DIVALPROEX SODIUM- divalproex sodium tablet, film coated, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

REMEDYREPACK INC.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Divalproex sodium extended-release tablets, USP are 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 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 [see Clinical Studie

Produktsammanfattning:

Divalproex Sodium Extended-release Tablets USP, 250 mg are available as white to off-white, capsule-shaped, biconvex, film-coated tablets imprinted with "ZA47" on one side and the other side plain and are supplied as follows: NDC 68001-105-00 in bottle of 100 tablets NDC 68001-105-03 in bottle of 500 tablets Divalproex Sodium Extended-release Tablets USP, 500 mg are available as white to off-white, capsule-shaped, biconvex, film-coated tablets imprinted with "ZA48" on one side and the other side plain and are supplied as follows: NDC 68001-106-00 in bottle of 100 tablets NDC 68001-106-03 in bottle of 500 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Maalox ® is the registered trademark of Novartis Consumer Health. Trisogel ® is the registered trademark of Eli Lilly Corporation. Titralac ® is the registered trademark of 3M Pharmaceuticals.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
REMEDYREPACK INC.
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MEDICATION GUIDE
Divalproex Sodium
(dye val PRO ex sew dee uhm)
Extended-release Tablets, USP
Read this Medication Guide before you start taking divalproex sodium
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?
Do not stop taking divalproex sodium without first talking to your
healthcare provider.
Stopping divalproex sodium suddenly can cause serious problems.
Divalproex sodium can cause serious side effects, including:
1.
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 may harm your unborn baby.
•
If you take divalproex sodium 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 the urine comes out (urethra) on the bottom of the penis
can also happen.
•
Birth defects may occur even in children born to women who are not
taking any medicines and do
n

Produktens egenskaper

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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, 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 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
1. Boxed Warning, Fetal Risk 2/2019
2. Indications and Usage, Important Limitations (1.4) 2/2019
3. Contraindications (4) 2/2019
Warnings and Precautions, Use in Women of Childbearing Potential (5.4)
2/2019
INDICATIONS AND USAGE
Divalproex sodium extended-release tablets, USP are 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 chewed ( 2.1, 2.2).
Mania: Initial dose is 25 mg/kg/day, increasing as rapidly as possible
to achieve therapeutic response or desired plasma
lev