DIVALPROEX SODIUM- divalproex sodium tablet, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

divalproex sodium (UNII: 644VL95AO6) (valproic acid - UNII:614OI1Z5WI)

Διαθέσιμο από:

Safecor Health, LLC

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Divalproex sodium extended-release tablet 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 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 Studies (14.1

Περίληψη προϊόντος:

Divalproex sodium extended-release tablets USP, 250 mg are available as white to off white, round shaped, beveled edge, biconvex coated tablets debossed “R” on one side and “533” on other side. Divalproex sodium extended-release tablets USP, 500 mg are available as grey colored, oval shaped, beveled edge, biconvex coated tablets debossed “R” on one side and “534” on other side. Each divalproex sodium extended-release tablet contains divalproex sodium equivalent to either 250 mg or 500 mg of valproic acid and are supplied in unit dose package of 100 (10 x 10). 250 mg Unit Dose Blister (NDC 48433-126-01) Box of 100 Unit Dose (NDC 48433-126-10) 500mg Unit Dose Blister (NDC 48433-125-01) Box of 100 Unit Dose (NDC 48433-125-10) Recommended Storage Store tablets at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

DIVALPROEX SODIUM - divalproex sodium tablet, extended release
Safecor Health, LLC
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MEDICATION GUIDE
Divalproex Sodium Extended-Release Tablets USP, 250 mg and 500 mg
(dye val' proe ex soe' dee um)
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.
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.
Stopping divalproex sodium extended-release tablets suddenly can cause
serious problems.
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. 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 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 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

Αρχείο Π.Χ.Π.

DIVALPROEX SODIUM - DIVALPROEX SODIUM TABLET, EXTENDED RELEASE
SAFECOR HEALTH, LLC
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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 TABLET 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 (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 response i