Question 1

What are the indications and effects of Topiramate 25 mg Tablet (Topiramate)?

Accepted Answer

This medication is effective for the treatment of epilepsy. It improves partial seizures and secondary generalized seizures as monotherapy in children and adults aged 6 years and older. Additionally, it can be used as an adjunct treatment in patients aged over 2 years whose seizures are not adequately controlled by existing antiepileptic drugs, aiding in various types of seizures, such as those associated with Lennox-Gastaut syndrome and tonic-clonic generalized seizures. It is also used for migraine prevention, contributing to alleviating patients' symptoms. Thus, it is effectively used for epilepsy and migraine prevention.

Question 2

What are the dosage and administration instructions for Topiramate 25 mg Tablet (Topiramate)?

Accepted Answer

It is desirable 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 administration of this medicine.
The recommended dose of this medicine is the same for all adults and children, including the elderly, in the absence of 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 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 approximately 1/3 every 2 weeks (see “5. General precautions” under Precautions for Use).
When enzyme-inducing drugs that affect drug metabolism are discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentrations occurs, the dose of this medicine may need to be reduced.
Adults (17 years and older): Start with 25 mg in the evening for the first week. Thereafter, increase the dose by 25 or 50 mg/day at intervals of 1-2 weeks and administer it in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the interval between dose increases. The dose and rate of titration should be determined according to clinical response. The recommended dose for adult monotherapy is 100～200mg/day. The maximum recommended dose is 500 mg/day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses of up to 1,000 mg/day.
2) Adjunctive therapy
Adults (17 years and older): The minimum effective dose is 200mg/day, and the usual dose is 200-400mg/day in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg/day. Start treatment with 25-50mg in the evening for the first week; treatment may also be initiated at a lower dose. Thereafter, increase the dose by 25-50mg at intervals of 1-2 weeks and administer it in 2 divided doses. If the patient has difficulty tolerating dose increases, smaller increments may be used or the interval between increases may be extended. The dose should be determined according to clinical response.
2. Prevention of migraine
Adults: Start 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 these increases, extend the interval between increases. The recommended dose is 100mg/day, administered in 2 divided doses. Some patients may respond to a dose of 50mg/day. Doses of up to 200mg/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 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: Since this medicine is removed from plasma by hemodialysis, the dose 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 system, and the patient's renal clearance, and administer the additional dose in divided portions 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.

Answer

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

Question 3

What are the side effects of Topiramate 25 mg Tablet (Topiramate)?

Accepted Answer

suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, paresthesia, myoclonus, ataxia, concentration disorder, attention disorder, confusion, dizziness, fatigue, hypesthesia, stupor, thought disorder, agitation, emotional instability, loss of appetite, asthenia, disorientation, memory impairment, diplopia, vertigo, speech disorder, word selection disorder, nausea, nystagmus, psychomotor retardation, tremor, visual disturbance, weight loss, gait disorder, aggressive reactions, apathy, perceptual disturbance, harmony disturbance, leukopenia, psychiatric symptoms, taste disorder, nephrolithiasis, thromboembolism, fatigue, asthenia, dorsal pain, chest pain, influenza-like symptoms, leg pain, allergy, flush, body odor, edema, rigidity, dizziness, ataxia, speech disorder, nystagmus, paresthesia, tremor, harmony disturbance, sensory loss, gait abnormality, involuntary muscle contractions, stupor, dizziness, nausea, dyspepsia, abdominal pain, constipation, gastroenteritis, thirst, gastrointestinal disorder, gingivitis, hearing disturbance, weight loss, myalgia, skeletal pain, epistaxis, purpura, myoclonus, psychomotor retardation, irritability, memory impairment, disorientation, depression, concentration disorder, loss of appetite, agitation, mood disorder, aggressive reactions, perceptual disorder, apathy, depersonalization, emotional instability, mastalgia, amenorrhea, menorrhagia, menstrual irregularities, prostate disorder, infection, viral infection, candidiasis, rhinitis, pharyngitis, sinusitis, dyspnea, erythematous rash, skin disorder, increased sweating, taste disorder, urinary tract infection, hematuria, urinary incontinence, frequent urination, urination disturbance, diplopia, visual disturbance, ocular pain, leukopenia, anemia, vasodilation, fever, syncope, halitosis, abdominal distension, alcohol intolerance, sub-sternal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension-type headache, erectile dysfunction, hallucinations, hyperactivity, psychosis, motor retardation, stupor, generalized seizures, hyperkinetic disorder, leg cramps, reflex reduction, neurosis, migraine, akinesia, hypersensitivity, movement disorder, retrocollis, speech disorder, scotoma, hypotonia, dystonia, coma, encephalopathy, fecal incontinence, insomnia, personality disorder, decreased libido, manic reactions, suicide attempts, paranoid responses, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities, goiter, thyroid disorder, diarrhea, vomiting, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, caries, stomatitis, dysphagia, melena, gastritis, hypersalivation, hiccups, gastroesophageal reflux, tongue edema, esophagitis, tinnitus, otalgia, auditory hypersensitivity, angina, palpitations, AV block bradycardia, bundle branch block, arrhythmia, atrial arrhythmia, atrial fibrillation, SGPT elevation, SGOT elevation, gallbladder disorder, γ-GT elevation, dehydration, weight gain, thirst, hypokalemia, alkaline phosphatase elevation, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, creatinine elevation, hyperchloremia, dry eye syndrome, diabetes, 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, leukopenia, lymphocytosis, agranulocytosis, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorder, galactorrhea, cough, bronchitis, asthma, bronchospasm, laryngospasm, acne, urticaria, alopecia, dermatitis, nail disorder, folliculitis, xerotic skin, eczema, skin depigmentation, psoriasis, photosensitivity reaction, erythematous rash, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, taste distortion syndrome, taste loss, hypogeusia, dysuria, nephrolithiasis, urinary tract infection, polyuria, urinary incontinence, urinary retention, facial swelling, renal colic, nocturia, albuminuria, polyuria, oliguria, flush, venous thrombosis, phlebitis, vascular spasm, conjunctivitis, dysregulation, photophobia, tearing, strabismus, color blindness, myopia, mydriasis, cataracts, corneal opacification, iritis, nasopharyngitis, neutropenia, allergic edema, hyperammonemia, hyperammonemic encephalopathy, despair, ocular dysesthesia, angle-closure glaucoma, conjunctival edema, ocular motility disorder, eyelid edema, macular disease, myopia, cough, chest discomfort, erythema multiforme, periorbital edema, peripheral edema, joint swelling, limb discomfort, tubular acidosis, renal calcinosis, systemic edema, influenza-like illness, weight gain, diaphoresis, worsening of epilepsy, psychiatric abnormalities, decreased comprehension, headache, drowsiness, mental retardation, word selection disorder, state of confusion, insomnia, aggression, anxiety, rage, stress, directional sense disturbance, mood changes, drowsiness, stuttering, forgetfulness, balance disorder, action tremor, taste abnormality, speech disorder, blurred vision, visual impairment, dry mouth, muscle cramp, musculoskeletal chest pain, gait disorder, vasodilation, syncope, halitosis, abdominal distension, alcohol intolerance, sub-sternal chest pain, tension-type headache, erectile dysfunction, hallucinations, hyperactivity, psychosis, motor retardation, generalized seizures, hyperkinetic disorder, leg cramps, reflex reduction, neurosis, migraine, akinesia, hypersensitivity, movement disorder, retrocollis, speech disorder, scotoma, hypotonia, dystonia, coma, encephalopathy, fecal incontinence, upper motor neuron damage, insomnia, personality disorder, decreased libido, manic responses, suicide attempts, paranoid responses, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities, cerebellar syndrome, tongue paralysis, increased libido, goiter, thyroid disorder, diarrhea, vomiting, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, caries, stomatitis, dysphagia, melena, gastritis, hypersalivation, hiccups, gastroesophageal reflux, tongue edema, esophagitis, tinnitus, otalgia, auditory hypersensitivity, angina, palpitations, AV block bradycardia, bundle branch block, arrhythmia, atrial arrhythmia, atrial fibrillation, SGPT elevation, SGOT elevation, gallbladder disorder, γ-GT elevation, dehydration, weight gain, thirst, hypokalemia, alkaline phosphatase elevation, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, creatinine elevation, hyperchloremia, dry eye syndrome, diabetes, 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, leukopenia, lymphocytosis, agranulocytosis, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorder, galactorrhea, cough, bronchitis, asthma, bronchospasm, laryngospasm, acne, urticaria, alopecia, dermatitis, nail disorder, folliculitis, xerotic skin, eczema, skin depigmentation, psoriasis, photosensitivity reaction, erythematous rash, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, taste distortion syndrome, taste loss, hypogeusia, dysuria, nephrolithiasis, urinary tract infection, polyuria, urinary incontinence, urinary retention, facial swelling, renal colic, nocturia, albuminuria, polyuria, oliguria, flush, venous thrombosis, phlebitis, vascular spasm, conjunctivitis, dysregulation, photophobia, tearing, strabismus, color blindness, myopia, mydriasis, cataracts, corneal opacification, iritis, nasopharyngitis, neutropenia, allergic edema, hyperammonemia, hyperammonemic encephalopathy, despair, ocular dysesthesia, angle-closure glaucoma, conjunctival edema, ocular motility disorder, eyelid edema, macular disease, myopia, cough, chest discomfort, erythema multiforme, periorbital edema, peripheral edema, joint swelling, limb discomfort, tubular acidosis, renal calcinosis, systemic edema, influenza-like illness, weight gain, diaphoresis, worsening of epilepsy, psychiatric abnormalities, decreased comprehension, headache, drowsiness, mental retardation, word selection disorder, state of confusion, insomnia, aggression, anxiety, rage, stress, directional sense disturbance, mood changes, drowsiness, stuttering, forgetfulness, balance disorder, action tremor, taste abnormality, speech disorder, blurred vision, visual impairment, dry mouth, muscle cramp, musculoskeletal chest pain, gait disorder, vasodilation, syncope, halitosis, abdominal distension, alcohol intolerance, sub-sternal chest pain, tension-type headache, erectile dysfunction, hallucinations, hyperactivity, psychosis, motor retardation, generalized seizures, hyperkinetic disorder, leg cramps, reflex reduction, neurosis, migraine, akinesia, hypersensitivity, movement disorder, retrocollis, speech disorder, scotoma, hypotonia, dystonia, coma, encephalopathy, fecal incontinence, insomnia, personality disorder, decreased libido, manic responses, suicide attempts, paranoid responses, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities

Question 4

What precautions should be taken when using Topiramate 25 mg Tablet (Topiramate)?

Accepted Answer

This medication is used as an antiepileptic agent and may increase the risk of mental health problems such as suicidal thoughts or behaviors and depression. Therefore, if any unusual mood or behavior occurs during treatment, medical staff should be informed immediately. There is a risk of sudden death in patients with epilepsy, requiring caution. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis can also occur; therefore, if any skin rash or unusual symptoms develop, the medication should be discontinued immediately. Patients with hypersensitivity to this medication or genetic issues such as lactose intolerance should not take it. Women who are pregnant or planning to become pregnant must take a pregnancy test before using this medication and ensure effective contraception during treatment, as it may cause harm to the fetus. Patients with impaired kidney or liver function may require dose adjustments due to delayed excretion of this medication, and those undergoing hemodialysis should adjust their dosage based on dialysis conditions. Adequate hydration is crucial as there is a risk of kidney stones. This medication can affect the central nervous system, causing drowsiness, dizziness, or visual disturbances, so caution is advised when driving or operating machinery. Various side effects, such as weight loss, appetite reduction, depression, memory impairment, and decreased concentration, can occur during treatment; therefore, patients should consult healthcare professionals if any unusual symptoms arise. This medication may interact with other drugs, so if the patient is taking other medications, they must inform their healthcare provider. Pregnant or lactating women should decide on the use of this medication after consulting healthcare professionals, as it may pose risks to the fetus and baby. Use is not recommended in children under 2 years due to lack of established safety and efficacy. In case of overdose, symptoms such as headache, seizures, drowsiness, vision abnormalities, and confusion may occur, requiring immediate emergency measures.

Topiramate 25 mg Tablet (Topiramate)

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Adult dosage

Children's dosage

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