valproic acid




Concise Prescribing Info
Valproic acid
Monotherapy or adjunctive therapy on the treatment of partial seizures (simple & complex) & absence seizure (petit mal).
Dosage/Direction for Use
Initially 15 mg/kg daily, increasing at 1-wk interval by 5-10 mg/kg daily until seizures are controlled & no aggravation of side effects. Max: 60 mg/kg daily. Dose >250 mg should be given in divided doses.
Should be taken with food.
Hypersensitivity. Patients w/ significant hepatic disease or dysfunction, urea cycle disorder.
Special Precautions
Discontinue use if confirmed or suspected impaired liver function. Perform liver function tests prior to therapy & at sufficient intervals after, especially during the 1st 6 mth of therapy. History of liver disease. Risk of hepatotoxicity in patients who use ≥2 anticonvulsants, have congenital metabolic disorders, severe seizure disorders w/ mental retardation, & patients w/ organic mental disorders (organic brain diseases). Monitor platelet counts & coagulation parameters pre-op. Measure antiepileptic drugs level in serum periodically during the beginning of therapy. May cause misinterpretation of ketone & urine tests. May affect ability to drive or operate machinery. Pregnancy. Nursing mothers. Childn especially those <2 yr & who use ≥2 antiepileptic drugs.
Adverse Reactions
Nausea, vomiting, indigestion, diarrhea, stomach cramps, constipation, anorexia w/ wt loss & increased appetite accompanied by wt gain; sedation, tremor, ataxia, headache, nystagmus, diplopia, asterixis, dysarthria, dizziness & incoordination; photosensitivity skin rash, generalized pruritus, erythema multiforme & SJS; emotional disorders, depression, psychosis, aggression, hyperactivity, & destructive behavior; weakness; thrombocytopenia, petechiae, bruising, hematoma formation & hemorrhage, lymphocytosis & hypofibrinogemia, leukopenia, eosinophilia, anemia, & bone marrow suppression; slight increases in serum conc of transaminases (eg, SGPT & SGOT) & LDH, increase in serum bilirubin & abnormal changes in other liver function tests; irregular menstruation & secondary amenorrhea, abnormal thyroid function tests; acute pancreatitis; hyperammonemia, hyperglycinemia; edema in extremities.
Drug Interactions
May increase CNS depressant activity from alcohol. May cause changes in the serum conc of aspirin, carbamazepine, & dicumarol. May increase penobarb serum through non-renal clearance. Decreased/increased phenytoin total plasma conc. Valproic acid & clonazepam can negate the effects of drugs w/ each other. Changes in serum conc of valproic acid & ethosuximide. Drugs that affect blood coagulation eg, aspirin & warfarin.
MIMS Class
ATC Classification
N03AG01 - valproic acid ; Belongs to the class of fatty acid derivatives antiepileptic.
Epilepsan syr 250 mg/5 mL
120 mL x 1's (Rp76,900/boks)
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