Medication info
Toramax Tablet 25mg (Topiramate)

Toramax Tablet 25mg (Topiramate)

Prescription medicationTablet
Ingredient · strength
Topiramate›25mg / 1 tablet
Manufacturer / importer
FarmGen Science Co., Ltd.
Appearance
Yellow round film-coated tablet
Packaging
30 tablets, 300 tablets/bottle
Approval status
Active

MFDS item code 200703121 · Notified 2007.03.14

Summary

Main use
Treatment of epilepsy (including partial seizures); prevention of migraine
Who uses it
Adults · Children
Adult dosage
Epilepsy monotherapy, adults (17 years and older): Begin treatment with 25㎎ in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50㎎ 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 daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses up to 1,000㎎ daily. Epilepsy adjunctive therapy, adults (17 years and older): The minimum effective dose is 200mg daily; the usual dose is 200-400mg daily, administered 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 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 the increased dose, smaller increments may be used or the interval between dose increases may be extended. The dose should be determined according to clinical response. Prevention of migraine, adults: Begin treatment with 25mg of this medicine in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, extend the interval between dose 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, with the dose and rate of titration determined according to clinical response. For 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. Patients undergoing hemodialysis: Because this medicine is removed from plasma by hemodialysis, the dose on dialysis days should be increased by approximately 1/2. The dose should be increased taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and should be divided between the beginning and end of hemodialysis. Use this medicine with caution in patients with hepatic impairment, as its clearance may be reduced.
Children's dosage
Epilepsy monotherapy, children (6-16 years): Begin treatment 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 it twice daily. If the patient has difficulty tolerating the dose increase, use smaller increments or extend the interval between increases. The dose and rate of increase 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-onset seizures. Epilepsy adjunctive therapy, 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 per day at intervals of 1-2 weeks, administered in 2 divided doses, until an appropriate clinical response is achieved. Dose titration should be determined according to clinical response. Doses up to 30mg/kg daily have been used and were generally well tolerated.

Ingredients

Manufacturer
FarmGen Science Co., Ltd.

Efficacy & effects

Treatment of epilepsy (including partial seizures); prevention of migraine

  • Secondary generalized seizures
  • partial seizures
  • seizures related to Lennox-Gastaut syndrome
  • primary generalized tonic-clonic seizures
  • migraines
View approved original text

This medication is used to treat epilepsy, specifically for the treatment of partial seizures and secondary generalized seizures in children over 6 years of age and adults as monotherapy. Additionally, it is used as an adjunct therapy for children and adults over 2 years of age whose epilepsy is not controlled by existing anticonvulsants, effective also in cases of seizures related to Lennox-Gastaut syndrome and primary generalized tonic-clonic seizures. Furthermore, it is used for the prevention of migraines, helping reduce the frequency of headaches experienced by patients and improving their quality of life. Thus, it is widely used for various seizures and migraine prevention.

Dosage and Administration

Adult dosage

Epilepsy monotherapy, adults (17 years and older): Begin treatment with 25㎎ in the evening for the first week. Thereafter, increase the total daily dose by 25 or 50㎎ 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 daily. The maximum recommended dose is 500㎎ daily. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses up to 1,000㎎ daily. Epilepsy adjunctive therapy, adults (17 years and older): The minimum effective dose is 200mg daily; the usual dose is 200-400mg daily, administered 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 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 the increased dose, smaller increments may be used or the interval between dose increases may be extended. The dose should be determined according to clinical response. Prevention of migraine, adults: Begin treatment with 25mg of this medicine in the evening for the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, extend the interval between dose 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, with the dose and rate of titration determined according to clinical response. For 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. Patients undergoing hemodialysis: Because this medicine is removed from plasma by hemodialysis, the dose on dialysis days should be increased by approximately 1/2. The dose should be increased taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and should be divided between the beginning and end of hemodialysis. Use this medicine with caution in patients with hepatic impairment, as its clearance may be reduced.

Children's dosage

Epilepsy monotherapy, children (6-16 years): Begin treatment 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 it twice daily. If the patient has difficulty tolerating the dose increase, use smaller increments or extend the interval between increases. The dose and rate of increase 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-onset seizures. Epilepsy adjunctive therapy, 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 per day at intervals of 1-2 weeks, administered in 2 divided doses, until an appropriate clinical response is achieved. Dose titration should be determined according to clinical response. Doses up to 30mg/kg daily have been used and were generally well tolerated.

Precautions

This medication is an anticonvulsant and may increase the risk of suicidal thoughts or behaviors in patients taking it. Therefore, patients or caregivers should immediately inform healthcare professionals if any symptoms of depression or mood changes occur. During the use of this medication, sudden skin rashes or severe skin reactions may occur, so if any skin abnormalities are noticed, usage should be stopped immediately and a hospital visit is necessary. Taking this medication during pregnancy may harm the fetus and increase the risk of preterm birth or low birth weight, so women who are pregnant or planning to become pregnant must consult with a doctor. Patients with impaired kidney function may have delayed drug excretion, necessitating dosage adjustments, and patients undergoing hemodialysis should also adjust the dosage according to dialysis conditions. This medication can increase the risk of kidney stone formation, so adequate hydration is necessary, and those with a history or family history of kidney stones should be particularly cautious. During the initial period of administration, central nervous system symptoms such as drowsiness, dizziness, and fatigue are common, so caution is needed when driving or operating machinery. Moreover, suddenly discontinuing this medication can exacerbate seizures, so the dosage should be gradually reduced under a doctor's guidance. This medication may interact with other anticonvulsants or multiple medications, so if any other medications are being taken, patients must inform their doctor or pharmacist. Contraceptive efficacy may be reduced, thus women of childbearing age should use effective contraceptive methods, and consulting with healthcare professionals is essential when planning a pregnancy. Regular blood tests and symptom monitoring are required during the use of this medication, and immediate consultation with healthcare professionals is necessary if any abnormal symptoms arise.

Side effects

  • Suicidal thoughts
  • suicidal behavior
  • depression
  • abnormal changes in mood and behavior
  • sudden death
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • sensory disturbances
  • hyporeflexia
  • ataxia
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  • concentration disorder
  • attention disorder
  • confusion
  • dizziness
  • fatigue
  • paresthesia
  • delirium
  • thought disturbances
  • excitement
  • emotional instability
  • loss of appetite
  • asthenia
  • confusion
  • memory impairment
  • diplopia
  • vertigo
  • language disorder
  • vocabulary selection disorder
  • nausea
  • nystagmus
  • psychomotor retardation
  • tremor
  • visual disturbances
  • weight loss
  • gait disturbances
  • aggressive reactions
  • apathy
  • perceptual disturbances
  • dysrhythmia
  • leukopenia
  • psychiatric symptoms
  • taste disturbances
  • nephrolithiasis
  • thromboembolism
  • fatigue
  • asthenia
  • back pain
  • chest pain
  • flu-like symptoms
  • leg pain
  • allergies
  • flushing
  • body odor
  • edema
  • rigidity
  • dizziness
  • ataxia
  • language disorders
  • nystagmus
  • sensory disturbances
  • tremors
  • dysrhythmia
  • hyposensitivity
  • gait abnormalities
  • involuntary muscle contractions
  • confusion
  • dizziness
  • nausea
  • dyspepsia
  • abdominal pain
  • constipation
  • gastroenteritis
  • thirst
  • gastrointestinal disturbances
  • gingivitis
  • auditory disturbances
  • weight loss
  • myalgia
  • skeletal pain
  • epistaxis
  • purpura
  • hyporeflexia
  • psychomotor retardation
  • neural hypersensitivity
  • memory impairment
  • confusion
  • depression
  • concentration disorder
  • excitement
  • mood disorders
  • aggressive reactions
  • cognitive disorders
  • decreased libido
  • apathy
  • depersonalization
  • emotional instability
  • mastalgia
  • amenorrhea
  • menorrhagia
  • abnormal menstruation
  • prostate disorders
  • infections
  • viral infections
  • candidiasis
  • rhinitis
  • pharyngitis
  • sinusitis
  • dyspnea
  • erythematous rash
  • skin disorders
  • increased sweating
  • taste abnormality
  • urinary tract infections
  • hematuria
  • urinary incontinence
  • frequent urination
  • urinary abnormalities
  • diplopia
  • visual disturbances
  • ocular pain
  • leukopenia
  • anemia
  • vasodilation
  • fever
  • syncope
  • halitosis
  • abdominal distension
  • alcohol intolerance
  • sternal chest pain
  • sudden death
  • hypertension
  • hypotension
  • orthostatic hypotension
  • tension headache
  • erectile dysfunction
  • hallucinations
  • hyperactivity
  • psychosis
  • psychomotor retardation
  • confusion
  • grand mal seizures
  • hyperactivity disorder
  • leg cramps
  • reduced reflexes
  • neurosis
  • migraine
  • akinesia
  • sensory hypersensitivity
  • movement abnormalities
  • speech disorders
  • scotoma
  • hypopsia
  • dyskinesia
  • coma
  • encephalopathy
  • fecal incontinence
  • insomnia
  • personality disorders
  • decreased libido
  • manic reactions
  • suicide attempts
  • paranoid reactions
  • 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 salivation
  • hiccups
  • gastroesophageal reflux
  • tongue edema
  • esophagitis
  • belching
  • tinnitus
  • otalgia
  • 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 phosphate enzyme
  • hypocalcemia
  • hyperlipidemia
  • acidosis
  • hyperglycemia
  • increased creatinine
  • 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 enlargement
  • eosinophilia
  • lymphocytopenia
  • leukopenia
  • lymphocytosis
  • granulocytopenia
  • thrombocytosis
  • erythrocytosis
  • bone marrow suppression
  • pancytopenia
  • intermenstrual bleeding
  • leucorrhea
  • dysmenorrhea
  • vaginitis
  • amenorrhea
  • ejaculation disorders
  • male galactorrhea
  • cough
  • bronchitis
  • asthma
  • bronchospasm
  • laryngospasm
  • acne
  • urticaria
  • alopecia
  • dermatitis
  • nail disorders
  • folliculitis
  • dry skin
  • eczema
  • skin depigmentation
  • psoriasis
  • photosensitivity reactions
  • erythematous rash
  • seborrheic dermatitis
  • decreased sweating
  • hair abnormalities
  • brown spots
  • gustatory hallucinations
  • taste loss
  • delayed taste
  • dysuria
  • nephrolithiasis
  • urinary tract infections
  • frequent urination
  • urinary incontinence
  • urinary retention
  • facial edema
  • renal colic
  • nocturia
  • albuminuria
  • polyuria
  • oliguria
  • flushing
  • venous thrombosis
  • phlebitis
  • vascular sclerosis
  • conjunctivitis
  • control disorders
  • photophobia
  • drooling
  • strabismus
  • color blindness
  • myopia
  • mydriasis
  • cataract
  • corneal opacification
  • iritis
  • leukopenia
  • allergic edema
  • hyperammonemia
  • hyperammonemia encephalopathy
  • despair
  • eye discomfort
  • angle-closure glaucoma
  • conjunctival edema
  • eye movement disorders
  • eyelid edema
  • maculopathy
  • myopia
  • cough
  • chest discomfort
  • erythema multiforme
  • periorbital edema
  • peripheral edema
  • joint swelling
  • limb discomfort
  • tubulopathy
  • renal calcification
  • systemic edema
  • influenza-like illness
  • weight gain
  • sweating
  • seizure deterioration
  • psychiatric disorders
  • decreased comprehension
  • eye fatigue

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to air and moisture, so it should be stored in a sealed container. Additionally, it is advisable to store it in a cool, dry place below 25 degrees Celsius. Proper storage will help maintain the efficacy of the medication.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets, 300 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.