Jongkundang Topiramate Extended Release Tablets 50 mg

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring serum concentrations is not necessary to optimize the dosage of this medicine. The recommended dosage 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 taken once daily. Because this is an extended-release formulation, do not break, crush, or chew it. Swallow the tablet whole. 1. Monotherapy When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, consider the potential effects on seizure control. Unless the other antiepileptic drug must be discontinued immediately for safety reasons, taper it gradually by approximately one-third every 2 weeks (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 medicine may need to be reduced. - Adults (17 years of age 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 cannot tolerate 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 100～200㎎ 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 of age 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. Initiate treatment with 25-50㎎ in the evening during the first week; treatment may also be started at a lower dose. 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 intervals between increases may be extended. The dose should be determined according to clinical effect. 3. Patients with renal impairment - In patients with moderate or severe renal impairment (CLcr < 70 mL/min/1.73 m2), it is recommended that the initial 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 on dialysis days equivalent to approximately 1/2 of the daily dose. Adjust the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's residual renal clearance, and administer the dose in divided doses at the beginning and end of hemodialysis. 4. Patients with hepatic impairment Because clearance of this medicine may be reduced in patients with hepatic impairment, administer with caution.

Child dose

- Children (6-16 years of age), 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 and administer once daily. If the patient has difficulty tolerating the dose increase, reduce the size of the increments or extend the intervals 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㎎/㎏ per day. Doses up to 500㎎ per day have been used in children diagnosed with partial-onset seizures. - Children (2-16 years of age), adjunctive therapy: The recommended dose is approximately 5-9㎎/㎏ per day, 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 and administer once daily until an appropriate clinical effect is achieved. 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 is used for the treatment of epilepsy and for the prevention of migraines. During treatment, there may be an increased risk of suicidal thoughts and behaviors, so patients and caregivers should closely monitor for these symptoms. Patients with impaired renal function may require dosage adjustments since the drug is eliminated slowly from the body. Patients undergoing dialysis must also adjust the dosage based on dialysis conditions. This medication may increase the risk of kidney stone formation, so adequate fluid intake is important. In patients with liver dysfunction, use should be cautious, and dietary adjustments may be necessary if there is a change in body weight. CNS side effects such as drowsiness, dizziness, and decreased concentration may occur, so caution should be exercised when driving or operating machinery. This medication can cause eye-related adverse symptoms such as visual disturbances, diplopia, and increased intraocular pressure, so any changes in vision should be reported to a healthcare professional immediately. Taking this medication during pregnancy may increase the risk of fetal malformations, so women of childbearing potential should use appropriate contraception and must consult a physician during pregnancy. Women who are breastfeeding should consult with a healthcare professional regarding the medication use as it may be excreted in breast milk. Abruptly discontinuing the medication may worsen seizures, so dosage should be gradually reduced before stopping. There may be drug interactions, so if the patient is taking other medications, it is essential to inform the healthcare professional, especially with antiepileptic drugs, oral contraceptives, lithium, etc. In case of overdose, severe symptoms and metabolic acidosis may occur, so dosage must be strictly adhered to, and immediate medical attention is required in case of overdose. When storing, keep out of reach of children and do not transfer to other containers for safety.

• Suicidal thoughts
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• sudden death
• hypersensitivity
• perceptual alterations
• stupor
• ataxia
• attention/concentration disorders

This medication should be stored in a tightly sealed container to protect it from air and moisture. The optimal storage temperature is at room temperature between 1 and 30 degrees Celsius.

Appearance

Pink round extended-release film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle