Topiramate Tablet 25 mg (Topiramate)

Adult dose

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.

Child dose

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

This medication may increase the risk of suicidal thoughts or behaviors, so if any mood changes or symptoms of depression occur during treatment, it is essential to consult a physician immediately. Moreover, patients taking this medication may be at risk of sudden death, hence careful monitoring of their condition is necessary. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so if any abnormalities appear on the skin, discontinue use immediately and inform medical personnel. This medication should not be taken if there is a hypersensitivity reaction to it or if there are certain genetic conditions such as lactose intolerance. Women who are pregnant or planning to become pregnant must consult their doctor before taking this medication and should use effective contraceptive methods; especially, this medication is not administered to women of childbearing age for migraine prevention purposes. Patients with impaired kidney or liver function may experience delayed drug excretion, so dosage adjustments and monitoring of their condition are necessary. Adequate hydration is important while taking this medication, and a high water intake is necessary to reduce the risk of kidney stones. Drowsiness, dizziness, and visual disturbances may occur during use, so it is advised to exercise caution when driving or operating machinery until accustomed to the medication. Discontinuation of this medication suddenly may result in seizures, so it should be tapered off gradually under a physician's guidance. There may be interactions with other medications, so it is crucial to inform healthcare providers of any ongoing medications, especially anticonvulsants, contraceptives, and lithium, as special caution is needed when taken together. This medication can cause various side effects such as weight loss, appetite reduction, depression, memory impairment, and if symptoms are severe, consultation with a physician is necessary. Pregnant women taking this medication may risk fetal malformations or low birth weight, so if pregnancy is planned or if the patient is pregnant, they must discuss with healthcare personnel. Lactating women should also consult a doctor before taking this medication and must report any unusual symptoms immediately.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• altered perception
• ataxia
• movement coordination disorder

This medication should be stored in a sealed container, as it is sensitive to air and moisture. It should be kept in a cool, dry place at or below 25 degrees Celsius to maintain its effectiveness.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle