Pondamis Tablet 100 mg (Topiramate)

Adult dose

It is preferable to start this drug at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize administration of this drug. The recommended dose of this drug is the same for all adults and children, including the elderly, in the absence of renal disease. This drug may be administered regardless of 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 impact on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, gradually reduce and discontinue them by approximately 1/3 every 2 weeks (see section “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 drug 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 it in 2 divided doses daily. If the patient has difficulty tolerating this titration schedule, extend the interval 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 per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated doses of up to 1,000㎎ per day as topiramate monotherapy. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg per day, and the usual dose is 200-400mg per day in 2 divided doses. Depending on the patient, doses up to the maximum recommended dose of 800mg per day may be administered. 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 it in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, the dose may be increased by a smaller amount or the interval between increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start 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 this dose increase, 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 up to 200mg 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), reducing the initial and maintenance doses to approximately 1/2 is recommended. - Hemodialysis patients: Since this drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and administer the increased dose in divided doses at the beginning and end of hemodialysis. 4. Patients with hepatic impairment Use this drug with caution in patients with hepatic impairment because its clearance may be reduced.

Child dose

Pediatric patients (6–16 years), monotherapy: Begin treatment with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at intervals of 1-2 weeks and administer it in 2 divided doses per day. If the patient has difficulty tolerating dose increases, reduce the increments or extend the intervals between increases. The dose and degree of dose increase should be determined according to clinical response. The recommended dose for pediatric monotherapy is 3-6mg/kg per day. Doses of up to 500㎎ per day have been used in children diagnosed with partial seizures. Pediatric patients (2–16 years), adjunctive therapy: The recommended daily dose is approximately 5-9mg/kg, divided into 2 doses per day. During the first week, administer 25mg (or less, based on 1-3mg/kg per day) in the evening. Thereafter, increase the dose by 1-3mg/kg per day at intervals of 1-2 weeks until an appropriate clinical effect is achieved, and administer it in 2 divided doses per day. Dose titration should be based on clinical effect. Doses of up to 30mg/kg per day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors; therefore, it is essential to consult a professional immediately if mood changes or symptoms of depression occur during treatment. Additionally, caution is necessary as there is a possibility of sudden death in epilepsy patients taking this medication. If severe skin rashes, redness, or blisters occur while taking this medication, discontinue use immediately and inform healthcare professionals. Patients with allergies to any component of this medication or certain genetic metabolic disorders should not take it. Women who are pregnant or planning to become pregnant must perform a pregnancy test before taking this medication and should use effective contraception during treatment, being fully aware of the risks to the fetus. Patients with impaired kidney or liver function should adjust the dose of this medication, and patients at risk for kidney stones need sufficient fluid intake. This medication can affect the central nervous system, causing drowsiness, dizziness, and blurred vision; thus, it is recommended to avoid driving or operating machinery during the initial period of treatment. Abruptly stopping this medication can worsen seizures; therefore, it should be gradually reduced under the guidance of healthcare professionals. During treatment, various side effects such as weight change, mood changes, memory impairment, and appetite changes may occur, so if there are abnormal symptoms, it is essential to consult healthcare professionals. This medication can interact with other drugs; therefore, it is crucial to inform healthcare professionals of any other medications being taken, particularly contraceptives, antiepileptic drugs, lithium, and blood pressure medications. It is important to maintain proper fluid intake during treatment to reduce the risk of side effects like kidney stones. Taking this medication during pregnancy may carry risks such as congenital disabilities or growth delays; therefore, women planning to become pregnant or who are pregnant should consult professionals. This medication may rarely cause increased intraocular pressure or visual changes; if visual disturbances occur, inform healthcare professionals immediately. This medication can induce metabolic acidosis, so regular blood tests to monitor kidney function and electrolyte status are essential. During treatment, sweating may decrease, causing difficulty in regulating body temperature; special care is necessary in hot environments. If signs of altered consciousness, severe drowsiness, or vomiting appear during treatment, immediate consultation with healthcare professionals should be sought considering the possibility of serious side effects like hyperammonemic encephalopathy.

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

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. 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, 200 tablets/bottle