Q: What precautions should be taken when using Hanwha Topiramate Tablets 25 mg?

This medication is used for the prevention of epilepsy and migraines. During treatment, thoughts of suicide or suicidal behavior may increase, thus patients and caregivers must inform healthcare professionals immediately if such symptoms occur. Sudden skin rashes or severe skin reactions may occur during treatment, so if any skin abnormalities appear, the medication should be discontinued immediately and healthcare advice should be sought. It can be harmful to the fetus during pregnancy; hence, women of childbearing potential should take a pregnancy test before starting the medication and use effective contraception while taking it. Patients with impaired kidney or liver function may experience slowed drug excretion, thus dosage adjustment is necessary, and adequate hydration is required to prevent kidney stones. Central nervous system-related side effects such as drowsiness, dizziness, or blurred vision may occur when taking this medication, thus it is advised to refrain from driving or operating machinery until accustomed to the medication. This medication may interact with other antiepileptic drugs or various medications; hence, it is crucial to inform healthcare professionals of any medications being taken concurrently. Abrupt discontinuation may trigger seizures, so it is essential to taper the dose according to healthcare guidance. During treatment, psychiatric symptoms such as weight loss, loss of appetite, depression, and decreased concentration may occur, and patients should consult healthcare professionals if any unusual symptoms arise. Nursing mothers should discuss with healthcare professionals as this medication may be excreted in breast milk.

Question 1

What are the indications and effects of Hanwha Topiramate Tablets 25 mg?

Accepted Answer

This medication is used to treat epilepsy. It can treat partial seizures or secondary generalized seizures in children over 6 years of age and adults as monotherapy. It is also used as an adjunct therapy in patients over 2 years old where existing treatments are inadequate, proving effective for seizures associated with Lennox-Gastaut syndrome and primary generalized tonic-clonic seizures. Additionally, it helps in the prevention of migraines. It is used for various seizures and for migraine prevention.

Question 2

What are the dosage and administration instructions for Hanwha Topiramate Tablets 25 mg?

Accepted Answer

It is preferable to start this medicine at a low dose and increase it to an effective dose.

Monitoring plasma concentrations is not necessary to optimize treatment with this medicine.

The recommended dose of this medicine applies equally to all adults and children, including elderly patients, provided they do not have renal disease.

It may be administered 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 at 2-week intervals (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 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 total 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 schedule, the interval between dose increases should be extended. 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 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. 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 1-2-week intervals and administer in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller dose increases may be made or the interval between increases may be extended. The dose should be determined according to clinical effect.

2. Migraine prevention
Adults: Start with 25mg of this medicine in the evening for the first week. Thereafter, increase by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, extend the interval between increases. The recommended daily dose is 100mg, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. Doses 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), reducing the starting and maintenance doses to approximately 1/2 is recommended.
- Patients on hemodialysis: Because this medicine is removed from plasma by hemodialysis, the dose on dialysis days should be increased by approximately 1/2. Increase the dose taking into account the duration of dialysis, dialyzer clearance, and the patient's residual renal clearance, and administer the dose in divided portions at the beginning 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㎎/㎏ in the evening for the first week. Thereafter, increase the total daily dose by 0.5-1㎎/㎏ at 1-2-week intervals and administer in 2 doses daily. If the patient has difficulty tolerating the increase, reduce the size of the dose increments or extend the interval 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. 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 by 1-3mg/kg daily at 1-2-week intervals until an appropriate clinical effect is achieved, administering 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 Hanwha Topiramate Tablets 25 mg?

Accepted Answer

Suicidal ideation, suicidal behavior, depression, abnormal mood and behavior changes, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, paresthesia, hyperesthesia, ataxia, concentration disorder, attention disorder, confusion, dizziness, fatigue, paresthesia, lethargy, abnormal thought, agitation, emotional instability, loss of appetite, asthenia, disorientation, memory impairment, diplopia, vertigo, speech impairment, word selection disorder, nausea, nystagmus, psychomotor retardation, tremor, visual disturbances, weight loss, walking disability, aggressive responses, flat affect, perceptual disturbances, dysesthesia, leukopenia, psychotic symptoms, taste disturbances, renal stones, thromboembolism, fatigue, asthenia, back pain, chest pain, influenza-like symptoms, leg pain, allergies, flushing, body odor, edema, rigidity, dizziness, ataxia, speech impairment, nystagmus, paresthesia, tremor, dysesthesia, sensory deficit, gait abnormalities, involuntary muscle contractions, confusion, syncope, nausea, dyspepsia, abdominal pain, constipation, gastroenteritis, thirst, gastrointestinal disturbances, gingivitis, hearing abnormalities, weight loss, myalgia, skeletal pain, epistaxis, purpura, hyperesthesia, psychomotor retardation, nervousness, memory impairment, disorientation, depression, concentration/attention disorder, loss of appetite, agitation, mood disorders, aggressive responses, personality disorders, flat affect, depersonalization, emotional instability, breast pain, amenorrhea, heavy menstruation, menstrual irregularities, prostate 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, eye pain, leukopenia, anemia, autonomic nervous system disorders, vasodilation, fever, syncope, halitosis, abdominal distention, alcohol intolerance, substernal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension headache, erectile dysfunction, hallucinations, dysphoria, psychosis, motor retardation, confusion, generalized tonic-clonic seizure, hyperactivity, leg cramps, reflex hypoactivity, neurosis, migraine, akinesia, hypersensitivity, movement disorders, paroxysmal dyskinesia, speech impairment, scotoma, hypoplasia, dystonia, coma, encephalopathy, fecal incontinence, insomnia, personality disorders, decreased libido, manic responses, suicide attempts, paranoid responses, increased appetite, delusions, paranoia, delirium, abnormal dreams, EEG abnormalities, cerebellar syndrome, lingual paralysis, increased libido, goiter, thyroid disorders, diarrhea, vomiting, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, dental caries, stomatitis, swallowing disorders, melena, gastritis, increased salivation, hiccups, gastroesophageal reflux, tongue swelling, esophagitis, belching, tinnitus, ear pain, auditory hypersensitivity, angina pectoris, palpitations, AV block bradycardia, heart block, arrhythmia, atrial arrhythmia, atrial fibrillation, elevated SGPT, elevated SGOT, gallbladder disorders, elevated gamma-GT, dehydration, weight gain, thirst, hypokalemia, increased alkaline phosphatase, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, increased creatinine, hyperchloremia, dry eye syndrome, diabetes mellitus, hypernatremia, abnormal serum folate, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthritis, osteoporosis, basal cell carcinoma, anemia, gum bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenopathy, eosinophilia, lymphopenia, lymphocytosis, neutropenia, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorders, 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 disorders, brown spots, taste dysesthesia, ageusia, tactile disturbances, dysuria, renal stones, urinary tract infections, polyuria, urinary incontinence, urinary retention, facial edema, renal colic, nocturnal enuresis, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular constriction, conjunctivitis, dysregulation, glare, lagophthalmos, strabismus, color blindness, myopia, mydriasis, cataracts, corneal opacities, iritis, leukopenia, lymphadenopathy, thrombocytopenia, hypersensitivity, hyperchloremic acidosis, hypokalemia, increased appetite, metabolic acidosis, polydipsia, abnormal behaviors, sexual indifference, emotional blunting, crying, distractibility, sexual arousal disorder, stuttering, early awakening, elevated mood, euphoria, affective blunting, hallucinations, auditory hallucinations, visual hallucinations, hypomania, early insomnia, lack of spontaneous combustion, decreased libido, drowsiness, anhedonia, hypomania, mid-insomnia, diminished climax sensation, panic attacks, panic disorder, panic responses, paranoia, obstinacy, reading disorder, restlessness, sleep disorders, suicidal ideation, suicide attempts, increased tear production, abnormal thoughts, ageusia, loss of motor function, anosmia, aphasia, akinetic mutism, prodrome, burning sensation, cerebellar syndrome, circadian rhythm sleep disorder, darkening, complex partial seizure, convulsion, decreased level of consciousness, orthostatic dizziness, drooling, writing disorder, movement disorders, speech impairment, muscle tone disorders, essential tremor, depersonalization, generalized tonic-clonic seizure, hypersensitivity, hypersomnia, taste decline, decreased activity, olfactory decline, peripheral neuropathy, abnormal olfaction, decreased sleep quality, seizure prodrome, repetitive language, sensory disorders, sensory loss, confusion, syncope, lack of reaction to stimuli, dysregulation, visual depth perception changes, amblyopia, eyelid spasm, temporary vision loss, unilateral vision loss, glaucoma, increased tear production, mydriasis, night blindness, photophobia, presbyopia, scintillating scotoma, scotoma, decreased vision, hearing loss, sensorineural hearing loss, unilateral hearing loss, ear discomfort, auditory disorders, bradycardia, parasympathetic bradycardia, palpitations, flushing, facial flushing, orthostatic hypotension, Raynaud's phenomenon, speech impairment, exercise-induced dyspnea, nasal obstruction, excessive sinus secretion, abdominal discomfort, lower abdominal pain, abdominal tenderness, halitosis, epigastric discomfort, gastroenteritis, lingual pain, oral sensory loss, oral pain, pancreatitis, excessive salivation, infinity syndrome, allergic dermatitis, erythema, maculopapular rash, skin discoloration, abnormal skin odor, facial swelling, urticaria, localized urticaria, side pain, muscle fatigue, muscle weakness, musculoskeletal rigidity, ureteral stones, urinary calculi, hematuria, incontinence, urgency, renal colic, renal pain, abnormal sensations, high fever, lethargy, laziness, abnormal sensations in the eyes, angle-closure glaucoma, conjunctival edema, eye movement disorder, eyelid edema, maculopathy, myopia, cough, chest discomfort, erythema multiforme, periorbital edema, peripheral edema, joint swelling, limb discomfort, renal tubular acidosis, nephrocalcinosis, generalized edema, influenza-like disease, weight gain, cold sweats, eye fatigue, chest discomfort, peripheral edema, sensory abnormalities, dizziness, headache, drowsiness, perceptual abnormalities, hypersomnia, tremor, syncope, sedation, speech impairment, dystonia, suicidal impulses, suicidal behavior, depression, early labor, preterm delivery, fetal injury, fetal growth restriction, low birth weight infant, low birth weight, mania, suicide attempts, suicidal ideation, suicide attempts, suicidal impulses, suicidal behavior, suicidal predictions, suicide risk, suicidal impulses, suicidal behavior, suicide attempts, suicidal ideation, suicide attempts, suicidal impulses, suicidal behavior, suicide attempts, suicidal ideation, suicide attempts, suicidal impulses, suicidal behavior, suicide attempts, suicidal ideation, suicide attempts, suicidal impulses, suicidal behavior, suicide attempts, suicidal ideation, suicide attempts, suicidal impulses, suicidal behavior, suicide attempts, suicidal ideation, suicide attempts, suicidal impulses, suicidal behavior, suicide attempts, suicidal ideation, suicide attempts, suicidal impulses, suicidal behavior, suicide attempts, suicidal ideation, suicide attempts, suicidal impulses, suicidal behavior, suicide attempts, suicidal ideation, suicide attempts, suicidal impulses, suicidal behavior, 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Question 4

