Topiramate 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.

As this drug is an antiepileptic medication, it may increase the risk of suicidal thoughts or behavior, so if symptoms such as depression, mood changes, or suicidal impulses occur during treatment, you must immediately inform your healthcare provider. Additionally, there is a risk of sudden death in epilepsy patients, and severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur during this treatment, so if you experience skin rashes or other unusual symptoms, you should discontinue use immediately and consult a hospital. Patients with allergies to any ingredients in this drug, or those with lactose intolerance, soybean oil or legume, or peanut allergies should not take this medication. Women who are pregnant or planning to become pregnant should take a pregnancy test before starting this medication and should use effective contraceptive methods during treatment, as there is a potential risk to the fetus and caution should be exercised. For patients with reduced kidney or liver function, dose adjustments may be needed as the excretion of this medication can be delayed, and adequate hydration is important for patients at risk of kidney stones. During treatment, central nervous system side effects such as drowsiness, dizziness, and decreased concentration may occur, and caution is advised when driving or operating machinery. This medication may interact with other antiepileptic drugs. Therefore, if you are taking other medications, you should discuss it with your healthcare provider, and note that the contraceptive effect may be reduced when taken with contraceptives, so report any changes in bleeding patterns. When discontinuing medication, tapering off should be done gradually to reduce the risk of seizures; a sudden stop may aggravate seizures. During treatment, various adverse reactions such as weight loss, appetite loss, mental confusion, depression, and insomnia may occur, so if severe symptoms emerge, consult your healthcare provider. Also, this drug may cause metabolic acidosis, so blood tests to check bicarbonate levels are necessary if used for a long time, and attention should be given to increased body temperature due to reduced sweating.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• perceptual abnormalities
• bradykinesia
• ataxia

This medication should be stored in a tightly sealed container to prevent exposure to air and humidity. It is best to maintain a storage temperature below 25 degrees Celsius in a cool, dry place with low humidity.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle