Topiramate Tablets 25 mg (Topiramate)

Adult dose

It is preferable 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 the elderly, in the absence of renal disease. It may be administered with or without food. 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 reduced by approximately 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 mg in the evening during the first week. Thereafter, increase the daily dose by 25 or 50 mg at 1- to 2-week intervals, dividing the dose into 2 administrations per day. If the patient has difficulty tolerating this titration schedule, increase 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 100–200 mg per day. The maximum recommended dose is 500 mg per day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses up to 1,000 mg per day. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200 mg per day, and the usual dose is 200-400 mg per day, divided into 2 administrations. Depending on the patient, the dose may be increased up to the maximum recommended dose of 800 mg per day. Start treatment with 25-50 mg in the evening during the first week; treatment may also be initiated at a lower dose. Thereafter, increase the dose by 25-50 mg at 1- to 2-week intervals, dividing the dose into 2 administrations per day. If the patient has difficulty tolerating the increased dose, smaller 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 25 mg of this medicine in the evening during the first week. Thereafter, increase the dose by 25 mg/day at 1-week intervals. If the patient has difficulty tolerating these dose increases, extend the intervals between increases. The recommended dose is 100 mg per day, divided into 2 administrations. Some patients may respond to a dose of 50 mg per day. The dose may be increased up to 200 mg per day, and the dose and rate of titration should be determined according to clinical response. 3. Patients with renal impairment - In patients with moderate or severe renal impairment (CLcr < 70 mL/min/1.73 m2), it is recommended that the initial and maintenance doses be reduced to approximately 1/2. - Hemodialysis patients: 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, dialyzer clearance, and the patient's residual renal clearance, and administer divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment because clearance of this medicine may be reduced.

Child dose

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

This medication may increase the risk of suicidal thoughts or behavior; if mood changes or unusual behaviors occur during treatment, consult a doctor immediately. There may be a risk of sudden death during the use of this medication, which requires special caution. Serious skin reactions may occur rarely, and if any unusual symptoms such as rash or blisters develop, discontinue use and visit a hospital immediately. Patients with allergies to any components of this medication or those with specific hereditary lactose issues should not take it. Women who are pregnant or planning to become pregnant must consult a doctor before using this medication, as it may harm the fetus if taken during pregnancy. Patients with impaired kidney or liver function may require dosage adjustments, and it is important to maintain adequate hydration due to the risk of kidney stones. Symptoms such as drowsiness, dizziness, or blurred vision may occur during treatment, so caution should be exercised when driving or operating machinery. Abruptly stopping this medication may lead to seizures, so taper off under a doctor’s guidance when discontinuing usage. There might be interactions when used with other drugs, so it is important to inform the doctor about all medications currently being taken. Sometimes side effects such as decreased appetite, weight loss, depression, memory impairment, and insomnia may occur; consult healthcare professionals if symptoms persist. This medication may alter body acidity and cause metabolic acidosis, hence regular blood tests may be necessary. Additionally, this drug may impair heat regulation due to reduced sweating, requiring special caution in hot environments. In pregnant women, the risk of fetal malformations and growth inhibition should be carefully considered when determining the use of this medication during pregnancy.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, perceptual disturbances, ataxia, motor incoordination, attention deficit, confusion, dizziness, fatigue, paresthesia, delirium, cognitive disturbances, agitation, emotional instability, appetite loss, asthenia, confusion, memory impairment, diplopia, vertigo, language impairment, word selection disorders, nausea, nystagmus, psychomotor retardation, tremors, visual disturbances, weight loss, gait disturbances, aggressive reactions, apathy, perceptual anomalies, sensory disturbances, leukopenia, psychotic symptoms, dysgeusia, kidney stones, thromboembolism, fatigue, asthenia, back pain, chest pain, influenza-like symptoms, limb pain, allergies, flushing, body odor, edema, rigidity, dizziness, motor ataxia, language impairment, nystagmus, perceptual disturbances, tremors, sensory disturbances, sensory loss, gait abnormalities, involuntary muscle contractions, confusion, dizziness, nausea, indigestion, abdominal pain, constipation, gastroenteritis, thirst, gastrointestinal disorders, gingivitis, auditory disturbances, weight loss, myalgia, skeletal pain, epistaxis, purpura, ataxia, psychomotor retardation, nervousness, memory impairment, confusion, depression, attention deficit, agitation, mood disorders, aggressive reactions, cognitive impairment, apathy, depersonalization, emotional instability, mastalgia, amenorrhea, menorrhagia, menstrual abnormalities, prostate disorders, infections, viral infections, candidiasis, rhinitis, pharyngitis, sinusitis, respiratory distress, erythematous rash, skin disorders, increased sweating, dysgeusia, 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, substernal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension disorders, erectile dysfunction, hallucinations, euphoria, psychosis, hypokinesia, confusion, grand mal seizures, hyperactivity, leg cramps, reflex suppression, neurosis, migraine, akinesia, sensory hyperreactivity, motor abnormalities, reflex movements, speech disorders, scotomas, ptosis, dystonia, coma, encephalopathy, fecal incontinence, insomnia, personality disorders, decreased libido, manic reactions, suicide attempts, paranoid responses, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities, goiter, thyroid disorders, diarrhea, vomiting, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, dental caries, stomatitis, dysphagia, melena, gastritis, increased salivation, hiccups, gastroesophageal reflux, tongue edema, esophagitis, belching, tinnitus, otalgia, auditory hyperesthesia, angina pectoris, palpitations, AV block bradycardia, complete heart block, arrhythmias, atrial arrhythmia, atrial fibrillation, increased SGPT, increased SGOT, gallbladder disorders, elevated γ-GT, dehydration, weight gain, thirst, hypokalemia, increased alkaline phosphatase, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, increased creatinine, hyperchloremia, dry eye syndrome, diabetes, hypernatremia, abnormal serum folate, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthropathy, osteoporosis, basal cell carcinoma, anemia, gum bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenitis, eosinophilia, lymphopenia, 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, phototoxic reactions, erythematous rash, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, dysgeusia, ageusia, paresthesia, 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, glare, tearing, strabismus, color blindness, myopia, mydriasis, cataracts, corneal opacity, iritis, suicidal impulses, suicide attempts, feelings of despair, abnormal sensations in the eyes, closed-angle glaucoma, conjunctival edema, ocular motility disorders, eyelid edema, macular degeneration, myopia, erythema multiforme, periorbital edema, peripheral edema, joint swelling, limb discomfort, tubular acidosis, nephrocalcinosis, generalized edema, influenza-like illnesses, weight gain, cold sweats, exacerbation of epilepsy, mental disorders, reduced comprehension, eye fatigue, chest discomfort, peripheral edema, headaches, drowsiness, hypersomnia, sedation, dystonia, ocular pain, blurred vision, thrombocytopenia, surgery (extended hospitalization), hyperammonemia, hyperammonemic encephalopathy, hypersomnia, vomiting, changes in consciousness level, changes in cognitive function, decreased sweating, increased body temperature, hypothermia, decreased serum bicarbonate, metabolic acidosis, kidney stones, growth and bone-related effects, weight loss, decreased bone mineral density, decreased growth rate, fever, insomnia, panic attacks, panic disorder, panic reactions, paranoia, obstinacy, reading disorders, restlessness, sleep disorders, suicidal thoughts, suicide attempts, increased tearing, abnormal thoughts, ageusia, motor paralysis, anosmia, aphasia, akinetic mutism, premonitory signs, burning sensations, cerebellar syndrome, circadian rhythm sleep disorders, darkness, complex partial seizures, convulsions, decreased level of consciousness, orthostatic dizziness, drooling, motor abnormalities, muscle tension abnormalities, essential tremors, depersonalization, grand mal seizures, hypersensitivity, hypersomnia, decreased taste sensitivity, reduced movement, olfactory loss, peripheral neuropathy, altered olfaction, decreased sleep quality, pre-syncope warning signs, repetitive speech, sensory disorders, sensory loss, confusion, syncope, unresponsive to stimuli, regulation disorders, changes in visual depth perception, amblyopia, eyelid spasms, temporary vision loss, unilateral vision loss, glaucoma, increased tearing, pupillary dilation, night blindness, photophobia, presbyopia, flash scotomas, scotomas, vision impairment, hearing loss, sensorineural hearing loss, unilateral hearing loss, ear discomfort, auditory disorders, bradycardia, sinus bradycardia, palpitations, flushing, facial flushing, orthostatic hypotension, Raynaud's phenomenon, speech disorders, exercise-induced respiratory distress, nasal obstruction, excessive secretion from sinuses, abdominal discomfort, lower abdominal pain, abdominal tenderness, halitosis, epigastric discomfort, air trapping in the stomach and intestines, tongue pain, oral sensory loss, oral pain, pancreatitis, excessive salivation, hyperesthesia, 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, kidney pain, abnormal sensations, feeling drunk, irritability, fatigue, peripheral coldness, lethargy, decreased serum bicarbonate, presence of crystallized urine, abnormality in straight-line walking test, decreased white blood cell count

Store this medication in a sealed container, as it may be sensitive to air or moisture. Moreover, it should be kept in a cool, dry place below 25 degrees Celsius to maintain its efficacy.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle