Topiramate Tablet 25 mg (Topiramate)

Adult dose

It is advisable to start this medication at a low dose and increase it to the effective dose. Monitoring plasma concentrations is not necessary to optimize treatment with this medication. The recommended dose of this medication 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, consider the potential effects on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, gradually taper and discontinue them by about 1/3 at 2-week intervals (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 medication may need to be reduced. Adults (17 years and older): Begin treatment with 25 mg in the evening for the first week. Thereafter, increase the daily dose by 25 or 50 mg at 1-2-week intervals 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 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 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. Begin 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 1-2-week intervals and administer in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller dose 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: Begin treatment with 25mg of this medication in the evening for the first week. Thereafter, increase the daily dose by 25mg at weekly intervals. If the patient has difficulty tolerating this titration, extend the intervals between dose 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 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. - Patients on hemodialysis: Because this medication is removed from plasma by hemodialysis, increase the dose of this medication by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, dialyzer clearance, 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 medication may be reduced.

Child dose

Children (6-16 years): Begin treatment with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the daily dose by 0.5-1㎎/㎏ 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 titration should be determined according to clinical response. The recommended dose for pediatric monotherapy is 3-6mg/kg daily. Doses up to 500㎎ daily have been used in children diagnosed with partial seizures. Children (2-16 years): The recommended daily dose is approximately 5-9mg/kg, 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 1-2-week intervals, administered 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 daily have been administered and were generally well tolerated.

This drug may increase the risk of suicidal thoughts or behaviors; therefore, patients should immediately consult a physician if they experience mood changes or symptoms of depression during treatment. Epilepsy patients taking this medication should be vigilant for sudden death occurrences, requiring attention to changes in symptoms. Severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur rarely, so if symptoms such as skin rash or blisters appear, drug intake should be immediately stopped and medical assistance sought. This drug should not be taken by anyone with an allergy to its components, and patients with certain genetic disorders such as lactose intolerance should exercise caution. Women who are pregnant or may become pregnant should conduct a pregnancy test before starting this medicine and use effective contraception, as taking this drug during pregnancy may harm the fetus and should be decided carefully. Patients with impaired renal or liver function may experience slower excretion of this medication; thus, dosage adjustments may be necessary, and patients undergoing dialysis should adjust their dose according to dialysis conditions. This drug may increase the risk of kidney stones; therefore, adequate hydration is necessary, especially for those with a family history or previous experience of kidney stones. During treatment, side effects such as drowsiness, dizziness, and decreased concentration may occur; thus, caution should be taken while driving or operating machinery. Sudden discontinuation of this medication may worsen seizures, so it should be gradually tapered off according to a physician’s instructions. Furthermore, this drug may interact with other medications; therefore, patients taking other medications should definitely inform their doctor or pharmacist. If a pregnant woman takes this medication, the risk of congenital malformations or low birth weight increases; thus, women planning pregnancy should consult an expert before deciding to take this medication. During treatment, if symptoms such as weight changes, mood changes, visual disturbances, skin rashes, or urinary abnormalities occur, inform healthcare personnel immediately.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• paresthesia
• ataxia
• movement disorders

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to keep it in a cool, dry place below 25 degrees Celsius.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle