DIVALPROEX SODIUM EXTENDED-RELEASE- divalproex sodium tablet, extended release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Contract Pharmacy Services-PA

INN (Kansainvälinen yleisnimi):

DIVALPROEX SODIUM

Koostumus:

VALPROIC ACID 500 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Divalproex sodium extended-release tablets, USP are valproates 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 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

Tuoteyhteenveto:

Divalproex Sodium Extended-Release Tablets, USP 500 mg are available as white, oval shaped film coated tablets printed with “A511” in black ink on one side and plain on the other side. Each divalproex sodium extended-release tablet contains divalproex sodium equivalent to 500 mg of valproic acid in the following packaging sizes: NDC 67046-143-07 blisterpacks of 7 NDC 67046-143-14 blisterpacks of 14 NDC 67046-143-15 blisterpacks of 15 NDC 67046-143-20 blisterpacks of 20 NDC 67046-143-21 blisterpacks of 21 NDC 67046-143-28 blisterpacks of 28 NDC 67046-143-30 blisterpacks of 30 NDC 67046-143-60 blisterpacks of 60 Recommended Storage Store tablets at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature] .

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

DIVALPROEX SODIUM EXTENDED-RELEASE- DIVALPROEX SODIUM TABLET, EXTENDED
RELEASE
Contract Pharmacy Services-PA
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MEDICATION GUIDE
Divalproex Sodium (dye val' proe ex soe' dee um) Extended-Release
Tablets, USP
Read this Medication Guide before you start taking divalproex sodium
extended-release tablets or
valproic acid 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:
•
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.
•
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, h

Valmisteyhteenveto

DIVALPROEX SODIUM EXTENDED-RELEASE- DIVALPROEX SODIUM TABLET, EXTENDED
RELEASE
CONTRACT PHARMACY SERVICES-PA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
143 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)/Multi-Organ
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 are intended for once-a-day
oral administration. Divalproex sodium
extended-release tablets should be swallowed whole and should not be
crushed or chewe