DIVALPROEX SODIUM tablet, delayed release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Proficient Rx LP

INN (Nome Internazionale):

DIVALPROEX SODIUM

Composizione:

VALPROIC ACID 250 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 continually reevaluate the long-term usefulness of the

Dettagli prodotto:

Divalproex Sodium Delayed Release Tablets USP are supplied as: 250 mg : Pink colored, oval shaped, biconvex enteric coated tablets imprinted with "UL 250" on one side and plain on other side: Bottles of 30………………NDC 63187-742-30 Bottles of 60………………NDC 63187-742-60 Bottles of 90 ……………NDC 63187-742-90 500 mg : Reddish pink colored, modified capsule shaped, biconvex enteric coated tablets imprinted with "UL 500" on one side and plain on other side Bottles of 30………………NDC 63187-743-30 Bottles of 60………………NDC 63187-743-60 Bottles of 90… …………NDC 63187-743-90 Recommended storage Store at 20o to 25o C (68o to 77o F) [See USP controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
Proficient Rx LP
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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 (urethra) o

Scheda tecnica

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
PROFICIENT RX LP
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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_.
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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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 125 mg, 250 mg and 500 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT UNICHEM PHARMACEUTICALS
(USA), INC. AT
1-866-562-4616 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
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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)
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)
Divalproex sodium delayed release tablets are administered orally in
divided doses. Divalproex
sodi