Topimed Tablet (Topiramate)

Adult dosage

It is advisable to start this drug at a low dose and increase it to the effective dose. Monitoring of blood concentrations is not necessary to optimize treatment with this drug. The recommended dosage of this drug applies to all adults and children, including older adults, who do not have renal disease. This drug may be administered 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, the potential effect on seizure control should be considered. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be gradually tapered and discontinued by approximately 1/3 every 2 weeks (see Precautions for Use, “5. General Precautions”). When enzyme-inducing drugs that affect drug metabolism are discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentration occurs, the dose of this drug may need to be reduced. Adults (17 years and older): Start treatment 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 titration interval. The dose and rate of titration should be determined 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 as topiramate monotherapy. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg daily, and the usual dosage 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. Treatment is initiated with 25-50mg in the evening for 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 increments may be used or the titration interval may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start treatment with 25mg of this drug in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this titration, extend the titration interval. The recommended daily dose is 100mg, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. Doses up to 200mg daily 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), reducing the starting and maintenance doses to approximately 1/2 is recommended. - Patients undergoing hemodialysis: Since this drug is removed from plasma by hemodialysis, the dose of this drug should be increased by approximately 1/2 on dialysis days. Increase the dose taking into consideration the duration of dialysis, the clearance of the dialysis equipment, and the patient's residual renal clearance, and administer the dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution in patients with hepatic impairment, as clearance of this drug 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 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 increments or extend the titration interval. The dose and extent of titration should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg daily. Doses up to 500㎎ daily 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 daily) in the evening. Thereafter, increase the daily dose by 1-3mg/kg at 1-2 week intervals and administer in 2 divided doses until an appropriate clinical effect is achieved. Dose titration should be determined according to clinical effect. Doses up to 30mg/kg daily have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors, so mental status should be monitored closely during treatment. There may be a risk of sudden death in epilepsy patients, so consistent treatment according to physician's instructions is necessary. Severe skin reactions may occur while taking this medication; therefore, if any skin abnormalities arise, medical personnel should be notified immediately. Individuals with an allergy to this medication's ingredients should not take it, and those with lactose intolerance should avoid this medication. Women who are pregnant or planning to become pregnant must consult a physician before taking this medication and should use effective contraceptive methods while on it. Patients with impaired kidney or liver function may require dosage adjustments; thus, they should follow medical personnel's directions. Adequate hydration during treatment is important, and it is advisable to drink plenty of water to reduce the risk of kidney stones. This medication may affect the central nervous system, causing symptoms such as drowsiness, dizziness, and blurred vision, so caution is needed while driving or operating machinery. If discontinuing this medication, do not stop suddenly, but gradually reduce the dosage under a physician's instructions to minimize the risk of seizures. This medication may interact with other drugs, so patients taking any other medications must inform their healthcare provider. If mood changes, depression, anxiety, or other mental symptoms occur while taking this medication, consult medical personnel immediately. Taking this medication during pregnancy could result in congenital malformations or growth disorders in the fetus, therefore, discussions with a specialist are crucial in cases of pregnancy or planning to conceive.

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

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, keep it in a cool place below 25 degrees Celsius and in a dry environment with low humidity.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle