CONTRAINDICATIONS: SHOULD NOT BE ADMINISTERED TO PATIENTS WITH HEPATIC DISEASE OR SIGNIFICANT HEPATIC DYSFUNCTION.

WARNINGS:

Hepatotoxicity: Hepatic failure resulting in fatalities has occurred in patients receiving Valproate sodium. These incidents usually have occurred during the first six months of treatment.

Pancreatitis: Cases of life-threatening pancreatitis have been reported in both children and adults receiving valproate.

Urea Cycle Disorders (UCD): Hyperammonemic encephalopathy, sometimes fatal, has been reported following initiation of valproate therapy in patients with urea cycle disorders, a group of uncommon genetic abnormalities, particularly ornithine transcarbamylase deficiency.

Somnolence in the Elderly: In elderly patients, dosage should be increased more slowly and with regular monitoring for fluid and nutritional intake, dehydration, somnolence, and other adverse events.

Thrombocytopenia: The frequency of adverse effects particularly elevated liver enzymes and thrombocytopenia may be dose-related.

Usage In Pregnancy: ACCORDING TO PUBLISHED AND UNPUBLISHED REPORTS, VALPROATE SODIUM MAY PRODUCE TERATOGENIC EFFECTS IN THE OFFSPRING OF HUMAN FEMALES RECEIVING THE DRUG DURING PREGNANCY. 

PRECAUTIONS:

Hepatic Dysfunction, Pancreatitis, Hyperammonemia. 

General: Because of reports of thrombocytopenia, inhibition of the secondary phase of platelet aggregation, and abnormal coagulation parameters, (e.g., low fibrinogen), platelet counts and coagulation tests are recommended before initiating therapy and at periodic intervals. Valproate is partially eliminated in the urine as a keto-metabolite which may lead to a false interpretation of the urine ketone test.

Pregnancy: Pregnancy Category D.

Nursing Mothers: Valproate is excreted in breast milk. Consideration should be given to discontinuing nursing when valproic acid is administered to a nursing woman.

Pediatric Use: Experience has indicated that pediatric patients under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity. 

Geriatric Use: The starting dose should be reduced in these patients, and dosage reductions or discontinuation should be considered in patients with excessive somnolence.

SIDE EFFECTS:

Behavioral changes, hepatotoxicity, hyperammonemia, diplopia, nystagmus, pancreatitis, thrombocytopenia, abdominal cramp, anorexia, menstrual irregularity, diarrhea, hair loss, nausea, vomiting, trembling of hands and arms, unusal weight loss or gain.

DOSAGE AND ADMINISTRATION: 15 mg/kg daily in divided dose and increments it 5-10 mg/kg/day every week. Maximum daily consumption is 60m/k/day.

How Supplied: Each Pack of Ruz-Valproate contains 50 E.C. tablets.

storage: Store tablets at 15-25°C.

Reference: USPDI for Professional Health Care, 2004, Page 2781-6

                  Martindale 2005, Page 380-3