Qupira Tablets (Topiramate)

Adult dosage

It is advisable to start this medicine at a low dose and gradually increase it to the effective dose. Monitoring of blood concentrations is not necessary to optimize treatment with this medicine. The recommended dose of this medicine applies to all adults and children, including the elderly, provided they do not have kidney disease. This medicine 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 other antiepileptic drugs must be discontinued immediately for safety reasons, gradually reduce and discontinue them by approximately 1/3 at 2-week intervals (see “5. General Precautions” under Precautions for Use). When drugs that induce drug-metabolizing enzymes 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 and older): Initiate treatment with 25 mg in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50 mg at 1- to 2-week intervals, administered in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend 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 mg per day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses up to 1,000 mg per day. 2) Adjunctive therapy Adults (17 years and older): The minimum effective dose is 200 mg per day; the usual dose is 200-400 mg per day in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800 mg per day. Initiate treatment with 25-50 mg in the evening for the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50 mg at 1- to 2-week intervals, administered in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller increments may be used or the interval between dose increases may be extended. The dose should be determined according to clinical response. 2. Prevention of migraine Adults: Initiate treatment with 25 mg of this medicine in the evening for the first week. Thereafter, increase the dose by 25 mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, extend the interval between dose increases. The recommended dose is 100 mg per day, administered in 2 divided doses. Some patients may respond to a dose of 50 mg per day. Doses up to 200 mg per day 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), reducing the initial and maintenance doses to approximately 1/2 is recommended. - Hemodialysis patients: 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 taking into account the duration of dialysis, the clearance of the dialysis equipment, and the patient's 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.

Children's dosage

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

This medication may increase the risk of suicidal thoughts or behavior, so if there are changes in mood or symptoms of depression during treatment, consult a doctor immediately. Patients with epilepsy taking this medication may have a slightly increased risk of sudden death, thus careful monitoring is required. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so if you experience severe rash or blisters, stop taking the medication immediately and notify your healthcare provider. Individuals allergic to any ingredient in this medication should not take it. Patients with certain genetic disorders, such as lactose intolerance, should not take this medication due to the presence of lactose. Women who are pregnant or planning pregnancy should consult a doctor prior to use, as it may harm the fetus, and effective contraception should be used. Patients with impaired kidney or liver function may require dose adjustments, as drug clearance may take longer. Adequate hydration is necessary during treatment, as the risk of kidney stones may increase, making it important to drink plenty of water. This medication may cause central nervous system side effects such as drowsiness, dizziness, and impaired concentration, so avoid driving or operating dangerous machinery during initial use. Do not suddenly stop taking the medication, as it may worsen seizures; dosages should be gradually tapered as directed by a physician. Side effects such as weight loss, loss of appetite, depression, and memory impairment may occur; consult a healthcare provider if any unusual symptoms develop. This medication can interact with other antiepileptic drugs or certain medications, so it is essential to inform your doctor of any other medications being taken. Particularly, taking this medication with valproate can lead to a serious side effect called hyperammonemia, requiring caution. Women on contraceptive medications should be aware that this medication may reduce contraceptive efficacy, so consult a doctor regarding any changes in bleeding or pregnancy risk during use. Taking this medication during pregnancy may carry risks of congenital malformations or growth restrictions to the fetus, so it is essential to consult with a healthcare provider if planning to become pregnant. If sudden vision changes or eye pain occur while taking this medication, seek medical advice immediately, as this may be related to secondary glaucoma. This medication can alter body acidity and cause metabolic acidosis, so it is important to have regular blood tests to monitor status. Decreased sweating may lead to issues with temperature regulation, so caution is advised, especially in children or when exposed to hot environments. If any gastrointestinal symptoms or side effects occur, notify your healthcare provider immediately, and regular monitoring and tests will be needed.

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

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is also recommended to store it in a cool, dry place below 25 degrees Celsius. Proper storage helps to maintain the medication's effectiveness over time.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle