DIVALPROEX SODIUM tablet, 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:

Contract Pharmacy Services-PA

INN (International Name):

DIVALPROEX SODIUM

Composition:

VALPROIC ACID 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Divalproex sodium extended-release tablets, USP 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, USP is based in part on studies of divalproex sodium delayed-release tablets, USP 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

Product summary:

Divalproex sodium extended-release tablets, USP, 500 mg , are available as white to off-white, capsule shaped, coated tablets with imprinting “AN 757” on one side and plain on the other side. Each divalproex sodium extended-release tablet, USP contains divalproex sodium, USP equivalent to 500 mg of valproic acid in the following packaging sizes: NDC 67046-150-07 blisterpacks of 7 NDC 67046-150-14 blisterpacks of 14 NDC 67046-150-15 blisterpacks of 15 NDC 67046-150-20 blisterpacks of 20 NDC 67046-150-21 blisterpacks of 21 NDC 67046-150-28 blisterpacks of 28 NDC 67046-150-30 blisterpacks of 30 NDC 67046-150-60 blisterpacks of 60 Recommended Storage Store tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, EXTENDED RELEASE
Contract Pharmacy Services-PA
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MEDICATION GUIDE
Divalproex (dye-val-PRO-ex) Sodium Extended-release Tablets
Read this Medication Guide before you start taking divalproex sodium
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?
Do not stop taking divalproex sodium without first talking to your
healthcare provider.
Stopping divalproex sodium suddenly can cause serious problems.
Divalproex sodium 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 may harm your unborn baby.
•
If you take divalproex sodium 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 (urethra) on the bottom of the penis
can also happen.
•
Birth defects may occur even in children born to women who are not
taking any medicines and do
not have other risk

Summary of Product characteristics

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, EXTENDED RELEASE
CONTRACT PHARMACY SERVICES-PA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
150 DIVALPROEX ER 500 MG
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 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
Warnings and Precautions, Birth Defects ( 5.2) 1/2015
Warnings and Precautions, Bleeding and Other Hematopoietic
Disorders ( 5.8) 1/2015
Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS)/Multiorgan Hypersensitivity
Reaction ( 5.12) 1/2015
INDICATIONS AND USAGE
Divalproex sodium extended-release tablets, USP 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 ADMINISTRATION
Divalproex sodium extended-release tablets, USP are intended for
once-a-day oral administration. Divalproex sodium
extended-release tablets, USP should be swallowed whole and should not
be crushed or chewed (2.1, 2.2).
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