Qdexy Sustained Release Capsules 50 mg (Topiramate)

Adult dose

It is preferable to start this medication at a low dose and gradually increase it to the effective dose. Monitoring blood levels is not necessary to optimize treatment with this medication. The recommended dose applies equally to all adults and children, including older adults, provided they do not have kidney disease. This medication may be taken with or without food. This medication is taken once daily. Swallow the capsule whole, or carefully open the capsule and sprinkle all of its contents onto a small amount (a teaspoonful) of soft food. Swallow the food and medication mixture immediately without chewing it. Do not store the mixture for later use. 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 stopped immediately for safety reasons, gradually reduce their dose by approximately 1/3 every 2 weeks until discontinued (see “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 medication may need to be reduced. - Adults (17 years and older) Start with 25㎎ in the evening for the first week. Thereafter, increase the dose by 25 or 50㎎ per day at 1-2 week intervals and administer once daily. If the patient has difficulty tolerating this rate of dose escalation, extend the interval between increases. The dose and rate of dose escalation should be determined according to clinical response. The recommended dose for monotherapy in adults is 100～200㎎ 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 200㎎ per day, and the usual dose is 200-400㎎ once daily. Depending on the patient, the dose may be increased up to the maximum recommended dose of 800㎎ per day. Start treatment with 25-50㎎ in the evening for the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50㎎ at 1-2 week intervals and administer once daily. If the patient has difficulty tolerating the increased dose, smaller increments may be used or the interval between increases may be extended. The dose 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. - Hemodialysis patients: Because this medication is removed from plasma by hemodialysis, hemodialysis patients should receive an additional dose equivalent to approximately 1/2 of the daily dose on dialysis days. Adjust the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and administer the dose in divided portions at the start and end of hemodialysis. 4. Patients with hepatic impairment Use this medication with caution in patients with hepatic impairment, as its clearance may be reduced.

Child dose

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

This medication is used as an antiepileptic drug, and there is an increased risk of suicidal thoughts or behaviors during treatment; therefore, patients and caregivers must inform healthcare professionals immediately if such symptoms arise. Special caution is required for patients with epilepsy due to the risk of sudden death, especially in those with impaired kidney or liver function, where dose adjustments may be necessary. Patients with hypersensitivity to any ingredient in this medication should not take it, and those with renal impairment should be administered cautiously as stabilizing plasma concentrations may take longer. Patients undergoing hemodialysis should adjust the dose according to dialysis conditions, and adequate hydration is recommended due to the risk of kidney stones. During treatment, there may be changes in body weight, so attention should be paid to dietary management and nutritional status. Central nervous system side effects such as drowsiness, dizziness, and blurred vision may occur, so caution is advised when driving or operating machinery. During pregnancy, there may be risks to the fetus, so women of childbearing age should employ adequate contraception and consult a physician if they need to take this medication while pregnant. Breastfeeding women should consult healthcare professionals regarding breastfeeding, as this medication may be excreted in breast milk. Sudden discontinuation of the medication may exacerbate seizures, so the dosage must be gradually reduced, and interactions with other medications may occur, so inform your healthcare provider about any other medications being taken. In cases of overdose, symptoms such as severe drowsiness, seizures, and confusion may occur, requiring immediate medical attention. Regular blood tests and renal function tests may be necessary during treatment. It is important to maintain proper hydration during treatment and consult healthcare professionals immediately if any unusual symptoms arise.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal mood and behavior changes
• perceptual disturbances
• hypomania
• ataxia
• impaired concentration
• attention deficit
• confusion

This medication should be stored in a tightly closed container to protect it from air and moisture. The recommended storage temperature is between 1 degree to 30 degrees Celsius at room temperature. Avoid storing in humid areas to maintain the medication's effectiveness.

Appearance

A hard capsule with yellow upper and gray lower parts containing white to off-white granules.

Package unit

30 capsules/bottle