Topirac Tablets 25 mg (Topiramate)

Adult dosage

It is advisable to start this medication at a low dose and increase it to the effective dose. There is no need to monitor blood levels to optimize treatment with this medication. The recommended dose of this medication applies to all adults and children, including older adults, without renal impairment. It may be taken with or without food. Tablets should be swallowed whole and not crushed. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, consideration should be given to the potential effect on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be gradually tapered 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 concentration occurs, the dose of this medication may need to be reduced. Adults (17 years and older): Start with 25㎎ in the evening during the first week. Thereafter, increase the dose by 25 or 50㎎ per day at 1- to 2-week intervals and administer in 2 divided doses per day. If the patient has difficulty tolerating this titration schedule, lengthen the titration intervals. The dose and rate of titration 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 relapsed epilepsy have tolerated topiramate monotherapy at doses up to 1,000㎎ per day. 2) Adjunctive therapy The minimum effective dose for adults (17 years and older) is 200mg per day; the usual dose is 200-400mg per day, administered in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg per day. Treatment is started with 25-50mg in the evening during the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50mg at 1- to 2-week intervals and administer in 2 divided doses per day. If the patient has difficulty tolerating the increased dose, the dose may be increased by smaller amounts or the titration intervals may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start with 25mg of this medication in the evening during the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this increase, lengthen the titration intervals. 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 initial and maintenance doses be reduced to approximately 1/2. - Patients undergoing hemodialysis: Because this medication is removed from plasma by hemodialysis, the dose on dialysis days should be increased by approximately 1/2. The dose should be adjusted taking into account the duration of dialysis, the clearance of the dialysis system, and the patient's renal clearance, and should be administered in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment This medication should be administered with caution to patients with hepatic impairment because its clearance may be reduced.

Children's dosage

For children (6-16 years), start with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at intervals of 1-2 weeks and administer in 2 divided doses per day. If the patient has difficulty tolerating dose increases, reduce the size of each increase or lengthen the interval between increases. The dose and rate of increase should be determined according to the 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. The recommended daily dose for children (2 years-16 years) is approximately 5-9mg/kg, administered in 2 divided doses per day. During the first week, administer 25mg (or less, based on 1-3mg/kg per day) in the evening. Thereafter, increase the dose by 1-3mg/kg per day at intervals of 1-2 weeks until an appropriate clinical effect is achieved, administered in 2 divided doses per day. Dose titration should be determined according to the clinical effect. Doses of up to 30mg/kg per day have been used and were generally well tolerated.

This medication is used for epilepsy and migraine prevention, and there may be an increased risk of suicidal thoughts or behaviors while taking it. Patients and caregivers should carefully observe for these symptoms. This medication may pose a risk of sudden death in patients with epilepsy, so continuous monitoring of the patient's condition during treatment is crucial. Severe allergic reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur, so symptoms like skin rash or blisters should be reported to medical personnel immediately. Patients who are allergic to any ingredients of this medication or those with certain genetic disorders such as lactose intolerance should not take it, and women who are pregnant or planning to become pregnant should consult a doctor before using this medication. Taking this medication during pregnancy may pose risks of malformations or growth retardation to the fetus; therefore, effective contraceptive measures should be used by women of childbearing age, and it is recommended to avoid taking it if pregnant. Patients with impaired kidney or liver function may have delayed excretion of the medication, necessitating dosage adjustment and careful administration. This medication may cause central nervous system side effects such as drowsiness, dizziness, and decreased concentration, so it is advisable to avoid driving or operating dangerous machinery during the initial phase of treatment. Adequate hydration is very important; patients should drink enough water to reduce the risk of kidney stones. Sudden discontinuation of this medication may worsen seizures, so when stopping, it should be gradually reduced according to a doctor's instructions. There may be interactions with other medications, so patients should inform their healthcare providers of any other medications they are taking, especially regarding contraceptive pills, lithium, and anti-epileptic medications.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• paresthesia
• rigid muscles
• ataxia

Store this medication in a tightly closed container to prevent air and moisture from entering, and keep it in a cool, dry place at temperatures below 25 degrees Celsius.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle