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:

DirectRx

INN (International Name):

DIVALPROEX SODIUM

Composition:

VALPROIC ACID 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1.1 Mania Divalproex sodium delayed release tablets are 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 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 usefulne

Product summary:

Divalproex Sodium Delayed Release Tablets, USP are supplied as: 125 mg: Orange colored, modified capsule shaped, biconvex, enteric coated tablets, imprinted with "UL 125" on one side and plain on other side: Bottles of 100……………… Bottles of 500……………… Bottles of 1,000…………..... 250 mg: Pink colored, oval shaped, biconvex, enteric coated tablets, imprinted with "UL 250" on one side and plain on other side: Bottles of 100……………… Bottles of 500……………… Bottles of 1,000…………….. 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 100……………… Bottles of 500……………… Bottles of 1,000……………. Recommended storage Store at 20° to 25°C (68° to 77°F) [see USP controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DIVALPROEX SODIUM- divalproex sodium tablet, delayed release
DirectRx
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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) on the bottom of the penis can also

Summary of Product characteristics

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
DIRECTRX
----------
DIVALPROEX SODIUM
1.1 Mania
Divalproex sodium delayed release tablets are 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 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 drug for the individual patient.
1.2 Epilepsy
Divalproex sodium delayed release tablets are indicated as monotherapy
and adjunctive
therapy in the treatment of patients with complex partial seizures
that occur either in
isolation or in association with other types of seizures. Divalproex
sodium delayed
release tablets are also indicated for use as sole and adjunctive
therapy in the treatment
of simple and complex absence seizures, and adjunctively in patients
with multiple
seizure types that include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or
loss of
consciousness accompanied by certain generalized epileptic discharges
without other
detectable clinical signs. Complex absence is the term used when other
signs are also
present.
1.3 Migraine
Divalproex sodium delayed release tablets are indicated for
prophylaxis of migraine
headaches. There is no evidence that divalpr