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:

Dr. Reddy's Laboratories Ltd

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, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women wit

Product summary:

Divalproex sodium delayed-release capsules USP, 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 bottles of 30’s, 100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                                   NDC 55111-532-30 Bottles of 100                                                 NDC 55111-532-01 Bottles of 500                                                 NDC 55111-532-05 Unit dose package of 100 (10 x 10)               NDC 55111-532-78 Recommended Storage : Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Dr. Reddy's Laboratories Ltd
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MEDICATION GUIDE
Divalproex Sodium (dye val’ proe ex soe’ dee um) Delayed-release
Capsules USP, for oral use
What is the most important information I should know about divalproex
sodium delayed-release capsules?
Do not stop divalproex sodium delayed-release capsules without first
talking to a healthcare provider. Stopping
divalproex sodium delayed-release capsules suddenly can cause
serious problems. Stopping a seizure medicine suddenly in a patient
who has epilepsy can cause seizures that will not
stop (status epilepticus).Divalproex sodium delayed-release capsules
can cause serious side effects, including:
1.Serious liver damage that can cause death, especially in children
younger than 2 years old and patients with
mitochondrial disorders. The risk of getting this serious liver damage
is more likely to happen within the first 6
months of treatment.
Call your healthcare provider right away if you get any of the
following symptoms:
•
feeling very weak, tired, or uncomfortable (malaise)
•
swelling of your face
•
not feeling hungry
•
nausea or vomiting that does not go away
•
diarrhea
•
pain on the right side of your stomach(abdomen)
•
dark urine
•
yellowing of your skin or the whites of your eyes
•
loss of seizure control in people with epilepsy
In some cases, liver damage may continue even though the medicine is
stopped. Your healthcare provider will do
blood tests to check your liver before and during treatment with
divalproex sodium delayed-release capsules.
2. Divalproex sodium delayed-release capsules may harm your
unbornbaby.
•
If you take divalproex sodium delayed-release capsules during
pregnancy for any medical condition, your
baby is at risk for serious birth
defects that affect the brain and spinal cord (such as spina bifida or
neural tube defects). These defects can
begin in the first month, even before you know you are pregnant. Other
birth defects that affect the structures
of the heart, head, arms, legs, and the opening where the urine

Summary of Product characteristics

DIVALPROEX SODIUM- DIVALPROEX SODIUM CAPSULE
DR. REDDY'S LABORATORIES LTD
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIVALPROEX SODIUM
DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES
DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES, 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 THE 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)
INDICATIONS AND USAGE
Divalproex sodium delayed-release capsule is an anti-epileptic drug
indicated for:
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 clinical response; if response is not
satisfactory, check valproate plasma
level; see full prescribing information for conversion to monotherapy
(2.1)
Absence Seizures: Start at 15 mg/kg/day, increasing at 1 week
intervals by 5 to 10 mg/kg/day until
seizure control or limiting side effects (2.1)
DOSAGE FORMS AND STRENGTHS
Capsules: 125 mg (3)
CON