DIVALPROEX SODIUM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

DIVALPROEX SODIUM

Composition:

VALPROIC ACID 125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Divalproex sodium delayed-release capsules are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed-release capsules are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.  Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unl

Product summary:

Divalproex sodium delayed-release capsules, USP (sprinkle) 125 mg for oral use are white to off-white, coated particles filled in ‘size 1’ hard gelatin capsules of light blue transparent cap imprinted ‘­ ↑THIS END UP↑ ­’ and white opaque body imprinted ‘RDY 532’ on the body using black ink and are supplied in blisterpacks of 30’s,15's and boxes of 30 unit dose. Blisterpacks of 30                                                 NDC 0615-1393-39 Blisterpacks of 15                                                 NDC 0615-1393-05 Boxes of 30 for Unit Dose Dispensing                     NDC 0615-1393-30  Recommended Storage Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIVALPROEX SODIUM- DIVALPROEX SODIUM CAPSULE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIVALPROEX SODIUM DELAYED-
RELEASE CAPSULES (SPRINKLE ) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DIVALPROEX
SODIUM DELAYED-RELEASE CAPSULES (SPRINKLE )
DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES (SPRINKLE), FOR ORAL USE
INITIAL U.S. APPROVAL: 1989
WARNING: LIFE THREATENING ADVERSE REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. _
HEPATOTOXICITY, INCLUDING FATALITIES, USUALLY DURING FIRST 6 MONTHS OF
TREATMENT. CHILDREN UNDER THE AGE
OF TWO YEARS AND PATIENTS WITH MITOCHONDRIAL DISORDERS ARE AT HIGHER
RISK. MONITOR PATIENTS CLOSELY, AND
PERFORM SERUM LIVER TESTING PRIOR TO THERAPY AND AT FREQUENT INTERVALS
THEREAFTER (5.1)
FETAL RISK, PARTICULARLY NEURAL TUBE DEFECTS, OTHER MAJOR
MALFORMATIONS, AND DECREASED IQ (5.2, 5.3,
5.4 )
PANCREATITIS, INCLUDING FATAL HEMORRHAGIC CASES (5.5)
RECENT MAJOR CHANGES
Warnings and Precautions, Birth Defects (5.2) 1/2015
Warnings and Precautions, Bleeding and Other Hematopeietic Disorders
(5.8) 1/2015
Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS)/Multiorgan Hypersensitivity
Reaction (5.12) 1/2015
INDICATIONS AND USAGE
Divalproex sodium delayed-release capsule is an anti-epileptic drug
indicated for: (1)
Monotherapy and adjunctive therapy of complex partial seizures and
simple and complex absence seizures; adjunctive
therapy in patients with multiple seizure types that include absence
seizures (1)
DOSAGE AND ADMINISTRATION
Divalproex sodium delayed-release capsules may be swallowed whole or
the contents may be sprinkled on soft food.
The drug/food mixture should be swallowed immediately (avoid chewing)
(2.2)
Safety of doses above 60 mg/kg/day is not established (2.1, 2.2)
Complex Partial Seizures: Start at 10 to 15 mg/kg/day, increasing at 1
week intervals by 5 to 10 mg/kg/day to achieve
optimal cli