Topam Tablet (Topiramate)

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring plasma concentrations is not necessary to optimize treatment with this medicine. The recommended dose of this medicine applies to all adults and children, including elderly patients, who do not have renal disease. It may be taken with or without food. Swallow the tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy: When discontinuing other antiepileptic medicines being taken concomitantly in order to use topiramate as monotherapy, consider the potential effect on seizure control. Unless other antiepileptic medicines must be discontinued immediately for safety reasons, gradually reduce and discontinue the other antiepileptic medicines by approximately 1/3 at 2-week intervals (see “5. General Precautions” under Precautions). When enzyme-inducing medicines 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 by 25 or 50㎎ per day at intervals of 1-2 weeks and administer in 2 divided doses daily. If the patient cannot tolerate this rate of increase, extend the interval between dose increases. Determine the dose and rate of increase according to clinical response. The recommended dose for monotherapy in adults is 100～200mg daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated up to 1,000㎎ daily of topiramate as monotherapy. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg daily, and the usual dose is 200-400mg daily in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg daily. Begin treatment with 25-50mg in the evening for the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50mg at intervals of 1-2 weeks and administer in 2 divided doses daily. If the patient cannot tolerate the increased dose, smaller increments may be used or the interval between dose increases may be extended. Determine the dose according to clinical effect. 2. Prevention of migraine Adults: Start with 25mg of this medicine in the evening for the first week. Thereafter, increase by 25mg/day at weekly intervals. If the patient cannot tolerate this rate of increase, extend the interval between dose increases. The recommended dose is 100mg daily, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. Doses up to 200mg daily may be administered; determine the dose and rate of increase according to clinical response. 3. Patients with renal impairment - For patients with moderate to severe renal impairment (CLcr < 70 mL/min/1.73 m2), it is recommended to reduce the initial and maintenance doses to approximately 1/2. - Hemodialysis patients: 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 considering the duration of dialysis, dialyzer clearance, and the patient's residual renal clearance, and administer in divided doses at 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 by 0.5-1㎎/㎏ per day at intervals of 1-2 weeks and administer twice daily. If the patient cannot tolerate the increase, use smaller increments or extend the interval between dose increases. Determine the dose and degree of increase according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg daily. In children diagnosed with partial seizures, doses up to 500㎎ daily have been used. Children (2-16 years): The recommended dose is approximately 5-9mg/kg daily, administered in 2 divided doses. For the first week, administer 25mg (or less, based on 1-3mg/kg daily) in the evening. Thereafter, increase by 1-3mg/kg per day at intervals of 1-2 weeks until an appropriate clinical effect is achieved, and administer in 2 divided doses. Determine dose titration according to clinical effect. Doses up to 30mg/kg daily have been administered and were generally well tolerated.

This medication is used as an anticonvulsant for epilepsy and migraine prevention. There is an increased risk of suicidal thoughts or behaviors while taking this medication, so patients and caregivers must immediately inform healthcare professionals of any signs of depression, mood changes, or suicidal symptoms. Additionally, this medication may cause severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis; therefore, if any abnormal skin symptoms occur, the patient should discontinue use immediately and visit a healthcare facility. Use of this medication during pregnancy may harm the fetus and increase the risk of fetal growth retardation or low birth weight; therefore, women who are pregnant or planning to become pregnant should consult a physician before taking it and use effective contraception. Patients with impaired kidney function may have increased concentrations of this medication in the body, necessitating dosage adjustments, while patients undergoing hemodialysis should adjust doses according to dialysis conditions. This medication can cause central nervous system symptoms such as drowsiness, dizziness, and blurred vision, so caution should be exercised when driving or operating machinery initially after starting treatment. Adequate hydration is important, and since there is a risk of kidney stones, patients should drink plenty of water. Moreover, this medication may interact with other drugs; thus, patients must inform their healthcare providers of any current medications, especially if using contraceptives or other anticonvulsants. If there are any unusual symptoms such as weight changes, mood changes, visual disturbances, skin rashes, or kidney pain, the patient should consult a physician immediately. Suddenly stopping this medication can worsen seizures; therefore, the dose should be gradually reduced, and discontinuation should be followed according to the healthcare provider's instructions.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• abnormal perception
• myoclonus
• ataxia

This medication is sensitive to air and moisture and should be stored in a tightly sealed container. It is also advisable to keep it in a cool, dry place at a temperature below 25 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle