Topacin Tablet 25 Milligrams (Topiramate)

Adult dosage

It is recommended to start this drug at a low dose and increase it to the effective dose. Monitoring plasma concentrations is not necessary to optimize treatment with this drug. The recommended dose of this drug applies to all adults and children, including the elderly, provided they do not have renal disease. This drug may be taken without regard to meals. Swallow the tablets whole; do not crush them. 1. Epilepsy 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 reduced and discontinued by approximately 1/3 every 2 weeks (see “5. General Precautions” under Precautions for Use). When enzyme-inducing drugs that affect drug metabolism are discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentrations occurs, the dose of this drug may need to be reduced. Adults (17 years and older): Start treatment with 25㎎ in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at 1-2-week intervals and administer in 2 divided doses. If the patient has difficulty tolerating this rate of dose escalation, extend the interval between increases. The dose and rate of escalation should be determined according to clinical response. The recommended dose for monotherapy in adults is 100～200mg per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses of 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, smaller increments may be used or the interval between increases may be extended. The dose should be determined according to clinical response. 2. Prevention of migraine Adults: Start treatment with 25mg of this drug in the evening during the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, extend 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 of up to 200mg per day may be administered; the dose and rate of escalation 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 that the initial and maintenance doses be reduced to approximately 1/2. - Hemodialysis patients: As this drug is removed from plasma by hemodialysis, increase the dose of this drug by approximately 1/2 on dialysis days. Adjust the dose taking into account the duration of dialysis, the clearance of the dialysis apparatus, and the patient's renal clearance, and administer the dose in divided amounts at the beginning and end of hemodialysis. 4. Patients with hepatic impairment Use this drug with caution in patients with hepatic impairment, as clearance of this drug may be reduced.

Children's dosage

Children (6-16 years): Start treatment with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the total daily dose by 0.5-1㎎/㎏ at 1-2-week intervals and administer in 2 divided doses. If the patient has difficulty tolerating the increase, use smaller increments or extend the interval between increases. The dose and degree of escalation should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. Doses of 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 5-9mg/kg, administered in 2 divided doses. During the first week, administer 25mg (or less, based on 1-3mg/kg per day) in the evening, and thereafter increase the total daily dose by 1-3mg/kg at 1-2-week intervals until an appropriate clinical response is achieved, administering it in 2 divided doses. Dose titration should be based on clinical response. Doses of up to 30mg/kg per day have been administered and were generally well tolerated.

