Topiramate Tablets (Topiramate)

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize administration of this medicine. The recommended dose of this medicine applies equally to all adults and children, including older adults, who do not have kidney disease. It 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, consider the potential effect on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, gradually taper them by about 1/3 at 2-week intervals (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 concentration 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 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, extend the intervals between dose increases. The dose and titration rate should be determined according to clinical response. The recommended dose for monotherapy in adults 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. Initiate treatment with 25-50mg in the evening for the first week; it is also possible to start 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 dose increments may be used or the intervals between increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start 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 intervals 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 titration rate 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 starting and maintenance doses to approximately 1/2 is recommended. - Hemodialysis patients: Since this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. Adjust the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and administer divided doses at the beginning and end of hemodialysis. 4. Patients with hepatic impairment 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 the daily dose by 0.5-1㎎/㎏ at 1-2-week intervals and administer in 2 divided doses. If the patient has difficulty tolerating the increase, use smaller dose increments or extend the intervals between increases. The dose and degree of titration should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. In children diagnosed with partial-onset seizures, doses up to 500㎎ per day have been used. 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 daily dose by 1-3mg/kg at 1-2-week intervals until an appropriate clinical effect is achieved, and administer in 2 divided doses. Dose titration should be determined according to clinical effect. Doses up to 30mg/kg per day have been administered and were generally well tolerated.

This medication is used as an antiepileptic to prevent epilepsy and migraines. There may be an increased risk of suicidal thoughts or behavior, so patients and caregivers should immediately inform healthcare providers if any signs of depression, mood changes, or unusual behaviors occur. This drug can cause serious skin conditions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so if symptoms like skin rash or blisters appear, discontinue use and consult a doctor immediately. Adjustments to the drug's concentration may be required according to renal function, and patients with renal impairment may need dosage adjustments. Additionally, since there is a risk of kidney stone formation, maintaining adequate hydration is crucial, and caution is advised for those with a history of or family history of kidney stones. During pregnancy, there may be risks of birth defects and growth delays, so women of childbearing potential should take a pregnancy test before starting the medication and use effective contraception during treatment. This drug can cause central nervous system side effects like drowsiness, dizziness, and blurred vision, so it is safer to avoid driving or operating machinery when starting treatment or adjusting dosage. It is advisable not to use this medication with other central nervous system depressants or alcohol, as it can interact with certain drugs, so inform your doctor or pharmacist about any other medications being taken. Suddenly stopping this medication may worsen seizures, therefore, it should be gradually tapered off under medical supervision. Lastly, various adverse reactions such as weight loss, loss of appetite, depression, and memory impairment may occur, and if any unusual symptoms persist or worsen, consult a specialist immediately.

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

This medication should be stored in a closed container to protect it from air and moisture, preferably in a cool, dry place below 25 degrees Celsius. Proper storage can help maintain the drug's effectiveness for a longer period.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle