Topiramate 100 mg Tablets

Adult dosage

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 the administration of this medication. The recommended dose of this medication applies to all adults and children, including older adults, provided they do not have kidney disease. This medication may be taken with or without food. The tablets should be swallowed whole and not crushed. 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 tapered and discontinued by reducing the dose by about 1/3 every 2 weeks (see “5. General Precautions” under Precautions for Use). When drugs that induce drug-metabolizing enzymes are discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentrations occurs, the dose of this medication may need to be reduced. Adults (17 years and older): Begin treatment with 25 mg in the evening for the first week. Thereafter, increase the daily dose by 25 or 50 mg at 1-2 week intervals, administered in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the intervals between dose increases. The dose and rate of titration should be determined according to clinical response. The recommended dose for monotherapy in adults is 100～200 mg/day. The maximum recommended dose is 500 mg/day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses up to 1,000 mg/day. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200 mg/day, and the usual dose is 200-400 mg/day, administered in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800 mg/day. Begin treatment with 25-50 mg in the evening for the first week; it is also possible to start at a lower dose. Thereafter, increase the dose by 25-50 mg at 1-2 week intervals, administered in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller dose increments may be used or the intervals between dose increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Begin treatment with 25 mg of this medication in the evening for the first week. Thereafter, increase the dose by 25 mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, extend the intervals between dose increases. The recommended dose is 100 mg/day, administered in 2 divided doses. Some patients may respond to a dose of 50 mg/day. Doses up to 200 mg/day may be administered; the dose and rate of titration should be determined according to clinical response. 3. Patients with renal impairment - For patients with moderate to 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. - Hemodialysis patients: Because this medication is removed from plasma by hemodialysis, the dose on the day of dialysis should be increased by approximately 1/2 in hemodialysis patients. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis system, and the patient's renal clearance, and administer the dose in divided doses at the start and end of hemodialysis. 4. Patients with hepatic impairment This medication should be administered with caution in patients with hepatic impairment, as its clearance may be reduced.

Children's dosage

1. Epilepsy 1) Monotherapy Children (6-16 years): Treatment is started at 0.5-1㎎/㎏ in the evening for the first week. Thereafter, the dose is increased by 0.5-1㎎/㎏ per day at 1-2-week intervals and administered twice daily. If the patient has difficulty tolerating dose increases, the increment may be reduced or the interval between increases may be extended. The dose and degree of dose increase are determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. In children diagnosed with partial seizures, doses of up to 500㎎ per day have been administered. 2) Adjunctive therapy Children (2-16 years): The recommended daily dose is approximately 5-9mg/kg, divided into 2 doses. For the first week, 25mg (or less, based on 1-3mg/kg per day) is administered in the evening. Thereafter, the dose is increased by 1-3mg/kg per day at 1-2-week intervals until an appropriate clinical effect is achieved, divided into 2 daily doses. 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 may increase the risk of suicidal thoughts or behaviors; therefore, if symptoms of depression or mood changes occur during treatment, inform the healthcare provider immediately. Patients taking this medication may have a slightly increased risk of sudden death, thus regular health monitoring is necessary. Serious skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur; if any abnormal skin symptoms arise, the medication should be discontinued immediately and consultation with a doctor is advised. Patients with an allergy to the components of this drug should not take it, nor should patients with certain genetic diseases such as lactose intolerance. Pregnant or planning to become pregnant women must take a pregnancy test before taking this medication and use effective contraception while on this medication, as it may be harmful to the fetus. Patients with impaired kidney or liver function may have delayed clearance of this medication, necessitating dose adjustments and careful monitoring. Adequate hydration is important during treatment, and patients should drink plenty of water to reduce the risk of kidney stones. Drowsiness, dizziness, and visual disturbances may occur during treatment, so it is advisable to avoid driving or operating hazardous machinery. Sudden discontinuation of this medication may increase the risk of seizures, so it must be tapered off gradually under a physician's guidance. This medication may interact with other drugs, so inform the healthcare provider of any concurrent medications, particularly central nervous system depressants or contraceptives. This medication may cause various side effects such as weight loss, decreased appetite, depression, cognitive impairment, etc., so if any unusual symptoms persist, consult a healthcare provider. Safety for pregnant women has not been established, and there is a risk of fetal malformation, so it is preferable to avoid use during pregnancy except in special cases.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, perceptual disturbances, rigidity, ataxia, concentration impairment, attention disturbances, confusion, dizziness, fatigue, paresthesia, stupor, thought disturbances, agitation, emotional instability, loss of appetite, asthenia, delirium, memory impairment, diplopia, vertigo, speech impairment, word choice disorder, nausea, nystagmus, psychomotor slowdown, tremors, abnormal vision, weight loss, gait disturbances, aggressive reactions, apathy, perceptual disturbances, discordant sense, leukopenia, psychiatric symptoms, taste disturbances, renal stones, thromboembolism, drowsiness, hyperirritability, asthenia, back pain, chest pain, influenza-like symptoms, leg pain, allergies, flushing, body odor, edema, stiffness, confusion, dizziness, dyspepsia, abdominal pain, constipation, gastroenteritis, thirst, gastrointestinal disturbance, gingivitis, auditory disturbances, myalgia, skeletal pain, epistaxis, purpura, rigidity, psychomotor slowing, neurogenic sensitivity, memory impairment, confusion, agitation, mood disorders, aggressive reactions, cognitive impairments, 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 disturbances, urinary tract infections, hematuria, urinary incontinence, frequent urination, abnormal urination, diplopia, visual disturbances, ocular pain, leukopenia, anemia, vasodilation of the autonomic nervous system, fever, syncope, halitosis, abdominal distension, alcohol intolerance, sub-sternal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, anxiety, erectile dysfunction, hallucinations, euphoria, psychosis, hypokinesia, generalized seizures, hyperactivity, leg cramps, reduced reflexes, neurosis, migraine, akinesia, hyperesthesia, movement abnormalities, parasthesia, speech disorders, scotoma, 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, 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, belching, tinnitus, otalgia, auditory hypersensitivity, angina, palpitations, AV block bradycardia, complete 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, increased creatinine, hyperchloremia, dry eyes, diabetes, hypernatremia, serum folate abnormalities, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscular weakness, arthrosis, osteoporosis, basal cell carcinoma, gum bleeding, pulmonary embolism, lymphadenopathy, lymphadenopathy, eosinophilia, lymphopenia, leukopenia, lymphocytosis, neutropenia, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorders, male galactorrhea, cough, bronchitis, asthma, bronchospasm, laryngospasm, acne, urticaria, alopecia, dermatitis, nail disorders, folliculitis, dry skin, eczema, skin depigmentation, psoriasis, photosensitivity reactions, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, taste loss, hypergeusia, dysuria, renal stones, urinary tract infections, frequent urination, urinary incontinence, urinary retention, facial edema, renal colic, nocturia, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular stiffness, conjunctivitis, dysregulation, glare, overflow, strabismus, color blindness, myopia, mydriasis, cataract, corneal opacity, iritis, leukopenia, lymphadenopathy, thrombocytopenia, hypersensitivity, hyperchloremic acidosis, hypokalemia, increased appetite, metabolic acidosis, polydipsia, abnormal behavior, sexual indifference, emotional blunting, crying, distractibility, sexual arousal disorder, stuttering, early awakening, elevated mood, euphoria, affective blunting, hallucinations, auditory hallucinations, visual hallucinations, hypomania, early insomnia, lack of spontaneous combustion, decreased sexual desire, lethargy, sexual desire loss, mania, moderate insomnia, decreased climax sensation, panic attacks, panic disorder, panic reactions, paranoia, obstinacy, reading disorders, restlessness, sleep disorders, suicidal ideation, suicide attempts, increased tears, abnormal thoughts, taste loss, inability to move, loss of smell, loss of speech, action loss syndrome, prodromal symptoms, burning sensations, cerebellar syndrome, circadian rhythm sleep disorders, darkness, complex partial seizures, convulsions, altered consciousness, orthostatic dizziness, drooling, movement abnormalities, muscle tension abnormalities, essential tremor, urge to move, generalized seizures, hyperesthesia, hypersomnia, taste decrease, reduced movement, sense of smell decrease, peripheral neuropathy, abnormal post-olfactory sensations, decreased sleep quality, presyncope symptoms, repetitive speech, sensory disturbances, sensory loss, confusion, syncope, unresponsiveness to stimuli, dysregulation, changes in visual depth perception, amblyopia, eyelid spasms, transient vision loss, unilateral vision loss, glaucoma, increased tearing, pupil dilation, night blindness, photophobia, presbyopia, scintillating scotoma, scotoma, visual impairment, hearing loss, sensorineural hearing loss, unilateral hearing loss, ear discomfort, auditory impairment, bradycardia, sinus bradycardia, palpitations, flushing, facial flushing, orthostatic hypotension, Raynaud's phenomenon, speech disorders, exercise-induced dyspnea, nasal congestion, sinus hypersecretion, abdominal discomfort, lower abdominal pain, abdominal tenderness, halitosis, epigastric discomfort, air in the gastrointestinal tract, tongue pain, oral sensory loss, oral pain, pancreatitis, excessive salivation, inefficacy, allergic dermatitis, maculopapular rash, skin discoloration, abnormal body odor, facial swelling, urticaria, localized urticaria, flank pain, muscle fatigue, muscular weakness, musculoskeletal stiffness, ureteral stones, urinary stones, hematuria, incontinence, urinary urgency, renal colic, renal pain, sexual dysfunction, facial edema, abnormal sensations, feeling drunk, irritability, lethargy, peripheral coldness, inertia, reduced blood bicarbonate levels, presence of crystalline urine.

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is also recommended to keep it in a cool, dry place below 25 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle