Drug Interaction:
Alcohol and CNS depression producing medications may potentiate CNS depressant drugs Significant drug interactions with aspirin, felbamate and rifampicin Drug interactions occur with most of the other anticonvulsants
Indication:
LIST OF DRUGS DURING 2004
Sr.No- 209
Name of the Drug- Divalproex Sodium E.R. Tablets
(750mg/1000mg)
Pharmacological Classification- Anti-Epileptic
Date of Approval- 24-06-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Divalproex Sodium oral soln. 23-12-2013
500mg/5ml
Addl.dosage form
For mono therapy and adjunctive therapy in the treatment of patients with
complex partial seizures that occur either in insolation or in association
with types of seizures for adult patients only
2. Diavalproax sodium 17-01-2002
Antiepileptic
3. Diavalproax sodium ER tablets 24-06-2004
750mg/ 1000mg
Antiepileptic
Epilepsy Migraine
Adverse Reaction:
Abdominal or stomach cramps, anorexia, diarrhea, indigestion, nausea and vomiting Tremor,dizziness mental changes, hepatoxicity, pancreatitis, diplopia, mystagmus Platelet aggregation, inhibition or thrombocytopenia, hair loss, unusual weight loss or gain
Contra-Indications:
Divalporoex sodium should not be administerd to patients with hepatic disease or significant hepatic dysfunction. It is contraindicated in patients with known hypersensitivity to the drug
Special Precautions:
Prior history of hepatic disease Children, especially those less than 2 years of age are at high risk of developing hepatic toxicity
Should be cautious when administering in patients with thrombocytopenia, hyperammonerrmia.
Valproic acid has reports of tetragenicity in pregnant women, caution in nursing mothers Insufficient information on the use of divalproex in elderly patients in the listed indications
Dosages/ Overdosage Etc:
Indications:
Epilepsy-
Dosage
Adults - Monotherapy- Initially 15mg/kg/day, increase the dose by 5 to 10 mg/kg/day as needed and as tolerated
Maximal recommended dosage is 60mg/kg/day. When the total daily dose is 125mg or gretater, it should be given in a divided regimen.
Maniac episodes- Dosage Initial dose is 750mg daily in divided doses. Dose should be increased as rapidly as possible to acheive the lowest therapeutic dose that produces the desired clinical effect
Migraine- Dosage Strating dose of 250mg twice daily
Patient Information:
1. Chilren especially less than 2 years of age are at high risk of developing hepatic toxicity
2. Not recommended for use in elderly patients
Pharmacology/ Pharmacokinetics:
Pharmacology:
Divalproex is a stable co-ordinatin compound of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralisation of valproic acid and with 0.5 equivalent of sodium hydroxide. The mechanisms by which valproate exerts its therapeutic effects have not been established. It is suggested that that activity in epilepsy is related to increased brain concentrations of gamma-amino butyric acid (GABA), possibly caused by decreased metabolism or decreased re-uptake in brain tissues.
Pharmacokinetics:
Concomittant administration with food may significantly slow the rate of of absorption, but not the extent. It is highly protein bound. Divalproex is hepatically metabolised.
Rate of metabolism is faster in children and in patients concurrently using enzyme-inducing medications. It is excreted mainly by renal route as glucoronide conjugate . Small amounts are excreted through feces and expired air.
Interaction with Food:
Concomittant administration with food may significantly slow the rate of absorption, but not the extent.
Pregnancy and lactation:
Valproic acid has reports of tetragenicity in pregnant women, caution in nursing mothers Not recommended for use in pregnant women and in nursing mothers.
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