Q: What precautions should be taken when using Boriel Topiramate Tablets 100 mg?

This medication is used as an antiepileptic drug for the prevention of epilepsy and migraines. During treatment, there may be an increased risk of suicidal thoughts or suicidal behavior, so patients and caregivers should report any mood changes or symptoms of depression to a doctor immediately. This medication may rarely cause serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so treatment should be discontinued immediately if any abnormal skin signs occur. It may pose risks to the fetus if used during pregnancy; therefore, women who are able to become pregnant should take a pregnancy test before starting the medication and use effective contraception during treatment. Patients with impaired kidney or liver function may experience delayed excretion of this medication, necessitating dosage adjustments. Patients undergoing dialysis should have the dosage adjusted according to dialysis conditions. This medication can affect the central nervous system, leading to symptoms such as drowsiness, dizziness, or blurred vision; thus, it is advisable to avoid driving or operating machinery in the initial stages of treatment. Adequate hydration is crucial, especially since there is a risk of kidney stones; sufficient fluid intake should be ensured. This medication may interact with other drugs; therefore, patients taking other medications should inform their physician, especially women using contraceptives, as contraceptive efficacy may be compromised. Dosage should be gradually adjusted according to the patient's condition, as sudden discontinuation may increase the risk of seizures. Patients experiencing changes in weight, mood, or unusual behavior while on this medication should consult healthcare professionals. Periodic check-ups including blood tests and kidney function monitoring may be necessary.

Question 1

What are the indications and effects of Boriel Topiramate Tablets 100 mg?

Accepted Answer

This medication is effective in treating epilepsy and can be used alone for partial seizures or secondary generalized seizures in children aged 6 and older and adults. Additionally, it is used as an adjunctive therapy for various types of seizures, such as those associated with Lennox-Gastaut syndrome or tonic/clonic generalized seizures, in patients over the age of 2 who are not controlled with existing antiepileptic medications. Furthermore, this medication helps in the prevention of migraines. Therefore, it is effectively used for both the control of epilepsy seizures and migraine prevention.

Question 2

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

Accepted Answer

It is advisable 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 of this medicine applies to all adults and children, including elderly patients, who do not have renal disease.
This medicine may be taken with or without food.
Swallow the tablets whole; do not crush them.
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, gradually reduce and discontinue them by approximately 1/3 at 2-week intervals (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 for the first week. Thereafter, increase the daily dose by 25 or 50㎎ at 1-2 week intervals and administer in 2 divided doses. If the patient has difficulty tolerating this titration, 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 per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated up to 1,000㎎ per day as topiramate monotherapy.
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. Start treatment 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 1-2 week intervals and administer in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller increments may be used or the interval between increases may be extended. The dose should be determined according to clinical effect.
Adults: Start with 25mg of this medicine in the evening for the first week. Thereafter, increase the daily dose by 25mg at 1-week intervals. If the patient has difficulty tolerating the increase, extend the interval between dose increases. The recommended dose is 100mg per day, administered in 2 divided doses. Some patients may respond to a dose of 50mg per day. The dose may be increased to 200mg per day; the dose and rate of increase should be determined according to clinical response.
In 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.
Hemodialysis patients: 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 equipment, and the patient's renal clearance, and administer the dose in divided amounts at the beginning and end of hemodialysis.
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㎎/㎏ in the evening for the first week. Thereafter, increase the daily dose by 0.5-1㎎/㎏ at 1-2 week intervals and administer twice daily. If the patient has difficulty tolerating the increase, reduce the 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 per day. In children diagnosed with partial seizures, doses up to 500㎎ per day have been used.
Children (2-16 years): The recommended dose is approximately 5-9mg/kg per day, 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 daily dose by 1-3mg/kg at 1-2 week intervals until an appropriate clinical effect is achieved, and administer in 2 divided doses. Dose titration should be determined according to clinical effect. Doses up to 30mg/kg per day have been administered and were generally well tolerated.

Question 3

What are the side effects of Boriel Topiramate Tablets 100 mg?

Accepted Answer

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, perceptual disturbances, rigidity, ataxia, attention deficit, concentration deficit, confusion, dizziness, fatigue, paresthesia, somnolence, cognitive disturbances, agitation, emotional instability, appetite loss, asthenia, delirium, memory impairment, double vision, vertigo, language disorders, word selection disorders, nausea, nystagmus, psychomotor retardation, tremors, visual disturbances, weight loss, gait abnormalities, aggressive reactions, apathy, perceptual abnormalities, dysesthesia, leukopenia, psychiatric symptoms, taste disturbances, nephrolithiasis, thromboembolism, fatigue, asthenia, back pain, chest pain, influenza-like symptoms, leg pain, allergies, flushing, body odor, edema, stiffness, dizziness, ataxia, language disorders, nystagmus, perceptual disturbances, tremors, dysesthesia, sensory loss, gait disorders, involuntary muscle contractions, confusion, dizziness, nausea, indigestion, abdominal pain, constipation, gastroenteritis, thirst, gastrointestinal disturbances, gingivitis, auditory disturbances, weight loss, myalgia, skeletal pain, epistaxis, purpura, rigidity, psychomotor retardation, nervousness, memory impairment, delirium, depression, concentration/attention deficit, appetite loss, agitation, mood disorders, aggressive reactions, personality disorders, apathy, depersonalization, emotional instability, breast pain, amenorrhea, menorrhagia, menstrual irregularities, prostate disorders, infections, viral infections, candidiasis, rhinitis, pharyngitis, sinusitis, shortness of breath, erythematous rash, skin disorders, increased sweating, taste disturbances, urinary tract infections, hematuria, urinary incontinence, frequent urination, urine changes, double vision, visual disturbances, ocular pain, leukopenia, anemia, autonomic nervous system abnormalities, vasodilation, fever, syncope, halitosis, abdominal distension, alcohol intolerance, retrosternal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension headaches, erectile dysfunction, hallucinations, euphoric feeling, psychosis, hypokinesia, confusion, grand mal seizures, hyperactivity, leg cramps, diminished reflexes, neurosis, migraines, akinesia, perceptual hypersensitivity, movement disorders, good response, speech disorders, scotoma, ptosis, dystonia, coma, encephalopathy, bowel incontinence, insomnia, personality disorders, decreased libido, manic symptoms, suicide attempts, paranoid reaction, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities, goiter, thyroid disorders, diarrhea, vomiting, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, dental caries, stomatitis, dysphagia, melena, gastritis, increased saliva, hiccups, gastroesophageal reflux, tongue swelling, esophagitis, tinnitus, ear pain, auditory hypersensitivity, angina, palpitations, AV block bradycardia, atrioventricular 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, muscle weakness, arthrosis, osteoporosis, basal cell carcinoma, anemia, gum bleeding, purpura, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymph node swelling, eosinophilia, lymphocytopenia, leukopenia, lymphocytosis, granulocytopenia, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculatory dysfunction, galactorrhea, cough, bronchitis, asthma, bronchospasm, laryngospasm, acne, urticaria, hair loss, dermatitis, nail disorders, folliculitis, dry skin, eczema, skin depigmentation, psoriasis, photosensitivity reactions, erythematous rash, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, taste disorder, taste loss, aftertaste, dysuria, nephrolithiasis, urinary tract infections, frequent urination, urinary incontinence, urinary retention, facial edema, renal colic, enuresis, albuminuria, polyuria, oliguria, flushing, venous thromboembolism, phlebitis, vascular constriction, conjunctivitis, tension abnormalities, photophobia, overlapping, strabismus, color blindness, myopia, mydriasis, cataract, corneal opacity, iritis, exacerbation of epilepsy, mental disturbances, impaired understanding, autonomic nervous system abnormalities, vasodilation, fever, syncope, halitosis, abdominal distension, alcohol intolerance, retrosternal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension headaches, erectile dysfunction, hallucinations, euphoric feeling, psychosis, hypokinesia, confusion, grand mal seizures, hyperactivity, leg cramps, diminished reflexes, neurosis, migraines, akinesia, perceptual hypersensitivity, movement disorders, good response, speech disorders, scotoma, ptosis, dystonia, coma, encephalopathy, bowel incontinence, insomnia, personality disorders, decreased libido, manic symptoms, suicide attempts, paranoid reaction, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities, goiter, thyroid disorders, diarrhea, vomiting, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, dental caries, stomatitis, dysphagia, melena, gastritis, increased saliva, hiccups, gastroesophageal reflux, tongue swelling, esophagitis, tinnitus, ear pain, auditory hypersensitivity, angina, palpitations, AV block bradycardia, atrioventricular 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, muscle weakness, arthrosis, osteoporosis, basal cell carcinoma, anemia, gum bleeding, purpura, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymph node swelling, eosinophilia, lymphocytopenia, leukopenia, lymphocytosis, granulocytopenia, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculatory dysfunction, galactorrhea, cough, bronchitis, asthma, bronchospasm, laryngospasm, acne, urticaria, hair loss, dermatitis, nail disorders, folliculitis, dry skin, eczema, skin depigmentation, psoriasis, photosensitivity reactions, erythematous rash, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, taste disorder, taste loss, aftertaste, dysuria, nephrolithiasis, urinary tract infections, frequent urination, urinary incontinence, urinary retention, facial edema, renal colic, enuresis, albuminuria, polyuria, oliguria, flushing, venous thromboembolism, phlebitis, vascular constriction, conjunctivitis, tension abnormalities, photophobia, overlapping, strabismus, color blindness, myopia, mydriasis, cataract, corneal opacity, iritis, leukopenia, lymph node swelling, thrombocytopenia, hypersensitivity, hyperchloremic acidosis, hypokalemia, increased appetite, metabolic acidosis, thirst, abnormal behavior, sexual indifference, emotional blunting, weeping, distractibility, sexual arousal disorder, stutter, early awakening, mood elevation, feeling of joy, affective flattening, hallucinations, auditory hallucinations, visual hallucinations, hypomania, early insomnia, lack of spontaneous combustion, decreased sexual desire, languor, sexual desire loss, mania, intermediate insomnia, decreased climax sensation, panic attacks, panic disorder, panic response, paranoia, obstinacy, reading disorder, restlessness, sleep disturbance, suicidal ideation, suicide attempts, increased tearfulness, abnormal thoughts, taste loss, motor disability, anosmia, loss of speech, akinetic mutism, prodromal, burning sensation, cerebellar syndrome, circadian rhythm sleep disorder, darkness, complex partial seizure, convulsions, decrease in consciousness, orthostatic dizziness, drooling, sensory disturbances, writing disorder, movement disorders, language disorders, muscle tone abnormalities, essential tremor, sensory dysesthesia, grand mal seizure, perceptual hypersensitivity, hypersomnia, reduced taste sensation, reduced movement, decreased olfactory sensation, peripheral neuropathy, olfactory distortion, reduced sleep quality, prodrome to syncope, repetitive language, sensory disorders, sensory loss, confusion, syncope, unresponsiveness to stimuli, control disorders, visual depth perception changes, amblyopia, eyelid twitching, transient vision loss, unilateral vision loss, glaucoma, increased tear production, pupillary dilation, night blindness, photophobia, presbyopia, scintillating scotoma, scotoma, visual impairment, hearing impairment, sensorineural hearing loss, unilateral hearing loss, ear discomfort, auditory disorders, bradycardia, sinus bradycardia, palpitations, flushing, facial flushing, orthostatic hypotension, Raynaud's phenomenon, speech disorders, exercise-induced dyspnea, nasal obstruction, excessive sinus secretion, abdominal discomfort, lower abdominal pain, abdominal tenderness, halitosis, epigastric discomfort, gastric air trapping, tongue pain, oral hypesthesia, oral pain, pancreatitis, excessive salivation, hyperuricemia, allergic dermatitis, erythema, maculopapular rash, skin discoloration, abnormal skin odor, facial swelling, urticaria, localized urticaria, flank pain, muscle fatigue, muscle weakness, musculoskeletal stiffness, ureterolithiasis, urinary stones, hematuria, incontinence, urgency, renal colic, renal pain, urinary incontinence, sexual dysfunction, facial edema, abnormal sensation, feeling drunk, irritability, lethargy, peripheral coldness, apathy, decreased serum bicarbonate, presence of crystalline urine, abnormal gait test

Question 4

What precautions should be taken when using Boriel Topiramate Tablets 100 mg?

Accepted Answer

This medication is used as an antiepileptic drug for the prevention of epilepsy and migraines.

During treatment, there may be an increased risk of suicidal thoughts or suicidal behavior, so patients and caregivers should report any mood changes or symptoms of depression to a doctor immediately.

This medication may rarely cause serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so treatment should be discontinued immediately if any abnormal skin signs occur.

It may pose risks to the fetus if used during pregnancy; therefore, women who are able to become pregnant should take a pregnancy test before starting the medication and use effective contraception during treatment.

Patients with impaired kidney or liver function may experience delayed excretion of this medication, necessitating dosage adjustments. Patients undergoing dialysis should have the dosage adjusted according to dialysis conditions.

This medication can affect the central nervous system, leading to symptoms such as drowsiness, dizziness, or blurred vision; thus, it is advisable to avoid driving or operating machinery in the initial stages of treatment.

Adequate hydration is crucial, especially since there is a risk of kidney stones; sufficient fluid intake should be ensured.

This medication may interact with other drugs; therefore, patients taking other medications should inform their physician, especially women using contraceptives, as contraceptive efficacy may be compromised.

Dosage should be gradually adjusted according to the patient's condition, as sudden discontinuation may increase the risk of seizures.

Patients experiencing changes in weight, mood, or unusual behavior while on this medication should consult healthcare professionals. Periodic check-ups including blood tests and kidney function monitoring may be necessary.

Boriel Topiramate Tablets 100 mg

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