Topiramate 25 mg Tablet

Adult dose

It is preferable to start this medicine at a low dose and increase it to the 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 the elderly, provided they do not have renal disease. It may be taken with or without food. Swallow the tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, consider the potential effect on seizure control. Unless other antiepileptic drugs must be stopped immediately for safety reasons, they should be gradually tapered and discontinued by reducing the dose by about 1/3 at 2-week intervals (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 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 daily dose by 25 or 50㎎ at 1-2 week intervals and administer in 2 divided doses daily. 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 adults receiving 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 up to the maximum recommended dose of 800mg daily. Start treatment with 25-50mg in the evening during 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 daily. If the patient has difficulty tolerating the increased dose, smaller increments may be used 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 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, extend the interval between dose 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 up to 200mg daily, and 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 about 1/2. - Patients on hemodialysis: Since this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by about 1/2 on dialysis days. Adjust the dose considering the duration of dialysis, the clearance of the dialysis equipment, 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 in patients with hepatic impairment, as clearance of this medicine may be reduced.

Child dose

Epilepsy monotherapy — Children (6-16 years): Start with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the daily dose by 0.5-1㎎/㎏ at 1-2 week intervals and administer twice daily. If the patient has difficulty tolerating the increase, use smaller increments 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 3-6mg/kg daily. Doses up to 500㎎ daily have been used in children diagnosed with partial-onset seizures. Epilepsy adjunctive therapy — Children (2-16 years): The recommended dose is approximately 5-9mg/kg daily, administered in 2 divided doses. During 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, administering 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 may increase the risk of suicidal thoughts or behaviors, so patients should inform their healthcare provider immediately if there are mood changes or abnormal behavior during treatment. There is a potential risk of sudden death in epilepsy patients taking this medication, so close observation of their condition is necessary during treatment. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may rarely occur, so if any abnormal skin symptoms arise, discontinue the medication immediately and consult your healthcare provider. Patients with allergies to any ingredient of this medication or with specific genetic lactose intolerance should not take it. Women of childbearing potential should undergo pregnancy testing prior to starting this medication, and during pregnancy, they should consult with their healthcare provider as it may harm the fetus, and effective contraception methods must be used. Patients with decreased kidney or liver function may require dosage adjustments as the elimination of the drug may be delayed, and those receiving hemodialysis must adjust the dosage according to the dialysis conditions. Adequate hydration is important due to the risk of kidney stones, and special caution is advised for patients with a history of kidney stones. This medication may affect the central nervous system and can cause drowsiness, dizziness, or blurred vision, so patients should avoid driving or operating machinery during the initial stages of treatment. While taking this medication, various side effects such as weight loss, loss of appetite, depression, or decreased concentration may occur, so changes in condition should be monitored carefully. Sudden discontinuation of this medication may worsen seizures, so it is necessary to taper off under the guidance of a healthcare provider. This medication may interact with other drugs, so patients should inform their healthcare provider about all other medications they are taking. Taking this medication during pregnancy may increase the risk of congenital malformations or growth delays in the fetus, so women planning a pregnancy or who are pregnant must consult with a specialist. Regular blood tests and kidney function tests should be conducted while taking this medication, and any abnormal symptoms should be reported to a healthcare provider immediately.

