Topiramate Tablet 25 mg (Topiramate)

Adult dose

It is advisable to start this drug at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize treatment with this drug. The recommended dose of this drug applies to all adults and children, including elderly patients, provided they do not have renal disease. This drug may be taken with or without food. Swallow the tablets whole; do not break them. Adults (17 years of age and older): Start with 25㎎ in the evening for the first week. Thereafter, increase the dose by 25 or 50㎎ per day at 1-2-week intervals, administered in 2 divided doses daily. If the patient has difficulty tolerating this titration schedule, use longer intervals between dose increases. Determine the dose and rate of titration according to clinical response. The recommended dose for adult monotherapy is 100～200mg daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated up to 1,000㎎ daily of topiramate as monotherapy. For adults (17 years of age and older), the minimum effective dose is 200mg daily, and the usual dose is 200-400mg daily in 2 divided doses. The dose may be increased to the maximum recommended dose of 800mg daily, depending on the patient. Begin 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, administered in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, increase by smaller increments or extend the interval between increases. Determine the dose according to clinical effect. Adults: Start with 25mg of this drug in the evening for the first week. Thereafter, increase by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, use longer intervals between increases. The recommended dose is 100mg daily, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. Doses up to 200mg daily may be administered; determine the dose and rate of titration according to clinical response. For patients with moderate or severe renal impairment (CLcr < 70 mL/min/1.73 m2), reducing the initial and maintenance doses to approximately 1/2 is recommended. Patients on hemodialysis: Because this drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on the day of dialysis. Adjust the dose considering the duration of dialysis, dialyzer clearance, and the patient's residual renal clearance, and administer the dose in divided portions 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

Pediatric patients (6-16 years) monotherapy: During the first week, initiate treatment with 0.5-1㎎/㎏ in the evening. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at intervals of 1-2 weeks, administering it twice daily. If the patient has difficulty tolerating dose increases, reduce the increment or extend the interval between increases. The dose and rate of increase should be determined according to clinical response. The recommended dose for pediatric monotherapy is 3-6mg/kg per day. Doses of up to 500㎎ per day have been administered to pediatric patients diagnosed with partial seizures. Pediatric patients (2-16 years) adjunctive therapy: The recommended daily dose is approximately 5-9mg/kg, divided into 2 doses. During the first week, administer 25mg (or less, based on 1-3mg/kg per day) in the evening. Thereafter, increase the dose by 1-3mg/kg per day at intervals of 1-2 weeks until an appropriate clinical effect is achieved, divided into 2 doses per day. 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 patients should immediately notify their doctor if they experience depression or abnormal mood changes during treatment. Additionally, there is a risk of sudden death in patients with epilepsy, so regular monitoring and management are necessary. This medication can rarely cause severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis; thus, if symptoms such as skin rashes, blisters, or mucosal damage occur, patients should immediately discontinue use and visit a hospital. Patients who are hypersensitive to this medication or have specific genetic metabolic disorders such as lactose intolerance should not take it. Women who are pregnant or may become pregnant should perform a pregnancy test before taking this medication and use effective contraception during use while being aware of the potential risks to the fetus. Patients with impaired kidney function may have delayed excretion of this medication, requiring dose adjustments, and patients undergoing dialysis should adjust their dosage based on dialysis conditions. Since there is a risk of kidney stones, it is crucial to maintain adequate hydration, and patients should consult a doctor if they experience any symptoms related to kidney stones. Patients with compromised liver function should also be cautious when taking this medication, and in cases of significant weight changes, dietary adjustments or supplements should be considered. This medication affects the central nervous system, which may cause drowsiness, dizziness, and blurred vision, so it's advisable to avoid driving or operating hazardous machinery during the initial treatment phase. Moreover, this medication may interact with other drugs, so if patients are currently taking other medications, they must inform their healthcare provider, especially if taking contraceptives, lithium, or some antiepileptic drugs. Sudden withdrawal of this medication may worsen seizures, so doses should be reduced gradually according to the physician's instructions. Regular monitoring of blood tests, kidney function, liver function, and serum bicarbonate levels is recommended during treatment. Finally, this medication can cause decreased sweating and increased body temperature, so extra precautions should be taken to prevent heatstroke, especially in children or patients in hot environments.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, perceptual disturbances, hypersensitivity, ataxia, attention deficit, confusion, dizziness, fatigue, paresthesia, stupor, cognitive disturbances, agitation, emotional instability, loss of appetite, weakness, confusion, memory impairment, diplopia, vertigo, speech disorders, word-finding difficulty, nausea, nystagmus, psychomotor retardation, tremors, visual abnormalities, weight loss, gait disturbances, aggressive reactions, apathy, perceptual distortion, dysphoria, leukopenia, psychiatric symptoms, taste disorders, nephrolithiasis, thromboembolism, fatigue, weakness, back pain, chest pain, influenza-like symptoms, limb pain, allergies, flushing, body odor, edema, rigidity, dizziness, ataxia, speech disorders, nystagmus, perceptual disturbances, tremors, dysphoria, sensory impairment, gait abnormalities, involuntary muscle contractions, confusion, syncope, nausea, dyspepsia, abdominal pain, constipation, gastroenteritis, polydipsia, gastrointestinal disturbances, gingivitis, auditory disturbances, weight loss, myalgia, skeletal pain, epistaxis, purpura, hypersensitivity, psychomotor retardation, neuroexcitability, memory impairment, confusion, depression, attention deficit/hyperactivity disorders, loss of appetite, agitation, mood disorders, aggressive reactions, personality disorders, apathy, depersonalization, emotional instability, mastalgia, amenorrhea, menorrhagia, menstrual disorders, prostate disorders, infections, viral infections, candidiasis, rhinitis, pharyngitis, sinusitis, dyspnea, erythematous rash, skin disorders, increased sweating, taste disorders, 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 headache, erectile dysfunction, hallucinations, euphoria, psychosis, hypokinesia, stupor, generalized seizures, hyperactivity, leg cramps, diminished reflexes, neurosis, migraine, akinesia, hypersensitivity, motor disturbances, aphasia, scotoma, hypotonia, 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 dysfunction, diarrhea, vomiting, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, dental caries, stomatitis, dysphagia, melena, gastritis, increased salivation, hiccups, gastroesophageal reflux, tongue swelling, esophagitis, belching, tinnitus, otalgia, auditory hypersensitivity, angina, palpitations, AV block bradycardia, bundle branch block, arrhythmia, atrial arrhythmia, atrial fibrillation, elevated SGPT, elevated SGOT, gallbladder disorder, elevated γ-GT, dehydration, weight gain, thirst, hypokalemia, elevated alkaline phosphatase, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, elevated creatinine, hyperchloremia, dry eye syndrome, diabetes, hypernatremia, serum folate abnormalities, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthropathy, osteoporosis, basal cell carcinoma, anemia, gum bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenitis, eosinophilia, lymphopenia, leukopenia, lymphocytosis, neutropenia, 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, xeroderma, eczema, skin depigmentation, psoriasis, photosensitivity reactions, erythematous rashes, seborrheic dermatitis, decreased sweating, hair disorders, brown spots, taste dysfunction, ageusia, dysgeusia, urinary difficulties, nephrolithiasis, urinary tract infections, frequent urination, urinary incontinence, urinary retention, facial edema, renal pain, nocturnal enuresis, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular sclerosis, conjunctivitis, regulatory disorders, photophobia, epiphora, strabismus, color blindness, myopia, mydriasis, cataract, corneal opacity, iritis, leukopenia, allergic edema, hyperammonemia, hyperammonemic encephalopathy, feelings of despair, visual disturbances, angle-closure glaucoma, conjunctival edema, ocular motility disorders, eyelid edema, maculopathy, myopia, cough, chest discomfort, erythema multiforme, periorbital edema, Stevens-Johnson syndrome, toxic epidermal necrolysis, peripheral edema, joint swelling, limb discomfort, nephrocalcinosis, systemic edema, influenza-like illness, weight gain, cold sweats, worsening of epilepsy, psychiatric disturbances, comprehension deficits, eye fatigue

This medication should be stored in a tightly closed container to protect it from air and moisture. It is also important to keep it in a cool and dry place below 25 degrees Celsius. Proper storage will help maintain the drug's effectiveness and safety for use.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle