Topiramate 25 mg Tablet (Topiramate)

Adult dosage

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize treatment with this medicine. The recommended dose applies to all adults and children, including the elderly, in the absence of renal disease. This medicine may be taken with or without food. 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 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 the dose by 25 or 50㎎ per day at 1-2 week intervals and administer in 2 divided doses 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 by 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 doses of up to 1,000㎎ per day as topiramate monotherapy. 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. During the first week, start treatment with 25-50mg in the evening; a lower starting dose may also be used. Thereafter, increase the dose by 25-50mg at 1-2 week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating the dose increase, a smaller dose increase may be used or the interval between increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: During the first week, start with 25mg of this medicine in the evening. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this dose increase, extend the intervals 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 titration 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 that the starting and maintenance doses be reduced to approximately 1/2. - Patients on hemodialysis: Because this medicine is removed from plasma by hemodialysis, increase the dose by approximately 1/2 on dialysis days. Adjust the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's residual renal clearance, and administer divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment Use caution when administering this medicine to patients with hepatic impairment, as its clearance may be reduced.

Children's dosage

Children (6-16 years): During the first week, start with 0.5-1㎎/㎏ in the evening. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at 1-2 week intervals and administer in 2 divided doses daily. If the patient has difficulty tolerating the dose increase, reduce the increment or extend the intervals between increases. The dose and extent of titration 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 seizures. Children (2 years-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. Thereafter, increase the dose by 1-3mg/kg per day at 1-2 week intervals and administer in 2 divided doses until an appropriate clinical effect is achieved. Dose titration should be determined according to clinical effect. Doses of up to 30mg/kg per day have been administered and were generally well tolerated.

This medication is used for seizures and migraine prevention and may increase the risk of suicidal thoughts or behaviors, so changes in mental state should be observed closely. During treatment with this medication, sudden skin rashes or severe skin reactions may occur; if such symptoms arise, discontinue use immediately and consult a healthcare professional. Women who are pregnant or planning to become pregnant should consult a healthcare professional before taking this medication, as it may harm the fetus during pregnancy. The blood concentration may vary in patients with reduced kidney function, requiring dosage adjustment, and patients undergoing dialysis should adjust the dosage according to dialysis conditions. It is essential to maintain adequate hydration during treatment, and drinking water frequently is recommended to reduce the risk of kidney stones or related kidney issues. This medication may cause central nervous system side effects such as drowsiness, dizziness, and blurred vision; therefore, it is safest to avoid driving or operating machinery at the beginning of treatment. Discontinuing this medication abruptly may lead to seizures, so the dosage should be gradually reduced according to the healthcare provider's instructions. This medication may interact with other antiepileptic drugs, so patients should inform their healthcare provider about any medications they are taking. Women taking contraceptives should be aware that the contraceptive effect may be reduced. Various side effects such as weight loss, decreased appetite, depression, and memory impairment may occur; if unusual symptoms persist or worsen, consult a healthcare professional. This medication can occasionally cause blood-related abnormalities or adverse reactions in the heart, gastrointestinal tract, skin, and other areas, necessitating regular check-ups and monitoring.

suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, paresthesia, hyporeflexia, ataxia, attention deficit, concentration disorder, confusion, dizziness, fatigue, tactile paresthesia, delirium, thought disturbance, agitation, emotional instability, loss of appetite, asthenia, confusion, memory impairment, diplopia, vertigo, speech impairment, word selectivity disorder, nausea, nystagmus, psychomotor retardation, tremors, visual disturbances, weight loss, gait disturbance, aggressive reactions, apathy, perceptual disturbances, harmonious disturbances, leukopenia, psychiatric symptoms, taste disorder, kidney stones, thromboembolism, drowsiness, irritability, hypersomnolence, stuttering, blurred vision, diarrhea, vomiting, constipation, gastroenteritis, gingivitis, auditory disturbances, weight gain, myalgia, epistaxis, purpura, rigidity, insomnia, anxiety, aggression, cognitive impairment, decreased libido, depersonalization, mastalgia, amenorrhea, menorrhagia, menstrual disorders, prostate disorders, infections, viral infections, candidiasis, rhinitis, pharyngitis, sinusitis, dyspnea, erythematous rash, skin disorders, increased sweating, urinary tract infections, hematuria, urinary incontinence, frequent urination, urinary abnormalities, leukopenia, anemia, vasodilation of the autonomic nervous system, fever, syncope, halitosis, abdominal distension, alcohol intolerance, retrosternal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension, erectile dysfunction, hallucinations, euphoria, psychosis, bradykinesia, grand mal seizures, hyperactivity, leg cramps, reflex weakening, neurosis, migraine, akinesia, hypersensitivity, motor disturbances, opposition reflex, vocal disorders, scotomas, ptosis, hypertonia, coma, encephalopathy, bowel incontinence, upper motor neuron damage, personality disorder, decreased libido, manic response, suicide attempt, paranoid psychotic response, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities, cerebellar syndrome, tongue paralysis, increased libido, goiter, thyroid disorders, diarrhea, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, cavities, stomatitis, swallowing difficulties, melena, gastritis, increased salivation, hiccups, gastroesophageal reflux, glossitis, esophagitis, belching, tinnitus, ear pain, auditory hypersensitivity, angina pectoris, palpitations, AV block bradycardia, cardiac block, arrhythmia, atrial arrhythmia, atrial fibrillation, elevated SGPT, elevated SGOT, gallbladder disorders, elevated γ-GT, dehydration, thirst, hypokalemia, increased alkaline phosphatase, hypocalcemia, hyperlipidemia, hyperglycemia, increased creatinine, hyperchloremia, dry eye syndrome, diabetes mellitus, hypernatremia, abnormal serum folate, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthropathy, osteoporosis, basal cell carcinoma, gingival bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenitis, eosinophilia, lymphocytopenia, lymphocytosis, granulocytopenia, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vulvovaginitis, ejaculation disorders, lactation, cough, bronchitis, asthma, bronchospasm, laryngospasm, acne, urticaria, alopecia, dermatitis, nail disorders, folliculitis, dry skin, eczema, skin depigmentation, psoriasis, photosensitivity, seborrheic dermatitis, reduced sweating, hair abnormalities, brown spots, taste loss, tactile anesthesia, dysuria, renal pain, enuresis, albuminuria, polyuria, oliguria, bright red urine, venous thrombosis, phlebitis, vascular stricture, conjunctivitis, dysregulation, photophobia, overflow tears, strabismus, color blindness, myopia, mydriasis, cataracts, corneal opacity, iritis, eye paresthesia, angle-closure glaucoma, conjunctival edema, eye movement disorders, eyelid swelling, macular degeneration, erythema multiforme, periorbital edema, peripheral edema, joint swelling, limb discomfort, tubular acidosis, renal calcifications, systemic edema, influenza-like illness, diaphoresis, eye fatigue, headache, drowsiness, sedation, speech impairment, hypertonia, orthostatic dizziness, vocal disorders, exercise-induced dyspnea, nasal obstruction, excessive sinus secretions, abdominal discomfort, lower abdominal pain, abdominal tenderness, epigastric discomfort, pancreatitis, excessive salivation, hyperaesthesia, allergic dermatitis, maculopapular rash, skin discoloration, skin odor abnormalities, facial swelling, localized urticaria, flank pain, muscle fatigue, muscle weakness, musculoskeletal rigidity, ureteral stones, urinary stones, hematuria, incontinence, urinary urgency, renal colic, renal pain, urinary incontinence, sexual dysfunction, facial swelling, abnormal sensation, feeling drunk, irritability, lethargy, peripheral coldness, inertia

Store this medication in a tightly sealed container to protect it from air and moisture, preferably in a cool, dry place below 25 degrees Celsius.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle