Q: What precautions should be taken when using TOMAX Tablet 25 mg (Topiramate)?

This medication may increase the risk of suicidal thoughts or behaviors during treatment, and patients and caregivers should immediately inform healthcare professionals if such symptoms occur. Additionally, there is a need for caution as sudden death may occur in epilepsy patients, and serious skin reactions may manifest during treatment. If any abnormal skin symptoms occur, medication should be stopped immediately, and a doctor should be consulted. This drug should not be administered to individuals with hypersensitivity to its components or lactose intolerance, and women who are pregnant or planning to become pregnant must consult a physician before use and should employ effective contraception. During pregnancy, this drug may cause fetal harm; therefore, the risks and benefits must be carefully considered when using this drug. Patients with impaired kidney or liver function may be affected by the excretion and metabolism of this medication, thus requiring dose adjustments, and adequate fluid intake is important for patients at risk of kidney stones. This medication acts on the central nervous system and may cause symptoms such as drowsiness, dizziness, and blurred vision, so caution is necessary when driving or operating machinery. It is recommended not to take this medication with alcohol or other central nervous system depressants, and patients should inform their doctor or pharmacist of any other medications they are currently taking, as there may be drug interactions. Also, this drug may cause side effects such as weight loss, loss of appetite, depression, and memory impairment, so if symptoms persist or worsen, consult a healthcare professional. Abrupt discontinuation of this drug may lead to exacerbation of seizures; hence, it should be tapered off under doctor’s guidance. Lastly, it is important to monitor for adverse reactions through regular check-ups and blood tests during treatment.

Question 1

What are the indications and effects of TOMAX Tablet 25 mg (Topiramate)?

Accepted Answer

This drug is used in the treatment of epilepsy. It can be used as monotherapy for the treatment of partial seizures and secondary generalized seizures in children aged 6 and older and adults, and may also be used as adjunctive therapy when controlled by existing treatments is not achieved. Additionally, it is effective for seizures associated with Lennox-Gastaut syndrome and primary generalized tonic-clonic seizures. Furthermore, it may help in the prevention of migraines. Therefore, it is used for epilepsy and migraine prevention.

Question 2

What are the dosage and administration instructions for TOMAX Tablet 25 mg (Topiramate)?

Accepted Answer

It is advisable to start this medication at a low dose and increase it to the effective dose.
Monitoring plasma concentrations is not necessary to optimize treatment with this medication.
The recommended dose of this medication applies unchanged to all adults and children, including older adults, who do not have kidney disease.
This medication may be taken with or without food.
Swallow the tablets whole; do not crush them.
Epilepsy monotherapy — Adults (17 years and older): Begin treatment with 25㎎ in the evening for the first week. Thereafter, increase the daily dose by 25 or 50㎎ at 1-2 week intervals and administer it in 2 divided doses. If the patient has difficulty tolerating this rate of dose escalation, extend the intervals between increases. The dose and rate of escalation should be determined according to clinical response. The recommended dose for monotherapy in adults is 100～200mg per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated doses of up to 1,000㎎ per day as topiramate monotherapy.
Epilepsy adjunctive therapy — Adults (17 years and older): The minimum effective dose is 200mg per day; the usual dose is 200-400mg per day in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg per day. Begin treatment with 25-50mg in the evening for the first week; it is also possible to start at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2 week intervals and administer it in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller dose increments may be used or the intervals between increases may be extended. The dose should be determined according to clinical effect.
Migraine prevention — Adults: Begin treatment with 25mg of this medication in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, extend 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 escalation should be determined according to clinical response.
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 medication is removed from plasma by hemodialysis, the dose should be increased by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis equipment, and the patient's renal clearance, and administer it in divided doses at the start and end of hemodialysis.
Use with caution in patients with hepatic impairment, as clearance of this medication may be reduced.

Answer

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

Question 3

What are the side effects of TOMAX Tablet 25 mg (Topiramate)?

Accepted Answer

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, perceptual abnormalities, ataxia, motor coordination impairment, attention deficit, confusion, dizziness, fatigue, paresthesia, clouding of consciousness, thought disturbance, agitation, emotional instability, loss of appetite, asthenia, confusion, memory impairment, diplopia, vertigo, speech impairment, word selection disorder, nausea, nystagmus, psychomotor retardation, tremors, visual disturbances, weight loss, gait disturbances, aggressive reactions, apathy, perceptual disturbances, coordination disturbances, leukopenia, psychiatric symptoms, taste disturbance, nephrolithiasis, thromboembolism, fatigue, asthenia, back pain, chest pain, influenza-like symptoms, leg pain, allergy, flushing, body odor, edema, rigidity, dizziness, ataxia, speech impairment, nystagmus, perceptual abnormalities, tremors, coordination disturbances, sensory loss, gait abnormalities, involuntary muscle contractions, confusion, dizziness, nausea, indigestion, abdominal pain, constipation, gastroenteritis, thirst, gastrointestinal disorders, gingivitis, auditory abnormalities, weight loss, myalgia, skeletal pain, epistaxis, purpura, ataxia, psychomotor retardation, neuroexcitability, memory impairment, confusion, depression, attention/ concentration deficits, loss of appetite, agitation, mood disorders, aggressive reactions, recognition disorders, decreased libido, apathy, depersonalization, emotional instability, breast pain, amenorrhea, menorrhagia, menstrual disorders, prostate disorders, infections, viral infections, candidiasis, rhinitis, pharyngitis, sinusitis, dyspnea, erythematous rash, skin disorders, increased sweating, taste disturbance, urinary tract infections, hematuria, urinary incontinence, frequent urination, urinary abnormalities, diplopia, visual disturbances, ocular pain, leukopenia, anemia, autonomic nervous system abnormalities, fever, syncope, halitosis, abdominal distension, alcohol intolerance, substernal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension-type headache, erectile dysfunction, hallucinations, hyperkinesia, psychosis, motor impairment, confusion, grand mal seizures, hyperactivity, leg cramps, decrease in reflexes, neurosis, migraine, akinesia, hypersensitivity, motor abnormalities, counter-rotation, speech disorders, scotomas, hypotonia, hypertonicity, coma, encephalopathy, fecal incontinence, insomnia, personality disorders, decreased libido, manic responses, suicide attempts, paranoid reactions, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities, goiter, thyroid disorders, diarrhea, vomiting, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, caries, stomatitis, swallowing disorders, melena, gastritis, increased salivation, hiccups, gastroesophageal reflux, glossitis, belching, tinnitus, ear pain, auditory hypersensitivity, angina, palpitations, AV block bradycardia, bundle branch block, arrhythmias, atrial arrhythmia, atrial fibrillation, elevated SGPT, elevated SGOT, gallbladder disorders, elevated γ-GT, dehydration, weight gain, thirst, hypokalemia, increased alkaline phosphatase, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, increased creatinine, hyperchloremia, dry eye syndrome, diabetes, hypernatremia, serum folate abnormalities, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthritis, osteoporosis, basal cell carcinoma, anemia, gingival bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenitis, eosinophilia, lymphocytopenia, leukopenia, lymphocytosis, granulocytopenia, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorders, male galactorrhea, cough, bronchitis, asthma, bronchospasm, laryngospasm, acne, urticaria, alopecia, dermatitis, nail disorders, folliculitis, dry skin, eczema, skin depigmentation, psoriasis, photosensitivity reaction, erythematous rash, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, taste disturbance, taste loss, allodynia, dysuria, nephrolithiasis, urinary tract infections, pollakiuria, urinary incontinence, urinary retention, facial edema, renal pain, nocturnal enuresis, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vasoconstriction, conjunctivitis, dysregulation, glare, lagophthalmos, strabismus, color blindness, myopia, mydriasis, cataracts, corneal opacity, iritis, leukopenia, allergic edema, hyperammonemia, hyperammonemic encephalopathy, despair, abnormal sensations in the eyes, closed-angle glaucoma, conjunctival edema, ocular motility disorders, eyelid edema, maculopathy, myopia, cough, chest discomfort, erythema multiforme, periorbital edema, Stevens-Johnson syndrome, toxic epidermal necrolysis, peripheral edema, joint swelling, discomfort in limbs, renal tubular acidosis, renal calcinosis, generalized edema, influenza-like illness, weight gain, sweating, exacerbation of epilepsy, psychiatric symptoms, encephalopathy, hyperammonemic encephalopathy, hypersomnia, vomiting, changes in level of consciousness, changes in cognitive function, drowsiness, dizziness, hyperreactivity, weight loss, psychomotor retardation, word selection disorder, confusion, insomnia, aggression, anxiety, anger, unease, direction sense impairment, mood changes, stuttering, memory impairment, attention disorders, tremors, forgetfulness, balance impairment, taste abnormalities, speech disorders, diplopia, blurred vision, diarrhea, dry mouth, myalgia, muscle cramps, musculoskeletal chest pain, somnolence, hypersomnia, anxiety, depression, insomnia, decreased appetite, aggression, abnormal behavior, mood changes, confusion, rash, alopecia, fever, epistaxis, thrombocytopenia, anemia, erectile dysfunction, urination disorders, pollakiuria, fever, hyperreactivity, gait disturbances, suicidal impulses, suicide attempts, suicidal ideation, suicidal behavior, suicide attempts, suicidal impulses, suicide attempts, suicidal ideation, suicidal behavior, suicide attempts, suicidal impulses, suicide attempts, suicidal ideation, suicidal behavior, suicide attempts, suicidal impulses, suicide attempts, suicidal ideation, suicidal behavior, suicide attempts, suicidal impulses, suicide attempts, suicidal ideation, suicidal behavior, suicide attempts, suicidal impulses, suicide attempts, suicidal ideation, suicidal behavior, suicide attempts, suicidal impulses, suicide attempts, suicidal ideation, suicidal behavior, suicide attempts, suicidal impulses, suicide attempts, suicidal ideation, suicidal behavior, suicide attempts, suicidal impulses, suicide attempts, suicidal ideation, suicidal behavior, suicide attempts, suicidal impulses, suicide attempts, 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Question 4

What precautions should be taken when using TOMAX Tablet 25 mg (Topiramate)?

Accepted Answer

This medication may increase the risk of suicidal thoughts or behaviors during treatment, and patients and caregivers should immediately inform healthcare professionals if such symptoms occur.

Additionally, there is a need for caution as sudden death may occur in epilepsy patients, and serious skin reactions may manifest during treatment. If any abnormal skin symptoms occur, medication should be stopped immediately, and a doctor should be consulted.

This drug should not be administered to individuals with hypersensitivity to its components or lactose intolerance, and women who are pregnant or planning to become pregnant must consult a physician before use and should employ effective contraception.

During pregnancy, this drug may cause fetal harm; therefore, the risks and benefits must be carefully considered when using this drug.

Patients with impaired kidney or liver function may be affected by the excretion and metabolism of this medication, thus requiring dose adjustments, and adequate fluid intake is important for patients at risk of kidney stones.

This medication acts on the central nervous system and may cause symptoms such as drowsiness, dizziness, and blurred vision, so caution is necessary when driving or operating machinery.

It is recommended not to take this medication with alcohol or other central nervous system depressants, and patients should inform their doctor or pharmacist of any other medications they are currently taking, as there may be drug interactions.

Also, this drug may cause side effects such as weight loss, loss of appetite, depression, and memory impairment, so if symptoms persist or worsen, consult a healthcare professional.

Abrupt discontinuation of this drug may lead to exacerbation of seizures; hence, it should be tapered off under doctor’s guidance.

Lastly, it is important to monitor for adverse reactions through regular check-ups and blood tests during treatment.

TOMAX Tablet 25 mg (Topiramate)

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Efficacy & effects

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Adult dosage

Children's dosage

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