Pitmeyte 100 mg (Topiramate)

Adult dosage

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring plasma concentrations is not necessary to optimize treatment with this medicine. The recommended dose of this medicine applies to all adults and children, including the elderly, in the absence of renal disease. This medicine may be taken with or without food. Swallow the tablets whole; do not crush them. (Tablets only) Sprinkle capsules are convenient for patients who have difficulty swallowing tablets, such as children and the elderly. Swallow the capsule whole, or carefully open it and sprinkle all of its contents onto a small amount (a teaspoonful) of soft food. Swallow the food and medicine mixture immediately without chewing. Do not store the mixture for later use. (Capsules only) 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, consider the possible effect on seizure control. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, gradually reduce their doses by approximately 1/3 at 2-week intervals before discontinuation (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, administered in 2 divided doses. If the patient has difficulty tolerating this rate of dose increase, lengthen the interval between increases. 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 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 to the maximum recommended dose of 800mg daily. Start treatment with 25-50mg in the evening for the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50mg at 1-2-week intervals, administered in 2 divided doses. If the patient has difficulty tolerating dose increases, smaller increases may be made or the interval 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 for the first week. Thereafter, increase the daily dose by 25mg at 1-week intervals. If the patient has difficulty tolerating these increases, lengthen the interval between increases. The recommended dose is 100mg daily, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. The dose may be increased to 200mg daily; the dose and rate of increase should be determined according to clinical response. 3. Patients with renal impairment - For patients with moderate to 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, increase the dose of this medicine by approximately 1/2 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 beginning 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 for the first week. Thereafter, increase the daily dose by 0.5-1㎎/㎏ at 1-2-week intervals, administered twice daily. If the patient has difficulty tolerating the increase, reduce the size of each increase or lengthen the interval between increases. The dose and extent of dose increase should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg daily. Doses up to 500㎎ daily have been used in children diagnosed with partial-onset seizures. Children (2-16 years) The recommended daily dose is approximately 5-9mg/kg, administered in 2 divided doses. For the first week, administer 25mg (or less, based on 1-3mg/kg daily) in the evening. Thereafter, increase the daily dose by 1-3mg/kg at 1-2-week intervals until an appropriate clinical effect is achieved, administered in 2 divided doses. Dose titration should be based on clinical effect. Doses up to 30mg/kg daily have been used and were generally well tolerated.

This medication is used as an antiepileptic drug for the prevention of epilepsy or migraines. During treatment with this medication, there may be an increased risk of suicidal thoughts or behaviors, so patients and caregivers should immediately inform medical personnel if such symptoms arise. Serious skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur rarely, so any abnormal skin symptoms should prompt immediate discontinuation of the medication and consultation with a physician. This medication may be harmful to the fetus during pregnancy; therefore, women who are pregnant or planning to become pregnant should consult their physician and use effective contraception. Patients with compromised kidney or liver function may experience delayed excretion of this medication, necessitating dosage adjustment, and patients undergoing hemodialysis should have their doses adjusted according to dialysis conditions. This medication may cause central nervous system side effects such as drowsiness, dizziness, and decreased concentration, so caution is needed when driving or operating machinery. Adequate fluid intake is essential during treatment, and it is advisable to drink plenty of water to reduce the risk of kidney stones. Abrupt discontinuation of the medication can worsen seizures, so it should be tapered off gradually according to medical advice. This medication may interact with other drugs, so all medications being taken should be disclosed to the physician, particularly caution is needed when used with other antiepileptic drugs, contraceptives, lithium, and diabetes medications. This medication may cause various side effects, including weight loss, loss of appetite, depression, memory disorders, speech disorders, dysgeusia, rash, itching, hair loss, skin disorders, thirst, muscle pain, joint pain, urinary difficulties, urinary tract infections, urinary incontinence, frequency of urination, hematuria, eye pain, tinnitus, and more.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. The appropriate storage temperature is a cool, dry place below 25 degrees Celsius. Proper storage helps maintain the effectiveness of the medication for a longer period.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle