Sodium Valproate Aguettant

Sodium Valproate Aguettant

valproic acid

Manufacturer:

Aguettant

Distributor:

Indochina Healthcare
Concise Prescribing Info
Contents
Na valproate
Indications/Uses
Temporary treatment of epilepsy in adults & childn, as a replacement for oral form when oral therapy is temporarily unusable.
Dosage/Direction for Use
In case of simple replacement Administer IV in a soln of 0.9% NaCl soln for inj between 4 & 6 hr after the last oral dose either in continuous infusion for 24 hr or fractionated doses in 4 one hr infusion/day at the previous dosage (mean usual dose: 20-30 mg/kg/day). In case of effective plasma conc to be reached rapidly & then maintained is required 15 mg/kg IV inj bolus given over 5 min before continuous infusion w/ 1 mg/kg/hr flow rate to be adjusted progressively to reach valproic acid blood levels in region of 75 mg/L.
Contraindications
History of hypersensitivity to valproate, divalproate & valpromide. Acute & chronic hepatitis. Personal or familial history of severe hepatitis, particularly drug-related. Hepatic porphyria. Concomitant use w/ mefloquine or St. John's wort.
Special Precautions
Do not administer IM. Risk of severe liver damage in infants & young childn <3 yr w/ severe epilepsy & epilepsy associated w/ brain disorders, psychomotor retardation &/or congenital metabolic or degenerative disease. Assess liver function prior to start of therapy, & then periodically during the first 6 mth of therapy. Discontinue use if abnormally low prothrombin time is confirmed, & pancreatitis occurs. Closely monitor for signs of suicidal ideation & behavior. Concomitant use w/ divalproate, valpromide; lamotrigine & penems. Patients w/ strict Na diet; urea cycle enzyme deficiency; systemic lupus erythematosus. Haemotological exam (CBC including platelets, bleeding time & coagulation test) prior to initiation of therapy, then after 15 days & at the end of therapy, & prior to surgery is recommended in case of spontaneous haematoma or bleeding. Avoid concomitant use of salicylates especially in childn. Renal insufficiency. Perform metabolic investigations (fasting & post-prandial serum ammon) prior to treatment in childn w/ history of unexplained hepatic or digestive disorders, lethargy or coma, mental retardation or family history of neonatal death or death in childhood metabolic investigations, in particular fasting & post-prandial serum ammonia. Risk of wt gain. False positive result of urine ketones in diabetics. Risk of rhabdomyolysis in patients w/ type II carnitine palmitoyltransferase deficiency. Alcohol intake during treatment is not recommended. May affect ability to drive or use machinery. Female adolescent, women of childbearing potential, pregnancy. Women of childbearing age should use effective contraception during treatment. Perform coagulation investigation including platelet count, fibrinogen, assay & clotting time in pregnant woman before delivery. Neonates. Lactation.
Adverse Reactions
Tremors; nausea. Congenital malformations, neurodevelopmental disorders. Anaemia, thrombocytopenia; wt gain; extrapyramidal disorder, stupor, sedation, convulsion, memory impairment, headache, nystagmus; hearing loss; vomiting, gingival disorders, stomatitis, epigastric pain, diarrhoea; transient &/or dose-dependent hair loss; hyponatremia; bleeding; nausea or dizziness (w/in min following inj); liver dysfunction; menstrual irregularities; confusion hallucinations; aggression, agitation, attention disorders.
Drug Interactions
Risk of occurrence of epileptic seizures by mefloquine. Risk of decreased plasma conc & efficacy w/ St. John's wort. Increase toxicity & plasma conc of lamotrigine. Risk of occurrence of seizures w/ penems, astreonam & rifampicin. Increase plasma conc of active metabolite of carbamazepine, phenobarb, zidovudine & nimodipine. Increased serum conc w/ felbamate. Risk of decreased plasma conc by phenytoin. Risk of occurrence of hyperammoniemia or encephalopathy w/ topiramate.
MIMS Class
ATC Classification
N03AG01 - valproic acid ; Belongs to the class of fatty acid derivatives antiepileptic.
Presentation/Packing
Form
Sodium Valproate Aguettant inj 400 mg/4 mL
Packing/Price
10 × 1's
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