DIVALPROEX SODIUM DR- divalproex sodium tablet, delayed release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Rebel Distributors Corp

INN (International Nazwa):

DIVALPROEX SODIUM

Skład:

VALPROIC ACID 250 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Mania Divalproex sodium delayed-release tablets 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 DSMIII-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, physicians who elect to use divalproex sodium delayed-release tablets for extended periods should continually reevaluate the long-term usefulnes

Podsumowanie produktu:

Divalproex sodium delayed-release tablets are supplied as: 250 mg lavender colored, oval shaped, biconvex, enteric coated tablets imprinted with “L006” (Black ink) on one side and plain on the other side. 60 DR Tabs NDC 21695-818-60 500 mg lavender colored, oval shaped, biconvex, enteric coated tablets imprinted with “L007” (Black ink) on one side and plain on the other side. 60 DR Tabs NDC 21695-819-60 90 DR Tabs NDC 21695-818-90 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

DIVALPROEX SODIUM DR- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
REBEL DISTRIBUTORS CORP
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DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP
125 MG, 250 MG AND 500 MG
RX ONLY
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
NONSPECIFIC 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.
AN