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:

A-S Medication Solutions

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 long-term usefulness of the drug

Product summary:

Product: 50090-4861 NDC: 50090-4861-0 30 TABLET, DELAYED RELEASE in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DIVALPROEX SODIUM - DIVALPROEX SODIUM TABLET, DELAYED RELEASE
A-S Medication Solutions
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MEDICATION GUIDE
Divalproex Sodium Delayed Release Tablets, USP
(dye val' proe ex soe' dee um)
Read this Medication Guide before you start taking divalproex sodium
delayed release tablets and each time
you get a refill. There may be new information. This information does
not take the place of talking to your
healthcare provider about your medical condition or treatment.
What is the most important information I should know about divalproex
sodium delayed release tablets?
Do not stop divalproex sodium delayed release tablets without first
talking to your healthcare provider.
Stopping divalproex sodium delayed release tablets suddenly can cause
serious problems.
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. 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:
•
nausea or vomiting that does not go away
•
loss of appetite
•
pain on the right side of your stomach (abdomen)
•
dark urine
•
swelling of your face
•
yellowing of your skin or the whites of your eyes
In some cases, liver damage may continue despite stopping the drug.
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 and are called spina
bifida or neural tube defects. These defects occur in 1 to 2 out of
every 100 babies born to mothers
who use this medicine during pregnancy. 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 out (

Summary of Product characteristics

DIVALPROEX SODIUM - DIVALPROEX SODIUM TABLET, DELAYED RELEASE
A-S MEDICATION SOLUTIONS
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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 information fo