Topit Tablet (Topiramate)

Adult dosage

It is advisable to start this medicine at a low dose and increase it to the effective dose. There is no need to monitor blood concentrations to optimize the administration of this medicine. The recommended dose of this medicine applies to all adults and children, including the elderly, in the absence of renal disease. It may be administered regardless of meals. 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 the other antiepileptic drugs must be discontinued immediately for safety reasons, they should be gradually tapered and discontinued by approximately one-third every 2 weeks. 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 treatment with 25 mg in the evening for the first week. Thereafter, increase the daily dose by 25 or 50 mg at intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the intervals between increases. The dose and rate of titration should be determined according to clinical response. The recommended dose for monotherapy in adults is 100～200mg daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses of up to 1,000㎎ daily. 2) Adjunctive therapy Adults (17 years of age and older) The minimum effective dose is 200mg daily, and the usual dose is 200-400mg daily in 2 divided doses. The dose may be increased to the maximum recommended dose of 800mg daily, depending on the patient. Start 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 intervals of 1-2 weeks and administer in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller dose increments may be used or the intervals between increases may be extended. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start treatment with 25mg of this medicine in the evening for the first week. Thereafter, increase the dose by 25mg/day at weekly intervals. If the patient has difficulty tolerating this titration, extend the intervals between increases. The recommended daily dose is 100mg, 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 titration 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. Patients on hemodialysis: Because this medicine is removed from plasma by hemodialysis, increase the dose of this medicine by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis device, and the patient's renal clearance, and administer the additional dose in divided doses at the beginning and end of hemodialysis. 4. Patients with hepatic impairment Administer with caution to patients with hepatic impairment, as clearance of this medicine may be reduced.

Children's dosage

Children (6-16 years): Start treatment with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the daily dose by 0.5-1㎎/㎏ at intervals of 1-2 weeks and administer twice daily. If the patient has difficulty tolerating the increase, reduce the size of the dose increment or extend the interval 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 daily. Doses of up to 500㎎ daily have been used in children diagnosed with partial seizures. Children (2-16 years): The recommended daily dose is approximately 5-9mg/kg, administered in 2 divided doses. For the first week, administer 25mg (or less, based on 1-3mg/kg daily) in the evening. Thereafter, increase the daily dose by 1-3mg/kg at intervals of 1-2 weeks 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 daily have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors, so if symptoms of depression or mood changes occur during use, you should consult a doctor immediately. Patients with epilepsy who take this medication may have a slightly increased risk of sudden death, so regular health check-ups are needed. This medication can cause serious skin reactions; if you experience rashes or blisters on the skin, stop taking it immediately and seek medical attention. Patients who are allergic to this drug or have lactose intolerance should not use it, and particularly women who are pregnant or planning to become pregnant must consult a doctor before taking it. Women with the possibility of pregnancy should take a pregnancy test before using this medication and should use effective contraception during use. Patients with impaired kidney or liver function may need dosage adjustments, and patients on hemodialysis may need dose adjustments depending on the dialysis conditions. It is important to maintain adequate hydration while taking this medication, and frequent water intake should be practiced to reduce the risk of kidney stones. While taking this medication, symptoms such as drowsiness, dizziness, and blurred vision may occur, so caution should be exercised when driving or operating machinery. This medication may cause side effects such as weight loss, poor appetite, fatigue, decreased concentration, memory impairment, etc., and if symptoms become severe, consult with healthcare professionals. Since it may interact with other medications, be sure to inform your physician or pharmacist if you are taking any other medications. Taking this medication during pregnancy can cause fetal malformations or growth disorders, so women who are pregnant or planning to become pregnant must exercise special caution. This medication may worsen seizures when discontinued, so doses should be reduced gradually under a doctor's supervision, and sudden discontinuation should be avoided. During the use of this medication, suicidal impulses or behaviors, as well as mood changes, may occur, so the patient and caregivers should observe these symptoms closely.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, sensory disturbances, hypomania, ataxia, attention deficit, concentration impairment, confusion, dizziness, fatigue, paresthesia, stupor, thought disturbances, agitation, emotional instability, loss of appetite, asthenia, delirium, memory impairment, diplopia, vertigo, language disorders, word selection impairment, nausea, nystagmus, psychomotor retardation, tremor, visual disturbances, weight loss, gait disturbances, aggressive reactions, apathy, perceptual disturbances, disharmony, leukopenia, psychiatric symptoms, taste disturbances, renal stones, thromboembolism, fatigue, asthenia, back pain, chest pain, influenza-like symptoms, limb pain, allergies, flushing, body odor, edema, rigidity, dizziness, ataxia, language disorders, nystagmus, sensory disturbances, tremor, disharmony, sensory loss, gait abnormalities, involuntary muscle contractions, confusion, dizziness, nausea, dyspepsia, abdominal pain, constipation, gastritis, thirst, gastrointestinal disorders, gingivitis, auditory disturbances, weight loss, myalgia, skeletal pain, epistaxis, purpura, hypomania, psychomotor retardation, neuroexcitability, memory impairment, delirium, depression, concentration/attention deficits, loss of appetite, agitation, mood disorders, aggressive reactions, personality disorders, apathy, depersonalization, emotional instability, breast pain, amenorrhea, menorrhagia, menstrual irregularities, prostatic 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, autonomic vascular dilation, fever, syncope, halitosis, abdominal distension, alcohol intolerance, substernal chest pain, sudden death, hypertension, hypotension, postural hypotension, tension headache, erectile dysfunction, hallucinations, hyperactivity, psychosis, hypokinesia, confusion, generalized tonic-clonic seizures, hyperactivity, leg cramps, reflex hyporeflexia, neurosis, migraine, akinesia, hypersensitivity, motor abnormalities, parkinsonism, speech disorders, scotoma, 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, gastritis, gingival hyperplasia, dental caries, stomatitis, dysphagia, melena, gastritis, increased salivation, hiccups, gastroesophageal reflux, lingual edema, esophagitis, belching, 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, elevated alkaline phosphatase, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, elevated creatinine, hyperchloremia, dry eye syndrome, diabetes mellitus, hypernatremia, abnormal serum folate, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthrosis, osteoporosis, basal cell carcinoma, anemia, gum bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenitis, eosinophilia, lymphopenia, leukopenia, lymphocytosis, agranulocytosis, 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, xerosis, eczema, skin depigmentation, psoriasis, photodermatitis, erythematous rash, seborrheic dermatitis, reduced sweating, hair abnormalities, brown spots, loss of taste, sensory disturbances, dysuria, renal stones, urinary tract infections, frequent urination, urinary incontinence, urinary retention, facial edema, kidney pain, nocturia, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular spasm, conjunctivitis, dysregulation, photophobia, overflow tears, strabismus, color blindness, myopia, mydriasis, cataracts, corneal opacity, iritis, leukopenia, lymphadenopathy, thrombocytopenia, hypersensitivity, hyperchloremic acidosis, hypokalemia, increased appetite, metabolic acidosis, polydipsia, abnormal behavior, sexual dysfunction, emotional bluntness, weeping, distractibility, sexual arousal disorder, stuttering, early awakening, elevated mood, sense of euphoria, affective flattening, hallucinations, auditory hallucinations, visual hallucinations, hypomania, initial insomnia, lack of spontaneous combustion, decreased sexual desire, lethargy, loss of sexual desire, mania, middle insomnia, decreased orgasm, panic attacks, panic disorder, panic reactions, paranoia, obstinacy, reading disorders, restlessness, sleep disorders, suicidal ideation, suicide attempts, increased tear production, abnormal thoughts, loss of taste, motor impairment, loss of smell, language loss, apraxia, aura, burning sensation, cerebellar syndrome, circadian rhythm sleep disorders, darkness, complex partial seizures, seizures, altered consciousness state, orthostatic dizziness, hypersalivation, sensory disturbances, writing disability, motor abnormalities, muscle tone abnormalities, essential tremor, palpitations, generalized tonic-clonic seizures, hypersensitivity, excessive sleep, taste decrease, reduced movement, smell decrease, peripheral neuropathy, abnormal olfaction, decreased sleep quality, prodromal symptoms, repetitive speech, sensory disturbances, sensory loss, confusion, syncope, unresponsiveness to stimuli, dysregulation, visual depth perception changes, amblyopia, eyelid spasm, temporary vision loss, unilateral vision loss, glaucoma, increased tearing, pupillary dilation, night blindness, photophobia, presbyopia, flash scotoma, scotoma, visual 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, respiratory distress, nasal obstruction, excessive sinus secretion, abdominal discomfort, lower abdominal pain, halitosis, epigastric discomfort, intestinal air retention, tongue pain, oral sensory loss, oral pain, pancreatitis, excessive salivation, infinite syndrome, allergic dermatitis, erythema, maculopapular rash, skin discoloration, unusual skin odor, facial swelling, urticaria, local urticaria, flank pain, muscle fatigue, muscle weakness, musculoskeletal stiffness, ureteral stones, urinary stones, hematuria, incontinence, urgency, renal colic, kidney pain, facial edema, unusual sensations, drunkenness, irritability, lethargy, peripheral cooling, laziness, decreased sodium bicarbonate in the blood, presence of crystalloid urine, abnormal walking test

This medication must be stored in a tightly sealed container to protect it from air and moisture. Additionally, avoid storing it in very hot or very cold places, and it is best to keep it at room temperature between 1 and 30 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets, 100 tablets