Topira Tablets (Topiramate)

Adult dose

It is recommended to start this medicine at a low dose and increase it to the effective dose. Monitoring plasma concentrations is not necessary to optimize the administration of this medicine. The recommended dose of this medicine applies to all adults and children, including older adults, provided they do not have renal disease. It may be administered 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, 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 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 by 25 or 50 ㎎ per day at 1-2 week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating this rate of increase, extend the interval between dose increases. The dose and rate of increase should be determined according to clinical response. The recommended dose for monotherapy in adults is 100∼200 mg per day. The maximum recommended dose is 500 ㎎ per day. Some patients with recurrent epilepsy have tolerated up to 1,000 ㎎ per day of topiramate as monotherapy. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200 mg per day, and the usual dose is 200-400 mg per day in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800 mg per day. Start treatment with 25-50 mg in the evening for the first week; it is also possible to start at a lower dose. Thereafter, increase the dose by 25-50 mg at 1-2 week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, increase by a smaller amount or extend the interval between dose increases. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start with 25 mg of this medicine in the evening for the first week. Thereafter, increase the dose by 25 mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, extend the interval between dose increases. The recommended dose is 100 mg per day, administered in 2 divided doses. Some patients may respond to a dose of 50 mg per day. Doses of up to 200 mg per day 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: Since this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on the day of dialysis. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis system, and the patient's renal clearance, and administer the dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in 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 by 0.5-1 ㎎/㎏ per day at 1-2 week intervals and administer twice daily. If the patient has difficulty tolerating the increase, reduce the increments or extend the interval between increases. The dose and extent of increase should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6 mg/kg per day. Doses of up to 500 ㎎ per day have been used in children diagnosed with partial seizures. Children (2-16 years): The recommended dose is approximately 5-9 mg/kg per day, administered in 2 divided doses. For the first week, administer 25 mg (or less, based on 1-3 mg/kg per day) in the evening; thereafter, increase by 1-3 mg/kg per day at 1-2 week intervals until an appropriate clinical effect is achieved, and administer in 2 divided doses daily. Dose titration should be determined according to clinical effect. Doses of up to 30 mg/kg per day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors; therefore, if mood changes or abnormal behaviors occur during treatment, it is essential to inform healthcare professionals immediately. Patients with epilepsy taking this medication may be at risk of sudden death and require regular monitoring. Serious skin allergy reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur. If symptoms such as skin rash or blisters appear, the medication should be discontinued immediately. Patients with known allergies to any component of this medication, or certain genetic lactose metabolism disorders, should not take this medication. Women who are pregnant or planning to become pregnant must conduct a pregnancy test before taking this medication, use effective contraception during treatment, and should be cautious as it may harm the fetus if pregnancy occurs. Patients with reduced kidney function may experience an increased concentration of this medication in the body, requiring dose adjustments and careful monitoring. This medication can be removed easily during hemodialysis, so dialysis patients should adjust their dosage according to dialysis conditions. Increased fluid intake is essential due to the risk of kidney stones; caution is especially advised for those with a history or family history of kidney stones. Patients with impaired liver function should be cautious, as the excretion of this medication may be slowed. This medication can affect the central nervous system, causing drowsiness, dizziness, decreased concentration, etc. Caution is necessary when driving or operating machinery. During treatment, psychological side effects such as depression, anxiety, or aggression may occur; thus, observing for changes in condition is crucial. Sudden discontinuation of this medication may worsen seizures; therefore, it must be gradually reduced under medical guidance when stopping. This medication can interact with other antiepileptic drugs or various medications. If other medications are being taken, healthcare professionals must be informed. In particular, when taken with contraceptives, the contraceptive effect may be reduced, hence additional contraceptive methods are recommended. If taken by pregnant women, there is a risk of congenital malformations or growth retardation in the fetus; therefore, it must be administered only after consulting with a physician during pregnancy. Patients may experience side effects such as weight loss, decreased appetite, kidney stones, and skin rashes; if symptoms persist or worsen, consultation with healthcare professionals is necessary. It is essential to maintain adequate hydration and pay attention to body temperature regulation, and to visit a hospital immediately if there are unusual symptoms.

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

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It is recommended to keep it in a cool, dry place, below 25 degrees Celsius, to maintain its effectiveness longer.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle