DIVALPROEX SODIUM tablet, delayed release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Dr.Reddy's Laboratories Limited

INN (שם בינלאומי):

divalproex sodium

הרכב:

divalproex sodium 125 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Divalproex sodium delayed-release tablet is a valproate and is 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 was 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 systematically evaluated 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 usefu

leaflet_short:

Divalproex sodium delayed-release tablets USP, 125 mg are light brown to brown colored, modified capsule shaped, biconvex coated tablets printed “R529” on one side with black ink and plain on other side. They are supplied in bottles of 30’s, 100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                                                           NDC 55111-529-30 Bottles of 100                                                                         NDC 55111-529-01 Bottles of 500                                                                         NDC 55111-529-05 Unit dose package of 100 (10 x 10)                                       NDC 55111-529-78  Divalproex sodium delayed-release tablets USP, 250 mg are cream colored, modified capsule shaped, biconvex coated tablets printed “R530” on one side with black ink and plain on other side. They are supplied in bottles of 30’s, 100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                                                           NDC 55111-530-30 Bottles of 100                                                                         NDC 55111-530-01 Bottles of 500                                                                         NDC 55111-530-05 Unit dose package of 100 (10 x 10)                                       NDC 55111-530-78  Divalproex sodium delayed-release tablets USP, 500 mg are light pink colored, modified capsule shaped, biconvex coated tablets printed “R531” on one side with black ink and plain on other side. They are supplied in bottles of 30’s, 100’s, 500’s and unit dose package of 100 (10 x 10).  Bottles of 30                                                                           NDC 55111-531-30 Bottles of 100                                                                         NDC 55111-531-01 Bottles of 500                                                                         NDC 55111-531-05 Unit dose package of 100 (10 x 10)                                       NDC 55111-531-78  Recommended storage: Store divalproex sodium delayed-release tablets at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

עלון מידע

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
Dr.Reddy's Laboratories Limited
----------
MEDICATION GUIDE
Divalproex Sodium Delayed-Release Tablets USP
Read this Medication Guide before you start taking a divalproex sodium
delayed-release tablet 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 in childr

מאפייני מוצר

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
DR.REDDY'S LABORATORIES LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIVALPROEX SODIUM SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR DIVALPROEX SODIUM.
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 ARE AT A CONSIDERABLY HIGHER RISK OF FATAL
HEPATOTOXICITY. MONITOR PATIENTS CLOSELY, AND
PERFORM LIVER FUNCTION TESTS PRIOR TO THERAPY AND AT FREQUENT
INTERVALS THEREAFTER (5.1)
FETAL RISK, PARTICULARLY NEURAL TUBE DEFECTS AND OTHER MAJOR
MALFORMATIONS (5.2, 5.3)
PANCREATITIS, INCLUDING FATAL HEMORRHAGIC CASES (5.4)
RECENT MAJOR CHANGES
Warnings and Precautions, Use in Women of Childbearing Potential (5.2)
10/2011
Warnings and Precautions, Birth Defects (5.3) 10/2011
INDICATIONS AND USAGE
Divalproex sodium delayed-release tablet is 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 AND ADMINISTRATION
Divalproex sodium delayed-release tablets are administered orally in
divided doses. Divalproex sodium delayed-
release tablets should be swallowed whole and should not be crushed or
chewed. (2.1, 2.2)
Mania: Initial dose is 750 mg daily 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
optima