DIVALPROEX SODIUM tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

BluePoint Laboratories

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Divalproex sodium delayed-release tablets are valproate and is 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 judgment, aggressiveness, and possible hostility. The efficacy of divalproex sodium delayed-release tablets was established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see Clinical Studies (14.1)]. 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 demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium delayed-release tablets for extended periods should continually reevaluate the

Product summary:

Divalproex sodium delayed-release tablets, USP are supplied as: 125 mg: Orange colored, modified capsule shaped, biconvex, enteric coated tablets, imprinted with "UL 125" on one side and plain on other side: Bottles of 100………………NDC 68001-472-00 Bottles of 500………………NDC 68001-472-03 250 mg : Pink colored, oval shaped, biconvex, enteric coated tablets, imprinted with "UL 250" on one side and plain on other side: Bottles of 100………………NDC 68001-473-00 Bottles of 500………………NDC 68001-473-03 500 mg : Reddish pink colored, modified capsule shaped, biconvex, enteric coated tablets, imprinted with "UL 500" on one side and plain on other side Bottles of 100………………NDC 68001-474-00 Bottles of 500………………NDC68001-474-03 Recommended storage Store at 20 ° to 25 ° C (68 ° to 77 ° F) [see USP controlled Room Temperature]. Preserve in tight, light resistant containers.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

BluePoint Laboratories
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MEDICATION GUIDE
Divalproex Sodium Delayed-Release Tablets, USP, for oral use
(dye val' proe ex soe' dee um)
What is the most important information I should know about divalproex
sodium delayed-release tablets?
Do not stop taking divalproex sodium delayed-release tablets without
first talking to a healthcare
provider. Stopping divalproex sodium delayed-release tablets 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 tablets 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 tablets.
2. Divalproex sodium delayed-release tablets may harm your unborn
baby.
•
If you take divalproex sodium delayed-release tablets 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 comes

Summary of Product characteristics

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
BLUEPOINT LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIVALPROEX SODIUM
DELAYED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS.
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1983
WARNINGS: 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 is an anti-epileptic drug indicated for:
Treatment of manic episodes associated with bipolar disorder ( 1.1)
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 ( 1.2)
Prophylaxis of migraine headaches ( 1.3)
DOSAGE AND ADMINISTRATION
Divalproex sodium delayed-release tablet is administered orally in
divided doses. Divalproex sodium
delayed-release tablets should be swallowed whole and should not be
crushed or chewed ( 2.1, 2.2).
Mania: Initial dose is 750 mg daily, increasing as rapidly as possible
to achieve therapeutic response or
desired plasma level (2.1). The maximum recommended dosage is 60
mg/kg/day ( 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 informat