Toramac Tablets (Topiramate)

Adult dosage

It is recommended that this medicine be started at a low dose and increased to an effective dose. Monitoring blood concentrations is not necessary to optimize treatment with this medicine. The recommended dose of this medicine applies to all adults and children, including older adults, provided they do not have renal disease. This medicine may be administered with or without food. Swallow tablets whole without crushing. 1. Epilepsy 1) Monotherapy: When discontinuing other antiepileptic medicines being used in combination in order to administer topiramate as monotherapy, consider the potential effect on seizure control. Unless other antiepileptic medicines must be discontinued immediately for safety reasons, taper and discontinue the other antiepileptic medicines gradually by approximately 1/3 every 2 weeks (see “5. General Precautions” under Precautions for Use). When enzyme-inducing medicines 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 or older): Start with 25㎎ in the evening during the first week. Thereafter, increase by 25 or 50㎎ per day at 1-2 week intervals and administer in 2 divided doses per day. If the patient has difficulty tolerating this rate of increase, lengthen the intervals between increases. The dose and rate of increase should be determined according to clinical response. The recommended dose for adult monotherapy is 100～200mg per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy doses of up to 1,000㎎ per day. 2) Adjunctive therapy Adults (17 years or older) The minimum effective dose is 200mg per day, and the usual dose is 200-400mg per day divided into 2 doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg per day. Start treatment with 25-50mg in the evening during the first week; treatment may also be started at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2 week intervals and administer in 2 divided doses per day. If the patient has difficulty tolerating the increased dose, smaller increments may be used or the intervals between increases may be lengthened. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start with 25mg of this medicine in the evening during the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, lengthen the intervals between increases. The recommended daily dose is 100mg, administered in 2 divided doses. Some patients may respond to a dose of 50mg per day. Doses of up to 200mg per day may be administered; the dose and rate of increase 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 initial and maintenance doses be reduced to approximately 1/2. - Patients on hemodialysis: Because 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 consideration the duration of dialysis, the clearance of the dialysis equipment, and the patient's residual renal clearance, and divide the dose between the start and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution to patients with hepatic impairment, as clearance of this medicine may be reduced.

Children's dosage

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

This medication may increase the risk of suicidal thoughts or behaviors, so if any mood changes or depressive symptoms occur during treatment, immediately consult a physician. Patients taking this medication may have a slight increase in the risk of sudden death, so caution is needed. Rarely, severe skin reactions may occur, so if a rash or blisters develop, stop taking the medication immediately and inform healthcare personnel. Patients allergic to any component of this medication should not take it, and those with lactose intolerance should be cautious as well. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication as it may harm the fetus during pregnancy. It is important to maintain adequate hydration during treatment to reduce the risk of kidney stones, and patients should drink plenty of water. Drowsiness, dizziness, or blurred vision may occur at the beginning of treatment or with dosage changes, so caution is advised while driving or operating machinery. Rapid discontinuation of this medication may increase the risk of seizures, so the dosage should be gradually reduced according to a physician's instructions. This medication may interact with several drugs, so it is essential to inform the physician if other medications are being taken. In particular, women taking contraceptive pills should use additional contraceptive methods as this medication may decrease the effectiveness of contraception. Women who are pregnant or breastfeeding must consult with healthcare personnel regarding the use of this medication.

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

This medication is sensitive to air and moisture and should be stored in a tightly sealed container. It should also be kept in a cool, dry place at or below 25 degrees to maintain its effectiveness.

Appearance

Yellow round film-coated tablets

Package unit

100 tablets/bottle, 30 tablets/bottle