children's dosage

1. Epilepsy 1) Monotherapy Children (6-16 years): Start with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the daily dose by 0.5-1㎎/㎏ at intervals of 1-2 weeks 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. In children diagnosed with partial seizures, doses up to 500㎎ daily have been used. 2) Adjunctive therapy Children (2-16 years): 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 the daily dose by 1-3mg/kg at intervals of 1-2 weeks until an appropriate clinical effect is achieved, and administer in 2 divided doses. Dose titration should be based on clinical effect. Doses up to 30mg/kg daily have been used and were generally well tolerated.

This medication is an antiepileptic drug and may increase the risk of suicidal thoughts or behaviors during treatment, so patients' mood changes or behavioral changes should be closely monitored. The risk of sudden death in patients with epilepsy may be higher than in healthy individuals, but this is at a similar level to the risk from epilepsy itself. This medication can rarely cause serious skin reactions; if a rash or blisters occur, use should be stopped immediately, and consultation with a physician is required. Patients with hypersensitivity to the ingredients or specific genetic lactose metabolism disorders should not take this medication. Women who are pregnant or planning to become pregnant must take a pregnancy test before using this medication and should use effective contraception during treatment. This medication may cause harm to the fetus and increase the risk of premature birth and low birth weight, so it should be administered cautiously during pregnancy. Patients with reduced kidney or liver function may require dosage adjustments due to delayed excretion of this medication, and patients receiving hemodialysis should have their dosage adjusted according to dialysis conditions. It is important to maintain adequate hydration during treatment, and patients should drink plenty of water to reduce the risk of kidney stones. CNS symptoms such as drowsiness, dizziness, and decreased concentration may occur, so caution is advised when driving or operating machinery. This medication may interact with other drugs; thus, if taking antiepileptic drugs, contraceptives, lithium, diabetes medications, etc., patients should inform their healthcare provider and be monitored. If mood changes, depression, suicidal impulses, etc., occur during treatment, healthcare providers should be informed immediately, and the medication should not be stopped suddenly but rather reduced gradually. This medication can cause various side effects, including weight loss, decreased appetite, skin rashes, and neurological symptoms, so regular monitoring of the patient's condition is necessary. Pregnant and breastfeeding women should consult a professional before taking this medication and decide whether to take it considering its effects on the fetus and newborn.

• Suicidal thoughts
• suicidal actions
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• perceptual disturbance
• ataxia
• movement disorder

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is important to store it at room temperature between 1 to 30 degrees Celsius to maintain the efficacy of the medication.

Appearance

White round film-coated tablet

Package unit

100 tablets/bottle, 30 tablets/bottle