Topiramate Tablet 25 mg (Topiramate)

Adult dose

It is preferable to start this drug at a low dose and increase it to the effective dose. There is no need to monitor blood concentrations to optimize the dose of this drug. The recommended dose of this drug applies to all adults and children, including the elderly, in the absence of renal disease. This drug 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. When drugs that induce drug-metabolizing enzymes are discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentrations occurs, the dose of this drug may need to be reduced. Adults (17 years and older): Start with 25㎎ in the evening for 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, extend the interval between dose increases. The dose and rate of increase 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 up to 1,000㎎ per day of topiramate as monotherapy. 2) Adjunctive therapy In 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. 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 and administer in 2 divided doses per day. If the patient has difficulty tolerating the increased dose, smaller dose increases may be made or the interval between increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start with 25mg of this drug 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. The dose may be increased to 200mg per day; 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 starting and maintenance doses be reduced to approximately 1/2. - Patients receiving hemodialysis: Because this drug is removed from plasma by hemodialysis, the dose of this drug should be increased by approximately 1/2 on dialysis days. Increase the dose taking into consideration the duration of dialysis, the clearance of the dialysis device, and the patient's renal clearance, and administer the dose in divided portions at the start and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment, as clearance of this drug 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 by 0.5-1㎎/㎏ per day at 1-2-week intervals and administer in 2 doses per day. If the patient has difficulty tolerating the increase, reduce the increment or extend the interval between increases. The dose and extent of increase should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. Doses up to 500㎎ per day have been used in children diagnosed with partial-onset seizures. 2) Adjunctive therapy Children (2-16 years): The recommended dose is approximately 5-9mg/kg per day, administered in 2 divided doses. For 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 per day. Dose titration should be determined according to clinical effect. Doses up to 30mg/kg per day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or actions; thus, mood changes or unusual behaviors should be closely monitored during treatment. Epilepsy patients taking this medication may experience sudden death, so regular health status checks are necessary. This medication can cause serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so if any abnormal skin symptoms occur, the medication should be stopped immediately, and a doctor should be consulted. Persons allergic to any component of this medication should not use it, and caution is advised for patients with lactose intolerance. Women who are pregnant or planning to become pregnant should consult their doctor before taking this medication, as usage during pregnancy may harm the fetus and requires special management. Patients with impaired kidney or liver function require dosage adjustments, and patients undergoing dialysis should adjust their dose based on dialysis conditions. This medication can increase the risk of kidney stone formation, so adequate hydration is important. While taking this medication, central nervous system side effects such as drowsiness, dizziness, and decreased concentration may occur, so caution is advised for driving or operating machinery. Sudden discontinuation of this medication can worsen seizures, so dosages should be gradually reduced following a physician's instructions. This medication may interact with other drugs, so it is essential to inform the doctor or pharmacist of any other medications being taken. Contraceptive effectiveness may be reduced, so effective contraceptive methods should be used, especially in women of childbearing age. During treatment, changes in weight, appetite, mood, depressive symptoms, and other aspects of mental health should be closely monitored. Regular tests such as blood tests, liver function tests, and kidney function tests may be needed. If any abnormal symptoms or side effects occur while taking this medication, they should be reported to medical personnel immediately for consultation.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, sensory disturbances, ataxia, motor incoordination, concentration disorder, attention disorder, confusion, dizziness, fatigue, paresthesia, stupor, thought disturbances, agitation, emotional instability, decreased appetite, asthenia, disorientation, memory impairment, diplopia, vertigo, speech disorder, word selection disorder, nausea, nystagmus, psychomotor retardation, tremors, visual disturbances, weight loss, gait disturbances, aggressive response, apathy, perceptual disturbances, harmony disturbances, leukopenia, psychiatric symptoms, taste disturbances, nephrolithiasis, thromboembolism, fatigue, asthenia, back pain, chest pain, flu-like symptoms, leg pain, allergies, flush, body odor, edema, rigidity, dizziness, motor incoordination, speech disorder, nystagmus, sensory disturbances, tremors, harmony disturbances, sensory reduction, gait abnormalities, involuntary muscle contractions, stupor, vertigo, nausea, indigestion, abdominal pain, constipation, gastritis, thirst, gingivitis, auditory disturbances, weight loss, myalgia, skeletal pain, epistaxis, purpura, ataxia, psychomotor retardation, neuroexcitability, memory disorder, disorientation, depression, concentration/attention disorder, agitation, mood disorder, aggressive response, personality disorder, apathy, depersonalization, emotional instability, mastalgia, amenorrhea, menorrhagia, menstrual abnormalities, prostate disorders, infections, viral infections, candidiasis, rhinitis, pharyngitis, sinusitis, dyspnea, erythematous rash, skin disorders, increased sweating, taste disturbances, urinary tract infections, hematuria, urinary incontinence, frequent urination, abnormal urination, diplopia, visual disturbances, eye pain, leukopenia, anemia, vasodilation of the autonomic nervous system, fever, syncope, halitosis, abdominal distension, alcohol intolerance, substernal chest pain, sudden cardiac death, hypertension, hypotension, orthostatic hypotension, tension headaches, erectile dysfunction, hallucinations, psychosis, hypokinesia, stupor, grand mal seizures, hyperactivity, leg cramps, reflex suppression, neurosis, migraine, akinesia, hyperesthesia, motor disturbances, response inhibition, speech disorders, scotoma, ptosis, dystonia, coma, encephalopathy, fecal incontinence, insomnia, personality disorder, decreased libido, manic reactions, suicide attempts, paranoid reactions, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities, cerebellar syndrome, tongue paralysis, goiter, thyroid disorders, diarrhea, vomiting, hemorrhoids, flatulence, gastritis, gingival hyperplasia, dental caries, stomatitis, dysphagia, melena, gastritis, increased salivation, hiccups, gastroesophageal reflux, tongue swelling, esophagitis, tinnitus, ear pain, auditory hyperesthesia, angina pectoris, palpitations, AV block bradycardia, bundle branch block, arrhythmias, atrial arrhythmias, atrial fibrillation, increased SGPT, increased SGOT, gallbladder disorders, increased γ-GT, dehydration, weight gain, thirst, hypokalemia, increased alkaline phosphatase, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, increased creatinine, hyperchloremia, dry eyes, diabetes, hypernatremia, abnormal serum folate, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthropathy, osteoporosis, basal cell carcinoma, anemia, gingival bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenitis, eosinophilia, lymphocytopenia, lymphocytosis, agranulocytosis, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorders, galactorrhea, cough, bronchitis, asthma, bronchospasm, laryngospasm, acne, urticaria, hair loss, dermatitis, nail disorders, folliculitis, dry skin, eczema, skin depigmentation, psoriasis, photosensitivity, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, taste disturbance syndrome, taste loss, aguesia, urinary difficulty, nephrolithiasis, urinary tract infections, increased urination, urinary incontinence, urinary retention, facial edema, nephralgia, nocturia, albuminuria, polyuria, oliguria, flush, venous thrombosis, phlebitis, vascular spasms, conjunctivitis, dysregulation, photophobia, overflow tears, strabismus, color blindness, myopia, mydriasis, cataracts, corneal opacity, iritis, leukopenia, lymphadenopathy, thrombocytopenia, hypersensitivity, hyperchloremic acidosis, hypokalemia, increased appetite, metabolic acidosis, polydipsia, abnormal behavior, sexual indifference, emotional blunting, crying, distractibility, sexual arousal disorder, stuttering, early awakening, elevated mood, euphoria, affective flattening, hallucinations, auditory hallucinations, visual hallucinations, hypomania, initial insomnia, lack of spontaneous combustion, decreased sexual desire, drowsiness, sexual desire loss, mania, intermediate insomnia, decreased orgasm, panic attacks, panic disorder, panic reactions, paranoia, obstinacy, reading disabilities, restlessness, sleep disorders, suicidal thoughts, suicide attempts, increased tearing, abnormal thoughts, taste loss, motor impairment, olfactory loss, speech loss, akinetic mutism, aura, burning sensation, cerebellar syndrome, circadian rhythm sleep disorder, darkness, complex partial seizures, convulsions, altered states of consciousness, orthostatic dizziness, drooling, sensory disturbances, writing disorders, motor disturbances, speech disorders, muscle tension abnormalities, essential tremors, feelings of déjà vu, grand mal seizures, hypersensitivity, hypersomnia, decreased taste sensitivity, reduced mobility, decreased olfaction, peripheral neuropathy, abnormal olfaction, deteriorated sleep quality, pre-syncope, repetitive speech, sensory disorders, sensory loss, stupor, syncope, unresponsiveness to stimuli, dysregulation, visual depth perception changes, amblyopia, eyelid spasms, temporary visual loss, unilateral visual loss, glaucoma, increased tearing, pupil dilation, night blindness, photophobia, presbyopia, scintillating scotomas, scotomas, visual impairment, hearing loss, peripheral sensorineural hearing loss, unilateral hearing loss, ear discomfort, auditory impairment, bradycardia, sinus bradycardia, palpitations, flushing, facial flushing, orthostatic hypotension, Raynaud's phenomenon, speech disorders, exercise-induced dyspnea, nasal congestion, excessive sinus secretion, abdominal discomfort, lower abdominal pain, abdominal tenderness, halitosis, epigastric discomfort, air in gastrointestinal tract, tongue pain, oral sensory reduction, oral pain, pancreatitis, excessive salivation, hyperhidrosis, allergic dermatitis, erythema, maculopapular rash, skin discoloration, abnormal skin odor, facial swelling, urticaria, localized urticaria, flank pain, muscle fatigue, muscle weakness, musculoskeletal stiffness, ureteral stones, urinary stones, hematuria, incontinence, urgency, nephralgia, nephralgia, sexual dysfunction, facial edema, abnormal sensations, sensation of intoxication, irritability, fatigue, peripheral coldness, laziness, reduced serum bicarbonate levels, presence of crystalline urine, abnormal gait test

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

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle