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:

NCS HealthCare of KY, Inc dba Vangard Labs

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 is 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 are available containing divalproex sodium, USP equivalent to 250 mg or 500 mg of valproic acid. The 250 mg tablets are white, film-coated, round, unscored tablets debossed with M over 177 on one side of the tablet and blank on the other side. They are available as follows: NDC 0615-7554-05 Blister Pack of 15 tablets NDC 0615-7554-39 Blister Pack of 30 tablets The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with M 473 on one side of the tablet and blank on the other side. They are available as follows: NDC 0615-7555-05 Blister Pack of 15 tablets NDC 0615-7555-39 Blister Pack of 30 tablets NDC 0615-7555-30 Unit-Dose Box ​of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. * Maalox® is a registered trademark of Novartis. † TitralacTM is a trademark of 3M.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
NCS HealthCare of KY, Inc dba Vangard Labs
----------
MEDICATION GUIDE
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP
(dye val′ proe ex soe′ dee um)
250 mg and 500 mg
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. The most common birth
defects with divalproex sodium
extended-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 kno

Summary of Product characteristics

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
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 EXTENDED-RELEASE TABLETS, USP 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 FIRST 6 MONTHS OF
TREATMENT. CHILDREN UNDER THE AGE
OF 2 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, Hepatotoxicity 07/2013
Boxed Warning, Fetal Risk 06/2013
Indications and Usage, Important Limitations (1.4) 06/2013
Contraindications, Known or Suspected Mitochondrial Disorders (4)
07/2013
Contraindications, Prophylaxis of Migraines in Pregnancy (4) 06/2013
Warnings and Precautions, Hepatotoxicity (5.1) 07/2013
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
INDICATIONS AND USAGE
Divalproex sodium extended-release tablets are an anti-epileptic drug
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 AD