Topamax 100 mg (Topiramate)

Adult dose

It is advisable to start this medicine at a low dose and increase the dose to the effective dose. There is no need to monitor blood concentrations to optimize the administration of this medicine. The recommended dose of this medicine applies to all adults and children, including older adults, without 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, consider the potential effects on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, taper them gradually by approximately 1/3 every 2 weeks before discontinuation (see “5. General Precautions” under Precautions for Use). When drugs that induce drug-metabolizing enzymes 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 treatment with 25㎎ in the evening for the first week. Thereafter, increase the dose by 25 or 50㎎/day at 1-2-week intervals and administer 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 monotherapy in adults is 100～200mg/day. The maximum recommended dose is 500㎎/day. Some patients with relapsed epilepsy have tolerated topiramate monotherapy at doses of up to 1,000㎎/day. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg/day, and the usual dose is 200-400mg/day in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg/day. Start treatment with 25-50mg in the evening during the first week; treatment may also be started 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 interval between dose increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start treatment with 25mg of this medicine in the evening during the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these dose increases, extend the interval between increases. The recommended dose is 100mg/day, administered in 2 divided doses. Some patients may respond to a dose of 50mg/day. Doses of up to 200mg/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 on hemodialysis: Because 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, the clearance of the dialysis equipment, and the patient’s renal clearance, and administer the additional dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Administer this medicine with caution to patients with hepatic impairment, as its clearance may be reduced.

Child dose

Pediatric patients (6-16 years), monotherapy: Start treatment with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the dose by 0.5-1㎎/㎏/day at 1-2-week intervals and administer twice daily. If the patient has difficulty tolerating the dose increase, reduce the dose increment or extend the interval between increases. The dose and rate of titration should be determined according to clinical response. The recommended dose for monotherapy in pediatric patients is 3-6mg/kg/day. Doses of up to 500㎎/day have been used in pediatric patients diagnosed with partial seizures. Pediatric patients (2-16 years), adjunctive therapy: The recommended dose is approximately 5-9mg/kg/day, administered in 2 divided doses. During the first week, administer 25mg (or less, based on 1-3mg/kg/day) in the evening. Thereafter, increase the dose by 1-3mg/kg/day at 1-2-week intervals and administer in 2 divided doses until an appropriate clinical effect is achieved. Dose titration should be based on clinical effect. Doses of up to 30mg/kg/day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors during use, so patients and caregivers should immediately inform healthcare professionals if such symptoms occur. Also, the possibility of sudden death may occur in patients taking this drug, so close observation is required. Severe skin reactions may occur; if symptoms such as rash or blisters appear, discontinue the medication and consult with healthcare professionals. Patients with an allergy to any ingredients of this medication or specific genetic metabolic abnormalities should not take this medication. Women who are pregnant or could become pregnant should take a pregnancy test before taking this medication and use effective contraception while taking it, as it may harm the fetus during pregnancy. Patients with impaired kidney or liver function may require dosage adjustments due to delayed excretion of this medication, and patients undergoing hemodialysis should adjust their dose accordingly. This medication may increase the risk of kidney stone formation, thus adequate hydration is necessary, and patients with a history of kidney stones or related symptoms should consult with healthcare professionals. During treatment, symptoms such as drowsiness, dizziness, and blurred vision may occur, so caution is needed when driving or operating machinery. This medication may lower bicarbonate levels and induce metabolic acidosis, so blood tests should be performed to monitor the condition, and dosage adjustments or discontinuation should be considered if abnormalities are found. Additionally, reduced sweating may make it difficult to regulate body temperature, so caution is particularly needed in hot environments. This medication can interact with various drugs, so if you are taking other medications, be sure to inform healthcare professionals, especially with antiepileptics, contraceptives, lithium, antipsychotics, and diabetes medications. Stopping this medication suddenly may worsen seizures, so it should be tapered off gradually under the guidance of a healthcare professional. It is important to be aware of the various side effects that may occur while taking this medication, and consult with healthcare professionals immediately if any unusual symptoms arise.

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

This medication should be stored in a tightly closed container to keep out air and moisture, and it should be kept in a cool, dry place below 25 degrees Celsius. Proper storage will help maintain the efficacy of the medication for a longer period.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle