DEPAKOTE ER- divalproex sodium tablet, extended release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Aphena Pharma Solutions - Tennessee, LLC

INN（国际名称）:

DIVALPROEX SODIUM

组成:

VALPROIC ACID 500 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Depakote ER is a valproate and is 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 Depakote ER is based in part on studies of Depakote (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 (14.1)] . The effectiveness of valproate for long-term

產品總結:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Depakote ER 250 mg is available as white ovaloid tablets with the “a” logo and the code (HF). Each Depakote ER tablet contains divalproex sodium equivalent to 250 mg of valproic acid in the following package sizes: Bottles of 60....……………………………………………(NDC 0074-3826-60). Bottles of 100……………………………………………..(NDC 0074-3826-13). Bottles of 500……………………………………………..(NDC 0074-3826-53). Unit Dose Packages of 100..................…………………..(NDC 0074-3826-11). Depakote ER 500 mg is available as gray ovaloid tablets with the “a” logo and the code HC. Each Depakote ER tablet contains divalproex sodium equivalent to 500 mg of valproic acid in the following packaging sizes: Bottles of 100...................................................................(NDC 0074-7126-13). Bottles of 500...................................................................(NDC 0074-7126-53). Unit Dose Packages of 100...............................................(NDC 0074-7126-11). Recommended Storage Store tablets at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

授权状态:

New Drug Application

资料单张

DEPAKOTE ER- DIVALPROEX SODIUM TABLET, EXTENDED RELEASE
Aphena Pharma Solutions - Tennessee, LLC
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MEDICATION GUIDE
DEPAKOTE ER (dep-a-kOte)
(divalproex sodium)
Extended Release Tablets
DEPAKOTE (dep-a-kOte)
(divalproex sodium)
Tablets
DEPAKOTE (dep-a-kOte)
(divalproex sodium coated particles in capsules)
Sprinkle Capsules
DEPAKENE (dep-a-keen)
(valproic acid)
Capsules and Oral Solution
Read this Medication Guide before you start taking Depakote or
Depakene 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 Depakote
and Depakene?
Do not stop taking Depakote or Depakene without first talking to your
healthcare provider.
Stopping Depakote or Depakene suddenly can cause serious problems.
Depakote and Depakene 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.
Depakote or Depakene may harm your unborn baby.
•
If you take Depakote or Depakene during pregnancy for any medical
condition, your baby
is at risk for serious birth defects. The most common birth defects
with Depakote or
Depakene 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. Ot

产品特点

DEPAKOTE ER- DIVALPROEX SODIUM TABLET, EXTENDED RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEPAKOTE ER SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DEPAKOTE ER.
DEPAKOTE ER (DIVALPROEX SODIUM) TABLET, 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 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, Hepatotoxicity 05/2013
Boxed Warning, Fetal Risk 05/2013
Indications and Usage, Important Limitations (1.4) 05/2013
Contraindications, Known or Suspected Mitochondrial Disorders (4)
05/2013
Contraindications, Prophylaxis of Migraines in Pregnancy (4) 05/2013
Warnings and Precautions, Hepatotoxicity (5.1) 05/2013
Warnings and Precautions, Birth Defects (5.2) 05/2013
Warnings and Precautions, Decreased IQ (5.3) 05/2013
Warnings and Precautions, Use in Women of Childbearing Potential (5.4)
05/2013
Warnings and Precautions, Brain Atrophy (5.7) 05/2013
Warning and Precautions, Medication Residue in the Stool (5.19)
02/2013
INDICATIONS AND USAGE
Depakote ER is 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