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:

BluePoint Laboratories

INN (International namn):

DIVALPROEX SODIUM

Sammansättning:

VALPROIC ACID 250 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Divalproex sodium extended-release tablets 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 Clin

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
BluePoint Laboratories
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MEDICATION GUIDE
Divalproex Sodium(dye val’ proe ex soe’ dee um)Extended-Release
Tablets, USP
What is the most important information I should know about divalproex
sodium extended-release tablets?
Do not stop divalproex sodium extended-release tablets without first
talking to a healthcare provider.
Stopping divalproex sodium extended-release tablets suddenly can cause
serious problems. Stopping a
seizure medicine suddenly in a patient who has epilepsy can cause
seizures that will not stop (status
epilepticus).
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 oldand
patients with mitochondrial disorders.
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:
•
feeling very weak, tired, or uncomfortable (malaise)
•
swelling of your face
•
not feeling hungry
•
nausea or vomiting that does not go away
•
diarrhea
•
pain on the right side of your stomach (abdomen)
•
dark urine
•
yellowing of your skin or the whites of your eyes
•
loss of seizure control in people with epilepsy
In some cases, liver damage may continue even though the medicine is
stopped. Your healthcare provider
will do blood tests to check your liver before and during treatment
with divalproex sodium extended-
release tablets.
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 that affect
the brain and spinal cord (such as
spina bifida or neural tube defects). These defects can begin in the
first month, even before you
know you are pregnant. Other birth defects that affect the structures
of the

Produktens egenskaper

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
BLUEPOINT LABORATORIES
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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)
INDICATIONS AND USAGE
Divalproex sodium extended-release tablets 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 level ( 2.1). The maximum recommended dosage is 60
mg/kg/day ( 2.1, 2.2).
Complex Partial Seizures: Start at 10 to 15 mg/kg/day, increasing at 1
week intervals by 5 to 10
mg/kg/day to achieve optimal clinical response; if respons