Epiram Injection (Sodium Valproate)

Adult administration

Preparation: Inject 4mL of the supplied diluent into the vial and dissolve the contents, then use the appropriate dose. The concentration of sodium valproate in the prepared solution is 95㎎/㎖. Administer this medicine by slow intravenous injection, or administer it concurrently with normal saline injection, 5% dextrose injection, or dextrose-saline injection through a separate intravenous line. 1. Adults: Depending on the patient's body weight, usually inject 400-800㎎ (maximum 10㎎/㎏) slowly intravenously, continuously or repeatedly, over 3-5 minutes. After intravenous injection, administer by continuous or repeated intravenous infusion, up to a maximum of 2500㎎ per day. 3. Elderly: Although pharmacokinetic changes occur, their clinical significance is minor. In principle, follow the adult dosing regimen, but determine the dose within the range that controls epileptic seizures. Adjust the dose as appropriate according to age and symptoms.

Child administration

2. Children: The usual daily dose is 20-30㎎ per kg of body weight, and the method of administration is the same as for adults. If an adequate effect is not achieved, the dose may be increased to 40㎎ per kg of body weight, but only when measurement of the blood valproate concentration is possible. If the daily dose exceeds 40㎎ per kg of body weight, perform clinical tests, such as blood tests.

This medication is used to treat epilepsy and bipolar disorder. A careful evaluation is required before administering this medication to pregnant women or women of childbearing potential, and a pregnancy prevention program must be strictly followed. This medication can cause serious congenital defects like neural tube defects in the fetus, and there is a risk of lowering the child's IQ when exposed in utero. Therefore, women who plan to become pregnant must consult a physician before using this medication and effective contraception must be used during treatment. This medication can cause severe damage to the liver and pancreas, thus it should not be administered to patients with a history of liver disease or poor liver function. In particular, it should be used cautiously as a monotherapy in children under 3 years of age due to the high risk of liver damage, and regular liver function tests are required. During the administration of this drug, symptoms of depression, suicidal impulses, or abnormal changes in behavior may occur, and patients and caregivers should carefully monitor for these symptoms and inform healthcare professionals immediately of any abnormalities. Additionally, this medication has many drug interactions, so caution is necessary when used in combination with other medications, particularly hormonal contraceptives that contain estrogen, as drug concentration changes should be monitored. This medication can affect the central nervous system, causing drowsiness or confusion; therefore, caution is advised when driving or operating hazardous machinery. Severe symptoms such as coma, muscle weakness, and hypotension may occur in the case of overdose, so the dosage must be strictly adhered to, and in case of overdose, immediate hospital visit is essential. Lastly, this medication requires special caution when administered to children, adolescents, and elderly individuals, and regular blood tests and liver function tests should be conducted to ensure safety.

Liver damage, increased liver enzymes, tremors, extrapyramidal syndrome, altered consciousness, drowsiness, seizures, memory impairment, headache, eye twitching, confusion, aggression, anxiety, attention deficit, hallucinations, coma, encephalopathy, reversible parkinsonism, ataxia, sensory disturbances, reversible dementia, cognitive impairment, abnormal behavior, psychomotor hyperactivity, learning disabilities, sedative effects, hallucinations, dizziness, insomnia, anxiety, visual disturbances, double vision, inability to maintain fixed postures, visual phenomenon of spots in front of the eyes, speech disorders, excessive salivation, coma, consciousness disturbances associated with hyperammonemia, emotional confusion, depression, psychosis, hyperactivity, behavioral dementia, suicidal impulses, suicidal behavior, depression, dysmenorrhea, SIADH, amenorrhea, hyperandrogenism, hypothyroidism, male infertility, polycystic ovary syndrome, irregular menstruation, breast enlargement, galactorrhea, hypersensitivity reactions, hair loss, angioedema, rash, hair abnormalities, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, DRESS syndrome, decreased bone density, osteopenia, osteoporosis, fractures, systemic lupus erythematosus, rhabdomyolysis, weakness, anemia, thrombocytopenia, pancytopenia, leukopenia, bone marrow failure, agranulocytosis, megaloblastic anemia, macrocytic anemia, hyperglycinemia, hemolytic anemia, megaloblastic hyperplasia, neutropenia, eosinophilia, decreased platelet aggregation, lymphopenia, neutropenia, petechiae, contusions, hematoma formation, true bleeding, weight gain, coagulation factor decrease, abnormal coagulation test, biotin deficiency, hearing loss, tinnitus, pleural effusion, nausea, vomiting, gum abnormalities, stomatitis, upper abdominal pain, diarrhea, increased appetite, decreased appetite, gastrointestinal discomfort, constipation, pancreatitis, kidney failure, tubulointerstitial nephritis, nocturia, hyponatremia, hyperammonemia, hyperinsulinemia, decreased insulin-like growth factor binding protein I, hypothermia, bleeding, vasculitis, erythematous lupus, allergic reactions, hematuria, thirst, fatigue, nasal bleeding, edema, peripheral edema, hypothermia, myelodysplastic syndrome, confusion, sedation, coma, myasthenia, decreased reflexes, areflexia, decreased muscle tone, hypotension, pupillary constriction, cardiovascular disease, respiratory disease, impaired respiratory function, cerebral edema, metabolic acidosis, hypokalemia, hypernatremia, circulatory collapse, shock

This medication should be stored in a sealed container that prevents air from entering, preferably at a temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy for an extended period.

Appearance

An injectable solution containing a colorless, transparent glass vial with freeze-dried powder, and a colorless, transparent ampoule containing a colorless, transparent solvent.

Package unit

1 vial/box [400mg/vial]