Topiramate Tablets 100mg (Topiramate)

Adult dose

It is advisable to start this medicine at a low dose and increase it to the effective dose. Monitoring plasma concentrations is not necessary to optimize treatment with this medicine. The recommended dose 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. Swallow the tablet whole; do not crush it. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to use 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, reducing the dose by approximately 1/3 at 2-week intervals (see Precautions for Use, “5. General Precautions”). When enzyme-inducing drugs are discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentrations occurs, the dose of this medicine may need to be reduced. Adults (17 years of age and older): Start with 25 mg in the evening during the first week. Thereafter, increase the total daily dose by 25 or 50 mg at intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating this titration, extend the interval between dose increases. The dose and rate of titration should be determined according to clinical response. The recommended dose for adult monotherapy is 100–200 mg daily. The maximum recommended dose is 500 mg daily. Some patients with recurrent epilepsy have tolerated up to 1,000 mg daily of topiramate monotherapy. 2) Adjunctive therapy Adults (17 years of age and older) The minimum effective dose is 200 mg daily, and the usual dose is 200-400 mg daily in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800 mg daily. Start treatment with 25-50 mg in the evening during the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50 mg at intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating the increased dose, the dose increase may be smaller or the interval between increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start with 25 mg of this medicine in the evening during the first week. Thereafter, increase the dose by 25 mg/day at 1-week intervals. If the patient has difficulty tolerating this titration, extend the interval between dose increases. The recommended dose is 100 mg daily, administered in 2 divided doses. Some patients may respond to a dose of 50 mg daily. Doses up to 200 mg 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 to reduce the starting and maintenance doses to approximately 1/2. - Hemodialysis patients: 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 taking into account the duration of dialysis, the clearance of the dialysis apparatus, 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 Use this medicine with caution in patients with hepatic impairment, as its clearance may be reduced.

Child dose

Children (6-16 years): Start with 0.5-1 mg/kg in the evening during the first week. Thereafter, increase the dose by 0.5-1 mg/kg/day at intervals of 1-2 weeks and administer twice daily. If the patient has difficulty tolerating the dose increase, use smaller increments or extend the interval between increases. The dose and extent of titration should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6 mg/kg daily. Experience is available with doses up to 500 mg daily in children diagnosed with partial seizures. Children (2-16 years): The recommended dose is approximately 5-9 mg/kg daily, administered in 2 divided doses. During the first week, administer 25 mg (or less, based on 1-3 mg/kg daily) in the evening; thereafter, increase the dose by 1-3 mg/kg/day at intervals of 1-2 weeks and administer in 2 divided doses until an appropriate clinical effect is achieved. Dose titration should be based on clinical effect. Doses up to 30 mg/kg daily have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors, so monitoring for mood changes or symptoms of depression during treatment is essential. In patients with epilepsy, the risk of sudden death may be increased when taking this medication, hence regular consultation with healthcare professionals is necessary to monitor the condition. This medication could cause severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so if any rash, blisters, or red spots appear, discontinue use immediately and inform your physician. Patients with allergies to the components of this medication should not take it, and patients with lactose intolerance should use caution. Women who are pregnant or planning to become pregnant should perform a pregnancy test before taking this medication and should use effective contraception during treatment. Taking this medication during pregnancy may increase the risk of congenital malformations, growth retardation, and preterm birth, so it should only be used after consulting a physician. Patients with impaired kidney or liver function may require dosage adjustments, as drug excretion may be delayed. Patients undergoing dialysis may also need dosage adjustments based on dialysis conditions. This medication may increase the risk of kidney stone formation, so adequate fluid intake is important, and patients with a history of kidney stones or a family history should be more cautious. Drowsiness, dizziness, decreased concentration, and memory impairment may occur during treatment, so caution is advised when driving or operating machinery. This medication may cause side effects such as weight loss, anorexia, sensory disturbances, and speech impairments, so consult a physician if unusual symptoms occur. During treatment, it is advisable not to take other central nervous system depressants or alcohol, as the contraceptive effect of oral contraceptives may be reduced when used together. In cases of pregnancy or breastfeeding, consider the potential effects on the fetus or newborn when deciding whether to take this medication, and observe for any adverse reactions in the child during breastfeeding. For pediatric patients under 2 years of age, safety and efficacy have not been established, so caution is advised. Taking this medication may lower bicarbonate levels in the blood, so regular monitoring may be necessary. In case of overdose, seek medical attention promptly for appropriate treatment.

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

This medication should be stored in a tightly closed container to prevent air and moisture ingress, preferably in a cool, dry place below 25 degrees Celsius.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle