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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (D's) » Divalproex



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.


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.

CATEGORIES, BRAND NAMES

CATEGORIES: Affective disorder, bipolar; Epilepsy, complex absence; Epilepsy, complex partial; Epilepsy, mixed pattern; Headache, migraine, prophylaxis; Mania; Pregnancy Category D; FDA Approved 1983 Mar; Top 200 Drugs

FDA Drug Classes: Anticonvulsants

BRAND NAMES:

BRAND NAMES: Depakote; Depakote Sprinkle; Epival
(Foreign Brand names outside U.S. in italics)

FOREIGN BRAND AVAILABILITY:
Epival (Canada; Korea)

COST OF THERAPY: $1197.20 (Epilepsy; Depakote Tablet; 500 mg; 2/day; 365 days)





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