DIVALPROEX SODIUM capsule, coated pellets

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

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

Product summary:

Divalproex Sodium Delayed-Release Capsules, USP equivalent to 125 mg of valproic acid are white to off-white free flowing pellets filled in size '0' hard gelatin capsules with blue colored cap  printed with "ZA66" in black ink and white body printed with "125mg" in black ink and are supplied as follows: NDC 68382-106-01 in bottle of 100 capsules NDC 68382-106-10 in bottle of 1,000 capsules NDC 68382-106-77 in unit-dose blister carton of 100 (10 x 10) Unit dose capsules Storage : Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].  Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Pharmaceuticals USA Inc.
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SPL MEDGUIDE
MEDICATION GUIDE
Divalproex Sodium (dye val' proe ex soe' dee um)
Delayed-Release Capsules , USP
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 unborn
baby.
•
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 ur

Summary of Product characteristics

DIVALPROEX SODIUM- DIVALPROEX SODIUM CAPSULE, COATED PELLETS
ZYDUS PHARMACEUTICALS USA INC.
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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 capsules are 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
Cap