Pondamis 25 mg (Topiramate)

Adult dosage

It is advisable to start this medicine at a low dose and gradually increase it to the effective dose. Monitoring plasma concentrations is not necessary to optimize treatment with this medicine. The recommended dose of this medicine applies to all adults and children, including older adults, in the absence of renal disease. This medicine 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 use 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 Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be gradually withdrawn by reducing the dose by about 1/3 every 2 weeks (see “5.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 concentrations occurs, the dose of this medicine may need to be reduced. Adults (17 years and older): Begin treatment with 25㎎ in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at intervals of 1-2 weeks and administer it in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the interval between dose increases. The dose and rate of titration 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 topiramate monotherapy at doses up to 1,000㎎ daily. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg daily; the usual dose is 200-400mg daily, administered in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg daily. Begin treatment with 25-50mg in the evening for the first week; treatment may also be initiated at a lower dose. Thereafter, increase the dose by 25-50mg at intervals of 1-2 weeks and administer it in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller increments may be used or the interval between dose increases may be extended. The dose should be determined according to clinical response. 2. Prevention of migraine Adults: Begin treatment with 25mg of this medicine in the evening for 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 dose increases. The recommended dose is 100mg daily, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. The dose may be increased to 200mg daily, with the dose and rate of titration 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. - Patients undergoing hemodialysis: Because this medicine is removed from plasma by hemodialysis, the dose on dialysis days should be increased by approximately 1/2. The dose should be increased taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and should be divided between the beginning and end of hemodialysis. 4. Patients with hepatic impairment Use this medicine with caution in patients with hepatic impairment, as its clearance may be reduced.

Children's dosage

Children (6-16 years): Begin treatment with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at intervals of 1-2 weeks and administer it twice daily. If the patient has difficulty tolerating the dose increase, use smaller increments or extend the interval between increases. The dose and rate 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-onset seizures. Children (2 years-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 intervals of 1-2 weeks, administered in 2 divided doses, until an appropriate clinical response is achieved. Dose titration should be determined according to clinical response. Doses up to 30mg/kg daily have been used and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or actions, so it's essential to monitor for mood changes or depressive symptoms while taking it. Also, sudden death may occur in epilepsy patients, so it's important to closely monitor their condition during treatment. This medication can cause severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so it should be discontinued immediately if any skin symptoms occur. Patients with allergies to the ingredients or lactose intolerance, as well as pregnant women or women of childbearing age not using effective contraception, should not take this medicine. Women of childbearing potential should take a pregnancy test before starting the medication and must use effective contraception while taking it, being aware that it may harm the fetus. Patients with impaired renal or liver function may experience delayed elimination of this drug, necessitating dose adjustments, and patients undergoing dialysis should adjust the dosage according to the conditions of dialysis. Adequate hydration is necessary while taking this medication, and caution is advised due to the risk of kidney stones. Drowsiness, dizziness, decreased concentration, and memory impairments may occur as central nervous system side effects, requiring careful attention when driving or operating machinery. This medication may interact with other drugs, so it's essential to inform healthcare providers of any other medications being taken. In particular, this drug may reduce the effectiveness of contraceptives, so women using birth control should be vigilant about any changes in bleeding or potential contraceptive failure. Taking this medication during pregnancy may increase the risk of fetal malformation, so women planning a pregnancy or who are pregnant should consult their healthcare provider. Sudden discontinuation of this medication may worsen seizures, so it should be tapered off gradually under a doctor's guidance. If any unusual symptoms or side effects occur during treatment, it is crucial to inform a healthcare provider immediately for appropriate action.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal mood and behavioral changes
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• sensory abnormalities
• hyperesthesia
• ataxia

This medication should be stored in a sealed container to prevent exposure to air and moisture. It should be kept in a cool place below 25 degrees Celsius and preferably in a dry location with low humidity.

Appearance

White circular film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle