Topiramate 25 mg Tablet

Adult dosage

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring serum concentrations is not necessary to optimize the dosage of this medicine. The recommended dose of this medicine is the same for all adults and children, including older adults, in the absence of renal disease. It may be administered with or without food. Swallow the tablets whole; do not crush them. 1. Epilepsy 1) Monotherapy: When discontinuing other concomitant antiepileptic medicines to use topiramate as monotherapy, consider the possible effect on seizure control. Unless other antiepileptic medicines must be discontinued immediately for safety reasons, gradually taper them by about 1/3 every 2 weeks (see Precautions for Use, “5. General Precautions”). When enzyme-inducing medicines 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 during the first week. Thereafter, increase by 25 or 50㎎ per day at 1-2-week intervals and administer in 2 divided doses. If the patient has difficulty tolerating this rate of increase, lengthen the interval between increases. Determine the dose and rate of increase according to clinical response. The recommended dose for adult monotherapy is 100～200mg per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses up to 1,000㎎ per day. 2) Adjunctive therapy Adults (17 years and older): The minimum effective dose is 200mg per day; 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. 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. If the patient has difficulty tolerating the increased dose, increase by a smaller amount or lengthen the interval between increases. Determine the dose according to clinical effect. 2. Prevention of migraine Adults: Start with 25mg of this medicine in the evening during the first week. Thereafter, increase by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this increase, lengthen the interval between 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 up to 200mg per day may be administered; determine the dose and rate of increase according to clinical response. 3. Patients with renal impairment - For patients with moderate or severe renal impairment (CLcr < 70 mL/min/1.73 m2), reduction to approximately 1/2 of the starting and maintenance doses is recommended. - Hemodialysis patients: Because this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. Increase the dose taking into consideration the duration of dialysis, dialyzer clearance, and the patient's residual clearance, and administer in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment, as clearance of this medicine may be reduced.

Children's dosage

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

This drug is an anticonvulsant medication and may increase the risk of suicidal thoughts or behaviors during treatment. Therefore, it is crucial to inform healthcare providers immediately if symptoms of mood changes, depression, or suicidal impulses occur during therapy. Additionally, patients with epilepsy taking this medication may have a slightly higher risk of sudden death compared to healthy individuals, so caution is advised. This medication can cause severe skin reactions, so if symptoms such as rashes, inflammation, or blisters occur, it is essential to discontinue use immediately and consult with a healthcare provider. This medication should not be used by individuals with allergies to its components or patients with certain genetic lactose metabolism disorders, and women who are pregnant or planning to become pregnant should consult a physician before use. Taking this medication during pregnancy could harm the fetus and increase the risk of low birth weight or congenital malformations, so it must be used very cautiously. Patients with renal or liver impairment may experience slower elimination of this drug, necessitating dosage adjustments, and patients undergoing dialysis may require dose adjustments based on dialysis conditions. This drug acts on the central nervous system and may cause symptoms such as drowsiness, dizziness, and blurred vision, so caution is essential during driving or operating machinery. Sufficient hydration is recommended to reduce the risk of kidney stone formation, and any weight changes should prompt consideration of dietary adjustments or nutritional supplementation. Suddenly stopping this medication may worsen seizures, so it is crucial to taper the dosage gradually under the instruction of a physician when discontinuing. Furthermore, this drug can interact with other medications, so patients must inform their healthcare provider of any other medications they are taking, especially hormonal contraceptives, as the contraceptive effect may be reduced. During treatment with this medication, symptoms such as mood changes, depression, anxiety, cognitive impairment may arise, requiring consultation with a healthcare provider if these symptoms persist or worsen. Finally, if any severe adverse reactions occur while taking this medication, including fever, severe fatigue, bleeding, difficulty breathing, or severe skin rashes, immediate emergency medical care is necessary.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, abnormal perception, ataxia, movement ataxia, concentration impairment, attention deficit, confusion, dizziness, fatigue, paresthesia, stupor, thought disorder, agitation, emotional instability, loss of appetite, asthenia, disorientation, memory impairment, diplopia, vertigo, speech disorder, word selection disorder, nausea, nystagmus, psychomotor retardation, tremor, visual disturbance, weight loss, gait disorder, aggressive reactions, apathy, perceptual disturbance, harmony disturbance, leukopenia, psychiatric symptoms, taste distortion, kidney stones, thromboembolism, fatigue, asthenia, back pain, chest pain, influenza-like symptoms, leg pain, allergies, flushing, body odor, edema, rigidity, dizziness, ataxia, speech disorder, nystagmus, perceptual disturbance, tremor, harmony disturbance, sensory impairment, gait disturbance, involuntary muscle contractions, confusion, syncope, nausea, indigestion, abdominal pain, constipation, gastroenteritis, thirst, gastrointestinal disturbances, gingivitis, auditory disturbances, weight loss, myalgia, skeletal pain, epistaxis, purpura, ataxia, psychomotor retardation, neuroexcitability, memory impairment, disorientation, depression, concentration/attention deficits, loss of appetite, agitation, mood disorders, aggressive reactions, personality disorders, apathy, depersonalization, emotional instability, breast pain, amenorrhea, menorrhagia, menstrual irregularities, prostate disorders, infections, viral infections, candidiasis, rhinitis, pharyngitis, sinusitis, dyspnea, erythematous rash, skin disorders, increased sweating, taste distortion, urinary tract infections, hematuria, urinary incontinence, frequent urination, urinary abnormalities, diplopia, visual disturbances, eye pain, leukopenia, anemia, autonomic nervous system disturbances, fever, syncope, halitosis, abdominal distension, alcohol intolerance, substernal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension headaches, erectile dysfunction, hallucinations, euphoria, psychosis, hypokinesia, confusion, generalized tonic-clonic seizure, hyperactivity, leg cramps, decreased reflexes, neurosis, migraine, akinesia, hyperesthesia, movement disturbances, reflexive agitation, speech disorders, scotoma, hypoptyalism, dystonia, coma, encephalopathy, fecal incontinence, insomnia, personality disorders, decreased libido, manic reactions, suicide attempts, paranoid reactions, 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, hypersalivation, hiccups, gastroesophageal reflux, glossitis, esophagitis, tinnitus, ear pain, auditory hyperesthesia, angina pectoris, palpitations, AV block bradycardia, heart block, arrhythmias, atrial arrhythmias, atrial fibrillation, elevated SGPT, elevated SGOT, gallbladder disorders, elevated γ-GT, 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, arthropathy, osteoporosis, basal cell carcinoma, anemia, gum bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenitis, eosinophilia, lymphocytopenia, lymphocytosis, agranulocytosis, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorders, galactorrhea, cough, bronchiolitis, asthma, bronchospasm, laryngospasm, acne, urticaria, alopecia, dermatitis, nail disorders, folliculitis, xerosis, eczema, skin depigmentation, psoriasis, phototoxic reactions, erythematous rash, seborrheic dermatitis, decreased sweating, hair disorders, brown spots, ageusia, ageusia, hypogeusia, urinary difficulty, kidney stones, urinary tract infections, polyuria, urinary incontinence, urinary retention, facial edema, renal colic, nocturia, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular rigidity, conjunctivitis, dysregulation, photophobia, overflow tearing, strabismus, color blindness, myopia, mydriasis, cataract, corneal opacity, iritis, leukopenia, neutropenia, allergic edema, hyperammonemia, hyperammonemia-induced encephalopathy, feelings of despair, visual sensory abnormalities, angle-closure glaucoma, conjunctival edema, ocular motility disorders, eyelid edema, macular disease, myopia, cough, chest discomfort, polymorphic erythema, periocular edema, peripheral edema, joint swelling, limb discomfort, renal tubular acidosis, nephrocalcinosis, systemic edema, influenza-like illness, weight gain, diaphoresis, worsening of epilepsy, psychiatric disorders, decreased sweating, elevated body temperature, hyperammonemia-induced encephalopathy, hyperammonemia, drowsiness, vomiting, altered consciousness, cognitive changes, abnormal behavior, sexual dysfunction, emotional blunting, crying, distractibility, sexual arousal disorder, stuttering, early awakening, elevated mood, feelings of happiness, affective flattening, hallucinations, auditory hallucinations, visual hallucinations, hypomania, early insomnia, lack of spontaneous combustion, reduced libido, lethargy, loss of sexual desire, mania, middle insomnia, reduced climax sensation, panic attacks, panic disorder, panic reactions, paranoia, stubbornness, reading disorders, restlessness, sleep disorders, suicidal ideation, suicide attempts, increased tear production, abnormal thoughts, ageusia, paralysis, anosmia, aphasia, akinetic mutism, aura, burning sensation, cerebellar syndrome, circadian rhythm sleep disorder, darkness, complex partial seizures, convulsions, altered states of consciousness, orthostatic dizziness, drooling, movement disorders, muscle tension disorders, essential tremor, depersonalization, generalized tonic-clonic seizure, hyperesthesia, hypersomnia, taste impairment, movement reduction, olfactory impairment, peripheral neuropathy, abnormal olfaction, decreased sleep quality, excessive psychomotor activity, psychomotor coordination disorders, syncope, tremors, control disorders, changes in visual depth perception, amblyopia, eyelid spasm, temporary visual loss, unilateral visual loss, glaucoma, increased tear flow, pupil dilation, night blindness, photophobia, presbyopia, scintillating scotoma, scotoma, vision loss, 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, halitosis, epigastric discomfort, pneumatosis intestinalis, tongue pain, oral sensory impairment, oral pain, pancreatitis, excessive salivation, infinity syndrome, allergic dermatitis, erythema, macular rash, skin discoloration, unusual skin odor, facial swelling, urticaria, localized urticaria, flank pain, muscle fatigue, muscle weakness, musculoskeletal rigidity, ureterolithiasis, urolithiasis, hematuria, incontinence, urgency, renal colic, kidney pain, urgency, polyuria, sexual dysfunction, facial edema, abnormal sensation, feeling intoxicated, irritability, lethargy, peripheral coldness, inertia, decreased bicarbonate levels in the blood, presence of crystalloid urine, abnormal tandem gait test

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

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle