DIVALPROEX SODIUM- divalproex sodium tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Impax Generics

INN (International Name):

DIVALPROEX SODIUM

Composition:

VALPROIC ACID 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. 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. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). The efficacy of divalproex sodium extended-release tablets are based in part on studies of divalproex sodium delayed-release tablets in this indication, and was confirmed in a 3-week trial with patients meeting DSM-IV TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania [see Clinical Studies

Product summary:

Divalproex sodium extended-release tablets USP, 250 mg are white to off-white, oval tablets, debossed with "691" on one side and plain on the other side. Divalproex sodium extended-release tablets USP, 500 mg are white to off-white, oval tablets, debossed with "692" on one side and plain on the other side. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
Impax Generics
----------
MEDICATION GUIDE
Divalproex (dye-VAL-proe-ex) Sodium Extended-Release Tablets, USP
Read this Medication Guide before you start taking divalproex sodium
extended-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 extended-release tablets?
Do not stop taking divalproex sodium extended-release tablets without
first talking to your healthcare
provider.
Stopping divalproex sodium extended-release tablets suddenly can cause
serious problems.
Divalproex sodium extended-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 extended-release tablets may harm your unborn
baby.
•
If you take divalproex sodium extended-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

Summary of Product characteristics

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
IMPAX GENERICS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIVALPROEX SODIUM EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR DIVALPROEX
SODIUM EXTENDED-RELEASE TABLETS.
DIVALPROEX SODIUM TABLETS, EXTENDED-RELEASE FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
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)
RECENT MAJOR CHANGES
Boxed Warning, Fetal Risk 2/2019
Indications and Usage, Important Limitations (1.4) 2/2019
Contraindications (4) 2/2019
Warnings and Precautions, Use in Women 2/2019
of Childbearing Potential (5.4)
INDICATIONS AND USAGE
Divalproex sodium extended-release tablets are indicated for:
Acute treatment of manic or mixed episodes associated with bipolar
disorder, with or without psychotic features (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 extended-release tablets are intended for once-a-day
oral administration. Divalproex sodium
extended-release tablets should be swallowed whole and should not be
crushed or chewed (2.1, 2.2).
Mania: Initial dose is 25 mg/kg/day, increasing as rapidly as possible
to achieve therapeutic response or desired plasma
level (2.1). The maximum