Sustained-Release Tablet 25mg (Topiramate)

Adult dose

It is advisable to start this medication at a low dose and increase it to the effective dose. Monitoring blood levels is not necessary to optimize treatment with this medication. The recommended dose applies to all adults and children, including older adults, without renal disease. This medication may be taken with or without food. This medication is taken once daily. Because this is an extended-release formulation, do not break, crush, or chew it. Swallow the tablet whole. 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, they should be gradually tapered and discontinued, reducing the dose by approximately 1/3 at 2-week intervals (see “5. General Precautions” under Precautions for Use). When an enzyme-inducing drug is discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentration occurs, the dose of this medication may need to be reduced. - Adults (17 years and older) Start with 25㎎ in the evening for the first week. Thereafter, increase by 25 or 50㎎ per day at 1-2 week intervals and administer once daily. If the patient has difficulty tolerating this titration schedule, extend the intervals between dose increases. The dose and rate of titration should be determined based on clinical response. The recommended dose for monotherapy in adults is 100～200㎎ 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 200㎎ per day, and the usual dose is 200-400㎎ per day administered once daily. Depending on the patient, the dose may be increased to the maximum recommended dose of 800㎎ per day. Begin treatment with 25-50㎎ in the evening for the first week; starting at a lower dose is also possible. Thereafter, increase the dose by 25-50㎎ at 1-2 week intervals and administer once daily. If the patient has difficulty tolerating the increased dose, increase the dose by smaller increments or extend the interval between dose increases. The dose 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 to reduce the starting and maintenance doses to approximately 1/2. - Hemodialysis patients: Because this medication is removed from plasma by hemodialysis, hemodialysis patients should receive an additional dose on the day of dialysis equivalent to approximately 1/2 of the daily dose. Adjust the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance. Divide the dose and administer it at the start and end of hemodialysis. 4. Patients with hepatic impairment Use with caution in patients with hepatic impairment, as clearance of this medication may be reduced.

Child dose

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

This medication is used in the treatment of epilepsy, and requires careful observation as the risk of suicidal thoughts or behavior may increase during use. Dosage adjustments are necessary for patients with impaired renal function since this medication is excreted slowly from the body. The dosage should be adjusted based on the conditions of dialysis. Sufficient hydration is important as there is a risk of kidney stones, especially for individuals with a history of kidney stones or a family history of kidney stones. Patients with liver function impairment should also be treated with caution as the excretion of this medication can be delayed. Because this medication can affect the central nervous system, it may cause drowsiness, dizziness, and concentration difficulties; care should be taken when driving or operating dangerous machinery. During use, changes in weight, mood changes, depression symptoms, and alterations in mental state may occur, so it is important to notify healthcare providers immediately if these symptoms arise. Women who are pregnant or may become pregnant should consult with their physician regarding the use of this medication as it may pose risks to the fetus, and appropriate contraception is recommended. Breastfeeding women should also consult with healthcare providers as this medication may be excreted in breast milk. This medication may interact with other antiepileptic drugs or various medications, so inform your healthcare provider of any other medications you are taking. Overdosage may lead to symptoms such as headache, coma, seizures, and metabolic acidosis, so strict adherence to the prescribed dosage is essential, and any abnormal symptoms should prompt immediate medical attention. Store this medication out of reach of children and avoid transferring it to other containers.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, hypersensitivity, perceptual disturbances, hypomania, ataxia, concentration difficulties, attention deficits, confusion, dizziness, fatigue, paresthesia, stupor, thought disturbances, agitation, emotional instability, decreased appetite, asthenia, disorientation, memory impairment, diplopia, vertigo, speech disorders, word choice disorders, nausea, nystagmus, psychomotor retardation, tremors, visual disturbances, weight loss, gait disturbances, aggressive responses, emotional blunting, perceptual distortions, dysphoria, leukopenia, psychiatric symptoms, dysgeusia, nephrolithiasis, thromboembolism, fatigue, asthenia, back pain, chest pain, flu-like symptoms, leg pain, flushing, body odor, edema, rigidity, confusion, dizziness, dyspepsia, abdominal pain, constipation, gastroenteritis, thirst, gastrointestinal disturbances, gingivitis, auditory disturbances, weight loss, myalgia, skeletal pain, epistaxis, purpura, hypomania, psychomotor retardation, neurosensitivity, memory impairment, disorientation, depression, agitation, mood disorder, aggressive responses, cognitive impairment, decreased libido, emotional blunting, depersonalization, emotional instability, breast pain, amenorrhea, menorrhagia, menstrual abnormalities, prostate disorders, infections, viral infections, candidiasis, rhinitis, pharyngitis, sinusitis, dyspnea, erythematous rash, skin disorders, increased sweating, dysgeusia, urinary tract infections, hematuria, urinary incontinence, frequent urination, urinary abnormalities, diplopia, visual disturbances, eye pain, leukopenia, anemia, vasodilation of the autonomic nervous system, fever, syncope, halitosis, abdominal distension, alcohol intolerance, substernal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension headaches, erectile dysfunction, hallucinations, delirium, psychosis, motor retardation, grand mal seizures, hyperactivity, leg cramps, reduced reflexes, neurosis, migraines, akinesia, hypersensitivity, movement disorders, echolalia, voice disorders, scotomas, hypotonia, dystonia, coma, encephalopathy, fecal incontinence, upper motor neuron damage, insomnia, personality disorders, decreased libido, manic reactions, suicide attempts, paranoid reactions, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities, cerebellar syndrome, glossoplegia, increased libido, goiter, thyroid disorders, diarrhea, vomiting, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, dental caries, stomatitis, swallowing disorders, melena, gastritis, increased salivation, hiccups, gastroesophageal reflux, tongue swelling, esophagitis, belching, tinnitus, otalgia, auditory hypersensitivity, angina pectoris, palpitations, AV block bradycardia, bundle branch block, arrhythmia, 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 mellitus, hypernatremia, serum folate abnormalities, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthrosis, osteoporosis, basal cell carcinoma, anemia, gum bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenomegaly, eosinophilia, lymphocytopenia, lymphocytosis, neutropenia, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorders, galactorrhea, cough, bronchitis, asthma, bronchospasm, laryngospasm, acne, urticaria, alopecia, dermatitis, nail disorders, folliculitis, xerosis, eczema, skin discoloration, psoriasis, phototoxic reactions, erythematous rash, seborrheic dermatitis, reduced sweating, hair anomalies, brown spots, taste disorder, taste loss, aftertaste, dysuria, nephrolithiasis, urinary tract infections, frequency of urination, urinary incontinence, urinary retention, facial edema, renal colic, nocturia, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular sclerosis, conjunctivitis, dysregulation, photophobia, lacrimation, strabismus, color blindness, myopia, mydriasis, cataracts, corneal opacity, iritis, headache, speech disorders, decreased mental functioning, somnolence, paresthesia, aphasia, dysarthria, psychomotor retardation, hypertension, decreased appetite, syncope, halitosis, abdominal distension, alcohol intolerance, substernal chest pain, sudden death, tension headaches, erectile dysfunction, hallucinations, delirium, psychosis, motor retardation, grand mal seizures, hyperactivity, leg cramps, reduced reflexes, neurosis, migraines, akinesia, hypersensitivity, movement disorders, echolalia, voice disorders, scotomas, hypotonia, dystonia, coma, encephalopathy, fecal incontinence, upper motor neuron damage, insomnia, personality disorders, decreased libido, manic reactions, suicide attempts, paranoid reactions, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities, cerebellar syndrome, glossoplegia, increased libido, goiter, thyroid disorders, diarrhea, vomiting, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, dental caries, stomatitis, swallowing disorders, melena, gastritis, increased salivation, hiccups, gastroesophageal reflux, tongue swelling, esophagitis, belching, tinnitus, otalgia, auditory hypersensitivity, angina pectoris, palpitations, AV block bradycardia, bundle branch block, arrhythmia, 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 mellitus, hypernatremia, serum folate abnormalities, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthrosis, osteoporosis, basal cell carcinoma, anemia, gum bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenomegaly, eosinophilia, lymphocytopenia, lymphocytosis, neutropenia, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorders, galactorrhea, cough, bronchitis, asthma, bronchospasm, laryngospasm, acne, urticaria, alopecia, dermatitis, nail disorders, folliculitis, xerosis, eczema, skin discoloration, psoriasis, phototoxic reactions, erythematous rash, seborrheic dermatitis, reduced sweating, hair anomalies, brown spots, taste disorder, taste loss, aftertaste, dysuria, nephrolithiasis, urinary tract infections, frequency of urination, urinary incontinence, urinary retention, facial edema, renal colic, nocturia, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular sclerosis, conjunctivitis, dysregulation, photophobia, lacrimation, strabismus, color blindness, myopia, mydriasis, cataracts, corneal opacity, iritis, headache, speech disorders, decreased mental functioning, somnolence, paresthesia, aphasia, dysarthria, psychomotor retardation

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. The preferred storage temperature is between 1°C and 30°C (room temperature).

Appearance

Pink round sustained-release film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle