Estof Tablet 100 mg (Topiramate)

Adult dose

It is advisable to start this drug at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize administration of this drug. The recommended dose of this drug applies to all adults and children, including older adults, who do not have renal disease. This drug may be taken with or without food. Swallow the tablet whole; do not crush it. 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 tapered and discontinued gradually, by reducing the dose by approximately 1/3 every 2 weeks (see Precautions for Use, “5. General Precautions”). When an enzyme-inducing drug is discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentration occurs, the dose of this drug may need to be reduced. Adults (17 years of age or older): Start treatment 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 titration schedule, extend 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 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 of age or older) The minimum effective dose is 200mg daily; 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; 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 or longer intervals between increases may be used. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start treatment with 25mg of this drug in the evening for the first week. Thereafter, increase 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 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 - In patients with moderate or severe renal impairment (CLcr < 70 mL/min/1.73 m2), reducing the starting and maintenance doses to approximately 1/2 is recommended. - Hemodialysis patients: Because this drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, dialyzer clearance, and residual clearance in the dialysis patient, and administer the dose in divided portions at the start and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution in patients with hepatic impairment, as clearance of this drug may be reduced.

Child dose

Children (6-16 years), epilepsy monotherapy: Start treatment 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 in 2 divided doses daily. If the patient has difficulty tolerating the increase, use smaller increments or extend the interval between increases. The dose and degree of increase should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg daily. Doses 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. During 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 and administer 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 used and were generally well tolerated.

This medication is an antiepileptic drug used for the prevention of epilepsy and migraines. During treatment, suicidal thoughts or impulses and symptoms of depression may occur; thus, patients and caregivers must notify healthcare providers immediately if such symptoms arise. This medication can cause serious skin diseases, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, which are serious skin reactions. If a rash, red spots, or blisters appear on the skin, immediately stop using this medication and visit a hospital. Taking this medication during pregnancy may pose risks of harm to the fetus; therefore, women of childbearing potential should take a pregnancy test before use and must use effective contraceptives during treatment. Patients with impaired kidney or liver function may have slower excretion of this medication, so careful dose adjustments are necessary, and adequate hydration is required due to the risk of kidney stones. This medication may cause central nervous system side effects such as drowsiness, dizziness, and decreased concentration; hence, caution is needed when driving or operating machinery. When discontinuing treatment, do not stop abruptly; taper off gradually under a physician's guidance to reduce the risk of seizures. There may be interactions with other medications, so notify healthcare providers if other medications are being taken, especially antiepileptic drugs, contraceptives, or lithium. While taking this medication, regular medical check-ups are necessary, and immediate consultation is needed for any unusual symptoms.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius. Storage in this way will help maintain the medication's effectiveness for a longer period.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle