DIVALPROEX SODIUM tablet, delayed release

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

NuCare Pharmaceuticals,Inc.

INN (Միջազգային անվանումը):

DIVALPROEX SODIUM

Կազմը:

VALPROIC ACID 250 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 continu

Ապրանքի ամփոփագիր:

Pink colored, oval shaped, biconvex enteric coated tablets imprinted with UL 250 on one side and plain on other side: NDC 68071-4102-3 Bottles of 30 NDC 68071-4102-5 Bottles of 45 NDC 68071-4102-6 Bottles of 60 Recommended storage Store at 20 o to 25 o C (68 o to 77 o F) [See USP controlled Room Temperature].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
NuCare Pharmaceuticals,Inc.
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MEDICATION GUIDE
Divalproex Sodium Delayed Release Tablets USP
(dye val' proe ex soe' dee um)
Read this Medication Guide before you start taking 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 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

Ապրանքի հատկությունները

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
NUCARE PHARMACEUTICALS,INC.
----------
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
Dosage and Administration, Dosing in Patients Taking Rufinamide ( 2.5)
2/2016
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 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/