Medication info

Valproin A Soft Capsule (Valproate)

Prescription medicationApproval withdrawn
Ingredient · strength
Valproic Acid›500mg / 1 capsule
Manufacturer / importer
Hankook Pharmaceutical Co., Ltd.
Appearance
Brownish rectangular soft capsule filled with a transparent oily substance
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Approval withdrawn

MFDS item code 199502679 · Notified 1995.03.04

This product's status changed to Approval withdrawn on 2024.12.13. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention and treatment of epilepsy (absence seizures, partial seizures, etc.) and associated personality and behavioral disorders
Who uses it
Adults · Children
Adult dosage
If the maximum daily dose exceeds 250㎎, administer in divided doses. In patients who experience gastrointestinal irritation, it is preferable to administer with food or to start at a low initial dose and increase it gradually. To avoid irritation of the mouth and throat, swallow this drug without chewing. Adjust the dose as appropriate according to age and symptoms.
Children's dosage
Administer valproic acid orally at an initial dose of 15㎎/kg of body weight per day, increasing by 5-10㎎/kg of body weight per day at intervals of 1 week until seizures are controlled or adverse effects occur with further dose increases. The maximum dose is 30㎎/kg of body weight per day.

Ingredients

Manufacturer
Hankook Pharmaceutical Co., Ltd.

Efficacy & effects

Prevention and treatment of epilepsy (absence seizures, partial seizures, etc.) and associated personality and behavioral disorders

  • Absence seizures
  • simple partial seizures
  • complex partial seizures
  • generalized seizures
  • complex partial seizures
  • behavioral disorders
  • psychotic disorders
View approved original text

This medication is used to treat various forms of epilepsy, such as absence seizures, partial seizures, complex partial seizures, and generalized seizures. It also helps prevent and treat behavioral disturbances caused by epilepsy. It is effective in reducing patients' seizures and alleviating mental symptoms, thus improving quality of life.

Dosage and Administration

Adult dosage

If the maximum daily dose exceeds 250㎎, administer in divided doses. In patients who experience gastrointestinal irritation, it is preferable to administer with food or to start at a low initial dose and increase it gradually. To avoid irritation of the mouth and throat, swallow this drug without chewing. Adjust the dose as appropriate according to age and symptoms.

Children's dosage

Administer valproic acid orally at an initial dose of 15㎎/kg of body weight per day, increasing by 5-10㎎/kg of body weight per day at intervals of 1 week until seizures are controlled or adverse effects occur with further dose increases. The maximum dose is 30㎎/kg of body weight per day.

Precautions

This medication may cause serious fetal malformations in pregnant women; therefore, it should not be taken by women who are pregnant or of childbearing potential unless a special precautionary program is followed. Women taking this medication must use effective pregnancy prevention methods and should immediately consult medical professionals if pregnancy is planned or occurs. It may affect liver function, so particularly children or those with a history of liver disease should regularly undergo liver function tests before and after administration. This medication can rarely cause severe liver damage or pancreatitis; thus, should any abnormal symptoms such as abdominal pain, vomiting, or malaise occur, inform a doctor immediately. It may affect mental health, therefore both patients and caregivers should keenly observe for any changes such as suicidal thoughts or behaviors or symptoms of depression. As there are many interactions with other medications, patients must inform their doctor or pharmacist of any other medications being taken, particularly when combined with hormonal contraceptives, antibiotics, or antidepressants. Due to its central nervous system depressant effects, drowsiness or dizziness may occur; therefore, driving or operating hazardous machinery should be avoided. There may be a risk of bleeding disorders; if any bleeding symptoms or easy bruising occur, consulting a medical professional immediately is advised. Children, especially those under 3 years of age, are at greater risk for liver damage; hence should be administered cautiously as monotherapy and combined use with salicylate derivatives should be avoided. In case of overdose, symptoms such as coma, confusion, or muscle weakness may occur, hence strict adherence to prescribed dosage is essential, and in doubt, immediate emergency treatment must be sought. When stored, keep out of reach of children and ensure not to transfer to other containers.

Side effects

Changes in liver function test results, severe liver damage, increased seizure frequency, clouding of consciousness, lethargy, coma, cognitive impairment, symptoms of dementia, Parkinson's disease, orthostatic microtremors, drowsiness, sedative effects, tremors, ataxia, headache, confusion, convulsions, hyponatremia, hallucinations, dizziness, insomnia, anxiety, visual disturbance, nystagmus, double vision, inability to maintain fixed posture, phenomenon of seeing spots in front of eyes, dysarthria, sensory changes, excessive salivation, coma, hyperammonemia, impaired consciousness, suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, increased appetite, abnormal weight gain, abdominal pain, loss of appetite, discomfort in the upper abdomen, constipation, stomatitis, nausea, abdominal pain, vomiting, diarrhea, pancreatitis, irregular menstruation, secondary amenorrhea, polycystic ovary syndrome, breast enlargement, galactorrhea, hyperandrogenemia, abnormal thyroid function tests, hair loss, hair discoloration, curly hair, skin rash, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exanthematous erythema, weakness, decreased fibrinogen, decreased coagulation factor VIII, prolonged bleeding time, hyperglycinemia, anemia, macrocytosis, pancytopenia, leukopenia, thrombocytopenia, hemolytic anemia, macrocytic anemia, granulocytopenia, eosinophilia, reduced platelet aggregation, lymphocytopenia, neutropenia, petechiae, contusion, hematoma formation, genuine bleeding, pure red cell aplasia, bone marrow failure, hearing loss, tinnitus, interstitial nephritis, nocturia, Fanconi syndrome, hyperinsulinemia, decreased IGFBP-I, hypothermia, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, allergic reactions, angioedema, DRESS syndrome, erythematous lupus, vasculitis, allergic reactions, brain atrophy, dementia, hematuria, polydipsia, fatigue, epistaxis, systemic edema, localized edema, weight loss, weight gain

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This will help to preserve the medication's efficacy for a longer duration.

Appearance and packaging

Appearance

Brownish rectangular soft capsule filled with a transparent oily substance

Package unit

30 capsules/bottle, 100 capsules/bottle

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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.