Medication info

Mireadivalproate Extended-release Tablets 500 mg (Sodium Divalproate)

Prescription medicationTablet경구
Ingredient · strength
Divalproex Sodium›538.12mg / 1 tablet
Manufacturer / importer
미래바이오제약(주)
Appearance
Gray oval extended-release tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202400190 · Approved 2024.01.24

Summary

Main use
Treatment of seizures (complex partial seizures, absence seizures), migraine prevention, treatment of mania
Who takes it
Adults · Children
Adult dose
This medication is intended for once daily administration and should be swallowed whole without breaking or chewing the tablets. For seizure treatment, it is usable in children over 10 years and adults, with an initial dose of 10 to 15 mg per kg of body weight, increasing weekly by 5 to 10 mg according to optimal clinical response. The recommended final dose is 60 mg or less per kg of body weight per day. For migraine prevention, 500 mg once daily for one week is given followed by 1
Child dose
Can be administered to children over 10 years. The initial dosage is 10 to 15 mg per kg of body weight, increased weekly by 5 to 10 mg according to optimal clinical response. The final dosage is 60 mg per kg of body weight per day.

Ingredients

Manufacturer
미래바이오제약(주)

Efficacy & effects

Treatment of seizures (complex partial seizures, absence seizures), migraine prevention, treatment of mania

  • Complex partial seizures
  • simple absence seizures
  • mixed absence seizures
  • various forms of seizures including absence seizures
  • migraines
  • mania
  • acute mania with or without psychotic features
  • mixed episodes
View approved original text

This medication is used as monotherapy or adjunctive therapy for the treatment of complex partial seizures and simple and mixed absence seizures in children and adults over 10 years old. Additionally, it is used as adjunctive therapy for multiple types of seizures including absence seizures in children and adults over 10 years old. For adults, it is effective in preventing migraines, primarily used for prevention rather than acute treatment. Moreover, it is utilized in the treatment of acute mania and mixed episodes associated with bipolar disorder in adults, whether or not accompanied by psychotic features. However, long-term use beyond three weeks for mania treatment has not established sufficient safety and efficacy, and continuous assessment of the patient's condition should be conducted during long-term use. This medication is effective for seizures, migraines, and mania.

How to take

Adult dose

This medication is intended for once daily administration and should be swallowed whole without breaking or chewing the tablets. For seizure treatment, it is usable in children over 10 years and adults, with an initial dose of 10 to 15 mg per kg of body weight, increasing weekly by 5 to 10 mg according to optimal clinical response. The recommended final dose is 60 mg or less per kg of body weight per day. For migraine prevention, 500 mg once daily for one week is given followed by 1

Child dose

Can be administered to children over 10 years. The initial dosage is 10 to 15 mg per kg of body weight, increased weekly by 5 to 10 mg according to optimal clinical response. The final dosage is 60 mg per kg of body weight per day.

Precautions

This medication requires special caution in pregnant women or women of childbearing potential, and strict adherence to pregnancy prevention programs is necessary. Even if the patient is not pregnant, this medication should not be administered to patients with impaired liver function or pancreatic issues. Regular liver function and blood tests should be performed during the course of this medication, especially during the first 6 months. This medication may increase the risk of suicidal thoughts or behaviors, so careful observation for mood changes or unusual behaviors is necessary during treatment. Additionally, this medication can cause serious side effects such as hepatotoxicity and pancreatitis; if abdominal pain, nausea, or vomiting occurs, immediate consultation with a healthcare professional is required. Thrombocytopenia may occur, so if there is a tendency to bleed or easy bruising, it should be reported immediately. This medication may interact with other drugs, so patients on carbapenem antibiotics or estrogen-containing preparations should definitely consult a physician. Elderly or pediatric patients require dosage adjustments and caution; sudden discontinuation may risk worsening seizures, so tapering should be gradual. Due to its central nervous system depressant effects, this medication may cause drowsiness, so it is advisable to avoid driving or operating hazardous machinery after taking it. Patients and caregivers should fully understand the side effects and cautions of this medication and promptly inform healthcare providers of any unusual symptoms.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination

Mild side effects

  • Headache
  • weakness
  • fever
  • nausea
  • vomiting
  • abdominal pain
  • diarrhea
  • loss of appetite
  • dyspepsia
  • constipation
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  • drowsiness
  • tremor
  • dizziness
  • diplopia
  • amblyopia/blurred vision
  • ataxia
  • nystagmus
  • emotional instability
  • abnormal thoughts
  • amnesia
  • flu-like symptoms
  • infections
  • bronchitis
  • rhinitis
  • alopecia
  • weight loss
  • weight gain
  • peripheral edema
  • insomnia
  • neurosis
  • depression
  • pharyngitis
  • tinnitus
  • incidental injury
  • low back pain
  • vasodilation
  • stomatitis

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture entry and at a temperature between 1 degree to 30 degrees Celsius. This storage method helps maintain the medication's efficacy.

Appearance and packaging

Appearance

Gray oval extended-release tablets

Package unit

30 tablets/bottle, 100 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.