Question 1

What are the indications and effects of Topiramate 100mg Tablet?

Accepted Answer

This medication is used for the treatment of epilepsy and is effective as monotherapy for partial seizures and secondary generalized seizures in children over 6 years and adults. It is also used as an add-on treatment for children and adults aged 2 years and older who have difficulty controlling seizures with existing treatments, including seizures related to Lennox-Gastaut syndrome and primary generalized tonic-clonic seizures. Additionally, it helps in preventing migraines, contributing to symptom relief for patients. Therefore, this drug is used for epilepsy and migraine prevention.

Question 2

What are the dosage and administration instructions for Topiramate 100mg Tablet?

Accepted Answer

It is preferable to start this drug at a low dose and increase it to the effective dose.

There is no need to monitor plasma concentrations to optimize the administration of this drug.

The recommended doses of this drug are the same for all adults and children, including older adults, provided they do not have renal disease.

It may be taken with or without food.

The tablets should be swallowed whole without crushing.

1. Epilepsy
1) Monotherapy: When discontinuing other antiepileptic drugs being used concomitantly in order to administer topiramate as monotherapy, the potential effects 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 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 drug may need to be reduced.
Adults (17 years and older):
Start with 25㎎ in the evening for the first week. Thereafter, increase the dose by 25 or 50㎎ per day at intervals of 1-2 weeks and administer in 2 divided doses daily. If the patient has difficulty tolerating this titration schedule, the intervals between dose increases should be lengthened. The dose and rate of titration should be determined according to clinical response. The recommended dose for adult monotherapy is 100～200mg daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated doses of up to 1,000㎎ daily as topiramate monotherapy.
2) Adjunctive therapy
Adults (17 years and older)
The minimum effective dose is 200mg daily, and the usual dose is 200-400mg daily in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg daily. Treatment is initiated with 25-50mg in the evening for the first week; it is also possible to start at a lower dose. Thereafter, increase the dose by 25-50mg at intervals of 1-2 weeks and administer in 2 divided doses daily. If the patient has difficulty tolerating the increased dose, smaller dose increments may be used or the interval between increases may be lengthened. The dose should be determined according to clinical effect.

2. Prevention of migraine
Adults: Start with 25mg of this drug in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating this titration, the intervals between dose increases should be lengthened. The recommended dose is 100mg daily, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. The dose may be increased to 200mg daily, and 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.
- Hemodialysis patients: Because this drug is removed from plasma by hemodialysis, the dose of this drug should be increased by approximately 1/2 on dialysis days. Increase the dose taking into account the duration of dialysis, the clearance of the dialysis apparatus, and the patient's residual renal clearance, and administer the increased dose in divided doses at the beginning and end of hemodialysis.

4. Patients with hepatic impairment
This drug should be administered with caution to patients with hepatic impairment, as its clearance may be reduced.

Answer

Children (6-16 years)
Start with 0.5-1㎎/㎏ in the evening for the first week. Thereafter, increase the dose by 0.5-1㎎/㎏ per day at intervals of 1-2 weeks and administer twice daily. If the patient has difficulty tolerating dose increases, reduce the size of the increments or lengthen the intervals between increases. The dose and degree of titration should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg daily. In children diagnosed with partial-onset seizures, doses of up to 500㎎ daily have been used.
Children (2 years-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 dose by 1-3mg/kg daily at intervals of 1-2 weeks until an appropriate clinical effect is achieved, and administer in 2 divided doses. Dose titration should be determined according to clinical effect. Doses of up to 30mg/kg daily have been administered; these were generally well tolerated.

Question 3

What are the side effects of Topiramate 100mg Tablet?

Accepted Answer

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, perceptual disturbances, ataxia, dysdiadochokinesia, concentration impairment, attention deficit, confusion, dizziness, fatigue, paresthesia, somnolence, thought disorders, agitation, emotional instability, loss of appetite, asthenia, confusion, memory impairment, diplopia, vertigo, speech disorders, word-selection disorder, nausea, nystagmus, psychomotor retardation, tremors, visual disturbances, weight loss, gait disturbances, aggressive responses, flat affect, perceptual abnormalities, dysphoria, leukopenia, psychiatric symptoms, taste disturbances, nephrolithiasis, thromboembolic disease, fatigue, asthenia, back pain, chest pain, influenza-like symptoms, leg pain, allergies, rash, body odor, edema, rigidity, dizziness, ataxia, speech disorders, nystagmus, perceptual disturbances, tremors, dysphoria, sensory deficit, gait abnormalities, involuntary muscle contractions, confusion, syncope, nausea, dyspepsia, abdominal pain, constipation, gastritis, thirst, gastrointestinal disorders, gingivitis, auditory anomalies, weight loss, myalgia, skeletal pain, epistaxis, purpura, ataxia, psychomotor retardation, neuropathic hypersensitivity, memory impairment, confusion, depression, concentration/attention deficit, loss of appetite, agitation, mood disorders, aggressive responses, personality disorders, flat affect, depersonalization, emotional instability, mastalgia, amenorrhea, hypermenorrhea, menstrual abnormalities, 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, urinary abnormalities, diplopia, visual disturbances, ocular pain, leukopenia, anemia, autonomic nervous system abnormalities, vasodilation, fever, syncope, halitosis, abdominal distension, alcohol intolerance, substernal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension headache, erectile dysfunction, hallucinations, hyperactivity, psychosis, motor impairment, generalized tonic-clonic seizure, hyperkinesia, leg cramps, diminished reflexes, neurosis, migraine, akinesia, hypersensitivity, motor disturbances, bilateral hemiparesis, speech disorders, scotomas, hypotonia, 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, melanosis, gastritis, increased salivation, hiccups, gastroesophageal reflux, tongue edema, esophagitis, belching, tinnitus, otalgia, auditory hypersensitivity, angina, palpitations, AV block bradycardia, complete block, arrhythmia, atrial arrhythmias, atrial fibrillation, elevated SGPT, elevated SGOT, gallbladder disorders, elevated γ-GT, dehydration, weight gain, thirst, hypokalemia, elevated alkaline phosphatase, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, increased creatinine, hyperchloremia, dry eye syndrome, diabetes mellitus, hypernatremia, serum folate abnormalities, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthrosis, osteoporosis, basal cell carcinoma, anemia, gum bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymph node swelling, eosinophilia, lymphopenia, lymphocytosis, neutropenia, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorders, male lactation, cough, bronchitis, asthma, bronchospasm, laryngospasm, acne, urticaria, alopecia, dermatitis, nail disorders, folliculitis, xerotic skin, eczema, skin depigmentation, psoriasis, photosensitivity reactions, erythematous rash, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, taste disturbance syndrome, loss of taste, tactile disturbances, urinary difficulties, nephrolithiasis, urinary tract infections, frequent urination, urinary incontinence, urinary retention, facial edema, kidney pain, nocturia, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular stiffness, conjunctivitis, dysregulation, glare, lagophthalmos, strabismus, color blindness, myopia, mydriasis, cataract, corneal opacity, iritis, nasopharyngitis, neutropenia, allergic edema, hyperammonemia, hyperammonemic encephalopathy, despair, visual anomalies, closed-angle glaucoma, conjunctival edema, ocular motility disorders, eyelid edema, macular disease, myopia, cough, chest discomfort, erythema multiforme, periorbital edema, peripheral edema, joint swelling, limb discomfort, nephrocalcinosis, systemic edema, influenza-like illness, weight gain, diaphoresis, epilepsy aggravation, mental disturbances, encephalopathy, hyperammonemic encephalopathy, hypothermia, reduced serum bicarbonate, hyperchloremic acidosis, decreased sweating, elevated body temperature, hyperammonemia, somnolence, coma, abnormal behavior, sexual dysfunction, emotional blunting, crying, distractibility, sexual arousal disorder, stuttering, early awakening, elevated mood, euphoric feelings, affective flattening, hallucination, auditory hallucination, visual hallucination, hypomania, initial insomnia, lack of spontaneous combustion, sexual desire reduction, lethargy, loss of libido, mania, middle insomnia, diminished orgasms, panic attacks, panic disorder, panic reaction, paranoia, stubbornness, reading disorder, restlessness, sleep disorders, suicidal ideation, suicide attempts, increased tears, abnormal thoughts, loss of taste, inability to move, loss of smell, loss of speech, akinetic mutism, aura, burning sensation, cerebellar syndrome, circadian rhythm sleep disorder, darkness, complex partial seizures, convulsions, impaired consciousness, orthostatic dizziness, drooling, motor disturbances, muscle tension abnormalities, essential tremor, somatic sensation, generalized tonic-clonic seizure, hypersensitivity, hypersomnia, diminished taste perception, decreased physical activity, reduced sense of smell, peripheral neuropathy, olfactory dysfunction, decreased sleep quality, psychomotor hyperactivity, psychomotor skill disorder, syncope, tremors, dysregulation, changes in visual depth perception, amblyopia, eyelid spasm, temporary vision loss, unilateral vision loss, glaucoma, increased tearing, dilated pupils, night blindness, photophobia, presbyopia, visual scintillations, scotomas, vision impairment, hearing loss, sensory neuropathy hearing loss, unilateral hearing loss, ear discomfort, auditory impairment, bradycardia, sinus bradycardia, palpitations, flushing, facial flushing, orthostatic hypotension, Raynaud's phenomenon, speech disorder, exercise-induced dyspnea, nasal congestion, sinus hypersecretion, abdominal discomfort, lower abdominal pain, abdominal tenderness, halitosis, discomfort in the epigastric region, air in the gastrointestinal tract, tongue pain, oral sensory deficit, oral pain, pancreatitis, excessive salivation, emetophobia, allergic dermatitis, erythema, maculopapular eruption, skin discoloration, abnormal skin odor, facial swelling, urticaria, local urticaria, flank pain, muscle fatigue, muscle weakness, musculoskeletal rigidity, ureteral stones, urinary stones, hematuria, incontinence, urgency, renal colic, kidney pain, sexual dysfunction, facial swelling, abnormal sensation, feeling hungover, irritability, lethargy, peripheral coldness, apathy, reduced serum bicarbonate, presence of crystalline urine, abnormal tandem gait test, decreased white blood cell count

Question 4

What precautions should be taken when using Topiramate 100mg Tablet?

Accepted Answer

Patients taking this medication may experience mental health issues such as suicidal impulses or thoughts and depression; should such symptoms arise, immediate consultation with a physician is necessary.

This medication may pose a risk of sudden death in epilepsy patients, thus careful monitoring during treatment is required.

There is a risk of severe allergic reactions on the skin; if symptoms such as rash, blisters, or mucosal damage occur, discontinue use immediately and inform medical personnel.

Patients with allergies to this drug or certain genetic forms of lactose intolerance should refrain from using it.

Women who are pregnant or planning to become pregnant should consult a physician before taking this medication and should use effective contraceptive methods.

Dosage adjustments are necessary for patients with reduced kidney function, and those undergoing dialysis must adjust their dose according to the dialysis conditions.

Adequate fluid intake is crucial due to the risk of kidney stones.

Patients with impaired liver function should also be cautious when taking this medication.

This drug may cause central nervous system side effects such as drowsiness, dizziness, or blurred vision; caution is needed while driving or operating machinery.

It is advisable not to use this medication in conjunction with alcohol or central nervous system depressants.

This drug may interact with various other medications; thus, if taking other drugs, it is essential to inform the physician or pharmacist.

During treatment, observe for symptoms like weight changes, appetite changes, mood changes, and memory decline; if abnormal symptoms appear, consult medical personnel.

When discontinuing, it is crucial to taper off gradually under a physician's guidance to reduce the risk of seizures.

This medication may affect body temperature regulation due to decreased sweating, so caution is particularly required in hot environments.

If pregnant women take this medication, there is a risk of congenital malformations or growth disorders in the fetus; thus, pregnancy-related treatment should be considered carefully.

During treatment, regular blood tests, kidney and liver function tests, and, if necessary, eye examinations are recommended.

Topiramate 100mg Tablet

Summary

Ingredients

Efficacy & effects

Dosage and Administration

Adult dosage

Children's dosage

Precautions

Side effects

Storage

Appearance and packaging

Appearance

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