Orphilas Extended Release 300 mg (Sodium Valproate)

Adult dose

1. Prevention and treatment of epilepsy and associated personality and behavioral disorders Adults: Administer an initial dose of 5-10mg/kg of sodium valproate orally and increase by 5mg every 4-7 days. The adult maintenance dose is 20mg/kg per day. Adjust the dose appropriately according to age and symptoms. 2. Treatment of mania associated with bipolar disorder Adults: The average daily dose of sodium valproate is 20㎎ per ㎏ of body weight, and the dose is adjusted according to each patient's clinical response to achieve a serum sodium valproate concentration of 50~125㎍/㎖. The maximum daily dose is 60 ㎎ per ㎏ of body weight and must not be exceeded.

Child dose

1. Prevention and treatment of epilepsy and associated personality and behavioral disorders The daily dose for children is 20-30mg/kg.

This medication must be used with great caution in pregnant women or women of childbearing potential. Particularly, during pregnancy, it can cause severe fetal malformations, so it should not be used without meeting pregnancy prevention programs. This drug may cause severe damage to the liver and pancreas; therefore, it should not be used in patients with liver disease or impaired liver function. In children, especially in infants under 3 years old, it should only be administered cautiously as a sole therapy due to a high risk of liver damage. Mental health changes such as suicidal impulses or depression should be closely monitored during treatment with this drug. Regular liver function tests should be performed, and if signs of liver damage appear, consult a physician immediately. Pancreatitis may occur, so if symptoms such as abdominal pain or vomiting appear, notify medical personnel immediately. This drug may interact with other medications, so it is essential to inform your physician of any other medications being taken. Caution is advised especially when used with estrogen-containing contraceptives, as this may reduce the effectiveness of this medication. Due to central nervous system depressant effects, this drug may cause drowsiness or dizziness, hence driving or operating hazardous machinery should be avoided. Serious symptoms may occur with overdose, so the prescribed dosage and administration must be strictly followed. Women planning to become pregnant or who are pregnant should consult a specialist before taking this medication and must use effective contraception. Male patients should also consult a doctor when planning to conceive and refrain from sperm donation during treatment and for 3 months after discontinuation. It is important for children and adolescents to confirm safety through regular liver function tests and blood tests. Sudden discontinuation of this medication may worsen seizures, so tapering should be done under a doctor’s guidance. If abnormal symptoms or side effects occur during treatment, immediately consult medical personnel for appropriate action.

Changes in liver function test results, severe liver damage, increased frequency of seizures, altered consciousness, somnolence, comatose state, cognitive impairment, symptoms of dementia, Parkinson's disease, postural fine tremor, drowsiness, sedative effects, tremor, ataxia, headache, confusion, convulsions, delirium, hallucinations, dizziness, insomnia, anxiety, visual disturbances, nystagmus, double vision, inability to maintain fixed position, seeing spots in front of the eyes, speech impairment, sensory changes, excessive salivation, coma, hyperammonemia, consciousness disorder, emotional confusion, depression, psychosis, aggressiveness, hyperactivity, behavioral dementia, increased appetite, abnormal weight gain, abdominal pain, loss of appetite, discomfort in the stomach area, constipation, stomatitis, nausea, stomach pain, vomiting, diarrhea, pancreatitis, irregular menstruation, secondary amenorrhea, polycystic ovary syndrome, cardiac hypertrophy, galactorrhea, hyperandrogenemia, hair loss, hair discoloration, curly hair, skin rash, erythema multiforme, skin and mucous membrane syndrome, toxic epidermal necrolysis, erythematous rash, weakness, decrease in fibrinogen, reduced factor VIII concentration, prolonged bleeding time, hyperglycemia, anemia, macrocytosis, pancytopenia, leukopenia, thrombocytopenia, hemolytic anemia, megaloblastic anemia, granulocytopenia, eosinophilia, reduced platelet aggregation, lymphopenia, neutropenia, petechiae, contusions, hematoma formation, true bleeding, pure red cell aplasia, bone marrow failure, hearing loss, tinnitus, interstitial nephritis, nocturia, Fanconi syndrome, hyperinsulinemia, decreased IGFBP-I, hypothermia, hyponatremia, inappropriate secretion of antidiuretic hormone syndrome, allergic reactions, vascular edema, DRESS syndrome, erythema nodosum, vasculitis, allergy reactions, brain atrophy, dementia, hematuria, polydipsia, malaise, epistaxis, generalized edema, localized edema, weight loss, weight gain

This medication should be stored in a tightly sealed container to protect it from exposure to air and moisture. It is crucial to maintain the storage temperature between 1 degree and 30 degrees Celsius to preserve the drug's efficacy and safety for an extended period.

Appearance

White, round film-coated extended-release tablet

Package unit

30 tablets/bottle, 500 tablets/bottle