DIVALPROEX SODIUM- divalproex sodium tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

DIVALPROEX SODIUM

Composition:

VALPROIC ACID 125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 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 dr

Product summary:

Divalproex sodium delayed-release tablets USP are supplied as follows: 125 mg: Reddish-brown, film coated, oval shaped, unscored tablet, imprinted with black ink 93│7439 on one side and plain on the other side. Bottles of 100 tablets (NDC 0093-7439-01) 250 mg: Beige, film coated, oval shaped, unscored tablet, imprinted with black ink 93│7440 on one side and plain on the other side. Bottles of 100 (NDC 0093-7440-01) Bottles of 500 (NDC 0093-7440-05) 500 mg: Dark pink, film coated, oval shaped, unscored tablet, imprinted with black ink 93│7441 on one side and plain on the other side. Bottles of 100 (NDC 0093-7441-01) Bottles of 500 (NDC 0093-7441-05) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
Divalproex (dye-val-PRO-ex) Sodium Delayed-Release Tablets
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 taking 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

Summary of Product characteristics

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
TEVA PHARMACEUTICALS USA, 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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1983
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 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/kg/day to achieve
optimal clinical response; if response is not satisfactory, check
valproate plasma level; s