Topiramate Tablets 25 mg (Topiramate)

Adult dose

It is preferable to start this drug at a low dose and increase it to the effective dose. Monitoring plasma concentrations is not necessary to optimize treatment with this drug. The recommended dose of this drug applies equally to all adults and children, including elderly patients, who do not have renal disease. It may be administered with or without food. Tablets should be swallowed whole and not crushed. Epilepsy - Monotherapy - Adults (17 years of age and older): Initiate treatment with 25㎎ in the evening for the first week. Thereafter, increase the dose by 25 or 50㎎ per day at 1-2-week intervals and administer 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 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 with topiramate monotherapy. Epilepsy - Adjunctive therapy - Adults (17 years of age 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 to the maximum recommended dose of 800mg per day. Initiate 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. If the patient has difficulty tolerating the increased dose, the dose increment may be reduced or the titration interval extended. The dose should be determined according to clinical response. Migraine prophylaxis - Adults: Initiate treatment 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 this titration, 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 clinical response. 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 drug is removed from plasma by hemodialysis, patients on hemodialysis should increase their dose of this drug by approximately 1/2 on the day of dialysis. Increase the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and administer divided doses at the start and end of hemodialysis. Use with caution in patients with hepatic impairment, as clearance of this drug may be reduced.

Child dose

Epilepsy - Monotherapy - Children (6-16 years of age): Initiate treatment with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at 1-2-week intervals and administer twice daily. If the patient has difficulty tolerating the dose increase, reduce the dose increment or extend the interval between increases. The dose and degree of titration should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. Doses of up to 500㎎ per day have been used in children diagnosed with partial seizures. Epilepsy - Adjunctive therapy - Children (2-16 years of age): The recommended dose is approximately 5-9mg/kg per day, administered in 2 divided doses. Administer 25mg (or less, based on 1-3mg/kg per day) in the evening for the first week, and thereafter increase the dose by 1-3mg/kg per day at 1-2-week intervals until an appropriate clinical effect is achieved, administered in 2 divided doses. Dose titration should be determined according to clinical response. Doses of up to 30mg/kg per day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behavior, so it is important to closely monitor changes in mood or behavior while taking it. It is particularly important to consult a healthcare provider immediately if symptoms of depression appear or worsen. Patients taking this medication are at risk of sudden death, which is generally reported within the range for epilepsy patients, but careful observation is required. Additionally, this medication can cause severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so if a rash or blisters occur, use should be stopped immediately and a doctor consulted. This medication is not administered to patients with allergies to its components or certain genetic lactose metabolic disorders. Women who are pregnant or planning to become pregnant must take a pregnancy test before taking this medication and utilize effective contraception while taking it, and must be fully informed of the risks to the fetus. Patients with renal or liver dysfunction may require dosage adjustments, and patients undergoing dialysis should adjust doses according to dialysis conditions. Adequate hydration is necessary while taking this medication, and precautions should be taken to avoid symptoms of kidney stones or kidney pain. If there is a change in weight or appetite during treatment, it is advisable to consult a healthcare provider. This medication affects the central nervous system and can cause drowsiness, dizziness, and decreased concentration; therefore, it is safest to avoid driving or operating machinery during the initial stages of treatment. Stopping this medication suddenly can worsen seizures, so it must be tapered off gradually according to a doctor's instructions. This medication may interact with other drugs, so patients should inform healthcare providers of all medications being taken, particularly when taking anti-epileptic drugs, contraceptives, lithium, or diabetes medications. There is a risk of congenital malformations or growth retardation in the fetus if taken during pregnancy; therefore, women of childbearing potential should consult healthcare providers before use. If any abnormal symptoms or side effects occur during treatment, patients should immediately notify healthcare providers and seek appropriate measures.

Suicidal ideation, suicidal behavior, depression, abnormal mood and behavior changes, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, sensory disturbance, hypotonia, ataxia, attention deficit, concentration difficulties, confusion, dizziness, fatigue, paresthesia, stupor, thought disorder, agitation, emotional instability, loss of appetite, asthenia, disorientation, memory impairment, diplopia, vertigo, language disorders, vocabulary selection disorder, nausea, nystagmus, psychomotor retardation, tremor, visual disturbances, weight loss, walking impairment, aggressive reactions, apathy, perceptual distortion, harmony distortion, leukopenia, symptoms of mental abnormalities, gustatory distortion, nephrolithiasis, thromboembolism, fatigue, asthenia, back pain, chest pain, influenza-like symptoms, leg pain, allergies, flushing, body odor, edema, rigidity, dizziness, ataxia, language disorders, nystagmus, sensory disturbance, tremor, harmony distortion, sensory loss, gait abnormalities, involuntary muscle contractions, confusion, syncope, nausea, dyspepsia, abdominal pain, constipation, gastritis, thirst, gastrointestinal disorders, gingivitis, auditory disturbances, weight loss, myalgia, skeletal pain, epistaxis, purpura, hypotonia, psychomotor retardation, nervous hyperexcitability, memory impairment, disorientation, depression, concentration/attention deficit, agitation, mood disorders, aggressive reactions, cognitive impairment, apathy, depersonalization, emotional instability, mastalgia, amenorrhea, menorrhagia, menstrual irregularities, prostate disorders, infections, viral infections, candidiasis, rhinitis, pharyngitis, sinusitis, dyspnea, erythematous rash, skin disorders, increased sweating, gustatory distortion, urinary tract infection, hematuria, urinary incontinence, frequent urination, abnormal urination, diplopia, visual disturbances, ocular pain, leukopenia, anemia, autonomic nervous system disorders, fever, syncope, halitosis, abdominal distention, alcohol intolerance, sternal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension-related disorders, erectile dysfunction, hallucinations, euphoria, psychosis, motor retardation, confusion, generalized tonic-clonic seizures, hyperactivity, leg cramps, diminished reflexes, neurosis, migraine, akinesia, hyperesthesia, movement disorders, dyskinesia, speech disorders, scotoma, ptosis, dystonia, coma, encephalopathy, fecal incontinence, insomnia, personality disorders, decreased libido, manic responses, suicide attempts, paranoid responses, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities, goiter, thyroid disorders, diarrhea, vomiting, hemorrhoids, flatulence, gastritis, gingival hyperplasia, dental caries, stomatitis, dysphagia, melena, gastritis, increased saliva, hiccups, gastroesophageal reflux, tongue swelling, esophagitis, belching, tinnitus, otalgia, hypersensitivity, angina pectoris, palpitations, AV block bradycardia, atrioventricular block, arrhythmia, 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 eye syndrome, diabetes mellitus, hypernatremia, serum folate abnormalities, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthrosis, osteoporosis, basal cell tumor, anemia, gum bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenitis, eosinophilia, lymphocytopenia, leukopenia, lymphocytosis, agranulocytosis, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leucorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorders, galactorrhea, cough, bronchitis, asthma, bronchospasm, laryngeal spasm, acne, urticaria, alopecia, dermatitis, nail disorders, folliculitis, xerosis, eczema, skin depigmentation, psoriasis, photosensitivity reactions, erythematous rash, seborrheic dermatitis, decreased sweat production, hair abnormalities, brown spots, taste loss, hypogeusia, dysuria, nephrolithiasis, urinary tract infection, frequent urination, urinary retention, facial edema, renal pain, nocturia, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular constriction, conjunctivitis, dysregulation, photophobia, overflow tears, strabismus, color blindness, myopia, mydriasis, cataract, corneal opacity, iritis, leukopenia, neutropenia, allergic edema, hyperammonemia, hyperammonemic encephalopathy, feelings of hopelessness, abnormal sensations in the eyes, angle-closure glaucoma, conjunctival edema, eye movement disorders, eyelid edema, maculopathy, myopia, cough, chest discomfort, erythema multiforme, periorbital edema, peripheral edema, joint swelling, limb discomfort, tubular acidosis, renal calcinosis, generalized edema, influenza-like illnesses, weight gain, diaphoresis, exacerbation of epilepsy, psychiatric abnormalities, decreased comprehension, eye fatigue, asthenia, chest discomfort, peripheral edema, edema, chest pain, sensory disturbances, headache, drowsiness, hypersomnia, tremors, sedation, dystonia, suicidal impulses, suicide attempts, suicidal thoughts, increased intraocular pressure, acute myopia syndrome, decreased vision, ocular pain, conjunctival injection, choroidal detachment, retinal pigment epithelial detachment, macular lesion, increased intraocular pressure, visual field defects independent of intraocular pressure elevation, hyperchloremic metabolic acidosis, bicarbonate concentration decrease, decreased sweating, increased body temperature, hyperammonemic encephalopathy, somnolence, vomiting, level of consciousness changes, cognitive function changes, abnormal behaviors, sexual indifference, emotional blunting, crying, distractibility, sexual arousal disorders, stuttering, early awakening, elevated mood, feelings of euphoria, affective flattening, hallucinations, auditory hallucinations, visual hallucinations, hypomania, initial insomnia, lack of spontaneous combustion, decreased sexual desire, lethargy, loss of sexual desire, mania, moderate insomnia, decreased climactic sensations, panic attacks, panic disorder, panic reactions, paranoia, obstinacy, reading disorders, restlessness, sleep disorders, suicide attempts, suicidal ideation, increased tearing, abnormal thoughts, taste loss, inability to move, smell loss, language loss, psychomotor retardation, aura, burning sensation, cerebellar syndrome, circadian rhythm sleep disorders, darkness, complex partial seizures, convulsions, decreased level of consciousness, orthostatic dizziness, drooling, movement disorders, language disorders, abnormal muscle tension, essential tremor, depersonalization, generalized tonic-clonic seizures, hypersensitivity, hypersomnia, gustatory impairment, decreased mobility, olfactory impairment, peripheral neuropathy, abnormal olfaction, decreased sleep quality, prodromal symptoms, repetitive speech, sensory disorders, sensory loss, confusion, syncope, unresponsiveness to stimuli, regulatory disorders, changes in depth perception, amblyopia, eyelid spasms, temporary vision loss, unilateral vision loss, glaucoma, increased tearing, pupillary dilation, night blindness, photophobia, presbyopia, glare scotoma, scotoma, visual impairment, hearing loss, sensorineural hearing loss, unilateral hearing loss, ear discomfort, hearing 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, intestinal gas retention, tongue pain, oral sensory loss, oral pain, pancreatitis, excessive salivation, infinity syndrome, allergic dermatitis, erythema, maculopapular rash, skin discoloration, skin odor abnormalities, facial swelling, urticaria, localized urticaria, flank pain, muscle fatigue, muscle weakness, musculoskeletal rigidity, ureterolithiasis, urolithiasis, hematuria, incontinence, urgency, renal colic, renal pain, facial edema, abnormal sensations, feelings of drunkenness, irritability, malaise, peripheral coldness, lethargy, decrease in serum bicarbonate sodium, presence of crystalline urine, abnormal tandem gait test

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

Appearance

Yellow round film-coated tablet

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 300 tablets/bottle