DIVALPROEX SODIUM tablet film coated extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Divalproex sodium (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)

Available from:

McKesson Packaging Services a business unit of McKesson Corporation

INN (International Name):

Divalproex sodium

Composition:

VALPROIC ACID 250 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION
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BOX WARNING
HEPATOTOXICITY
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
DELAYED-RELEASE TABLETS 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 WARNINGS, INFORMATION FOR PATIENTS.
A PATIENT INFORMATION LEAFLET DESCRIBING THE TERATO