Topiramate 100 mg Tablets (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 treatment with this drug. The recommended dose of this drug applies to all adults and children, including elderly patients, provided they do not have renal disease. This drug may be taken with or without food. Swallow the tablets whole; do not break them. 1. Epilepsy 1) Monotherapy Adults (17 years of age and older): Start with 25㎎ in the evening for the first week. Thereafter, increase the dose by 25 or 50㎎ per day at 1-2-week intervals, administered in 2 divided doses daily. If the patient has difficulty tolerating this titration schedule, use longer intervals between dose increases. Determine the dose and rate of titration 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㎎ daily of topiramate as monotherapy. 2) Adjunctive therapy For 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. The dose may be increased to the maximum recommended dose of 800mg daily, depending on the patient. 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, administered in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, increase by smaller increments or extend the interval between increases. Determine the dose according to clinical effect. 2. Prevention of migraine Adults: Start 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, use longer intervals 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; determine the dose and rate of titration according to clinical response. 3. Patients with renal impairment - For patients with moderate or severe renal impairment (CLcr < 70 mL/min/1.73 m2), reducing the initial and maintenance doses to approximately 1/2 is recommended. - Patients on hemodialysis: Because this drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on the day of dialysis. Adjust the dose considering the duration of dialysis, dialyzer clearance, and the patient's residual renal clearance, and administer the dose in divided portions at the start and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment, as clearance of this drug may be reduced.

Child dose

Children (6-16 years): Start with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at 1-2-week intervals, administered twice daily. If the patient has difficulty tolerating the increases, use smaller increments or extend the interval between increases. Determine the dose and degree of titration 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): 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 dose by 1-3mg/kg per day at 1-2-week intervals, administered in 2 divided doses, until an appropriate clinical effect is achieved. Determine dose titration according to clinical effect. Doses up to 30mg/kg daily have been administered and were generally well tolerated.

This medication is used as an antiepileptic and may increase the risk of suicidal thoughts or behaviors during treatment; therefore, patients and caregivers should closely monitor for these symptoms. Furthermore, during treatment, sudden skin rashes or severe skin reactions may occur. If any abnormal skin symptoms develop, the treatment should be discontinued immediately and medical consultation should be sought. Taking this medication during pregnancy can harm the fetus, so women who are pregnant or planning to become pregnant must consult their healthcare provider and use effective contraceptive methods. Patients with decreased renal or liver function may require dosage adjustments due to delayed drug excretion, and sufficient fluid intake is important to reduce the risk of kidney stones. This medication may cause central nervous system side effects such as drowsiness, dizziness, and blurred vision; therefore, caution is needed when driving or operating machinery. Abrupt discontinuation of the drug may worsen seizures, so when stopping the medication, it must be reduced gradually according to the healthcare provider's instructions. There may be interactions with other medications; if you are taking any other medications, be sure to inform your healthcare provider, particularly with other antiepileptic drugs, contraceptives, lithium, and diabetes medications. Lastly, this medication contains lactose, so patients with lactose intolerance should not take it.

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

Store this medication in a tightly sealed container to protect it from air and moisture, and keep it in a cool, dry place below 25 degrees Celsius.

Appearance

Yellow, round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle