Topimed 100 mg Tablet (Topiramate)

Adult dosage

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize the dose of this medicine. The recommended dose of this medicine is the same for all adults and children, including the elderly, in the absence of renal disease. May be administered with or without food. Swallow the tablet whole without crushing it. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, consider the potential effect on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, reduce the dose of the other antiepileptic drug gradually by approximately 1/3 at 2-week intervals until discontinued (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 medicine may need to be reduced. Adults (17 years and older): Start with 25㎎ in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the interval between increases. The dose and titration rate should be determined according to clinical response. The recommended dose for adult monotherapy is 100～200mg daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated doses 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 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; it is also possible to start at a lower dose. Thereafter, increase the dose by 25-50mg at intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating the increased dose, the dose may be increased by smaller increments or the interval between increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start with 25mg of this medicine in the evening for the first week. Thereafter, increase the dose by 25mg/day at weekly intervals. If the patient has difficulty tolerating these increases, extend the interval between 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; 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. Increase the dose considering the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and divide the dose between the beginning 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.

Children's dosage

Children (6-16 years) Start with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the total daily dose by 0.5-1㎎/㎏ at intervals of 1-2 weeks and administer twice daily. If the patient has difficulty tolerating the increase, use smaller dose increments or extend the interval between increases. The dose and degree of increase should be determined according to clinical response. The recommended dose for pediatric monotherapy 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. Administer 25mg (or less, based on 1-3mg/kg daily) in the evening for the first week; thereafter, increase the dose by 1-3mg/kg daily at intervals of 1-2 weeks 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; therefore, if mood changes or symptoms of depression occur during treatment, it is important to immediately inform a healthcare professional. Furthermore, patients taking this medication may experience a sudden worsening of seizures or the emergence of new symptoms, so it is crucial to taper off the medication under a doctor’s guidance if discontinuation is necessary. This medication can affect the central nervous system, causing symptoms such as drowsiness, dizziness, and blurred vision; caution is advised when driving or operating machinery. Adequate hydration is important during treatment, and it is recommended to drink plenty of water to reduce the risk of kidney stones. Taking this medication during pregnancy may harm the fetus; thus, women who might become pregnant should always take a pregnancy test before use and utilize effective contraception methods. Patients with reduced kidney or liver function may experience delayed elimination of this medication; therefore, dose adjustments and careful monitoring are necessary. This medication may cause serious allergic reactions on the skin, so if rash, red spots, or blisters occur, it is essential to stop taking the medication immediately and consult a healthcare provider. During treatment, various side effects such as weight loss, decreased appetite, memory impairment, depression, and insomnia may appear, and symptoms should be closely monitored, reporting any abnormalities to a healthcare professional. Additionally, this medication may interact with other drugs, so all medications being taken should be disclosed to a healthcare professional; particularly, contraceptive users should be aware that contraceptive effectiveness may be reduced. Lastly, regular blood tests and evaluations of renal and liver function should be conducted during treatment to detect any abnormalities.

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

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

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle