DIVALPROEX SODIUM tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

DIVALPROEX SODIUM

Composition:

VALPROIC ACID 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Divalproex sodium delayed-release tablets (divalproex sodium) are indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgement, aggressiveness, and possible hostility. The efficacy of divalproex sodium delayed-release tablets was established in 3 week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania (see Clinical Trials under CLINICAL PHARMACOLOGY ). The safety and effectiveness of divalproex sodium delayed-release tablets for long-term use in mania, i.e., more than 3 weeks, has not been systematically evaluated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium delayed-release tablets for extended periods should continually reevaluate

Product summary:

Divalproex sodium delayed-release tablets USP are supplied as: The 250 mg tablets are orange colored, oval shaped, biconvex coated tablets imprinted ‘797’ with black ink on one side and plain on the other side. Bottles of 30’s with Child Resistant Cap…...........NDC 33261-0641-30 Bottles of 60’s with Child Resistant Cap ……..… NDC 33261-0641-60 Bottles of 90’s with Non Child Resistant Cap…....NDC 33261-0641-90 Recommended storage: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30° C (59° - 86° F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
AIDAREX PHARMACEUTICALS LLC
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DIVALPROEX SODIUM DELAYED-RELEASE TABLETS
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 DELAYED-RELEASE TABLETS ARE 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 DESCRIBI