Topami Tablet 25 mg (Topiramate)

Adult dosage

It is preferable to start this drug at a low dose and increase it to the effective dose. Monitoring the blood concentration of this drug is not necessary to optimize treatment. The recommended dose of this drug applies to all adults and children, including older adults, 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 concomitant antiepileptic drugs in order to administer topiramate as monotherapy, consider the potential effect on seizure control. Unless the other antiepileptic drug must be discontinued immediately for safety reasons, gradually taper it by approximately one-third every 2 weeks (see section “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 drug may need to be reduced. Adults (17 years and older): Start treatment with 25㎎ in the evening during the first week. Thereafter, increase the daily dose by 25 or 50㎎ at 1-2 week intervals, administered in 2 divided doses per day. If the patient has difficulty tolerating this titration schedule, lengthen the interval between dose increases. 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 recurrent epilepsy have tolerated topiramate monotherapy at doses up to 1,000㎎ per day. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg per day; the usual dose is 200-400mg per day in 2 divided doses. Depending on the patient, the dose may be increased up to the maximum recommended dose of 800mg per day. Start treatment with 25-50mg in the evening during the first week; treatment may also be initiated at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2 week intervals, administered in 2 divided doses per day. If the patient has difficulty tolerating dose increases, smaller increments or longer intervals between increases may be used. The dose should be determined according to clinical response. 2. Prevention of migraine Adults: Start treatment with 25mg of this drug in the evening during the first week. Thereafter, increase the daily dose by 25mg at weekly intervals. If the patient has difficulty tolerating these increases, lengthen the interval between dose increases. The recommended daily dose is 100mg, 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 - In 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. - Hemodialysis patients: Because this drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on dialysis days. Adjust the dose taking into account the duration of dialysis, the clearance of the dialysis system, and the patient's residual renal clearance, and administer the dose in divided portions at the beginning and end of hemodialysis. 4. Patients with hepatic impairment Use 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 during the first week. Thereafter, increase the daily dose by 0.5-1㎎/㎏ at 1-2 week intervals, administered twice daily. If the patient has difficulty tolerating the increase, use smaller increments or lengthen the interval between increases. The dose and rate of titration should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. Doses up to 500㎎ per day have been used in children diagnosed with partial seizures. Children (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 daily dose by 1-3mg/kg at 1-2 week intervals, administered in 2 divided doses, until an appropriate clinical response is achieved. Dose titration should be determined according to clinical response. Doses up to 30mg/kg per day have been administered and were generally well tolerated.

This medication is used as an antiepileptic agent for the prevention of epilepsy and migraines. There is an increased risk of mental health issues such as suicidal thoughts, suicidal behavior, and depression during treatment, so careful observation is required. Patients taking this medication should be closely monitored by a physician or caregiver for any abnormal changes in mood or behavior. If any such symptoms occur, medical personnel must be notified immediately. This medication can cause serious skin disorders, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, which are significant skin reactions; consequently, if any rashes, red spots, or blisters appear, the medication should be stopped immediately and medical attention sought. During pregnancy, this medication may harm the fetus, so women who are pregnant or planning to become pregnant should consult a physician before taking it, and effective contraception should be used during treatment. Patients with impaired kidney or liver function may be affected in the elimination and metabolism of this medication, so dosage adjustments may be needed, especially for patients undergoing hemodialysis as dosages should be adjusted according to dialysis conditions. This medication may increase the risk of kidney stones, so adequate hydration is necessary, especially for those with a history of kidney stones or a family history of them. Drowsiness, dizziness, and blurred vision may occur during treatment, so caution is needed when driving or operating machinery. Additionally, this medication may interact with several other medications, so if taking other medications, it is imperative to inform a physician or pharmacist, particularly for women taking contraceptive pills as there may be a reduction in contraceptive effectiveness. When stopping this medication, do not discontinue abruptly; instead, taper off gradually as per the instructions of a physician to reduce the risk of seizures. Various side effects, such as weight changes, appetite changes, mood changes, and memory impairment, may occur during treatment, and any unusual symptoms should be discussed with healthcare professionals.

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

This medication should be stored in a tightly sealed container that is well-ventilated, preferably in a cool, dry place at or below 25 degrees Celsius. It may be sensitive to moisture or heat, so avoid direct sunlight or places with high humidity.

Appearance

Yellow round film-coated tablet

Package unit

300 tablets/bottle, 30 tablets/bottle