DIVALPROEX SODIUM tablet, delayed release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

State of Florida DOH Central Pharmacy

Designació comuna internacional (DCI):

DIVALPROEX SODIUM

Composición:

VALPROIC ACID 500 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 were 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 the long-term usefulness of the

Resumen del producto:

Divalproex Sodium Delayed Release Tablets USP are available as: 125 mg: Orange colored, modified capsule shaped, biconvex enteric coated tablets imprinted with "UL 125" on one side and plain on other side. 250 mg : Pink colored, oval shaped, biconvex enteric coated tablets imprinted with "UL 250" on one side and plain on other side. 500 mg : Reddish pink colored, modified capsule shaped, biconvex enteric coated tablets imprinted with "UL 500" on one side and plain on other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Recommended storage Store at 200 to 250 C (680 to 770 F) [See USP controlled Room Temperature].

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

DIVALPROEX SODIUM - DIVALPROEX SODIUM TABLET, DELAYED RELEASE
State of Florida DOH Central Pharmacy
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MEDICATION GUIDE
Divalproex Sodium Delayed Release Tablets USP
Read this Medication Guide before you start taking a 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 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. The most common birth
defects with divalproex
sodium delayed 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 happen.
•
Birth defects may occur even i

Fitxa tècnica

DIVALPROEX SODIUM - DIVALPROEX SODIUM TABLET, DELAYED RELEASE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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 USP FOR ORAL USE.
INITIAL U.S. APPROVAL: 1983
WARNINGS: LIFE THREATENING ADVERSE REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
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)
RECENT MAJOR CHANGES
Boxed Warning, Hepatotoxicity 07/2013
Boxed Warning, Fetal Risk 06/2013
Indications and Usage, Important Limitations (1.2) 06/2013
Contraindications, Known or Suspected Mitochondrial Disorders (4)
07/2013
Contraindications, Prophylaxis of Migraines in Pregnancy (4) 06/2013
Warnings and Precautions, Hepatotoxicity (5.1) 07/2013
Warnings and Precautions, Birth Defects (5.2) 06/2013
Warnings and Precautions, Decreased IQ (5.3) 06/2013
Warnings and Precautions, Use in Women of Childbearing Potential (5.4)
06/2013
Warnings and Precautions, Medication Residue in the Stool (5.18)
02/2013
INDICATIONS AND USAGE
Divalproex sodium delayed release tablets are an anti-epileptic drug
indicated for:
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)
DOSAGE