Medication info

Orphyl Syrup (Sodium Valproate)

Prescription medicationOral
Ingredient · strength
Sodium Valproate›6000mg / 100mL
Manufacturer / importer
Bukwang Pharmaceutical Co., Ltd.
Appearance
A slightly viscous liquid with a yellowish hue. It has an aromatic smell and taste.
Packaging
150 milliliters/bottle
Approval status
Active

MFDS item code 200001939 · Notified 2000.05.22 · Insurance code 642201732

Summary

Main use
Prevention and treatment of epilepsy (absence seizures, partial seizures, etc.) and associated personality and behavioral disorders
Who takes it
Adults · Children
Adult dose
Adults: Administer an initial dose of 5-10 mg/kg of sodium valproate orally, increasing the dose by 5 mg every 4-7 days. The adult maintenance dose is 20 mg/kg per day. Adjust the dose appropriately according to age and symptoms.
Child dose
The daily dose for children is 20-30 mg/kg.

Ingredients

Manufacturer
Bukwang Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Absence seizures
  • mild seizures
  • partial seizures
  • focal seizures
  • psychomotor seizures
  • mixed seizures
  • personality disorders
  • behavioral disorders
View approved original text

This medication is used to treat various forms of epilepsy, including absence seizures, partial seizures, psychomotor seizures, and mixed seizures. It also aids in the prevention and treatment of behavioral problems that may arise due to epilepsy. In other words, it is effective in improving various symptoms of epilepsy and alleviating associated psychiatric and behavioral issues.

How to take

Adult dose

Adults: Administer an initial dose of 5-10 mg/kg of sodium valproate orally, increasing the dose by 5 mg every 4-7 days. The adult maintenance dose is 20 mg/kg per day. Adjust the dose appropriately according to age and symptoms.

Child dose

The daily dose for children is 20-30 mg/kg.

Precautions

This medication requires special caution in pregnant women or women of childbearing potential. Pregnant women should only use this medication when no alternative treatment is available, and women of childbearing potential should strictly adhere to a pregnancy prevention program. This medication can affect liver function, so patients with liver disease or impaired liver function should avoid its use. Special care should be taken when administering this medication alone to children, especially those under 3 years of age, due to a higher risk of liver damage. This medication may increase the risk of suicidal thoughts or behaviors, so changes in mental status should be carefully monitored during treatment. Occasionally, severe side effects such as significant liver damage or pancreatitis may occur, so regular liver function tests are essential during the first 6 months. Since there are many drug interactions, it is crucial to inform the physician or pharmacist of any other medications being taken. This medication can affect the central nervous system and may cause drowsiness or sedation, so it is advisable to avoid driving or operating dangerous machinery. Additionally, abruptly reducing or discontinuing the dose may exacerbate seizures, so adjustments should be made gradually according to the physician's instructions. Regular blood tests and liver function tests are important to monitor for adverse reactions during treatment. If planning for pregnancy or currently pregnant, it is essential to consult medical personnel for an appropriate treatment plan. Male patients should also exercise caution regarding sperm donation or pregnancy planning while taking this medication, and contraception is recommended for 3 months after discontinuation of treatment. This medication may cause a variety of side effects such as weight gain, hair loss, gastrointestinal disturbances, and blood abnormalities, so any symptoms should be reported to healthcare personnel immediately.

Side effects

Changes in liver function test values, severe liver damage, increased seizure frequency, altered consciousness, drowsiness, coma, cognitive impairment, symptoms of dementia, Parkinson's disease, postural tremors, drowsiness, sedative effects, tremors, ataxia, headache, confusion, convulsions, altered mental status, hallucinations, dizziness, insomnia, anxiety, visual disturbances, nystagmus, diplopia, inability to maintain fixed posture, visual phenomena of spots, speech disturbances, sensory changes, excessive salivation, coma, hyperammonemia, consciousness disorders, emotional confusion, depression, psychosis, aggressiveness, hyperactivity, behavioral dementia, hyperammonemia, suicidal impulses, suicidal behavior, depression, 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, hair loss, hair discoloration, curly hair, skin rash, erythema multiforme, skin and mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyle's syndrome, erythematous rash, myasthenia, decreased fibrinogen, reduced concentration of coagulation factor VIII, prolonged bleeding time, hyperglycinemia, anemia, macrocytosis, pancytopenia, leukopenia, thrombocytopenia, hemolytic anemia, megaloblastic anemia, granulocytopenia, eosinophilia, decreased platelet aggregation, lymphocytopenia, neutropenia, petechiae, contusions, hematoma formation, true hemorrhage, 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, thirst, fatigue, epistaxis, systemic edema, localized edema, weight loss, weight gain, lupus-like syndrome, confusion, sedation, coma, myasthenia, diminished reflexes, areflexia, hypotension, miosis, cardiovascular diseases, respiratory diseases, cerebral edema, metabolic acidosis, hypokalemia, hypernatremia, abnormal neurological responses, behavioral changes, seizures

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. Additionally, it is important to maintain a room temperature, specifically between 1 to 30 degrees Celsius, to preserve the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

A slightly viscous liquid with a yellowish hue. It has an aromatic smell and taste.

Package unit

150 milliliters/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.