Topamax Tablets 25 milligrams (Topiramate)

Adult dosage

It is advisable to start this medicine at a low dose and increase it to the effective dose. Monitoring of blood concentrations is not necessary to optimize the dosage of this medicine. The recommended dosage of this medicine applies to all adults and children, including older adults, provided they do not have renal disease. This medicine may be taken with or without food. The tablets should be swallowed whole without crushing. Epilepsy 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 drugs must be discontinued immediately for safety reasons, taper them gradually by approximately 1/3 at 2-week intervals (see “5. General Precautions” under Precautions for Use). 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 medicine may need to be reduced. Epilepsy monotherapy in adults (17 years and older): Initiate 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 per day. If the patient has difficulty tolerating this rate of dose escalation, extend the intervals between dose increases. The dose and rate of dose escalation 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 up to 1,000㎎ per day of topiramate monotherapy. Epilepsy adjunctive therapy in adults (17 years and older): The minimum effective dose is 200mg per day, and the usual dose is 200-400mg per day in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg per day. Initiate treatment with 25-50mg in the evening for the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50mg at 1-2-week intervals and administer in 2 divided doses per day. If the patient has difficulty tolerating the increased dose, smaller dose increases may be made or the intervals between dose increases may be extended. The dose should be determined according to clinical effect. Migraine prevention in adults: Initiate treatment 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 dose increases, extend the intervals between dose increases. The recommended dose is 100mg per day, administered in 2 divided doses. Some patients may respond to a dose of 50mg per day. The dose may be increased to 200mg per day; the dose and rate of dose escalation should be determined according to clinical response. 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: Since this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis equipment, and the patient's renal clearance, and administer the additional dose in divided doses at the start and end of hemodialysis. Administer with caution to patients with hepatic impairment, as clearance of this medicine may be reduced.

Children's dosage

Epilepsy monotherapy in children (6-16 years): Initiate 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 twice daily. If the patient has difficulty tolerating the dose increase, reduce the size of each increase or extend the intervals between dose increases. The dose and extent of dose escalation should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. Doses of up to 500㎎ per day have been used in children diagnosed with partial-onset seizures. Epilepsy adjunctive therapy in children (2-16 years): The recommended dose is approximately 5-9mg/kg per day, administered in 2 divided doses. For 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 until an appropriate clinical effect is achieved, and administer in 2 divided doses per day. Dose titration should be determined according to clinical effect. Doses of up to 30mg/kg per day have been administered and were generally well tolerated.

This medication may increase thoughts or behaviors related to suicide during treatment, so patients and caregivers should notify medical personnel immediately if these symptoms occur. There may be a slight increase in the risk of sudden death in patients taking this medication, but this falls within the general range of risks typically associated with epilepsy patients. Serious skin reactions may occur rarely, so if rash or blisters appear on the skin, the use of this medication should be stopped immediately and the doctor should be consulted. Patients with allergies to the components of this medication or certain genetic lactose intolerances should not take it. Women who are pregnant or planning to become pregnant should take a pregnancy test before starting this medication and must use a very effective contraceptive method while taking the medication. This medication can harm the fetus, thus it should be administered cautiously during pregnancy based on the doctor's judgment. Patients with impaired kidney or liver function may require dosage adjustments, and those undergoing dialysis may also need dosage adjustments based on the conditions of blood dialysis. Adequate hydration while taking this medication is important to reduce the risk of kidney stones, and patients should drink plenty of water. During treatment, symptoms such as drowsiness, dizziness, and blurred vision may occur, so care must be taken while driving or operating machinery. Suddenly stopping this medication can lead to seizures; therefore, discontinuation should be done gradually. Chronic metabolic acidosis may occur, so regular blood tests are recommended to monitor the condition. This medication may interact with other medications, so patients should inform their doctors or pharmacists if they are taking other drugs. Especially for women taking contraceptives, caution is necessary as the efficacy of the contraceptive may be reduced when taken together with this medication. During treatment, abnormal behavior, mood changes, depression, or thoughts of suicide may appear, so careful monitoring is required. Taking this medication during pregnancy may increase the risk of congenital disabilities and growth delays in the fetus, hence consultation with medical personnel is necessary when planning pregnancy. This medication may cause various side effects such as weight loss, decreased appetite, fatigue, and memory impairment; if any unusual symptoms persist, patients should consult with healthcare professionals.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• sensory abnormalities
• ataxia
• hypokinesia

Store this medication in a tightly sealed container as it may be sensitive to air and moisture. Additionally, keep it in a cool, dry place at or below 25 degrees Celsius to maintain its effectiveness.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle