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:

Cardinal Health 107, LLC

INN (International Name):

DIVALPROEX SODIUM

Composition:

VALPROIC ACID 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Divalproex sodium delayed-release tablets are a valproate and are 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 t

Product summary:

Divalproex sodium delayed-release tablets, USP are supplied as: Divalproex Sodium Delayed-Release Tablets USP, 250 mg are peach colored, oval shaped enteric-coated tablets, imprinted with “D 85” on one side with black edible ink and plain on other side. Overbagged with 10 tablets per bag, NDC 55154-7145-0 Divalproex Sodium Delayed-Release Tablets USP, 500 mg are pink colored, oval shaped enteric-coated tablets, imprinted with “D 86” on one side with black edible ink and plain on other side. Overbagged with 10 tablets per bag, NDC 55154-4679-0 Recommended Storage Store 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]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
Cardinal Health 107, LLC
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MEDICATION GUIDE
8278261/1020
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 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 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 th

Summary of Product characteristics

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
CARDINAL HEALTH 107, LLC
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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
WARNING: LIFE THREATENING ADVERSE REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
Divalproex sodium is an anti-epileptic drug indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 125 mg, 250 mg and 500 mg (3)
CONTRAINDICATIONS
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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)
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)
Divalproex sodium delayed-release tablets are 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