Medication info
Atomax 25 mg (Topiramate)

Atomax 25 mg (Topiramate)

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

MFDS item code 201907140 · Approved 2019.10.09 · Insurance code 058200380

Summary

Main use
Treatment of epilepsy (partial seizures, etc.), prevention of migraine
Who takes it
Adults · Children
Adult dose
It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize the dosage of this medicine. For adults, including older adults, without renal disease, the recommended dose applies. This medicine may be taken with or without food. Tablets should be swallowed whole and not crushed. Epilepsy monotherapy, 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- to 2-week intervals and administer in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the interval between dose increases. The dose and titration rate 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 up to 1,000㎎ daily during topiramate monotherapy. Epilepsy 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 up to the maximum recommended dose of 800mg daily. Start treatment with 25-50mg in the evening during the first week; treatment may also be initiated at a lower dose. Thereafter, increase the dose by 25-50mg at 1- to 2-week intervals and administer 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 effect. 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 daily, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. Doses of up to 200mg daily may be administered; the dose and titration rate should be determined according to clinical response. 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: Since this medicine is removed from plasma by hemodialysis, increase the dose by approximately 1/2 on dialysis days. The dose should be increased taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and divided between the start and end of hemodialysis. Administer with caution in patients with hepatic impairment, as clearance of this medicine may be reduced.
Child dose
Epilepsy monotherapy, children (6-16 years): Start with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the daily dose by 0.5-1㎎/㎏ at 1- to 2-week intervals and administer twice daily. If the patient has difficulty tolerating dose increases, 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 3-6mg/kg daily. Doses up to 500㎎ daily have been used in children diagnosed with partial-onset seizures. Epilepsy adjunctive therapy, children (2 to 16 years): The recommended dose is approximately 5-9mg/kg daily, divided into 2 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- to 2-week intervals and administer in 2 divided doses until an appropriate clinical effect is achieved. Dose titration should be determined according to clinical effect. Doses up to 30mg/kg daily have been administered and were generally well tolerated.

Ingredients

Manufacturer
Ari Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of epilepsy (partial seizures, etc.), prevention of migraine

  • Secondary generalized seizures
  • partial seizures
  • seizures associated with Lennox-Gastaut syndrome
  • primary generalized tonic-clonic seizures
View approved original text

This medication is used in the treatment of epilepsy. It is used as monotherapy for treating partial seizures and secondary generalized seizures in individuals aged 6 years and older, and can also be used as an adjunctive therapy when existing medications do not control the seizures. Additionally, it is effective for seizures associated with Lennox-Gastaut syndrome and primary generalized tonic-clonic seizures. It is also used for the prevention of migraines. It is a medication that helps in the treatment of various neurological diseases and symptoms.

How to take

Adult dose

It is preferable to start this medicine at a low dose and increase it to the effective dose. Monitoring blood concentrations is not necessary to optimize the dosage of this medicine. For adults, including older adults, without renal disease, the recommended dose applies. This medicine may be taken with or without food. Tablets should be swallowed whole and not crushed. Epilepsy monotherapy, 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- to 2-week intervals and administer in 2 divided doses. If the patient has difficulty tolerating this titration schedule, extend the interval between dose increases. The dose and titration rate 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 up to 1,000㎎ daily during topiramate monotherapy. Epilepsy 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 up to the maximum recommended dose of 800mg daily. Start treatment with 25-50mg in the evening during the first week; treatment may also be initiated at a lower dose. Thereafter, increase the dose by 25-50mg at 1- to 2-week intervals and administer 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 effect. 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 daily, administered in 2 divided doses. Some patients may respond to a dose of 50mg daily. Doses of up to 200mg daily may be administered; the dose and titration rate should be determined according to clinical response. 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: Since this medicine is removed from plasma by hemodialysis, increase the dose by approximately 1/2 on dialysis days. The dose should be increased taking into account the duration of dialysis, dialyzer clearance, and the patient's renal clearance, and divided between the start and end of hemodialysis. Administer with caution in patients with hepatic impairment, as clearance of this medicine may be reduced.

Child dose

Epilepsy monotherapy, children (6-16 years): Start with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the daily dose by 0.5-1㎎/㎏ at 1- to 2-week intervals and administer twice daily. If the patient has difficulty tolerating dose increases, 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 3-6mg/kg daily. Doses up to 500㎎ daily have been used in children diagnosed with partial-onset seizures. Epilepsy adjunctive therapy, children (2 to 16 years): The recommended dose is approximately 5-9mg/kg daily, divided into 2 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- to 2-week intervals and administer in 2 divided doses until an appropriate clinical effect is achieved. Dose titration should be determined according to clinical effect. Doses up to 30mg/kg daily have been administered and were generally well tolerated.

Precautions

This medication may increase the risk of suicidal thoughts or behavior, so if any changes in mood or behavior occur during treatment, consult a doctor immediately. Patients with epilepsy taking this medication should be carefully monitored, as there is a possibility of sudden death. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, which can cause serious skin reactions, may occur, so if such symptoms appear, discontinue the medication immediately and inform healthcare personnel. Do not use this medication if you have an allergy to any of its components or have certain genetic diseases like lactose intolerance. Women who may become pregnant or are planning to become pregnant should take a pregnancy test before taking this medication and should use effective contraception while taking it. This medication can be harmful to the fetus during pregnancy, so consulting a doctor is essential. Patients with impaired kidney or liver function should adjust dosages while carefully observing drug effects and side effects. This medication can cause central nervous system symptoms such as drowsiness, dizziness, and blurred vision, so caution should be taken when driving or operating dangerous machinery after taking it. Adequate hydration is important, and since there is a risk of kidney stones, it is advisable to drink plenty of water. Changes in weight or appetite may occur during medication, so if such symptoms arise, consult healthcare personnel. This medication may interact with other drugs, so it's crucial to inform your doctor or pharmacist if you are taking other medications. Suddenly stopping this medication may worsen seizures, so dosages should be gradually reduced following a doctor's instructions. This medication can reduce sweating and impact body temperature regulation; thus, caution is required, especially in hot weather. A condition called hyperammonemia may occur, which can lead to drowsiness or changes in consciousness; therefore, inform healthcare personnel immediately if such symptoms arise. It is essential to have regular medical check-ups while taking this medication to monitor for any abnormal symptoms.

Side effects

  • Suicidal ideation
  • suicidal behavior
  • depression
  • abnormal changes in mood and behavior
  • sudden death
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • perceptual disturbances
  • stupor
  • ataxia
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  • concentration disorders
  • attention disorders
  • confusion
  • dizziness
  • fatigue
  • paresthesia
  • clouding of consciousness
  • thought disturbances
  • agitation
  • emotional instability
  • decreased appetite
  • asthenia
  • confusion
  • memory impairment
  • diplopia
  • vertigo
  • language disorders
  • word selection disorders
  • nausea
  • nystagmus
  • psychomotor retardation
  • tremor
  • visual disturbances
  • weight loss
  • gait disorders
  • aggressive reactions
  • emotional blunting
  • perceptual disorders
  • harmony disturbances
  • leukopenia
  • psychiatric symptoms
  • taste disturbances
  • kidney stones
  • thrombosis
  • fatigue
  • asthenia
  • back pain
  • chest pain
  • influenza-like symptoms
  • leg pain
  • allergies
  • flushing
  • body odor
  • edema
  • rigidity
  • dizziness
  • ataxia
  • language disorders
  • nystagmus
  • perceptual disturbances
  • tremor
  • harmony disturbances
  • sensory deficit
  • gait anomalies
  • involuntary muscle contractions
  • stupor
  • dizziness
  • nausea
  • dyspepsia
  • abdominal pain
  • constipation
  • gastroenteritis
  • thirst
  • gastrointestinal disturbances
  • gingivitis
  • auditory disturbances
  • weight loss
  • myalgia
  • skeletal pain
  • nasal bleeding
  • purpura
  • stupor
  • psychomotor retardation
  • neuroexcitability
  • memory impairment
  • confusion
  • depression
  • concentration/attention disorders
  • decreased appetite
  • agitation
  • mood disorders
  • aggressive reactions
  • perceptual disorders
  • decreased libido
  • emotional blunting
  • depersonalization
  • emotional instability
  • breast pain
  • amenorrhea
  • heavy menstrual bleeding
  • 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
  • urinary abnormalities
  • diplopia
  • visual disturbances
  • eye pain
  • leukopenia
  • anemia
  • autonomic nervous system disorders
  • fever
  • syncope
  • halitosis
  • abdominal distension
  • alcohol intolerance
  • sternal pain
  • sudden death
  • hypertension
  • hypotension
  • orthostatic hypotension
  • anxiety
  • erectile dysfunction
  • hallucinations
  • hyperactivity
  • psychosis
  • exercise intolerance
  • stupor
  • generalized seizures
  • hyperactivity
  • leg cramps
  • hypo-reflexia
  • neurosis
  • migraine
  • akinesia
  • hypersensitivity
  • movement disorders
  • oppositional defiance
  • speech disorders
  • scotoma
  • hypotonia
  • dystonia
  • coma
  • encephalopathy
  • fecal incontinence
  • insomnia
  • personality disorders
  • decreased libido
  • manic responses
  • suicide attempts
  • paranoid symptoms
  • 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
  • hypersalivation
  • hiccups
  • gastroesophageal reflux
  • tongue swelling
  • esophagitis
  • belching
  • tinnitus
  • otalgia
  • auditory hypersensitivity
  • angina
  • palpitations
  • AV block bradycardia
  • atrioventricular block
  • arrhythmia
  • atrial arrhythmia
  • atrial fibrillation
  • elevated SGPT
  • elevated SGOT
  • gallbladder disorders
  • elevated gamma-GT
  • dehydration
  • weight gain
  • thirst
  • hypokalemia
  • elevated alkaline phosphatase
  • hypocalcemia
  • hyperlipidemia
  • acidosis
  • hyperglycemia
  • elevated creatinine
  • hyperchloremia
  • dry eyes
  • diabetes
  • hypernatremia
  • abnormal serum folate levels
  • hyponatremia
  • hypocholesterolemia
  • hypoglycemia
  • hypophosphatemia
  • arthralgia
  • muscle weakness
  • arthrosis
  • osteoporosis
  • basal cell carcinoma
  • anemia
  • gum bleeding
  • thrombocytopenia
  • pulmonary embolism
  • lymphadenopathy
  • lymphadenitis
  • eosinophilia
  • lymphocytopenia
  • leukopenia
  • lymphocytosis
  • granulocytopenia
  • 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
  • phototoxic reactions
  • erythematous rash
  • seborrheic dermatitis
  • decreased sweating
  • hair abnormalities
  • brown spots
  • gustatory dysfunction
  • taste loss
  • tactile distortion
  • dysuria
  • kidney stones
  • urinary tract infections
  • frequent urination
  • urinary incontinence
  • urinary retention
  • facial edema
  • renal colic
  • nocturia
  • albuminuria
  • polyuria
  • oliguria
  • flushing
  • venous thrombosis
  • phlebitis
  • vascular sclerosis
  • conjunctivitis
  • dysregulation
  • glare
  • overflow tears
  • strabismus
  • color blindness
  • myopia
  • mydriasis
  • cataract
  • corneal opacity
  • iritis
  • nasopharyngitis
  • neutropenia
  • allergic edema
  • hyperammonemia
  • hyperammonemia-related encephalopathy
  • feelings of hopelessness
  • abnormal sensations in the eyes
  • closed-angle glaucoma
  • conjunctival edema
  • ocular motility disorders
  • eyelid edema
  • macular disease
  • myopia
  • cough
  • chest discomfort
  • erythema multiforme
  • periorbital edema
  • peripheral edema
  • joint swelling
  • limb discomfort
  • tubular acidosis
  • nephrocalcinosis
  • systemic edema
  • influenza-like illness
  • weight gain
  • diaphoresis
  • worsening of epilepsy
  • psychiatric disorders
  • decreased comprehension
  • eye fatigue
  • asthenia
  • chest discomfort
  • peripheral edema
  • edema
  • chest pain
  • sensory alterations
  • dizziness
  • headache
  • drowsiness
  • perceptual disturbances
  • hypersomnia
  • tremor
  • dizziness
  • sedation
  • language disturbances
  • dystonia
  • eye pain
  • blurred vision
  • decreased appetite
  • menstrual irregularities
  • thrombocytopenia
  • surgical extension of hospitalization
  • decreased sweating
  • elevated body temperature
  • hyperammonemia-related encephalopathy
  • hypersomnia
  • vomiting
  • altered level of consciousness
  • cognitive function change
  • hyperammonemia
  • hypothermia
  • hypersomnia
  • confusion
  • coma
  • cardiovascular abnormalities
  • respiratory system abnormalities
  • decreased prothrombin time
  • decreased INR
  • worsening of epilepsy
  • psychiatric disorders
  • decreased comprehension

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

Storage

This medication should be stored in a sealed container to prevent exposure to air and moisture. Additionally, it is important to store it in a cool and dry place below 25 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 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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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.