This drug is used as an antiepileptic agent for epilepsy and migraine prevention, and there may be an increased risk of suicidal thoughts or behaviors during treatment. Therefore, patients and their caregivers should inform healthcare professionals immediately if symptoms of depression, mood changes, or suicidal impulses appear. Do not abruptly discontinue the drug; rather, it should be reduced gradually as directed by a physician to avoid sudden onset or increased frequency of seizures. As it can affect the central nervous system, causing symptoms such as drowsiness, dizziness, and blurred vision, it is safest to avoid driving or operating machinery in the early stages of treatment. Adequate hydration is very important as it helps reduce the risk of kidney stone formation. Women of childbearing age should undergo pregnancy testing before conception and use effective contraceptive methods, and if they are taking this drug during pregnancy, they should consult with their physician adequately since it may harm the fetus. Patients with reduced kidney or liver function may require dose adjustments, and those undergoing dialysis should adjust their doses according to dialysis conditions. This drug may cause severe allergic reactions on the skin; therefore, if a rash or skin abnormality appears, administration should be stopped immediately and healthcare personnel consulted. Other side effects such as weight loss, loss of appetite, fatigue, mental confusion, memory impairment, and depression may occur, so patients should inform their doctor if any unusual symptoms arise. There may be interactions with other drugs, so if a patient is taking other medications, they must inform healthcare providers, especially when taken together with contraceptives, lithium, antihypertensives, and antidiabetic medications.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, perceptual disturbances, hallucinations, ataxia, attentional impairment, attention deficit, confusion, dizziness, fatigue, paresthesia, lethargy, thought disorder, agitation, emotional instability, appetite loss, asthenia, disorientation, memory impairment, diplopia, vertigo, language disorder, word retrieval difficulty, nausea, nystagmus, psychomotor retardation, tremors, visual disturbances, weight loss, gait disturbances, aggressive reaction, emotional blunting, perceptual disorder, dissociation, leukopenia, psychiatric symptoms, taste distortion, nephrolithiasis, thromboembolism, fatigue, asthenia, back pain, chest pain, influenza-like symptoms, leg pain, allergy, flushing, body odor, edema, rigidity, lethargy, dizziness, dyspepsia, abdominal pain, constipation, gastroenteritis, polydipsia, gastrointestinal disorders, gingivitis, auditory disturbances, myalgia, skeletal pain, epistaxis, purpura, hallucinations, psychomotor retardation, neuroirritability, memory impairment, disorientation, depression, attention deficit, agitation, mood disorder, aggressive reaction, cognitive impairment, decreased libido, emotional blunting, mastalgia, amenorrhea, menorrhagia, menstrual disorders, prostate disorders, infections, viral infections, candidiasis, rhinitis, pharyngitis, sinusitis, dyspnea, erythematous rash, skin disorders, hyperhidrosis, taste distortion, urinary tract infection, hematuria, urinary incontinence, frequent urination, urinary abnormalities, diplopia, visual disturbances, ocular pain, leukopenia, anemia, autonomic nervous system vasodilation, fever, syncope, halitosis, abdominal distension, alcohol intolerance, retrosternal chest pain, sudden cardiac death, hypertension, hypotension, orthostatic hypotension, tension dysregulation, erectile dysfunction, hallucinations, euphoric mood, psychosis, hypokinesia, generalized seizures, hyperactivity, leg cramps, diminished reflexes, neurosis, migraine, akinesia, hypersensitivity, movement disorders, paroxysmal dyskinesia, speech disorders, scotoma, drooping eyelids, 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 disorders, diarrhea, vomiting, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, dental caries, stomatitis, swallowing difficulties, melena, gastritis, hypersalivation, hiccups, gastroesophageal reflux, tongue edema, esophagitis, tinnitus, ear pain, auditory hypersensitivity, angina, 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, increased alkaline phosphatase, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, elevated creatinine, hyperchloremia, dry eyes, diabetes mellitus, hypernatremia, serum folate abnormalities, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthrosis, osteoporosis, basal cell tumor, anemia, gingival bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenitis, eosinophilia, lymphocytopenia, leukopenia, 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, xeroderma, eczema, skin depigmentation, psoriasis, photosensitivity rash, erythematous rash, seborrheic dermatitis, reduced sweating, hair abnormalities, brown spots, taste loss, hypogeusia, dysuria, nephrolithiasis, urinary tract infection, polyuria, urinary incontinence, urinary retention, facial edema, kidney pain, nocturnal enuresis, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular constriction, conjunctivitis, dysregulation, photophobia, proptosis, strabismus, color blindness, myopia, mydriasis, cataracts, corneal opacification, iritis, leukopenia, lymphadenopathy, thrombocytopenia, hypersensitivity, hyperammonemia, hyperammonemic encephalopathy, hopelessness, ocular dysesthesia, 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, proximal renal tubular acidosis, nephrocalcinosis, systemic edema, influenza-like illness, weight gain, diaphoresis, worsening epilepsy, psychiatric disorders, cognitive decline, eye fatigue, asthenia, chest discomfort, peripheral edema, edema, chest pain, sensory disturbances, headache, drowsiness, hypersomnia, tremors, sedation, dystonia, suicidal ideation, suicide attempts, ocular pain, blurred vision, appetite loss, menstrual disorders, thrombocytopenia, surgery (hospitalization extension), hyperhidrosis, elevated body temperature, hyperammonemic encephalopathy, drowsiness, vomiting, altered level of consciousness, cognitive function changes, hyperchloremic acidosis, hypokalemia, increased appetite, metabolic acidosis, polydipsia, abnormal behavior, sexual dysfunction, emotional numbing, crying, distractibility, sexual arousal disorder, stuttering, early awakening, elevated mood, euphoria, emotional blunting, hallucinations, auditory hallucinations, visual hallucinations, hypomania, initial insomnia, lack of spontaneous combustion, decreased libido, lethargy, loss of libido, mania, middle insomnia, decreased orgasmic sensation, panic attacks, panic disorder, panic reactions, paranoia, obstinacy, reading disorders, restlessness, sleep disorders, suicide attempts, abnormal thoughts, taste loss, motor impairment, anosmia, loss of speech, akinetic mutism, aura, burning sensation, cerebellar syndrome, circadian rhythm sleep disorder, darkness, complex partial seizures, spasms, decreased level of consciousness, orthostatic dizziness, drooling, writing difficulties, movement disorders, speech disorders, muscle tone abnormalities, essential tremor, depersonalization, generalized seizures, hypersensitivity, excessive sleep, hypogeusia, decreased movement, hyposmia, peripheral neuropathy, phantom smell, decreased sleep quality, prodromal symptoms, repetitive speech, sensory disorders, sensory loss, lethargy, syncope, unresponsiveness to stimuli, dysregulation, visual depth perception changes, amblyopia, eyelid spasms, transient vision loss, unilateral vision loss, glaucoma, increased tearing, pupil dilation, night blindness, photophobia, presbyopia, scintillating scotomas, scotomas, vision impairment, hearing loss, sensory neural hearing loss, unilateral hearing loss, ear discomfort, hearing impairment, bradycardia, sinus bradycardia, palpitations, flushing, facial flushing, orthostatic hypotension, Raynaud's phenomenon, speech disorders, exertional dyspnea, nasal congestion, excessive sinus secretion, abdominal discomfort, lower abdominal pain, abdominal tenderness, halitosis, epigastric discomfort, air retention in the gastrointestinal tract, tongue pain, oral sensory reduction, oral pain, pancreatitis, increased salivation, infinity syndrome, allergic dermatitis, erythema, maculopapular rash, skin discoloration, abnormal body odor, facial edema, urticaria, localized urticaria, flank pain, muscle fatigue, muscle weakness, musculoskeletal stiffness, ureterolithiasis, urolithiasis, hematuria, incontinence, urgency, kidney stone pain, kidney pain, abnormal sensations, intoxication feeling, irritability, malaise, peripheral coldness, lethargy

This medication is sensitive to air and moisture, so it must be stored in a sealed container. 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