Topamax Tablet 25 mg (Topiramate)

Adult dosage

It is advisable to start this medicine at a low dose and increase it to the effective dose. There is no need to monitor blood concentrations to optimize the administration of this medicine. The recommended dose of this medicine applies to all adults and children, including older adults, without renal disease. It may be taken with or without food. The tablets should be swallowed whole and not crushed. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, the potential effect on seizure control should be considered. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be gradually tapered and discontinued by approximately 1/3 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 concentrations occurs, the dose of this medicine may need to be reduced. Adults (17 years and older): Start treatment with 25㎎ in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at intervals of 1-2 weeks and administer it in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the interval between dose increases. The dose and rate of titration should be determined according to the 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 topiramate monotherapy at doses of up to 1,000㎎ per day. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg per day, and the usual dose is 200-400mg per day in 2 divided doses. Depending on the patient, the dose may be increased up to the maximum recommended dose of 800mg per day. 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 intervals of 1-2 weeks and administer it in 2 divided doses. If the patient has difficulty tolerating the increased dose, the dose may be increased by a smaller amount or the interval between dose increases may be extended. The dose should be determined according to the clinical response. 2. Prevention of migraine Adults: Start treatment 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 these increases, extend the interval between dose increases. The recommended dose is 100mg per day, 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 titration should be determined according to the 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 starting and maintenance doses be reduced to approximately 1/2. - Hemodialysis patients: Because this medicine is removed from plasma by hemodialysis, the dose on dialysis days should be increased by approximately 1/2. The dose should be increased taking into account the duration of dialysis, the clearance of the dialysis machine, and the patient's renal clearance, and divided doses should be administered at the start and end of hemodialysis. 4. Patients with hepatic impairment This medicine should be administered with caution to patients with hepatic impairment, as its clearance may be reduced.

Children's dosage

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

This medication is used for epilepsy and migraine prevention and may increase the risk of suicidal thoughts or behavior during use. Therefore, patients and caregivers should immediately inform healthcare providers if any signs of depression, mood changes, or suicidal thoughts occur. Serious skin rashes or allergic reactions may also develop while taking this medication, so if such symptoms appear, the medication should be stopped immediately, and a hospital visit should be made. During pregnancy, it may cause harm to the fetus, so pregnant women or those who may become pregnant should take a pregnancy test before using this medication and use effective contraception. For patients with impaired kidney or liver function, the dosage may need adjustment as the drug's elimination may be delayed, based on the doctor's advice. This drug can cause central nervous system side effects such as drowsiness, dizziness, and blurred vision, so caution should be exercised in driving or operating machinery during initial use. Adequate hydration is important, particularly for patients at risk of kidney stones, who should maintain hydration to protect kidney health. Stopping this medication abruptly can worsen seizures, so dosage should be gradually reduced under medical supervision when discontinuing. Additionally, this medication may interact with other drugs, so any other medications being taken should be reported to healthcare providers. When used together with birth control pills, contraceptive effectiveness may decrease, so it is advisable to use additional contraceptive methods. Finally, while taking this medication, symptoms such as weight loss, loss of appetite, mood changes, and memory impairment may occur, necessitating close monitoring of these symptoms.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, paresthesia, myoclonic jerks, ataxia, concentration disorder, attention disorder, confusion, dizziness, fatigue, tactile hallucination, lethargy, thought disturbance, agitation, emotional instability, loss of appetite, weakness, delusion, memory impairment, diplopia, vertigo, speech disorder, word retrieval difficulty, nausea, nystagmus, psychomotor retardation, tremors, visual disturbances, weight loss, gait disorders, aggressive reactions, apathy, perceptual disturbances, disturbance of harmony, leukopenia, psychiatric symptoms, taste abnormalities, nephrolithiasis, thromboembolism, fatigue, weakness, back pain, chest pain, influenza-like symptoms, leg pain, allergies, flushing, body odor, edema, rigidity, dizziness, ataxia, speech disorder, nystagmus, paresthesia, tremors, disturbance of harmony, sensory impairment, gait abnormalities, involuntary muscle contractions, confusion, dizzy spells, nausea, dyspepsia, abdominal pain, constipation, gastritis, thirst, gastrointestinal disorders, gingivitis, auditory abnormalities, weight loss, myalgia, skeletal pain, epistaxis, purpura, myoclonus, psychomotor retardation, neural hypersensitivity, memory impairment, delusion, depression, concentration/attention disorders, agitation, mood disorders, aggressive reactions, personality disorders, apathy, depersonalization, emotional instability, breast pain, amenorrhea, menorrhagia, menstrual abnormalities, prostate disorders, infections, viral infections, candidiasis, rhinitis, pharyngitis, sinusitis, dyspnea, erythematous rash, skin disorders, increased sweating, taste abnormalities, urinary tract infections, hematuria, urinary incontinence, frequent urination, urinary disturbances, diplopia, visual disturbances, eye pain, leukopenia, anemia, vasodilation of the autonomic nervous system, fever, syncope, halitosis, abdominal distension, alcohol intolerance, substernal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension headaches, erectile dysfunction, hallucinations, dysphoria, psychosis, decreased motor activity, lethargy, grand mal seizures, hyperactivity, leg cramps, reflex hypoactivity, neurosis, migraines, akinesia, sensory hypersensitivity, movement disorders, dysarthria, scotoma, ptosis, dystonia, visual impairment, coma, encephalopathy, fecal incontinence, insomnia, personality disorders, decreased libido, manic reactions, suicide attempts, paranoid reactions, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities, cerebellar syndrome, tongue paralysis, increased libido, goiter, thyroid abnormalities, diarrhea, vomiting, hemorrhoids, flatulence, gastritis, gingival hyperplasia, cavities, stomatitis, swallowing difficulties, melena, gastritis, increased salivation, hiccups, gastroesophageal reflux, tongue swelling, esophagitis, belching, tinnitus, otalgia, auditory hypersensitivity, angina, palpitations, AV block bradycardia, bundle branch block, arrhythmia, 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, elevated creatinine, hyperchloremia, dry eyes, diabetes mellitus, hypernatremia, serum folate abnormalities, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthropathy, osteoporosis, basal cell carcinoma, anemia, gum bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenitis, eosinophilia, lymphocytopenia, leukopenia, lymphocytosis, agranulocytosis, 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, phototoxic reactions, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, taste disorder, taste loss, posttaste disturbances, dysuria, nephrolithiasis, urinary tract infections, frequent urination, urinary incontinence, urinary retention, facial edema, renal pain, nocturia, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular constriction, conjunctivitis, regulatory disturbances, photophobia, tear flow, strabismus, color blindness, myopia, mydriasis, cataracts, corneal opacity, iritis, leukopenia, neutropenia, allergic edema, hyperammonemia, hyperammonemic encephalopathy, despair, eye abnormal sensations, angle-closure glaucoma, conjunctival edema, eye movement disorders, eyelid edema, macular disease, myopia, cough, chest discomfort, polymorphic erythema, periorbital edema, peripheral edema, joint swelling, limb discomfort, tubular acidosis, renal calcinosis, systemic edema, influenza-like illness, weight gain, nocturnal sweating, eye fatigue, headache, drowsiness, hypersomnia, tremors, sedation, dystonia, suicidal thoughts, suicide attempts, chest discomfort, peripheral edema, worsening of epilepsy, mental disorders, decreased comprehension

This medication should be stored in a tightly closed container, as it may deteriorate when exposed to air or moisture. It is best kept in a cool, dry place below 25 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

100 tablets/bottle, 30 tablets/bottle