Suicidal thoughts, suicidal behavior, depression, abnormal mood and behavior changes, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, perceptual disturbances, muscular rigidity, ataxia, attention disorder, concentration disorder, confusion, dizziness, fatigue, paresthesia, delirium, thought disturbances, agitation, emotional instability, loss of appetite, asthenia, confusion, memory impairment, double vision, vertigo, speech disorders, word selection disorder, nausea, nystagmus, psychomotor retardation, tremor, visual disturbances, weight loss, gait disturbances, aggressive responses, apathy, perceptual disturbances, harmony disturbances, leukopenia, psychopathological symptoms, dysgeusia, nephrolithiasis, thrombosis, fatigue, asthenia, back pain, chest pain, influenza-like symptoms, leg pain, allergies, flushing, body odor, edema, rigidity, dizziness, ataxia, speech disorder, nystagmus, perceptual disturbances, tremor, harmony disturbances, sensory loss, gait abnormalities, involuntary muscle contractions, confusion, dizziness, nausea, dyspepsia, abdominal pain, constipation, gastroenteritis, thirst, gastrointestinal disorders, gingivitis, auditory disturbances, weight loss, myalgia, skeletal pain, epistaxis, purpura, muscular rigidity, psychomotor retardation, hyperesthesia, memory impairment, confusion, depression, concentration/attention disorder, loss of appetite, agitation, mood disorders, aggressive responses, cognitive impairment, 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, dysgeusia, urinary tract infection, hematuria, urinary incontinence, frequent urination, abnormal urine, double vision, visual disturbances, ocular pain, leukopenia, anemia, vasodilation in the autonomic nervous system, fever, syncope, halitosis, abdominal distension, alcohol intolerance, substernal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension-type headaches, erectile dysfunction, hallucinations, hypochondria, psychosis, decreased motor activity, confusion, grand mal seizures, hyperactivity, leg cramps, diminished reflexes, neurosis, migraine, akinesia, hyperesthesia, movement abnormalities, possible hallucinations, speech disorders, scotomas, hypotonia, dystonia, visual impairment, coma, encephalopathy, fecal incontinence, insomnia, personality disorders, decreased libido, manic episodes, suicide attempts, paranoid delusions, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities, cerebellar syndrome, tongue paralysis, increased libido, goiter, thyroid disorders, diarrhea, vomiting, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, dental caries, stomatitis, dysphagia, melena, gastritis, increased salivation, hiccups, gastroesophageal reflux, tongue swelling, esophagitis, tinnitus, otalgia, hyperacusis, angina pectoris, palpitations, AV block bradycardia, bundle branch block, arrhythmias, atrial arrhythmias, atrial fibrillation, SGPT elevation, SGOT elevation, gallbladder disorders, γ-GT elevation, dehydration, weight gain, thirst, hypokalemia, alkaline phosphatase elevation, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, creatinine elevation, hyperchloremia, dry eyes, diabetes, hypernatremia, abnormal serum folate, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthrosis, osteoporosis, basal cell carcinoma, anemia, gum 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, xerosis, eczema, skin depigmentation, psoriasis, photosensitivity reactions, erythematous rash, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, dysgeusia, ageusia, aftertaste, dysuria, nephrolithiasis, urinary tract infection, urinary frequency, urinary incontinence, urinary retention, facial edema, renal colic, enuresis, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular sclerosis, conjunctivitis, dysregulation, glare, overflow, strabismus, color blindness, myopia, mydriasis, cataract, corneal opacity, iritis, leukopenia, neutropenia, allergic edema, hyperammonemia, hyperammonemia encephalopathy, feelings of despair, visual sensations, angle-closure glaucoma, conjunctival edema, oculomotor dysfunction, eyelid edema, maculopathy, myopia, cough, chest discomfort, polymorphic light eruption, periorbital edema, peripheral edema, joint swelling, limb discomfort, nephrocalcinosis, systemic edema, influenza-like illness, weight gain, diaphoresis, exacerbation of epilepsy, mental disturbances, decreased sweating, elevated body temperature, hyperammonemia encephalopathy, somnolence, vomiting, changes in consciousness level, changes in cognitive function, vasodilation in the autonomic nervous system, fever, syncope, halitosis, abdominal distension, alcohol intolerance, substernal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension-type headaches, erectile dysfunction, hallucinations, hypochondria, psychosis, decreased motor activity, confusion, grand mal seizures, hyperactivity, leg cramps, diminished reflexes, neurosis, migraine, akinesia, hyperesthesia, movement abnormalities, possible hallucinations, speech disorders, scotomas, hypotonia, dystonia, visual impairment, coma, encephalopathy, fecal incontinence, insomnia, personality disorders, decreased libido, manic episodes, suicide attempts, paranoid delusions, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities, cerebellar syndrome, tongue paralysis, increased libido, goiter, thyroid disorders, diarrhea, vomiting, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, dental caries, stomatitis, dysphagia, melena, gastritis, increased salivation, hiccups, gastroesophageal reflux, tongue swelling, esophagitis, tinnitus, otalgia, hyperacusis, angina pectoris, palpitations, AV block bradycardia, bundle branch block, arrhythmias, atrial arrhythmias, atrial fibrillation, SGPT elevation, SGOT elevation, gallbladder disorders, γ-GT elevation, dehydration, weight gain, thirst, hypokalemia, alkaline phosphatase elevation, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, creatinine elevation, hyperchloremia, dry eyes, diabetes, hypernatremia, abnormal serum folate, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthrosis, osteoporosis, basal cell carcinoma, anemia, gum 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, xerosis, eczema, skin depigmentation, psoriasis, photosensitivity reactions, erythematous rash, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, dysgeusia, ageusia, aftertaste, dysuria, nephrolithiasis, urinary tract infection, urinary frequency, urinary incontinence, urinary retention, facial edema, renal colic, enuresis, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular sclerosis, conjunctivitis, dysregulation, glare, overflow, strabismus, color blindness, myopia, mydriasis, cataract, corneal opacity, iritis, leukopenia, neutropenia, allergic edema, hyperammonemia, hyperammonemia encephalopathy, feelings of despair, visual sensations, angle-closure glaucoma, conjunctival edema, oculomotor dysfunction, eyelid edema, maculopathy, myopia, cough, chest discomfort, polymorphic light eruption, periorbital edema, peripheral edema, joint swelling, limb discomfort, nephrocalcinosis, systemic edema, influenza-like illness, weight gain, diaphoresis, exacerbation of epilepsy, mental disturbances, decreased sweating

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. It should be kept in a cool, dry place below 25 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle