Topamax Tablets 25 mg (Topiramate)

Adult dose

It is advisable to start this medicine at a low dose and increase it to the effective dose. There is no need to monitor blood concentrations to optimize administration of this medicine. The recommended dose of this medicine applies to all adults and children, including older adults, who do not have renal disease. This medicine may be taken with or without food. Swallow tablets whole; do not crush them. (Tablets only) Sprinkle capsules are convenient for patients who have difficulty swallowing tablets, such as children or older adults. Swallow the capsule whole, or carefully open the capsule and sprinkle all of its contents over a small amount (a teaspoonful) of soft food. Swallow the food and medicine mixture immediately without chewing. Do not store the mixture for later use. (Capsules only) 1. Epilepsy 1) Monotherapy: When discontinuing another antiepileptic drug being used concomitantly in order to administer topiramate as monotherapy, consider the potential effect on seizure control. Unless another antiepileptic drug must be discontinued immediately for safety reasons, gradually taper and discontinue the other antiepileptic drug by approximately 1/3 every 2 weeks (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 medicine may need to be reduced. Adults (17 years of age and older): Start with 25㎎ in the evening for the first week. Thereafter, increase the daily dose by 25 or 50㎎ at 1-2 week intervals and administer in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the titration interval. The dose and rate of titration 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 up to 1,000㎎ of topiramate daily as monotherapy. 2) Adjunctive therapy Adults (17 years of age 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. Start treatment with 25-50mg in the evening for the first week; it is also possible to start 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, increase by a smaller amount or extend the titration interval. The dose should be determined according to clinical response. 2. Prevention of migraine Adults: Start with 25mg of this medicine in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, extend the titration interval. 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 receiving hemodialysis: Since this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. Adjust the dose considering the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and administer 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.

Child dose

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 1-2 week intervals and administer in 2 doses daily. If the patient has difficulty tolerating the increase, reduce the increments or extend the titration interval. 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. Doses up to 500㎎ daily have been used in children diagnosed with partial-onset seizures. 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 daily dose by 1-3mg/kg at 1-2 week intervals until an appropriate clinical effect is achieved, and administer in 2 divided doses. Dose titration should be determined according to clinical effect. Doses up to 30mg/kg daily have been administered and were generally well tolerated.

This medication is used for the prevention of seizures and migraines. There is an increased risk of suicidal thoughts or behaviors while taking this medication, so if mood changes or symptoms of depression occur, consult your doctor immediately. Abruptly stopping this medication can result in seizures; therefore, the dosage should be gradually reduced under medical supervision. Symptoms of central nervous system effects such as drowsiness, dizziness, and blurred vision may occur while taking this medication, necessitating caution when driving or operating machinery. It is important to maintain adequate hydration to reduce the risk of kidney stone formation. Use during pregnancy may increase the risk of fetal malformations or low birth weight; therefore, women who may become pregnant should have a pregnancy test before taking this medication and should use effective contraceptive methods. Patients with impaired kidney or liver function may experience delayed excretion of this medication, and dosage adjustments should be made according to the doctor's instructions. This medication can cause severe allergic reactions or serious skin conditions; if symptoms like rash, blisters, or skin peeling occur, stop taking the medication immediately and notify your healthcare provider. This medication may interact with other medications; therefore, if you are taking other medicines, inform your doctor or pharmacist. In particular, when used with contraceptives, the contraceptive effect may be reduced; therefore, it is advisable to use additional contraceptive methods. Weight changes, decreased appetite, changes in mental state, memory loss, and symptoms of depression may develop while using this medication; consult your healthcare provider if these symptoms worsen or persist. Regular check-ups with healthcare providers are essential during the course of this medication, and changes in adverse reactions or symptoms should be carefully monitored.

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

This medication should be stored in a tightly closed container to prevent air or moisture from entering and kept in a cool place at or below 25 degrees Celsius. Proper storage can help maintain the medication's effectiveness for a longer period.

Appearance

White round film-coated tablets

Package unit

Bottle - 28 tablets/bottle [HDPE bottle], Bottle - 60 tablets/bottle [HDPE bottle]