DIVALPROEX SODIUM tablet, delayed release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

DIRECT RX

INN (Международно Name):

DIVALPROEX SODIUM

Композиция:

VALPROIC ACID 250 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

1.1 Mania 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 usefulnes

Каталог на резюме:

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      NDC 29300-138-01 Bottles of 500      NDC 29300-138-05 Bottles of 1000     NDC 29300-138-10 250 mg: Pink colored, oval shaped, biconvex enteric coated tablets imprinted with "UL 250" on one side and plain on other side: Bottles of 100      NDC 29300-139-01 Bottles of 500      NDC 29300-139-05 Bottles of 1000     NDC 29300-139-10 500 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      NDC 29300-140-01 Bottles of 500      NDC 29300-140-05 Bottles of 1000     NDC 29300-140-10 Recommended storage Store at 200 to 250C (680 to 770F) [See USP controlled Room Temperature].

Статус Оторизация:

Abbreviated New Drug Application

Листовка

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
DIRECT RX
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SPL MEDGUIDE SECTION
MEDICATION GUIDE
Divalproex Sodium Delayed Release Tablets USP
Read this Medication Guide before you start taking a 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. 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

Данни за продукта

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
DIRECT RX
----------
DIVALPROEX SODIUM
BOXED WARNING SECTION
WARNING: LIFE THREATENING ADVERSE REACTIONS
Hepatotoxicity
General Population: Hepatic failure resulting in fatalities has
occurred in patients receiving
valproate and its derivatives. These incidents usually have occurred
during the first six months of
treatment. Serious or fatal hepatotoxicity may be preceded by
non-specific symptoms such as
malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In
patients with epilepsy, a loss
of seizure control may also occur. Patients should be monitored
closely for appearance of these
symptoms. Serum liver tests should be performed prior to therapy and
at frequent intervals
thereafter, especially during the first six months [see Warnings and
Precautions (5.1)].
Children under the age of two years are at a considerably increased
risk of developing fatal
hepatotoxicity, especially those on multiple anticonvulsants, those
with congenital metabolic
disorders, those with severe seizure disorders accompanied by mental
retardation, and those with
organic brain disease. When divalproex sodium is used in this patient
group, it should be used
with extreme caution and as a sole agent. The benefits of therapy
should be weighed against the
risks. The incidence of fatal hepatotoxicity decreases considerably in
progressively older patient
groups.
Patients with Mitochondrial Disease: There is an increased risk of
valproate-induced acute liver
failure and resultant deaths in patients with hereditary
neurometabolic syndromes caused by DNA
mutations of the mitochondrial DNA Polymerase γ (POLG) gene (e.g.
Alpers Huttenlocher
Syndrome). Divalproex sodium is contraindicated in patients known to
have mitochondrial
disorders caused by POLG mutations and children under two years of age
who are clinically
suspected of having a mitochondrial disorder [see Contraindications
(4)]. In patients over two
years of age who are clinically suspected of having a hereditary
mit