Atomac Tablet 100 mg (Topiramate)

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize the dose of this medicine. The recommended dose of this medicine applies to all adults and children, including the elderly, provided they do not have renal disease. This medicine may be administered 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 their dose by approximately 1/3 every 2 weeks until discontinued (see Precautions for Use, “5. General Precautions”). 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 and older): Start with 25㎎ in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at 1-2 week intervals, dividing the dose into 2 administrations per day. If the patient has difficulty tolerating this titration schedule, extend the titration intervals. The dose and rate of increase should be determined according to clinical response. The recommended dose for adult monotherapy is 100～200mg daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses of up to 1,000㎎ daily. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg daily, and the usual dose is 200-400mg daily in 2 divided doses. Depending on the patient, the dose may be increased up to the maximum recommended dose of 800mg daily. Start treatment with 25-50mg in the evening for the first week; treatment may also be initiated at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2 week intervals, dividing the dose into 2 administrations per day. If the patient has difficulty tolerating the increased dose, smaller increments or longer intervals between increases may be used. The dose should be determined according to clinical response. 2. Prevention of migraine Adults: Start with 25mg of this medicine in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this titration, extend the titration intervals. The recommended daily dose is 100mg, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. Doses of up to 200mg daily may be administered; the dose and rate of increase should be determined according to clinical response. 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: Since this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's residual renal clearance, and administer in divided doses at the beginning and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment, as clearance of this medicine may be reduced.

Child dose

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

This drug may increase the risk of suicidal thoughts, suicidal behavior, or suicide itself, so if any mood changes or unusual behaviors occur during treatment, you should immediately notify a healthcare professional. Patients taking this medication may have a slightly increased risk of sudden death, which necessitates regular health checks. Serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis can occur, so if any skin abnormalities are observed, discontinue the medication and consult a physician immediately. Patients with hypersensitivity to this medication or specific genetic issues such as lactose intolerance should not take it. Women who are pregnant or planning to become pregnant should do a pregnancy test before taking this medication and use effective contraception during treatment to avoid potential harm to the fetus. Patients with compromised kidney or liver function may require dose adjustments and careful monitoring due to potentially delayed drug excretion. This medication can cause central nervous system symptoms such as drowsiness, dizziness, or blurred vision, so caution should be taken when driving or operating machinery. It is important to stay hydrated during treatment, and drinking plenty of water is recommended to reduce the risk of kidney stones. This medication may interact with other drugs, so patients should inform their doctor or pharmacist about any other medications they are taking. Discontinuing this medication abruptly can worsen seizures, so any discontinuation should be done gradually according to medical advice. During treatment, side effects such as weight changes, mood changes, appetite changes, or memory impairment may occur; patients should inform healthcare professionals if any such symptoms arise.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, ideally in a cool and dry place below 25 degrees Celsius.

Appearance

Yellow, round, film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle