Unitopa Tablets 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 administration of this drug. The recommended dose of this drug is the same for all adults and pediatric patients, including the elderly, when renal disease is absent. This drug may be administered regardless of meals. Swallow the tablet whole; do not break it. 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 and discontinued 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 drug may need to be reduced. Adults (17 years and older): Initiate treatment 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 dose escalation schedule, extend the intervals between increases. The dose and rate of dose escalation should be determined 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 doses of up to 1,000㎎ daily as topiramate monotherapy. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg daily, and the usual dose is 200-400mg daily in 2 divided doses. Depending on the patient, the dose may be increased up to the maximum recommended dose of 800mg daily. Initiate 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, a smaller increase or a longer interval between dose increases may be used. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Initiate treatment with 25mg of this drug in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this dose escalation, extend the 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 of up to 200mg daily may be administered; the dose and rate of dose escalation 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 to reduce the starting and maintenance doses to approximately 1/2. - Patients undergoing hemodialysis: Because this drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and divide the dose between the start and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution in patients with hepatic impairment because clearance of this drug may be reduced.

Child dose

Pediatric patients (6-16 years): Initiate treatment with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at 1-2 week intervals, administered twice daily. If the patient has difficulty tolerating the increase, reduce the size of dose increments or extend the intervals between increases. The dose and degree of dose escalation should be determined according to clinical response. The recommended dose for monotherapy in pediatric patients is 3-6mg/kg daily. Doses of up to 500㎎ daily have been used in pediatric patients diagnosed with partial seizures. Pediatric patients (2-16 years): The recommended daily dose is approximately 5-9mg/kg, administered in 2 divided doses. Administer 25mg (or less, based on 1-3mg/kg daily) in the evening during the first week. Thereafter, increase the dose by 1-3mg/kg per day at 1-2 week intervals until an appropriate clinical effect is achieved, administered in 2 divided doses. Dose titration should be determined according to clinical effect. Doses of up to 30mg/kg daily have been administered and were generally well tolerated.

This medication is used as an antiepileptic drug for the prevention of epilepsy and migraines. While on this medication, there may be an increased risk of suicidal thoughts or behaviors, therefore, patients and guardians should immediately inform healthcare professionals of any mood changes or abnormal behaviors. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur during use of this medication, so if any abnormal skin symptoms appear, discontinue use immediately and consult a doctor. Taking this medication during pregnancy may pose risks of congenital malformations or growth problems for the fetus, thus women planning to become pregnant or who might become pregnant should discuss with a doctor and use effective birth control methods. Patients with reduced kidney function may have altered concentrations of this medication in the body, and dosage adjustments should be made according to a physician's directions. This medication can cause central nervous system side effects such as drowsiness, dizziness, and blurred vision, so caution should be exercised while driving or operating machinery. Adequate hydration during use is crucial, and it's recommended to drink water frequently to reduce the risk of kidney stones. Abrupt discontinuation of this medication may worsen seizures, thus the dosage should be gradually tapered before stopping. There may be interactions with other medications, so if you are currently taking any medications, it's essential to inform healthcare providers, especially with regards to the use of contraceptives or other antiepileptic drugs.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, sensory disturbances, asthenia, ataxia, attention deficit, inattention, confusion, dizziness, fatigue, paresthesia, stupor, thought disorders, agitation, emotional instability, loss of appetite, asthenia, disorientation, memory impairment, diplopia, vertigo, speech disorders, word selection disorders, nausea, nystagmus, psychomotor retardation, tremors, visual disturbances, weight loss, gait disturbance, aggressive reactions, apathy, perceptual disturbances, dysphoria, leukopenia, psychiatric symptoms, taste disorder, nephrolithiasis, thromboembolism, fatigue, asthenia, back pain, chest pain, influenza-like symptoms, leg pain, allergies, flushing, body odor, edema, rigidity, dizziness, ataxia, speech disorders, nystagmus, sensory disturbances, tremors, dysphoria, sensory impairment, gait abnormalities, involuntary muscle contractions, confusion, dizziness, nausea, dyspepsia, abdominal pain, constipation, gastroenteritis, thirst, gastrointestinal disorders, gingivitis, auditory disturbances, weight loss, myalgia, skeletal pain, epistaxis, purpura, asthenia, psychomotor retardation, neuroirritability, memory impairment, disorientation, depression, attention/concentration disorders, loss of appetite, agitation, mood disorders, aggressive reactions, perceptual disturbances, decreased libido, apathy, depersonalization, emotional instability, breast pain, amenorrhea, menorrhagia, menstrual irregularities, prostate disorders, infection, viral infection, candidiasis, rhinitis, pharyngitis, sinusitis, dyspnea, erythematous rash, skin disorders, increased sweating, taste distortion, urinary tract infection, hematuria, urinary incontinence, frequent urination, urinary abnormalities, diplopia, visual disturbances, eye pain, leukopenia, anemia, autonomic nervous system abnormalities, vasodilatation, fever, syncope, halitosis, abdominal distension, alcohol intolerance, substernal chest pain, sudden death, hypertension, hypotension, postural hypotension, tension-related disorders, erectile dysfunction, hallucinations, delirium, psychosis, exercise intolerance, confusion, grand mal seizures, hyperactivity, leg cramps, reflex achiness, neurosis, migraine, immobility, sensory hypersensitivity, movement disorders, opposition to action, speech disorders, scotoma, hypotonia, abnormal tension, 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 swelling, esophagitis, tinnitus, otalgia, auditory hypersensitivity, angina, palpitations, AV block bradycardia, bundle branch block, arrhythmia, atrial arrhythmia, atrial fibrillation, elevated SGPT, elevated SGOT, gallbladder disorders, elevated γ-GT, dehydration, weight gain, thirst, hypokalemia, increased alkaline phosphatase, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, elevated creatinine, hyperchloridemia, dry eye syndrome, diabetes, hypernatremia, serum folate abnormalities, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthrosis, osteoporosis, basal cell tumor, anemia, gingival bleeding, pulmonary embolism, lymphadenopathy, lymphadenopathy, eosinophilia, lymphopenia, leukopenia, lymphocytosis, agranulocytosis, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorders, male breast secretion, cough, bronchitis, asthma, bronchospasm, laryngospasm, acne, urticaria, alopecia, dermatitis, nail disorders, folliculitis, dry skin, eczema, skin depigmentation, psoriasis, photosensitivity reactions, erythematous rash, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, taste dysfunction, taste loss, hypogeusia, urinary difficulty, nephrolithiasis, urinary tract infection, frequent urination, urinary incontinence, urinary retention, facial edema, renal colic, nocturnal enuresis, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular sclerosis, conjunctivitis, control disorders, photophobia, remorse, strabismus, color blindness, myopia, mydriasis, cataract, corneal opacification, iritis, nasopharyngitis, neutropenia, allergic edema, hyperammonemia, hyperammonemic encephalopathy, feelings of despair, abnormal visual sensations, closed-angle glaucoma, conjunctival edema, ocular motility disorders, eyelid edema, maculopathy, myopia, cough, chest discomfort, polymorphic erythema, periorbital edema, peripheral edema, joint swelling, limb discomfort, tubulointerstitial nephritis, renal calcinosis, systemic edema, influenza-like illness, weight gain, sweating, exacerbation of epilepsy, mental disorders, decreased comprehension, decreased sweating, elevated body temperature, hyperammonemic encephalopathy, hypersomnia, vomiting, changes in level of consciousness, changes in cognitive function, suicidal impulses, suicide attempts, suicide, acute myopia syndrome, vision decline, ocular pain, myopia, mydriasis, narrowed anterior chamber, ocular congestion, choroidal detachment, retinal pigment epithelium detachment, macular lesions, increased intraocular pressure, visual field loss, hyperchloridemic metabolic acidosis, decreased serum bicarbonate concentration, nephrolithiasis, renal calcinosis, decreased growth rate, decreased sweating, increased body temperature, hyperammonemia, hyperammonemic encephalopathy, abnormal behavior, hypoactive sexual desire, emotional blunting, crying, distractibility, sexual arousal disorder, stuttering, early awakening, elevated mood, feelings of well-being, affective flattening, hallucinations, auditory hallucinations, visual hallucinations, hypomania, early insomnia, lack of spontaneous ignition, decreased sexual desire, lethargy, loss of libido, mania, intermediate insomnia, decreased sense of ecstasy, panic attacks, panic disorder, panic responses, paranoia, obstinacy, reading disabilities, restlessness, sleep disorders, suicidal ideation, suicide attempts, increased tearing, abnormal thoughts, taste loss, exercise incapacity, olfactory loss, speech loss, action loss syndrome, prodrome, burning sensation, cerebellar syndrome, circadian rhythm sleep disorder, darkness, complex partial seizures, spasms, decreased state of consciousness, orthostatic dizziness, drooling, movement disorders, speech disorders, muscle tone disorders, essential tremor, depersonalization, grand mal seizures, sensory hypersensitivity, hypersomnia, taste impairment, decreased mobility, olfactory impairment, peripheral neuropathy, abnormal post-olfactory sensation, decreased sleep quality, prodromal syncope, repetitive speech, sensory disorders, sensory loss, confusion, syncope, unresponsiveness to stimuli, control disorders, changes in visual depth perception, amblyopia, eyelid twitching, temporary loss of vision, unilateral vision loss, glaucoma, increased lacrimation, pupillary dilation, night blindness, photophobia, presbyopia, phosphenes, scotoma, decreased visual acuity, 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 dyspnea, nasal congestion, excessive secretion from sinuses, abdominal discomfort, lower abdominal pain, abdominal tenderness, halitosis, discomfort in the epigastric region, intra-abdominal air trapping, tongue pain, oral sensory impairment, oral pain, pancreatitis, excessive salivation, infinity syndrome, allergic dermatitis, erythema, maculopapular rash, skin discoloration, abnormal skin odor, facial swelling, urticaria, localized urticaria, flank pain, muscle fatigue, muscle weakness, musculoskeletal rigidity, ureterolithiasis, urolithiasis, hematuria, incontinence, urgency, renal colic, renal pain, sexual dysfunction, facial edema, abnormal sensation, feeling drunk, irritability, malaise, peripheral coldness, lethargy, decreased serum sodium bicarbonate, presence of crystalline urine, abnormal tandem walking test, decreased leukocyte count

This medication should be stored in a tightly closed container to prevent air and moisture exposure, and kept in a cool, dry place below 25 degrees Celsius.

Appearance

White, round, film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle