DIVALPROEX SODIUMDELAYED-RELEASE DELAYED-RELEASE- divalproex sodium tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

DIVALPROEX SODIUM

Composition:

VALPROIC ACID 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Divalproex sodium is a 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, USP 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, USP 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, USP for extended periods should continually re-evaluate the long-term usefulness of the drug for

Product summary:

Divalproex sodium delayed-release tablets, USP are supplied as: 500 mg - pink, oval-shaped tablets, debossed “2707” on one side and debossed “V” on the reverse side: Recommended storage Store tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Maalox® is a registered trademark of Novartis Consumer Health, Inc. Titralac® is a registered trademark of Minnesota Mining and Manufacturing Company.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DIVALPROEX SODIUMDELAYED-RELEASE DELAYED-RELEASE- DIVALPROEX
SODIUM TABLET, FILM COATED
Aidarex Pharmaceuticals LLC
----------
MEDICATION GUIDE
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 taking 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. The most common birth
defects with divalproex
sodium delayed-release tablets 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 can happen.
•
Birth defects may occur even in children born to women

Summary of Product characteristics

DIVALPROEX SODIUMDELAYED-RELEASE DELAYED-RELEASE- DIVALPROEX
SODIUM TABLET, FILM COATED
AIDAREX PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS,
USP.
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP 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 ARE AT A CONSIDERABLY HIGHER RISK OF FATAL
HEPATOTOXICITY. MONITOR PATIENTS CLOSELY, AND
PERFORM LIVER FUNCTION TESTS 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
Boxed Warning, Fetal Risk 06/2013
Indications and Usage, Important Limitations (1.4) 06/2013
Contraindications (4) 06/2013
Warnings and Precautions, Birth Defects (5.2) 06/2013
Warnings and Precautions, Decreased IQ (5.3) 06/2013
Warnings and Precautions, Use in Women of Childbearing Potential (5.4)
06/2013
Warnings and Precautions, Medication Residue in the Stool (5.18)
02/2013
INDICATIONS AND USAGE
Divalproex sodium delayed-release tablets, USP are antiepileptic drugs
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 tablets are administered orally in
divided doses. Divalproex sodium delayed-
release tablets should be swallowed whole and shoul