Qdexi Sustained Release Capsules 100 mg (Topiramate)

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. There is no need to monitor blood concentrations to optimize treatment with this medicine. The recommended dose of this medicine applies to all adults and children, including older adults, without renal disease. This medicine may be taken with or without food. This medicine is administered once daily. The capsule may be swallowed whole, or it may be carefully opened and all of its contents sprinkled onto a small amount (a teaspoon) of soft food. Swallow the food and medicine mixture immediately without chewing. Do not store the mixture for later use. 1. Monotherapy When discontinuing other concomitant antiepileptic drugs 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 section "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 concentrations occurs, the dose of this medicine 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, administered once daily. If the patient has difficulty tolerating this titration schedule, lengthen 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 100～200㎎ 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㎎ per day, administered 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 during the first week; it is also possible to start at a lower dose. Thereafter, increase the dose by 25-50㎎ at 1-2-week intervals, administered once daily. If the patient has difficulty tolerating the increased dose, smaller dose increases may be used or the intervals between increases may be extended. The dose should be determined according to clinical effect. 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. - Patients on hemodialysis: Because this medicine is removed from plasma by hemodialysis, patients on hemodialysis should receive an additional dose equivalent to approximately 1/2 of the daily dose on dialysis days. Adjust the dose taking into consideration the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and administer it in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Administer this medicine with caution to patients with hepatic impairment, as its clearance may be reduced.

Child dose

- Children (6-16 years), monotherapy Start with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at 1-2-week intervals, administered once daily. If the patient has difficulty tolerating the dose increase, use smaller increments or lengthen the intervals 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㎎/㎏ per day. In children diagnosed with partial-onset seizures, doses up to 500㎎ per day have been used. - Children (2-16 years), adjunctive therapy The recommended daily dose is approximately 5-9㎎/㎏, administered once daily. During 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 effect is achieved, administered once daily. Dose titration should be determined according to clinical effect. Doses up to 30㎎/㎏ per day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors, so any mood changes or abnormal behavior while taking the medication should be reported to a physician immediately. Careful observation is required as sudden deaths can occur in patients with epilepsy while taking this medication. Patients who are allergic to any component of this medication should not take it. In patients with impaired renal function, the elimination of this medication may be slower, so dose adjustment is necessary, and those undergoing dialysis should adjust the dose according to dialysis conditions. Patients at risk of kidney stones should maintain adequate hydration to prevent the formation of kidney stones. Patients with poor liver function should also be cautious as the elimination of this medication may be reduced. If there are changes in weight while taking this medication, dietary adjustments should be considered. This medication can cause central nervous system symptoms such as drowsiness, dizziness, and blurred vision, so it is advisable to avoid driving or operating machinery at the beginning of treatment. Adequate hydration is necessary while taking this medication, especially in hot environments where there is a risk of increased body temperature and reduced sweating. Taking this medication during pregnancy may increase the risk of fetal deformities, so women who may become pregnant should use appropriate contraception, and pregnant women should consult a physician before taking it. If breastfeeding, this medication may be excreted in breast milk, so consult a physician regarding breastfeeding and medication use. There may be interactions with other medications while taking this medication, so inform a physician or pharmacist of any other medications being taken. When discontinuing treatment, doses should be gradually reduced to minimize the risk of seizures, and abrupt cessation should be avoided. In case of overdose, symptoms such as headache, seizures, drowsiness, and confusion may occur, so immediate emergency treatment should be sought if suspected. This medication has not established safety and efficacy in children, especially those under 2 years old, so caution is required for use.

• Suicidal ideation
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• hypersensitivity
• perceptual disturbances
• somnolence
• ataxia
• attention impairment

This medication should be stored in a sealed container that is air-tight, preferably between 1°C and 30°C at room temperature. Additionally, precautions should be taken to prevent the medication from coming into contact with moisture.

Appearance

Hard capsules with a reddish-brown upper part and gray lower part containing white to slightly yellow granular substance

Package unit

30 capsules/bottle