Topirate Tablet 25 mg (Topiramate)

Adult dose

It is advisable to start this medicine at a low dose and increase it to the effective dose. Monitoring of blood concentrations is not necessary to optimize treatment with this medicine. The recommended dose applies to all adults and children, including older adults, provided they do not have kidney disease. May be taken with or without food. Tablets should be swallowed whole and not crushed. 1. Epilepsy 1) Monotherapy: When discontinuing other antiepileptic drugs used concomitantly in order to administer topiramate as monotherapy, consider the potential effect on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be tapered and discontinued gradually, by approximately one-third every 2 weeks (see “5. General Precautions” under Precautions for Use). When enzyme-inducing drugs that affect drug metabolism 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 for the first week. Thereafter, increase the daily dose by 25 or 50㎎ at 1-2 week intervals and administer in 2 divided doses per day. 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 adult monotherapy 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 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. Begin treatment with 25-50mg in the evening for the first week; treatment may also be initiated at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2 week intervals and administer in 2 divided doses per day. If the patient has difficulty tolerating an increased dose, the dose may be increased by smaller amounts or the titration interval may be extended. 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 this titration, extend the titration interval. The recommended daily dose is 100mg, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. The dose may be increased up to 200mg daily; 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 initial and maintenance doses be reduced to approximately 1/2. - Patients on 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 increase considering the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and administer the dose in divided portions at the beginning and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution to 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 per day. If the patient has difficulty tolerating the dose increase, use smaller 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. 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 until an appropriate clinical response is achieved, and administer in 2 divided doses per day. Dose titration should be determined according to clinical response. Doses up to 30mg/kg daily have been used and were generally well tolerated.

This drug is an antiepileptic medication and may increase the risk of suicidal thoughts or behavior, therefore any mood changes or unusual behaviors while on medication should be reported to a healthcare professional immediately. Additionally, during the use of this drug, serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so if any skin abnormalities appear, the medication should be discontinued immediately. During pregnancy, it may cause harm to the fetus, so women of childbearing potential should have a pregnancy test before use, and effective contraception should be utilized during treatment; the use in pregnancy should be carefully considered. This drug's concentration in the body may vary according to kidney function, so patients with renal impairment may require dose adjustments, and dosages during dialysis should be personalized according to dialysis conditions. It is crucial to maintain adequate hydration during the use of this medication to reduce the risk of kidney stone formation. Common side effects like drowsiness, dizziness, and blurred vision may occur; thus, caution should be exercised when driving or operating machinery during the initial phase of treatment. This drug may interact with other antiepileptic drugs or multiple medications, so any concurrent medications should be discussed with healthcare providers. Discontinuation of this medication should be done gradually to minimize the risk of seizures; sudden withdrawal should be avoided. This drug may cause a variety of adverse reactions such as weight loss, decreased appetite, depression, and memory impairment, so any unusual symptoms should be discussed with healthcare providers.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• sensory disturbances
• hyperactivity
• ataxia

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is important to keep the medication in a cool, dry place below 25 degrees Celsius to maintain its effectiveness.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle