Topimed Extended Release Tablet 50mg (Topiramate)

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. There is no need to monitor blood concentrations to optimize the dosage of this medicine. The recommended dosage of this medicine applies to all adults and children, including older adults, provided they do not have renal disease. It may be taken with or without food. This medicine is administered once daily. As this is an extended-release formulation, do not break, crush, or chew it. Swallow the tablet whole. 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 tapered and discontinued at intervals of 2 weeks, reducing the dose by approximately 1/3 (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) Start with 25㎎ in the evening for the first week. Thereafter, increase the dose by 25 or 50㎎ per day at intervals of 1-2 weeks and administer once daily. 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 the clinical response. The recommended dose for monotherapy in adults is 100～200㎎ per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses of up to 1,000㎎ per day. 2. Adjunctive therapy - Adults (17 years and older) The minimum effective dose is 200㎎ per day, and the usual dose is 200-400㎎ once daily. Depending on the patient, the dose may be increased up to the maximum recommended dose of 800㎎ per day. Start treatment with 25-50㎎ in the evening for the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50㎎ at intervals of 1-2 weeks and administer once daily. If the patient has difficulty tolerating the increased dose, smaller dose increments may be used or the interval between increases may be extended. The dose should be determined according to the 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 starting and maintenance doses be reduced to approximately 1/2. - Patients on hemodialysis: As this medicine is removed from plasma by hemodialysis, patients on hemodialysis should receive an additional dose equivalent to approximately 1/2 of the daily dose on dialysis days. The dose should be adjusted taking into account the duration of dialysis, the clearance of the dialysis equipment, and the patient’s renal clearance, and should be divided between the start and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution to 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 the dose by 0.5-1㎎/㎏ per day at intervals of 1-2 weeks and administer once daily. If the patient has difficulty tolerating the dose increase, reduce the increment or extend the interval between increases. The dose and degree of titration should be determined according to the clinical response. The recommended dose for monotherapy in children is 3-6㎎/㎏ per day. In children diagnosed with partial-onset seizures, doses of up to 500㎎ per day have been used. - Children (2-16 years): The recommended daily dose is approximately 5-9㎎/㎏, administered once daily. For the first week, administer 25㎎ (or less, based on 1-3㎎/㎏ per day) in the evening. Thereafter, increase the dose by 1-3㎎/㎏ per day at intervals of 1-2 weeks until an appropriate clinical effect is achieved, and administer once daily. Dose titration should be determined according to the clinical response. Doses of up to 30㎎/㎏ per day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behavior, so if mood changes or symptoms of depression occur during treatment, you must inform your healthcare provider immediately. Patients taking this medication are at risk of sudden death, so regular health checks are required. Individuals allergic to any component of this drug should not take it. Patients with impaired kidney function may need dosage adjustments as the effect and side effects of this drug may differ; dosage should be adjusted based on dialysis conditions. Adequate hydration is important to reduce the risk of kidney stones, and those with a history of kidney stones or family history should take special care. Patients with liver function impairment should also take this medication cautiously. If there are changes in weight, dietary adjustments or nutritional supplementation should be considered. This medication can cause central nervous system side effects such as sedation, dizziness, and reduced concentration, so caution is necessary when driving or operating machinery. Sufficient hydration should be maintained during use to prevent kidney stones and dehydration. This medication may worsen mood disorders or depression, so mental health status should be monitored regularly. Abrupt discontinuation may increase the risk of seizures, so dosage should be gradually reduced according to healthcare provider's instructions. Pregnant women may harm the fetus, so women of childbearing potential should use appropriate contraception, and if taking the medication during pregnancy, consult a doctor. Breastfeeding women should consult their doctor regarding the possibility of this drug being excreted in breast milk. It is not recommended for children under the age of 2 due to lack of safety and efficacy data. This medication may interact with other drugs, so it is essential to inform your healthcare provider of any other medications being taken. Overdose may cause symptoms such as headache, seizures, drowsiness, and confusion, and requires immediate emergency care. This drug should be kept out of reach of children and not transferred to other containers.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• perceptual disturbances
• drowsiness
• ataxia
• attention/concentration disorders
• confusion
• dizziness

This medication must be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the drug's effectiveness and prevent degradation.

Appearance

Pink round extended release film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle