Quedexy Extended-Release Capsule 25 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

1. Monotherapy - 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. 2. Adjunctive therapy - 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, as an antiepileptic drug, may increase the risk of suicidal thoughts or behaviors. If mood changes or symptoms of depression occur during treatment, inform a doctor immediately. Sudden death may occur in patients with epilepsy, so prompt medical consultation is necessary if abnormal symptoms arise. Those with an allergy to the components should not take this medication. Patients with reduced kidney function may have slower drug elimination, requiring dosage adjustments and careful monitoring during dialysis. Adequate hydration is essential due to the risk of kidney stones, and patients with impaired kidney or liver function should exercise caution when taking this medication. If weight changes occur during treatment, dietary adjustments or nutritional supplementation should be considered. This medication may cause central nervous system side effects such as drowsiness, dizziness, or decreased concentration, so it is advisable to avoid driving or operating machinery during the initial stages of treatment. Watch for symptoms like decreased appetite, weight loss, memory impairment, and depression while taking this medication. During pregnancy, there is a risk of harm to the fetus, so women of childbearing potential should use appropriate contraception, and pregnant women must consult their doctor before taking this medication. In breast-feeding cases, this medication may be secreted in breast milk, so consult with a healthcare provider regarding nursing. This drug may interact with other medications, so report any other medications being taken to healthcare professionals. In the case of overdose, symptoms may include headache, seizures, drowsiness, and confusion, requiring immediate emergency treatment. When storing this medication, keep it out of reach of children, do not transfer it to a different container, and avoid mixing it with food.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• perceptual disturbances
• lethargy
• motor incoordination
• concentration/attention disorders
• confusion
• dizziness

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Maintaining room temperature between 1°C and 30°C is important. Additionally, keep it away from humid areas to preserve the efficacy of the drug.

Appearance

A hard capsule with pink upper part and gray lower part containing white to pale yellow granules.

Package unit

30 capsules/bottle