Topiramate 25mg Tablets (Topiramate)

Adult dosage

It is advisable to start this medicine at a low dose and increase it to the effective dose. Monitoring plasma concentrations is not necessary to optimize treatment with this medicine. The recommended dose of this medicine applies to all adults and children, including older adults, without renal disease. This medicine 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 discontinued immediately for safety reasons, gradually taper them 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 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 dose by 25 or 50㎎ per day at intervals of 1-2 weeks, divided into 2 doses per day. If the patient has difficulty tolerating this titration schedule, extend the intervals 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 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, divided into 2 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 intervals of 1-2 weeks, divided into 2 doses per day. 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. 2. Prevention of migraine Adults: Start 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 intervals between dose increases. The recommended dose is 100mg per day, divided into 2 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. 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 on hemodialysis: Because this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. Adjust the dose taking into account 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 start and end of hemodialysis. 4. Patients with hepatic impairment Use this medicine with caution in patients with hepatic impairment, as its clearance may be reduced.

Children's dosage

Children (6-16 years): During the first week, start treatment with 0.5-1 mg/kg in the evening. Thereafter, increase the dose by 0.5-1 mg/kg/day every 1-2 weeks and administer it in 2 divided doses. If the patient has difficulty tolerating dose increases, reduce the size of each increase or lengthen the interval between increases. The dose and rate of increase should be determined according to the clinical response. The recommended dose for monotherapy in children is 3-6 mg/kg/day. Doses of up to 500 mg/day have been used in children diagnosed with partial-onset seizures. Children (2-16 years): The recommended dose is approximately 5-9 mg/kg/day, administered in 2 divided doses. During the first week, administer 25 mg (or less, based on 1-3 mg/kg/day) in the evening. Thereafter, increase the dose by 1-3 mg/kg/day every 1-2 weeks until an appropriate clinical effect is achieved, administering it in 2 divided doses. Dose titration should be guided by the clinical response. Doses of up to 30 mg/kg/day have been administered, and were generally well tolerated.

This medication may increase the risk of suicidal thoughts and behaviors in patients taking it, so patients and caregivers should immediately inform healthcare professionals if such symptoms occur. During treatment, sudden skin rashes or severe skin reactions may occur; if any skin abnormalities appear, the medication should be stopped immediately and a doctor consulted. Women who are pregnant or planning to become pregnant should consult their doctor before taking this medication, as taking it during pregnancy may harm the fetus and should be done with caution. Dose adjustments are necessary for patients with reduced kidney function, and drug concentrations in the body may vary based on kidney function, requiring caution. This medication can cause kidney stones, so adequate hydration is necessary, and patients with a history of kidney stones should be particularly cautious. Symptoms such as drowsiness, dizziness, and blurred vision may occur during treatment, so caution is needed when driving or operating machinery. Abrupt discontinuation of this medication may worsen seizures, so dosage should be reduced gradually according to the doctor's instructions. This medication may interact with other drugs, so if patients are taking other medications, they must inform their doctor or pharmacist. Especially when used with contraceptives, the contraceptive effect may be reduced, so effective contraceptive methods should be used. During treatment, symptoms such as weight changes, mood changes, or memory deterioration may occur, so any unusual symptoms should be discussed with healthcare professionals. Regular visits to the hospital for blood tests or other examinations may be necessary, making it important to check the patient's condition regularly.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, perceptual abnormalities, ataxia, motor ataxia, concentration impairment, attention deficit, confusion, dizziness, fatigue, tactile hallucinations, stupor, thought disorder, agitation, emotional instability, loss of appetite, asthenia, confusion, memory impairment, diplopia, vertigo, language impairment, word selection disorder, nausea, nystagmus, psychomotor retardation, tremor, visual disturbances, weight loss, gait disturbance, aggressive response, emotional blunting, perceptual distortion, harmonization disturbance, leukopenia, psychiatric symptoms, taste disorder, kidney stones, thromboembolism, fatigue, asthenia, back pain, chest pain, influenza-like symptoms, leg pain, allergy, flushing, body odor, edema, rigidity, dizziness, motor ataxia, language impairment, nystagmus, perceptual abnormalities, tremor, harmonization disturbances, sensory impairment, gait abnormalities, involuntary muscle contractions, stupor, syncope, nausea, dyspepsia, abdominal pain, constipation, gastroenteritis, thirst, gastrointestinal disorders, gingivitis, auditory abnormalities, weight loss, myalgia, skeletal pain, epistaxis, purpura, ataxia, psychomotor retardation, hyperesthesia, memory impairment, confusion, depression, attention/concentration deficits, agitation, mood disorders, aggressive responses, perceptual distortions, decreased libido, emotional blunting, mastalgia, amenorrhea, menorrhagia, menstrual irregularities, prostate disorders, infections, viral infections, candidiasis, rhinitis, pharyngitis, sinusitis, dyspnea, erythematous rashes, skin disorders, increased sweating, taste disorder, urinary tract infections, hematuria, urinary incontinence, frequent urination, abnormal urination, diplopia, visual disturbances, ocular pain, leukopenia, anemia, autonomic nervous system disorders, fever, syncope, halitosis, abdominal distension, alcohol intolerance, retrosternal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, stress-induced disorders, erectile dysfunction, hallucinations, euphoria, psychosis, hypokinesia, stupor, grand mal seizures, hyperkinesia, leg cramps, reflex suppression, neurosis, migraine, akinesia, hyperesthesia, movement disorders, parkinsonism, speech disorders, scotoma, ptosis, dystonia, visual impairment, coma, encephalopathy, fecal incontinence, insomnia, personality disorders, decreased libido, manic responses, suicide attempts, paranoid reactions, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities, cerebellar syndrome, tongue paralysis, goiter, thyroid disorders, diarrhea, vomiting, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, dental caries, stomatitis, swallowing disorders, melena, gastritis, increased salivation, hiccups, gastroesophageal reflux, tongue edema, esophagitis, belching, tinnitus, otalgia, auditory hypersensitivity, angina, palpitations, AV block bradycardia, heart block, arrhythmia, atrial arrhythmia, atrial fibrillation, elevated SGPT, elevated SGOT, gallbladder disorders, elevated γ-GT, dehydration, weight gain, thirst, hypokalemia, elevated alkaline phosphatase, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, elevated creatinine, hyperchloremia, dry eyes, diabetes mellitus, hypernatremia, abnormal serum folate levels, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthritic disorders, osteoporosis, basal cell tumor, anemia, gum bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphatic swelling, eosinophilia, lymphopenia, lymphocytosis, neutropenia, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leucorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorders, male galactorrhea, cough, bronchitis, asthma, bronchospasm, laryngospasm, acne, urticaria, hair loss, dermatitis, nail disorders, folliculitis, xerosis, eczema, skin depigmentation, psoriasis, photosensitivity reactions, erythematous rashes, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, taste distortion, taste loss, tactile hallucination, dysuria, kidney stones, urinary tract infections, frequent urination, urinary incontinence, urinary retention, facial edema, renal colic, nocturia, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular sclerosis, conjunctivitis, dysregulation, photophobia, overflow tears, strabismus, color blindness, myopia, mydriasis, cataracts, corneal opacity, iritis, leukopenia, neutropenia, allergic edema, hyperammonemia, hyperammonemic encephalopathy, despair, visual disturbances, closed-angle glaucoma, conjunctival edema, eye movement disorders, eyelid edema, macular degeneration, myopia, cough, chest discomfort, polymorphic erythema, periorbital edema, Stevens-Johnson syndrome, toxic epidermal necrolysis, peripheral edema, joint swelling, limb discomfort, renal tubular acidosis, nephrocalcinosis, generalized edema, influenza-like illness, weight gain, night sweats, worsening of epilepsy, psychiatric disturbances, decreased sweating, elevated body temperature, hyperammonemic encephalopathy, somnolence, vomiting, changes in consciousness level, changes in cognitive function, suicidal impulses, suicide attempts, suicide, secondary angle-closure glaucoma, acute myopic syndrome, visual decline, ocular pain, myopia, mydriasis, narrowed anterior chamber, retinal congestion, choroidal detachment, retinal pigment epithelium detachment, macular spots, increased intraocular pressure, visual field loss, hyperchloremic metabolic acidosis, decreased serum bicarbonate levels, decreased sweating, increased body temperature, hyperammonemia, hyperammonemic encephalopathy, abnormal behavior, sexual dysfunction, emotional blunting, crying, distractibility, sexual arousal disorder, stuttering, early awakening, elevated mood, euphoria, emotional flatness, hallucinations, auditory hallucinations, visual hallucinations, hypomania, initial insomnia, lack of spontaneous combustion, decreased sexual desire, lethargy, sexual desire loss, mania, moderate insomnia, diminished intensity of feelings, panic attacks, panic disorder, panic responses, paranoia, insistence, reading disabilities, restlessness, sleep disorders, suicidal ideation, suicide attempts, increased tears, abnormal thoughts, taste loss, motor incapacity, olfactory loss, language loss, apraxia, aura, burning sensation, cerebellar syndrome, circadian rhythm sleep disorder, darkness, complex partial seizures, convulsions, decreased consciousness, orthostatic dizziness, drooling, movement disorders, muscle tone abnormalities, essential tremor, depersonalization, grand mal seizures, sensory hypersensitivity, hypersomnia, sensory reduction, decreased movement, decreased olfaction, peripheral neuropathy, abnormal olfaction, decreased sleep quality, pre-syncopal symptoms, repetitive language, sensory disturbances, sensory loss, stupor, syncope, unresponsiveness to stimuli, dysregulation, visual depth perception changes, amblyopia, eyelid spasms, transient visual loss, unilateral vision loss, glaucoma, increased tearing, pupil dilation, night blindness, photophobia, presbyopia, glare scotoma, scotoma, visual decline, hearing loss, 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, halitosis, epigastric discomfort, intragastric air trapping, tongue pain, oral sensory loss, oral pain, pancreatitis, excessive salivation, hyperosmia, allergic dermatitis, erythema, maculopapular rash, skin discoloration, abnormal skin odor, facial swelling, urticaria, localized urticaria, flank pain, muscle fatigue, muscle weakness, musculoskeletal rigidity, ureteral stones, urinary stones, hematuria, incontinence, urgency, renal colic, renal pain, urinary incontinence, sexual dysfunction, facial edema, abnormal sensations, intoxicated feeling, irritability, fatigue, peripheral coldness, lethargy, decreased serum bicarbonate, presence of crystallized urine, abnormal results in the line walking test

This medication can be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it should be kept in a cool, dry place below 25 degrees Celsius to maintain its effectiveness.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle