Topard 25mg (Topiramate)

Adult dosage

It is preferable to start this medication at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize the dose of this medication. The recommended dose of this medication applies to all adults and children, including older adults, in the absence of renal disease. It may be taken with or without food. 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, the potential effect on seizure control should be considered. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, taper and discontinue them gradually by approximately 1/3 every 2 weeks (see “5. General precautions” under Precautions for use). When a drug that induces drug-metabolizing enzymes is discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentration occurs, the dose of this medication may need to be reduced. Adults (17 years and older): Start with 25㎎ in the evening during the first week. Thereafter, increase by 25 or 50㎎ daily at 1-2-week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating this rate of increase, lengthen the intervals between dose increases. The dose and rate of increase 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 doses of topiramate monotherapy up to 1,000㎎ daily. 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. Start treatment with 25-50mg in the evening during the first week; treatment may also be started at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2-week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, increase by smaller amounts or extend the intervals between dose increases. The dose should be determined according to clinical effect. 2. Migraine prevention Adults: Start treatment with 25mg of this medication in the evening during the first week. Thereafter, increase by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, lengthen the intervals between dose 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; the dose and rate of increase 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: Because this medication is removed from plasma by hemodialysis, increase the dose of this medication by approximately 1/2 on the day of dialysis. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis equipment, and the patient's residual renal clearance, and administer the additional dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution to patients with hepatic impairment because the clearance of this medication may be reduced.

Children's dosage

Children (6-16 years): Start with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase by 0.5-1㎎/㎏ daily at 1-2-week intervals and administer twice daily. If the patient has difficulty tolerating the increase, reduce the increments or lengthen the intervals between dose increases. The dose and degree of increase 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 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 by 1-3mg/kg daily at 1-2-week intervals until an appropriate clinical effect is achieved, administering the dose 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 may increase the risk of suicidal thoughts or behaviors, so any changes in mood or behavior during treatment should be discussed with a physician immediately. There may be a risk of sudden death among patients with epilepsy taking this drug, thus regular monitoring is necessary. Severe skin reactions can occur rarely; if a rash or blister appears on the skin, the medication should be discontinued immediately and healthcare professionals should be notified. This medication should not be used if there is an allergy to its components, and patients with lactose intolerance should also refrain from taking it. Women who are pregnant or planning to become pregnant must consult a physician before taking this medication, as it may cause harm to the fetus during pregnancy. Patients with impaired kidney function require dose adjustment since the drug is eliminated from the body more slowly. Dosages must also be adjusted for patients undergoing hemodialysis. Patients at risk for kidney stones should ensure adequate fluid intake to prevent stone formation. Patients with impaired liver function should also be cautious when taking this drug. This medication can cause central nervous system side effects such as drowsiness, dizziness, and decreased concentration; thus, driving or operating machinery should be avoided initially. When discontinuing the medication, it should not be stopped abruptly and should be gradually reduced according to a doctor’s instructions to minimize the risk of seizures. This drug may interact with other medications; therefore, any current medications should be disclosed to the physician or pharmacist. Women taking contraceptives should be aware that this drug may reduce contraceptive effectiveness; using additional contraceptive methods is recommended. During use of this medication, sufficient fluid intake is necessary to reduce the risks of dehydration and kidney stone formation. This drug may cause various side effects including weight loss, loss of appetite, depression, and memory impairment; consultation with professionals should occur if any unusual symptoms arise. Instances of encephalopathy related to hyperammonemia have been reported rarely; if sudden drowsiness or changes in consciousness occur, healthcare professionals should be notified immediately. There is a risk of congenital malformations or growth retardation in the fetus if this drug is taken during pregnancy, so treatment methods should be reassessed when planning for pregnancy. If sudden vision loss or eye pain occurs while taking this medication, it should be stopped immediately, and ophthalmologic evaluation should be sought. This medication can affect blood tests, thus regular testing is required. If mood changes, suicidal impulses, or depressive symptoms worsen during treatment, prompt consultation with healthcare professionals is necessary.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and must be kept in a cool, dry place under 25 degrees Celsius. It is important to avoid direct sunlight and maintain a dry environment since the drug may be sensitive to moisture and heat.

Appearance

White, round, film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle