Indications
Sodium Valproate is indicated for –
Epilepsy: All types of epilepsy such as Absence seizure, Myoclonic seizure, Tonic-clonic seizure, Atonic, Mixed, simple or generalized, Secondary generalized seizure etc.
Mania: For the treatment of manic episodes of bipolar disorders.
Other: As an alternative treatment for febrile convulsion & migraine prophylaxis.
Therapeutic Class
Primary anti-epileptic drugs
Pharmacology
Sodium Valproate shows antiepileptic properties in various types of seizures. The exact mechanism of Sodium Valproate is not yet established. However it is suggested that its activity is related to increased brain levels of Gama Amino Butyric Acid (GABA).
Dosage & Administration
Oral:
Adults:
Initial: 600 mg/day in 2 divided doses, preferably after food. Dose may be increased by 200mg/day at 3 days interval to a maximum of 2.5 gm daily in divided doses until control of seizure is achieved.
Maintenance dose: Usually 1-2 gm daily (20-30 mg/kg daily).
Children (up to 20 kg):
Initial: 20 mg/kg daily in divided doses. Dose may be increased in severe cases with proper monitoring of plasma concentration.
Children (over 20 kg):
Initial: 400 mg/ day (irrespective of weight). Dose may be increased by 20-30 mg/ kg if required to achieve control.
Injection:
Sodium Valproate is for intravenous use only. Use of Sodium Valproate for periods of more than 14 days has not been studied. Patients should be switched to oral valproate products as soon as it is clinically feasible.
Sodium Valproate should be administered as a 60 minute infusion (but not more than 20 mg/min) with the same frequency as the oral products, although plasma concentration monitoring and dosage adjustments may be necessary.
In one clinical safety study, approximately 90 patients with epilepsy and with no measurable plasma levels of valproate were given single infusions of Sodium Valproate (up to 15 mg/kg and mean dose of 1184 mg) over 5-10 minutes (1.5-3.0 mg/kg/min). Patients generally tolerated the more rapid infusions well. This study was not designed to assess the effectiveness of these regimens.
Interaction
Sodium Valproate is a non specific inhibitor of drug metabolism. Phenobarbital, Phenytoin, Warfarin, Aspirin etc. interacts with Sodium Valproate.
Contraindications
Sodium Valproate is contra-indicated in patients with known hypersensitivity of Sodium Valproate, personal or family history of severe active liver disease, hepatic dysfunction, porphyria and known urea cycle disorder.
Side Effects
Gastric irritation, nausea, ataxia & tremor; hyperammonaemia, increased appetite & weight gain; transient hair loss, oedema, thrombocytopenia, and inhibition of platelet aggregation, impaired hepatic function leading rarely to fetal hepatic failure; rashes; sedation; rarely lethargy and confusion and also increased alertness; rarely pancreatitis, leucopenia, pancytopenia, red cell hypoplasia, fibrinogen reduction; irregular periods, amenorrhoea, gynaecomastia, toxic epidermal necrolysis, hearing loss, Fancoli’s syndrome, dementia, Steven’s-Johnson syndrome, and vasculitis have also been reported.
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