PM Este Topiramate Tablets 25mg

Adult dose

It is advisable to start this medicine at a low dose and increase it to the effective dose. There is no need to monitor serum concentrations to optimize the dose of this medicine. The recommended dose of this medicine is the same for all adults and children, including older adults, in the absence of renal disease. It may be taken with or without food. Tablets should be swallowed whole and not crushed. Adults (17 years and older): Start with 25㎎ in the evening for the first week. Thereafter, increase by 25 or 50㎎ per day at intervals of 1-2 weeks, administered in 2 divided doses daily. If the patient has difficulty tolerating this titration schedule, extend 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 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 during topiramate monotherapy. The minimum effective dose for adults (17 years and older) is 200mg per day, and 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 for the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50mg at intervals of 1-2 weeks and administer in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, a smaller increase or a longer interval between increases may be used. The dose should be determined according to clinical effect. Adults: Start with 25mg of this medicine in the evening for the first week. Thereafter, increase by 25mg/day at weekly intervals. If the patient has difficulty tolerating these increases, extend the intervals between increases. The recommended daily dose is 100mg, administered in 2 divided doses. Some patients may respond to a dose of 50mg per day. The dose may be increased to 200mg per day, and the dose and rate of increase should be determined according to clinical response. For patients with moderate or severe renal impairment (CLcr < 70 mL/min/1.73 m2), it is recommended that the starting and maintenance doses be reduced to approximately 1/2. Patients on hemodialysis: Because this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis device, and the patient's residual clearance, and divide the dose between the start and end of hemodialysis. 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 intervals of 1-2 weeks and administer twice daily. If the patient has difficulty tolerating the increase, reduce the increment or extend the interval between increases. The dose and extent of 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. Children (2-16 years): The recommended daily dose is approximately 5-9mg/kg, divided into 2 doses. For the first week, administer 25mg (or less, based on 1-3mg/kg per day) in the evening, and thereafter increase by 1-3mg/kg per day at intervals of 1-2 weeks until an adequate clinical effect is achieved, in 2 divided doses daily. Dose titration should be determined according to clinical effect. Doses of up to 30mg/kg per day have been administered and were generally well tolerated.

This medication is an antiepileptic drug used for treating epilepsy and preventing migraines. Patients taking this medication may have an increased risk of suicidal thoughts or behavior, so it is important for patients and caregivers to report any such symptoms to healthcare professionals immediately. Additionally, there may be a slightly elevated risk of sudden death in epilepsy patients taking this drug, so caution is necessary. This medication can cause serious skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so if any abnormal skin symptoms occur, users should stop taking the medication and consult their healthcare provider immediately. Patients with hypersensitivity to any component of this drug or certain hereditary lactose intolerances should not take it. Women who are pregnant or may become pregnant should take a pregnancy test before taking this medication and must use effective contraception while on it due to the risk of congenital malformations or growth retardation in the fetus. Caution should be taken when prescribing this medication to patients with reduced kidney or liver function, as its excretion may be delayed. This drug may affect the central nervous system, leading to drowsiness, dizziness, and blurred vision, so it is advisable to avoid driving or operating machinery at the initiation of treatment. Maintaining adequate hydration is necessary to minimize the risk of side effects like kidney stones or metabolic acidosis, especially in those with a history of kidney stones or family history. Stopping this drug suddenly may worsen seizures; therefore, when discontinuing, it should be done gradually under medical supervision. During treatment, changes in weight, mood, depression, cognitive impairment, and other neuropsychiatric symptoms may occur; severe symptoms should be discussed with a healthcare provider. Furthermore, this medication may interact with other drugs, so patients should inform healthcare professionals of any current medications. Women taking contraceptive pills should be especially cautious, as this medication may decrease contraceptive effectiveness. Regular medical check-ups to monitor for adverse reactions while taking this medication are important.

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

This medication can be sensitive to air and humidity; therefore, it should be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius to preserve its efficacy.

Appearance

White or nearly white round film-coated tablet

Package unit

30 tablets/bottle