Topiramate Tablets 25 Milligrams (Topiramate)

Adult dosage

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 levels 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. 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 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 concentrations occurs, the dose of this medicine may need to be reduced. Adults (17 years and older): Start treatment with 25㎎ in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at 1-2 week intervals and administer in 2 divided doses. If the patient has difficulty tolerating this titration schedule, lengthen 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 per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses up to 1,000㎎ per day. 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, 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; treatment may also be initiated at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2 week intervals and administer 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: Start 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, lengthen the interval between dose 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 titration 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 starting 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. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis equipment, and the patient's residual renal clearance, and administer the dose in divided portions at the start 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): Start treatment with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the total daily dose by 0.5-1㎎/㎏ at 1-2 week intervals and administer twice daily. If the patient has difficulty tolerating the increase, reduce the dose increment or lengthen the interval between dose increases. The dose and extent of titration should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. Doses up to 500㎎ per day have been used in children diagnosed with partial-onset seizures. Children (2-16 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 per day) in the evening. Thereafter, increase the total daily dose by 1-3mg/kg at 1-2 week intervals until an appropriate clinical response is achieved, administering it in 2 divided doses. Dose titration should be determined according to clinical response. Doses 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, so if there are mood changes or unusual behaviors during treatment, consult a doctor immediately. Patients with epilepsy taking this medication may be at risk for sudden death, necessitating regular health check-ups. Serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur rarely, so if severe rashes or blisters develop, stop the medication immediately and consult medical personnel. People with allergies to any ingredients in this medication or those with specific genetic lactose intolerance should not take it. Women who are pregnant or planning to become pregnant must take a pregnancy test before taking this medication, and effective contraceptive measures should be used during treatment. Taking this medication during pregnancy can harm the fetus, so it is important to follow prenatal check-ups and a doctor's instructions strictly. Patients with poor kidney function may need to adjust the medication dose as the amount in the body may vary; dosage adjustments should be made according to the doctor’s orders. Adequate hydration is crucial while taking this medication, especially to reduce the risk of kidney stones. This medication can cause central nervous system side effects such as drowsiness, dizziness, and blurred vision, so it is advisable to avoid driving or operating hazardous machinery during the initial stages of treatment. Abrupt discontinuation of the medication can worsen seizures, so if discontinuation is necessary, it should be done gradually under a doctor's instructions. This medication may interact with other antiepileptic medications or various drugs, so patients should inform their doctor or pharmacist about any other medications they are taking. Women taking contraceptives should consult their doctor regarding the potential reduction in contraceptive effectiveness due to this medication. Patients might experience side effects such as weight loss, loss of appetite, depression, and cognitive impairment, so notify medical personnel of any unusual symptoms. Children and the elderly may be more sensitive to side effects, hence careful monitoring and management are necessary. Regular blood tests and health check-ups during treatment are advisable. This medication can reduce sweat secretion affecting body temperature regulation, so caution is necessary when engaging in activities in hot environments. If symptoms like altered consciousness, severe fatigue, vomiting, or lethargy occur during treatment, consult medical personnel immediately.

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

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, it should be kept in a cool and dry place below 25 degrees Celsius to maintain its efficacy.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle