Q: What precautions should be taken when using Topas Tablets 100 Milligrams (Topiramate)?

This medication may increase the risk of suicidal thoughts or behaviors, so if any changes in mood or unusual behavior occur during treatment, you should consult a doctor immediately. Patients taking this medication may have a slight increase in the risk of sudden death, although this is within the overall risk range observed in patients with epilepsy. Rarely, severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so if there are any unusual skin symptoms, you should stop taking the medication and visit a hospital immediately. Patients who are allergic to any of the components of this drug or have specific genetic lactose metabolism disorders should not take it. Special caution is needed for women who are pregnant or planning to become pregnant. Women who could become pregnant should take a pregnancy test before starting treatment, and effective contraception should be used during treatment. If pregnant, consultation with a doctor is essential as it may harm the fetus. Patients with impaired kidney or liver function may have delayed excretion of this medication, requiring dose adjustments and careful monitoring. Adequate hydration during treatment is important, and it is advisable to drink plenty of water to reduce the risk of kidney stones. This medication can cause central nervous system side effects such as drowsiness, dizziness, or blurred vision, so caution should be taken when driving or operating dangerous machinery after taking it. Abrupt discontinuation of this medication may worsen seizures, so doses should be reduced gradually according to a doctor's instructions. This medication may interact with other drugs; if you are taking other medications, be sure to inform your doctor or pharmacist. Administration of this medication to pregnant women may increase the risk of congenital malformations and low birth weight, so its use during pregnancy should be carefully considered.

Question 1

What are the indications and effects of Topas Tablets 100 Milligrams (Topiramate)?

Accepted Answer

This medicine is used for the treatment of epilepsy and is prescribed to treat partial seizures and secondary generalized seizures in children aged 6 years and older and adults. It is also effective as an adjunct therapy in cases that are not controlled by existing treatments, helping to improve various types of seizures, such as those related to Lennox-Gastaut syndrome or primary generalized tonic-clonic seizures. Additionally, it is used for the prevention of migraines, helping to improve both seizure and migraine symptoms.

Question 2

What are the dosage and administration instructions for Topas Tablets 100 Milligrams (Topiramate)?

Accepted Answer

It is preferable to start this medication at a low dose and increase it to the effective dose.
There is no need to monitor blood concentrations to optimize administration of this medication.
The recommended dose of this medication is the same for all adults and children, including elderly patients, in the absence of renal disease.
It may be administered 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 possible effect on seizure control should be considered. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, taper and discontinue the other antiepileptic drugs gradually, by approximately 1/3 every 2 weeks (see section "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 medication may need to be reduced.
Adults (17 years and older): Begin treatment with 25㎎ in the evening for the first week. Thereafter, increase the daily dose by 25 or 50㎎ at 1-2 week intervals, administered in 2 divided doses daily. If the patient has difficulty tolerating this rate of dose escalation, lengthen the intervals between increases. The dose and rate of dose escalation are 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 topiramate monotherapy at doses up to 1,000㎎ daily.
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. Begin treatment with 25-50mg in the evening for the first week; treatment may also be started at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2 week intervals, administered in 2 divided doses daily. 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: Begin treatment with 25mg of this medication 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 dose escalation, lengthen the intervals between increases. 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 dose escalation 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 to reduce the starting and maintenance doses to approximately 1/2.
- Hemodialysis patients: Since this medication is removed from plasma by hemodialysis, increase the dose of this medication 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 in divided doses at the start and end of hemodialysis.
4. Patients with hepatic impairment
Administer with caution in patients with hepatic impairment, as clearance of this medication may be decreased.

Answer

Children (6-16 years): Begin treatment 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, administered twice daily. If the patient has difficulty tolerating the dose increase, reduce the size of the dose increments or lengthen the intervals between increases. The dose and extent of dose escalation are determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg daily. Doses 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. During 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 1-2 week intervals until an appropriate clinical effect is achieved, administered in 2 divided doses. Dose titration should be determined according to clinical effect. Doses up to 30mg/kg daily have been administered and were generally well tolerated.

Question 3

What are the side effects of Topas Tablets 100 Milligrams (Topiramate)?

Accepted Answer

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, perceptual disturbances, hypesthesia, ataxia, concentration impairment, attention deficit, confusion, dizziness, fatigue, paresthesia, stupor, cognitive distortions, excitement, emotional instability, loss of appetite, asthenia, disorientation, memory impairment, diplopia, vertigo, speech disorders, word selection disorder, nausea, nystagmus, psychomotor retardation, tremor, visual disturbances, weight loss, gait disturbances, aggressive responses, apathy, perception abnormalities, harmony abnormalities, leukopenia, psychiatric symptoms, taste disorders, nephrolithiasis, thromboembolism, fatigue, asthenia, back pain, chest pain, influenza-like symptoms, limb pain, allergy, flushing, body odor, edema, rigidity, confusion, dizziness, dyspepsia, abdominal pain, constipation, gastritis, thirst, gastrointestinal disorders, gingivitis, auditory disturbances, myalgia, skeletal pain, epistaxis, purpura, hypesthesia, psychomotor retardation, neuroexcitability, memory impairment, disorientation, depression, concentration/attention disorders, excitement, mood disorders, aggressive responses, cognitive impairment, decreased libido, apathy, depersonalization, emotional instability, breast pain, amenorrhea, menorrhagia, dysmenorrhea, prostate disorders, infections, viral infections, candidiasis, rhinitis, pharyngitis, sinusitis, dyspnea, erythematous rash, skin disorders, increased sweating, taste disorders, urinary tract infections, hematuria, urinary incontinence, frequent urination, urinary abnormalities, diplopia, visual abnormalities, ocular pain, leukopenia, anemia, autonomic nervous system disorders, fever, syncope, halitosis, abdominal distention, alcohol intolerance, substernal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension headaches, erectile dysfunction, hallucinations, hypomania, psychosis, reduced motor activity, generalized seizures, hyperactivity, leg cramps, hyporeflexia, neurosis, migraine, akinesia, hyperesthesia, motor abnormalities, opposition reflex, speech disorders, scotoma, ptosis, 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, glossopharyngeal paralysis, increased libido, goiter, thyroid disorders, diarrhea, vomiting, hemorrhoids, flatulence, gastritis, gingival hyperplasia, tooth decay, stomatitis, dysphagia, melena, gastritis, increased salivation, hiccups, gastroesophageal reflux, tongue swelling, esophagitis, belching, tinnitus, ear pain, auditory hypersensitivity, angina, palpitations, AV block bradycardia, blockages, 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, elevated creatinine, hyperchloremia, dry eyes, diabetes mellitus, hypernatremia, abnormal serum folate, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, osteoarthritis, osteoporosis, basal cell carcinoma, anemia, gum bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenitis, eosinophilia, lymphocytopenia, leukopenia, lymphocytosis, neutropenia, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorders, galactorrhea in males, cough, bronchitis, asthma, bronchospasm, laryngospasm, acne, urticaria, hair loss, dermatitis, nail disorders, folliculitis, xerotic skin, eczema, skin depigmentation, psoriasis, photodermatitis, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, taste perception disorders, taste loss, dysgeusia, urinary difficulty, nephrolithiasis, urinary tract infections, frequent urination, urinary incontinence, urinary retention, facial swelling, kidney pain, nocturia, albuminuria, polyuria, oliguria, flushing, venous thrombosis, venitis, vascular rigidity, conjunctivitis, perceptual disturbances, 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 indifference, emotional blunting, crying, distraction, sexual arousal disorder, stuttering, early rising, elevated mood, feelings of elation, emotional blunting, hallucinations, auditory hallucinations, visual hallucinations, euphoric mania, early insomnia, lack of spontaneous combustion, decreased sex drive, lethargy, loss of libido, mania, intermediate insomnia, reduced climactic pleasure, panic attacks, panic disorder, panic reactions, paranoia, stubbornness, reading disability, restlessness, sleep disorders, suicidal ideation, suicide attempts, increased tearfulness, abnormal thoughts, taste loss, motor incapacity, olfactory loss, speech loss, akinetic mutism, aura, burning sensation, cerebellar syndrome, circadian rhythm sleep disorders, darkness, complex partial seizures, convulsions, decreased consciousness state, orthostatic dizziness, drooling, writing disability, motor abnormalities, muscle tension abnormalities, essential tremor, kinesthetic sensation, generalized seizures, hyperesthesia, hypersomnia, taste decline, reduced movement, olfactory decline, peripheral neuropathy, abnormal sense of smell, decreased sleep quality, excessive psychomotor activity, psychomotor skill disorder, syncope, tremors, control disorders, visual depth perception changes, amblyopia, eyelid twitching, temporary vision loss, unilateral vision loss, glaucoma, increased tear flow, pupillary dilation, night blindness, photophobia, presbyopia, scintillating scotomas, scotomas, vision decline, hearing loss, sensorineural hearing loss, unilateral hearing loss, ear discomfort, auditory impairment, bradycardia, sinoatrial bradycardia, palpitations, flushing, facial flushing, orthostatic hypotension, Raynaud's phenomenon, speech disabilities, exercise-induced dyspnea, nasal congestion, excessive secretion from sinuses, abdominal discomfort, lower abdominal pain, abdominal tenderness, halitosis, epigastric discomfort, intragastric gas retention, tongue pain, oral sensory loss, oral pain, pancreatitis, increased salivation, hypersensitivity, allergic dermatitis, erythema, maculopapular rash, skin discoloration, abnormal skin odor, facial swelling, urticaria, localized urticaria, flank pain, muscle fatigue, muscle weakness, musculoskeletal stiffness, ureterolithiasis, urolithiasis, hematuria, incontinence, urgency, nephralgia, kidney pain, sexual dysfunction, facial swelling, abnormal sensations, feeling drunk, irritability, fatigue, peripheral coldness, lethargy, decreased serum bicarbonate levels, presence of crystalline urine, abnormal walking test

Question 4

What precautions should be taken when using Topas Tablets 100 Milligrams (Topiramate)?

Accepted Answer

This medication may increase the risk of suicidal thoughts or behaviors, so if any changes in mood or unusual behavior occur during treatment, you should consult a doctor immediately.

Patients taking this medication may have a slight increase in the risk of sudden death, although this is within the overall risk range observed in patients with epilepsy.

Rarely, severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so if there are any unusual skin symptoms, you should stop taking the medication and visit a hospital immediately.

Patients who are allergic to any of the components of this drug or have specific genetic lactose metabolism disorders should not take it. Special caution is needed for women who are pregnant or planning to become pregnant.

Women who could become pregnant should take a pregnancy test before starting treatment, and effective contraception should be used during treatment. If pregnant, consultation with a doctor is essential as it may harm the fetus.

Patients with impaired kidney or liver function may have delayed excretion of this medication, requiring dose adjustments and careful monitoring.

Adequate hydration during treatment is important, and it is advisable to drink plenty of water to reduce the risk of kidney stones.

This medication can cause central nervous system side effects such as drowsiness, dizziness, or blurred vision, so caution should be taken when driving or operating dangerous machinery after taking it.

Abrupt discontinuation of this medication may worsen seizures, so doses should be reduced gradually according to a doctor's instructions.

This medication may interact with other drugs; if you are taking other medications, be sure to inform your doctor or pharmacist.

Administration of this medication to pregnant women may increase the risk of congenital malformations and low birth weight, so its use during pregnancy should be carefully considered.

Topas Tablets 100 Milligrams (Topiramate)

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Adult dosage

Children's dosage

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