Topiramate Tablet 25 Milligrams (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 dose of this medicine applies to all adults and children, including elderly patients, provided they do not have renal disease. It may be administered with or without food. Swallow the tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, the potential effect on seizure control should be considered. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be gradually tapered and discontinued by approximately 1/3 every 2 weeks (see Precautions for Use, section “5. General Precautions”). 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 during 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 interval between increases. The dose and rate of titration 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 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 up to the maximum recommended dose of 800mg daily. Initiate 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. If the patient has difficulty tolerating an increased dose, smaller dose 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 weekly intervals. If the patient has difficulty tolerating this titration, extend the interval between increases. The recommended daily dose is 100mg, 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 titration 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. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis device, and the patient's renal clearance, and administer the additional dose in divided portions at the beginning 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.

Children's dosage

Children (6-16 years): Start with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the total 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 interval between increases. The dose and extent of titration 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 of up to 500㎎ daily have been used. 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 total daily dose by 1-3mg/kg at intervals of 1-2 weeks until an appropriate clinical effect is achieved, administered 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 medication may increase the risk of suicidal thoughts or behaviors; therefore, patients should immediately consult a physician if they experience depression or mood changes during treatment. Patients taking this medication should be closely monitored as there may be a risk of sudden death. This medication can rarely cause serious skin reactions, so if any unusual skin symptoms occur, it should be discontinued immediately and medical personnel should be informed. People with allergies to any ingredients of this medication or specific genetic lactose intolerance should not take it. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication and should use effective contraception during use. Patients with reduced kidney or liver function may require dosage adjustment, as the rate at which the drug clears from the body varies according to kidney function. This medication may increase the risk of kidney stones; therefore, sufficient fluid intake is important. During treatment, central nervous system symptoms such as drowsiness, dizziness, or blurred vision may occur, so caution should be taken while driving or operating machinery. Sudden discontinuation of this medication may lead to seizures; therefore, it should be gradually reduced under the guidance of a physician when discontinuing. This medication may interact with other drugs, so it is essential to inform the physician or pharmacist of any other medications being taken. During treatment, side effects such as weight loss, decreased appetite, mood changes, or memory impairment may appear, and severe symptoms should prompt consultation with medical personnel. Taking this medication during pregnancy poses a risk of congenital malformations or growth delays in the fetus, so special caution is warranted during pregnancy. It is recommended to regularly monitor kidney function and electrolyte status through blood tests while taking this medication. As this medication may affect temperature regulation, caution should be exercised to avoid dehydration and heatstroke in hot environments. This medication may impact brain function; therefore, if symptoms such as altered consciousness, confusion, or vomiting occur, medical personnel should be informed immediately.

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

This medication should be stored in a tightly sealed container to prevent air and humidity exposure and kept in a cool, dry place below 25 degrees Celsius.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle