Caralium

Uses

Sodium Valproate is used 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.

Dosage

Caralium dosage

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 withepilepsyand 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.

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.

Precaution

Liver function should be monitored before therapy and during first six months, especially in those patients who seem most at risk. Blood tests are recommended before surgery. Renal impaired patients, pregnant and brest feeding mother should be specially cared. Valproate is eliminated mainly through the kidney, partly in the form of ketone bodies which may lead to false statement in urine ketone test. Sudden withdrawal of therapy should be avoided

Interaction

Sodium Valproate is a non specific inhibitor of drug metabolism. Phenobarbital, Phenytoin, Warfarin, Aspirin etc. interacts with Sodium Valproate.

Pregnancy & Breastfeeding use

Sodium Valproate crosses the placenta in humans which may lead to neural tube defects such as anencephaly and spina bifida if exposed in the first trimester. Sodium Valproate may excrete in breast milk. So treatment with Sodium Valproate may cause harm to new born baby.

Contraindication

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.

Storage Condition

Syrup: Store below 30° C, protected from light.

Tablet: Store below 30° C, protected from light. Keep all medicines out of the reach of children.

Innovators Monograph

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