Medication info
Divalproex Extended Release 250 mg (Divalproex Sodium)

Divalproex Extended Release 250 mg (Divalproex Sodium)

Prescription medicationTablet경구
Ingredient · strength
Divalproex Sodium›269.05mg / 1 tablet
Manufacturer / importer
(주)한국파마
Appearance
White to off-white oval extended-release coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202303449 · Approved 2023.12.27 · Insurance code 653006930

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 taken once daily and should be swallowed whole, not crushed or chewed. The initial dose for monotherapy of complex partial seizures is 10–15 mg per kg of body weight per day, increasing by 5–10 mg per kg each week. Typically, optimal clinical response occurs at a dose of less than 60 mg per kg per day. The initial dose for simple and mixed absence seizures is 15 mg per kg of body weight per day and should be increased by 5–10 mg per kg at weekly intervals until appropriate response is achieved.
Child dose
This medication can be administered to children aged 10 and older, with the starting dose for monotherapy of complex partial seizures being 10–15 mg per kg of body weight per day, increasing to 5–10 mg per kg at weekly intervals.

Ingredients

Manufacturer
(주)한국파마

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
  • various forms of seizures
  • migraines
  • mania
  • acute mania associated with bipolar disorder with or without psychotic features
  • mixed episodes
View approved original text

This medication is used for treating various forms of seizures in children over 10 years of age and adults, particularly complex partial seizures and simple and mixed absence seizures. It is effective as monotherapy or adjunctive therapy for these seizures. It also aids in the prevention of migraines in adults, but evidence is lacking for acute migraine treatment. Furthermore, it is utilized in treating acute mania or mixed episodes associated with bipolar disorder, regardless of the presence of psychotic features, and its efficacy and safety should be continuously assessed during long-term use. Thus, this medication is widely used for seizures, migraine prevention, and mania treatment.

How to take

Adult dose

This medication is taken once daily and should be swallowed whole, not crushed or chewed. The initial dose for monotherapy of complex partial seizures is 10–15 mg per kg of body weight per day, increasing by 5–10 mg per kg each week. Typically, optimal clinical response occurs at a dose of less than 60 mg per kg per day. The initial dose for simple and mixed absence seizures is 15 mg per kg of body weight per day and should be increased by 5–10 mg per kg at weekly intervals until appropriate response is achieved.

Child dose

This medication can be administered to children aged 10 and older, with the starting dose for monotherapy of complex partial seizures being 10–15 mg per kg of body weight per day, increasing to 5–10 mg per kg at weekly intervals.

Precautions

This medication should not be administered to pregnant women or women of childbearing age due to the risk of congenital malformations and developmental disorders in the fetus. Effective contraception must be used while taking this medication, and immediate consultation with a doctor is necessary if pregnancy is planned or confirmed. Concomitant use with estrogen-containing hormonal contraceptives can lower the blood concentration of this medication, so the physician may carefully monitor therapeutic response and may check blood concentrations if necessary. The use of this medication can lead to suicidal thoughts, depression, mood changes, and other mental health issues; it is important to notify healthcare professionals immediately if such symptoms occur. Significant hepatic damage may occur, especially in patients under 3 years of age or with liver disease, and this medication should be used cautiously in these patients, with regular liver function tests during the first six months of treatment. Pancreatitis may develop, so immediate medical attention is required if symptoms such as abdominal pain, nausea, vomiting, or loss of appetite occur. Patients with urea cycle disorders are at risk for hyperammonemic encephalopathy when using this medication; confirmation of any urea cycle disorder is necessary before administration. The elderly may experience greater sensitivity to drowsiness and dehydration, so dosing should be adjusted slowly, and hydration and unusual symptoms should be carefully monitored. Thrombocytopenia may occur, increasing the risk of bleeding, so regular blood tests are needed to monitor platelet levels. This medication should not be taken concurrently with certain antibiotics (carbapenems) as it may reduce the blood level, leading to diminished therapeutic efficacy. Avoid sudden changes in dosage while on this medication, as CNS depressant effects may lead to drowsiness, which necessitates caution when driving or operating hazardous machinery. Additionally, this medication may cause various side effects, so prompt consultation with healthcare professionals is essential if any unusual symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweats, paleness, severe rash with fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, breathlessness, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • lethargy
  • fever
  • nausea
  • vomiting
  • abdominal pain
  • diarrhea
  • loss of appetite
  • dyspepsia
  • constipation
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  • drowsiness
  • tremors
  • dizziness
  • diplopia
  • amblyopia/blurred vision
  • ataxia
  • nystagmus
  • emotional instability
  • abnormal thoughts
  • memory loss
  • flu-like syndrome
  • infections
  • bronchitis
  • rhinitis
  • alopecia
  • weight loss
  • weight gain
  • peripheral edema
  • insomnia
  • neurosis
  • tinnitus
  • back pain
  • chest pain
  • vasodilation
  • dry mouth
  • bloating
  • oral mucositis

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

Storage

Store this medication in a tightly closed container to prevent exposure to air and moisture. It is important to maintain storage temperatures between 1°C and 30°C at room temperature.

Appearance and packaging

Appearance

White to off-white oval extended-release coated tablet

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.