Topamax Tablet 100 mg (Topiramate)

Adult dosage

It is advisable to start this medicine at a low dose and increase it to the effective dose. There is no need to monitor blood concentrations to optimize administration of this medicine. The recommended dose of this medicine applies to all adults and children, including older adults, who do not have renal disease. This medicine may be taken with or without food. Swallow tablets whole; do not crush them. (Tablets only) Sprinkle capsules are convenient for patients who have difficulty swallowing tablets, such as children or older adults. Swallow the capsule whole, or carefully open the capsule and sprinkle all of its contents over a small amount (a teaspoonful) of soft food. Swallow the food and medicine mixture immediately without chewing. Do not store the mixture for later use. (Capsules only) 1. Epilepsy 1) Monotherapy: When discontinuing another antiepileptic drug being used concomitantly in order to administer topiramate as monotherapy, consider the potential effect on seizure control. Unless another antiepileptic drug must be discontinued immediately for safety reasons, gradually taper and discontinue the other antiepileptic drug by approximately 1/3 every 2 weeks (see “5. General precautions” under Precautions for use). When an enzyme-inducing drug is 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 of age and older): Start 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㎎ of topiramate daily as monotherapy. 2) Adjunctive therapy Adults (17 years of age 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. Start 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 1-2 week intervals and administer in 2 divided doses. If the patient has difficulty tolerating the increased dose, increase by a smaller amount or extend the titration interval. The dose should be determined according to clinical response. 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 1-week intervals. If the patient has difficulty tolerating these increases, extend the titration interval. 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 receiving hemodialysis: Since 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 renal clearance, and administer in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in 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 daily dose by 0.5-1㎎/㎏ at 1-2 week intervals and administer in 2 doses daily. If the patient has difficulty tolerating the increase, reduce the 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. During 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 until an appropriate clinical effect is achieved, and administer in 2 divided doses. Dose titration should be determined according to clinical effect. Doses up to 30mg/kg daily have been administered and were generally well tolerated.

This drug is used for the prevention of epilepsy or migraines. There may be an increased risk of suicidal thoughts or behavior during treatment, so if there are any mood changes or symptoms of depression, one should immediately consult medical personnel. Patients taking this medication can experience severe allergic reactions on the skin, so if symptoms such as rash, blisters, or mucosal damage occur, they should stop taking the medication immediately and seek medical attention. Dosing adjustments may be necessary in patients with impaired kidney function as drug concentration may increase, and adequate hydration is important due to the risk of kidney stones. Women who are pregnant or could become pregnant should take a pregnancy test before taking this drug, and during pregnancy, they should avoid medication or consult with a doctor as it may harm the fetus. During treatment, symptoms such as drowsiness, dizziness, or blurred vision may occur, so caution is needed when driving or operating machinery. This medication may interact with other drugs, so if you are taking any other medications, make sure to inform your doctor or pharmacist. Sudden discontinuation of the medication may provoke seizures, so the dosage must be gradually reduced according to the doctor's instructions. This drug can cause various side effects including weight loss, decreased appetite, memory impairment, insomnia, and depression, so if any abnormal symptoms persist or worsen, one should consult with a medical professional. Also, this drug can cause difficulties in temperature regulation due to decreased sweating, so special care should be taken to prevent dehydration and heat stroke in hot environments.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• perceptual disturbances
• ataxia
• motor coordination impairment

This drug can be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, to maintain the drug's efficacy, it is important to store it at a cool temperature below 25 degrees.

Appearance

Yellow, round film-coated tablet

Package unit

28 tablets/bottle [HDPE bottle], 60 tablets/bottle [HDPE bottle]