Topiramate Tablets 100 mg (Topiramate)

Adult dosage

It is recommended to start this drug at a low dose and increase it to the effective dose. Monitoring plasma concentrations is not necessary to optimize treatment with this drug. The recommended dose of this drug applies to all adults and children, including the elderly, provided they do not have renal disease. This drug may be taken without regard to meals. Swallow the tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs 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 gradually reduced and discontinued by approximately 1/3 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 concentrations occurs, the dose of this drug may need to be reduced. Adults (17 years and older): Start treatment with 25㎎ in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at 1-2-week intervals and administer in 2 divided doses. If the patient has difficulty tolerating this rate of dose escalation, extend the interval between increases. The dose and rate of escalation should be determined according to clinical response. The recommended dose for monotherapy in adults is 100～200mg per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses of up to 1,000㎎ per day. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg per day; the usual dose is 200-400mg per day in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg per day. Start treatment with 25-50mg in the evening during 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. If the patient has difficulty tolerating the increased dose, smaller increments may be used or the interval between increases may be extended. The dose should be determined according to clinical response. 2. Prevention of migraine Adults: Start treatment with 25mg of this drug in the evening during the first week. Thereafter, increase the dose 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 per day, administered in 2 divided doses. Some patients may respond to a dose of 50mg per day. Doses of up to 200mg per day may be administered; the dose and rate of escalation 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. - Hemodialysis patients: As this drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on dialysis days. Adjust the dose taking into account the duration of dialysis, the clearance of the dialysis apparatus, and the patient's renal clearance, and administer the dose in divided amounts at the beginning and end of hemodialysis. 4. Patients with hepatic impairment Use this drug with caution in patients with hepatic impairment, as clearance of this drug may be reduced.

Children's dosage

Children (6-16 years) Start treatment with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the total daily dose by 0.5-1㎎/㎏ at 1-2-week intervals and administer in 2 divided doses. If the patient has difficulty tolerating the increase, use smaller increments or extend the interval between increases. The dose and degree of escalation should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. Doses of up to 500㎎ per day 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 per day) in the evening, and thereafter increase the total daily dose by 1-3mg/kg at 1-2-week intervals until an appropriate clinical response is achieved, administering it in 2 divided doses. Dose titration should be based on clinical response. Doses of up to 30mg/kg per day have been administered and were generally well tolerated.

This medication is used for the prevention of epilepsy and migraines, and the risk of suicidal thoughts or behaviors may increase during treatment, so patients and caregivers should carefully monitor for any changes. Patients taking this medication may experience sudden skin rashes or severe skin reactions, so any abnormal symptoms should be reported to medical personnel immediately. In patients with impaired kidney function, the drug concentration in the body may persist longer, so the dosage should be adjusted according to a doctor's instructions. Women who are pregnant or planning to become pregnant should consult with a physician before taking this medication, as using it during pregnancy may pose risks to the fetus and should be approached with caution. Adequate fluid intake is important during treatment, and drinking plenty of water is recommended to reduce the risk of kidney stones. This medication may cause drowsiness, dizziness, or blurred vision, so it is safer to avoid driving or operating machinery during the initial period of treatment. Sudden discontinuation of the medication may worsen seizures, so if discontinuing, it must be done gradually under a physician's supervision. This medication may interact with other drugs, so if you are taking other medications, it is crucial to inform your medical personnel, especially if combined with oral contraceptives, lithium, or antiepileptic drugs, caution is required. Various side effects may occur, including weight loss, depression, memory problems, and loss of appetite, so if abnormal symptoms persist or worsen, consulting with medical personnel is necessary. This medication is also used in children, but its safety and efficacy have not been established in children under 2 years of age, so it is not used in that group. Regular monitoring, such as blood tests or kidney function tests, may be required during treatment, and any abnormal signs should be reported to medical personnel immediately.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is advisable to keep it in a cool, dry place below 25 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle