WARNING
HEPATIC FAILURE
RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS RECEIVING
VALPROIC ACID AND ITS DERIVATIVES. EXPERIENCE HAS
INDICATED THAT CHILDREN UNDER THE AGE OF TWO YEARS
ARE AT A CONSIDERABLY INCREASED RISK OF DEVELOPING
FATAL HEPATOTOXICITY, ESPECIALLY THOSE ON MULTIPLE
ANTICONVULSANTS, THOSE WITH CONGENITAL METABOLIC DISORDERS,
THOSE WITH SEVERE SEIZURE DISORDERS ACCOMPANIED BY
MENTAL RETARDATION, AND THOSE WITH ORGANIC BRAIN DISEASE.
WHEN DIVALPROEX SODIUM IS USED IN THIS PATIENT GROUP,
IT SHOULD BE USED WITH EXTREME CAUTION AND AS A SOLE
AGENT. THE BENEFITS OF THERAPY SHOULD BE WEIGHED AGAINST
THE RISKS. ABOVE THIS AGE GROUP, EXPERIENCE IN EPILEPSY
HAS INDICATED THAT THE INCIDENCE OF FATAL HEPATOTOXICITY
DECREASES CONSIDERABLY IN PROGRESSIVELY OLDER PATIENT
GROUPS.
THESE INCIDENTS USUALLY HAVE OCCURRED DURING THE FIRST
SIX MONTHS OF TREATMENT. SERIOUS OR FATAL HEPATOTOXICITY
MAY BE PRECEDED BY NON-SPECIFIC SYMPTOMS SUCH AS MALAISE,
WEAKNESS, LETHARGY, FACIAL EDEMA, ANOREXIA AND VOMITING.
IN PATIENTS WITH EPILEPSY, A LOSS OF SEIZURE CONTROL
MAY ALSO OCCUR. PATIENTS SHOULD BE MONITORED CLOSELY
FOR APPEARANCE OF THESE SYMPTOMS. LIVER FUNCTION TESTS
SHOULD BE PERFORMED PRIOR TO THERAPY AND AT FREQUENT
INTERVALS THEREAFTER, ESPECIALLY DURING THE FIRST
SIX MONTHS.
Teratogenicity:
VALPROATE CAN PRODUCE TERATOGENIC EFFECTS SUCH AS
NEURAL TUBE DEFECTS (E.G., SPINA BIFIDA), ACCORDINGLY,
THE USE OF DIVALPROEX SODIUM IN WOMEN OF CHILDBEARING
POTENTIAL REQUIRES THAT THE BENEFITS OF ITS USE
BE WEIGHED AGAINST THE RISK OF INJURY TO THE FETUS.
THIS IS ESPECIALLY IMPORTANT WHEN THE TREATMENT
OF A SPONTANEOUSLY REVERSIBLE CONDITION NOT ORDINARILY
ASSOCIATED WITH PERMANENT INJURY OR RISK OF DEATH
(E.G., MIGRAINE) IS CONTEMPLATED. SEE PRECAUTIONS,
Information for the Patient.
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DESCRIPTION
Divalproex sodium is a stable co-ordination compound
comprised of sodium valproate and valproic acid in a 1:1
molar relationship and formed during the partial neutralization
of valproic acid with 0.5 equivalent of sodium hydroxide.
Chemically it is designated as sodium hydrogen bis (2-propylpentanoate).
Divalproex sodium occurs as a white powder with a characteristic
odor.
Depakote tablets and Sprinkle capsules are antiepileptics
for oral administration.
Depakote Sprinkle Capsules: Depakote
Sprinkle capsules contain specially coated particles of
divalproex sodium equivalent to 125 mg of valproic acid
in a hard gelatin capsule.Inactive Ingredients: Cellulosic
polymers, D&C red no. 28, FD&C blue no. 1, gelatin,
iron oxide, magnesium stearate, silica gel, titanium dioxide
and triethyl citrate.
Depakote Tablets: Depakote
tablets are supplied in three dosage strengths containing
divalproex sodium equivalent to 125 mg, 250 mg or 500
mg of valproic acid.Inactive Ingredients: Cellulosic polymers,
diacetylated monoglycerides, povidone, pregelatinized
starch (contains corn starch), silica gel, talc, titanium
dioxide and vanillin.
In Addition, Individual Tablets Contain:
125 mg Tablets: FD&C blue no. 1 and FD&C red
no. 40.250 mg Tablets: FD&C yellow no. 6 and iron
oxide. 500 mg Tablets: D&C red no. 30, FD&C blue
no. 2, and iron oxide.
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