Medication info

Mireidivalprostar 250 mg (Divalproex Sodium)

Prescription medicationTablet경구
Ingredient · strength
Divalproex Sodium›269.06mg / 1 tablet
Manufacturer / importer
미래바이오제약(주)
Appearance
White to off-white oval prolonged-release tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202401255 · Approved 2024.05.22

Summary

Main use
Treatment of seizures (complex partial seizures, absence seizures), prevention of migraines, treatment of mania
Who takes it
Adults · Children
Adult dose
This medication is designed for once-daily administration and should be swallowed whole without crushing or chewing. 1. Treatment of seizures - Monotherapy for complex partial seizures (initial therapy): The initial dose is 10 to 15 mg per kg body weight per day, increasing weekly by 5 to 10 mg until the optimal clinical response is achieved. The maximum recommended daily dose is 60 mg per kg body weight. If doses exceed 60 mg per kg, the safety is not established.
Child dose
Can be administered to children aged 10 and older, with doses starting at 10 to 15 mg per kg body weight per day, increasing weekly by 5 to 10 mg until the optimal clinical response is achieved.

Ingredients

Manufacturer
미래바이오제약(주)

Efficacy & effects

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

  • Complex partial seizures
  • simple absence seizures
  • mixed absence seizures
  • absence seizures
  • multiple forms of seizures
  • migraines
  • acute mania
  • mixed episodes
View approved original text

This medication is used to treat various forms of seizures in children aged 10 and older, as well as adults, particularly complex partial seizures and absence seizures, either as monotherapy or adjunctive therapy. It is also effective in preventing migraines in adults, which is separate from the acute treatment of migraines. Additionally, it is utilized for the treatment of acute mania or mixed episodes related to bipolar disorder. However, the safety and efficacy should be continuously monitored with long-term use (over 3 weeks) for the treatment of mania. It is used to improve symptoms of various neurological and psychiatric disorders.

How to take

Adult dose

This medication is designed for once-daily administration and should be swallowed whole without crushing or chewing. 1. Treatment of seizures - Monotherapy for complex partial seizures (initial therapy): The initial dose is 10 to 15 mg per kg body weight per day, increasing weekly by 5 to 10 mg until the optimal clinical response is achieved. The maximum recommended daily dose is 60 mg per kg body weight. If doses exceed 60 mg per kg, the safety is not established.

Child dose

Can be administered to children aged 10 and older, with doses starting at 10 to 15 mg per kg body weight per day, increasing weekly by 5 to 10 mg until the optimal clinical response is achieved.

Precautions

This medication requires special caution for women who are pregnant or may become pregnant, and effective contraceptive measures must be followed. In particular, this medication should not be administered during pregnancy, and those planning to become pregnant should consult a doctor to consider alternative treatments. This medication may affect liver function, therefore, patients with liver disease or a history of liver dysfunction should use it cautiously, and regular liver function tests are required before and after use. Caution is needed when administering this medication alone to children, especially those under 3 years of age, due to the risk of liver damage and pancreatitis. This medication can cause pancreatitis; if symptoms such as abdominal pain, nausea, vomiting, or appetite loss occur, immediate medical consultation is required. Blood abnormalities like thrombocytopenia may occur, so routine blood tests to check platelet levels are necessary. During treatment with this medication, there may be changes in mental health such as suicidal thoughts or behaviors and depression, so patients and caregivers should observe for these symptoms carefully. There may be interactions with other medications, especially in combination with carbapenem antibiotics or estrogen-containing compounds, so it is essential to consult a doctor. This medication can cause drowsiness or dizziness due to central nervous system depressant effects, so caution should be exercised while driving or operating dangerous machinery. Sudden discontinuation may worsen symptoms, so dosage should be tapered slowly according to a doctor's instructions. Serious side effects such as hyperammonemic encephalopathy may occur; if symptoms such as changes in consciousness, lethargy, or vomiting occur, immediate medical assistance should be sought. This medication contains lactose, so patients with lactose intolerance should not take it. Regular blood tests, liver function tests, and clinical symptom observations are crucial for monitoring adverse reactions.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by coughing and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • malaise
  • fever
  • nausea
  • vomiting
  • abdominal pain
  • diarrhea
  • loss of appetite
  • dyspepsia
  • constipation
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  • drowsiness
  • tremor
  • dizziness
  • diplopia
  • amblyopia/visual impairment
  • ataxia
  • nystagmus
  • emotional instability
  • abnormal thoughts
  • memory loss
  • influenza-like symptoms
  • infections
  • bronchitis
  • rhinitis
  • alopecia
  • weight loss
  • weight gain
  • peripheral edema
  • insomnia
  • neurosis
  • depression
  • tinnitus
  • back pain
  • vasodilation
  • dry mouth
  • bloating
  • 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 from entering, and it is safe to store it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

White to off-white oval prolonged-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.