Topimed Sustained Release Tablet 25 mg (Topiramate)

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring plasma concentrations is not necessary to optimize treatment with this medicine. The recommended dose of this medicine applies to all adults and children, including older adults, in the absence of renal disease. May be administered with or without food. Administer this medicine once daily. As this is an extended-release product, 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 stopped immediately for safety reasons, gradually reduce and discontinue the other antiepileptic drugs 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 medicine may need to be reduced. - 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 and administer once daily. If the patient cannot tolerate this rate of dose escalation, lengthen the intervals between increases. The dose and rate of escalation should be determined according to clinical response. The recommended dose for adult monotherapy 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 of age and older) The minimum effective dose is 200㎎ per day, and the usual dose is 200-400㎎ 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 during 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 an increased dose, smaller increments may be used or the intervals between increases may be lengthened. The dose should be determined according to clinical effect. 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 initial and maintenance doses to approximately 1/2. - Hemodialysis patients: Because this medicine is removed from plasma by hemodialysis, hemodialysis patients should receive an additional dose equivalent to approximately 1/2 of the daily dose on dialysis days. Adjust the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and administer it 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.

Child dose

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

This drug is an antiepileptic medication and there may be an increased risk of suicidal thoughts or behavior during treatment, so changes in mood or behavior should be carefully monitored. In patients with impaired kidney function, it may take longer for blood concentrations to stabilize, thus dosage should be adjusted according to a physician's instructions. Patients undergoing hemodialysis may need to adjust the dosage of this medication according to dialysis conditions. Adequate fluid intake is essential due to the risk of kidney stones, and caution should be exercised, especially in those with a history or family history of kidney stones. Patients with liver dysfunction may experience a delay in the excretion of this drug, so it should be used cautiously. This medication works on the central nervous system and may cause symptoms such as drowsiness, dizziness, and decreased concentration, so it is advisable to avoid driving or operating machinery initially. There may be psychiatric and neurological adverse reactions during treatment, such as weight loss, decreased appetite, depression, and memory impairment, so changes in condition should be closely monitored. During pregnancy, there is a risk of fetal malformations; therefore, women of childbearing potential should consult a doctor and practice appropriate contraception, and the decision to use this medication during pregnancy should be done cautiously. If breastfeeding, it is important to discuss with healthcare providers since this medication may be excreted in breast milk. Sudden discontinuation of this drug may worsen seizures, so it must be gradually tapered off according to a physician's instructions. Regular blood tests to monitor kidney function and electrolyte status should be conducted alongside adequate fluid intake during treatment. There may be drug interactions, so all medications being taken should be reported to healthcare providers and closely monitored.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, perceptual disturbances, hypomania, ataxia, attention deficit, confusion, dizziness, fatigue, paresthesia, confusion, thought disorder, agitation, emotional instability, loss of appetite, weakness, disorientation, memory impairment, diplopia, vertigo, speech disorders, word selection disorder, nausea, nystagmus, psychomotor retardation, tremors, visual disturbances, weight loss, gait abnormalities, aggressive reactions, apathy, perceptual distortions, dysphoria, leukopenia, psychiatric symptoms, taste disturbance, nephrolithiasis, thromboembolism, fatigue, weakness, back pain, chest pain, influenza-like symptoms, leg pain, allergies, flushing, body odor, edema, rigidity, dizziness, ataxia, speech disorders, nystagmus, perceptual disturbances, tremors, dysphoria, sensory loss, gait abnormalities, involuntary muscle contractions, stupor, dizziness, nausea, dyspepsia, abdominal pain, constipation, gastroenteritis, thirst, gastrointestinal disturbances, gingivitis, auditory disturbances, weight loss, myalgia, skeletal pain, epistaxis, purpura, hypomania, psychomotor retardation, neuroirritability, memory impairment, disorientation, depression, attention deficit, loss of appetite, agitation, mood disorders, aggressive reactions, cognitive impairment, decreased libido, 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 disturbance, urinary tract infections, hematuria, urinary incontinence, increased frequency of urination, abnormal urination, diplopia, visual disturbances, ocular pain, leukopenia, anemia, autonomic nervous system vascular dilation, fever, syncope, halitosis, abdominal distension, alcohol intolerance, sub sternal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension-type headaches, erectile dysfunction, hallucinations, hyperhedonia, psychosis, reduced motor activity, stupor, generalized tonic-clonic seizures, hyperactivity, leg cramps, reflex weakening, neurosis, migraine, akinesia, hyperperception, motor disturbances, reflex hyperactivity, speech disorders, scotomas, ptosis, 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, cerebellar syndrome, tongue paralysis, increased libido, 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, hyperacusis, angina pectoris, palpitations, AV block bradycardia, blockages, arrhythmia, atrial arrhythmia, atrial fibrillation, SGPT elevation, SGOT elevation, gallbladder disorders, γ-GT elevation, dehydration, weight gain, thirst, hypokalemia, alkaline phosphatase increase, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, elevated creatinine, hyperchloremia, dry eyes, diabetes mellitus, hypernatremia, abnormal serum folate, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthropathy, osteoporosis, basal cell tumor, anemia, gingival bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenopathy, eosinophilia, lymphopenia, lymphocytosis, agranulocytosis, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorders, galactorrhea, cough, bronchitis, asthma, bronchospasm, laryngospasm, acne, urticaria, hair loss, dermatitis, nail disorders, folliculitis, xerosis, eczema, skin depigmentation, psoriasis, photosensitivity reactions, erythematous rash, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, taste distortion, taste loss, hyperosmia, dysuria, nephrolithiasis, urinary tract infections, frequent urination, urinary incontinence, urinary retention, facial edema, renal colic, nocturnal enuresis, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular sclerosis, conjunctivitis, dysregulation, photophobia, blepharoptosis, color blindness, myopia, pupillary dilation, cataracts, corneal opacity, iritis, leukopenia, allergic edema, feelings of despair, anomalous sensations in the eyes, 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, tubular acidosis, generalized edema, influenza-like illness, weight gain, cold sweats, worsening epilepsy, psychiatric disorders, headaches, drowsiness, somnolence, tremors, sedation, somnolence, disorientation, coma, metabolic acidosis, hypokalemia, coordination disturbances, hypotension, anxiety, aggression, insomnia, anxiety, anger, anxiety, agitation, anger, anxiety, aggression, insomnia, anxiety, memory impairment, attention deficit, speech disorders, stuttering, balance disorders, tremors, forgetfulness, blurred vision, hazy vision, increased tearing, ear pain, palpitations, bradycardia, orthostatic hypotension, nasal congestion, excessive sinus secretion, speech disorders, respiratory distress, oral sensory loss, oral pain, pancreatitis, hypersensitivity, allergic dermatitis, erythema, maculopapular rash, skin discoloration, abnormal body odor, facial swelling, urticaria, flank pain, muscle fatigue, muscle weakness, musculoskeletal stiffness, ureterolithiasis, urolithiasis, hematuria, incontinence, urgency, irritability, lethargy, peripheral coldness, apathy, suicidal thoughts, suicide attempts, suicidal impulses, suicidal behavior

This medication should be stored in a tightly sealed container to prevent contact with air or moisture, and it is important to keep the storage temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness and prevent deterioration.

Appearance

Pink round sustained-release film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle