DIVALPROEX SODIUM tablet, film coated, extended release

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

TYA Pharmaceuticals

INN (Isem Internazzjonali):

DIVALPROEX SODIUM

Kompożizzjoni:

VALPROIC ACID 500 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 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 . The effecti

Sommarju tal-prodott:

NDC:64725-0595-1 in a CONTAINER of 68 TABLET, FILM COATED, EXTENDED RELEASES

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

DIVALPROEX SODIUM - DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
TYA Pharmaceuticals
----------
MEDICATION GUIDE
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.
Stopping divalproex sodium
extended-release tablets suddenly can cause serious problems. . The
risk of getting this serious liver
damage is more likely to happen within the first 6 months of
treatment. Divalproex Sodium Extended-
Release Tablets USP [Divalproex (dye val PROE ex)]
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.
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
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 know you are pregnant. Other birth defects can

Karatteristiċi tal-prodott

DIVALPROEX SODIUM - DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
TYA PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS
USP. 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 , ,
(5.25.35.4 )
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 06/2013 Contraindications, Known or Suspected
Mitochondrial Disorders 07/2013 Contraindications,
Prophylaxis of Migraines in Pregnancy 06/2013 Warnings and
Precautions, Hepatotoxicity 07/2013 Warnings and
Precautions, Birth Defects 06/2013 Warnings and Precautions, Decreased
IQ 06/2013 Warnings and Precautions,
Use in Women of Childbearing Potential 06/2013
(1.4)
(4)
(4)
(5.1)
(5.2)
(5.3)
(5.4)
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 ADMINISTRA