What precautions should be taken when using Hanwha Topiramate Tablets 25 mg?

Accepted Answer

This medication is used for the prevention of epilepsy and migraines.

During treatment, thoughts of suicide or suicidal behavior may increase, thus patients and caregivers must inform healthcare professionals immediately if such symptoms occur.

Sudden skin rashes or severe skin reactions may occur during treatment, so if any skin abnormalities appear, the medication should be discontinued immediately and healthcare advice should be sought.

It can be harmful to the fetus during pregnancy; hence, women of childbearing potential should take a pregnancy test before starting the medication and use effective contraception while taking it.

Patients with impaired kidney or liver function may experience slowed drug excretion, thus dosage adjustment is necessary, and adequate hydration is required to prevent kidney stones.

Central nervous system-related side effects such as drowsiness, dizziness, or blurred vision may occur when taking this medication, thus it is advised to refrain from driving or operating machinery until accustomed to the medication.

This medication may interact with other antiepileptic drugs or various medications; hence, it is crucial to inform healthcare professionals of any medications being taken concurrently.

Abrupt discontinuation may trigger seizures, so it is essential to taper the dose according to healthcare guidance.

During treatment, psychiatric symptoms such as weight loss, loss of appetite, depression, and decreased concentration may occur, and patients should consult healthcare professionals if any unusual symptoms arise.

Nursing mothers should discuss with healthcare professionals as this medication may be excreted in breast milk.

Hanwha Topiramate Tablets 25 mg

Summary

Ingredients

Efficacy & effects

Dosage and Administration

Adult dosage

Children's dosage

Precautions

Side effects

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Appearance

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