PM EsTopiramate Tablet 100 mg

Adult dose

It is preferable 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 is the same for all adults and children, including older adults, in the absence of 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 use 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 over approximately 2-week intervals, reducing the dose by about 1/3 each time (see “5. General Precautions” under Precautions for Use). When an enzyme-inducing drug is 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): Start with 25㎎ in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at 1-2-week intervals, divided into 2 doses per day. If the patient has difficulty tolerating this rate of increase, lengthen the interval between dose 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 topiramate monotherapy at doses of up to 1,000㎎ per day. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg per day, and the usual dose is 200-400mg per day, divided into 2 doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg per day. 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, divided into 2 doses per day. If the patient has difficulty tolerating the 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 medication in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this increase, lengthen the interval between dose increases. The recommended dose is 100mg per day, divided into 2 doses. Some patients may respond to a dose of 50mg per day. Doses of up to 200mg per day 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 undergoing hemodialysis: Because this medication 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 dose in divided doses at the beginning and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution in patients with hepatic impairment, as clearance of this medication may be reduced.

Child dose

1. Epilepsy 1) Monotherapy Children (6-16 years): Start with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the total daily dose by 0.5-1㎎/㎏ at 1-2-week intervals, administered in 2 doses per day. If the patient has difficulty tolerating the increase, use smaller increments or extend 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. Experience is available with doses of up to 500㎎ per day in children diagnosed with partial seizures. 2) Adjunctive therapy Children (2-16 years): The recommended daily dose is approximately 5-9mg/kg, divided into 2 doses. Administer 25mg (or less, based on 1-3mg/kg per day) in the evening for the first week. Thereafter, increase the total daily dose by 1-3mg/kg at 1-2-week intervals, divided into 2 doses per day, until an appropriate clinical effect is achieved. Dose titration should be based on clinical effect. Doses of up to 30mg/kg per day have been administered and were generally well tolerated.

This medication is an antiepileptic drug used for the prevention of epilepsy and migraines. During the use of this medication, there may be an increase in suicidal thoughts or urges, so patients and caregivers should inform their doctor immediately if such symptoms occur. Additionally, there may be a slight increase in the risk of sudden death among patients taking this medication, so caution is advised. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, therefore, if any unusual skin symptoms appear, usage should be stopped immediately, and a doctor should be consulted. Patients who have hypersensitivity to this medication or have specific genetic issues such as lactose intolerance should not be administered this drug. Women who are pregnant or planning to become pregnant should take a pregnancy test before using this medication and use effective contraception while taking it, fully recognizing the risks to the fetus. Patients with impaired kidney or liver function may have delayed excretion of this medication, thus dosage adjustments and careful monitoring are necessary. This medication may cause central nervous system side effects such as drowsiness, dizziness, and blurred vision, so caution is advised when driving or operating machinery. Adequate hydration is important to reduce the risk of kidney stone formation, so it is essential to drink plenty of water while on this medication. This medication may interact with other drugs, so it is crucial to inform your doctor or pharmacist of all other medications being taken. During treatment, monitoring for changes in weight, mood, skin, urination, and other symptoms is important, and any unusual symptoms should be reported to medical personnel immediately. This medication should not be abruptly discontinued, as doing so may worsen seizures; if discontinuation is necessary, it should be tapered off gradually according to a physician’s instructions.

• suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• sensory disturbances
• ataxia
• motor incoordination

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

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle