DIVALPROEX SODIUM tablet, extended release

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

RedPharm Drug, Inc.

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. 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. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). The efficacy of divalproex sodium extended-release tablets is based in part on studies of divalproex sodium delayed-release tablets in this indication, and was confirmed in a 3-week trial with patients meeting DSM-IV TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania [see

제품 요약:

Divalproex sodium extended-release tablets USP, 250 mg are available as white to off-white, round, coated tablets with imprinting “AN 755” on one side and plain on the other side. Each divalproex sodium extended-release tablet, USP contains divalproex sodium, USP equivalent to 250 mg of valproic acid in the following package sizes: Bottles of 100:                                    NDC 65162-755-10 Bottles of 500:                                    NDC 65162-755-50 Divalproex sodium extended-release tablets USP, 500 mg are available as white to off-white, capsule shaped, coated tablets with imprinting “AN 757” on one side and plain on the other side. Each divalproex sodium extended-release tablet, USP contains divalproex sodium, USP equivalent to 500 mg of valproic acid in the following packaging sizes: Bottles of 100:                                    NDC 65162-757-10 Bottles of 500:                                    NDC 65162-757-50 Recommended Storage: Store tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, EXTENDED RELEASE
RedPharm Drug, Inc.
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MEDICATION GUIDE
Divalproex (dye val’ proe ex) Sodium Extended-Release Tablets, USP
Read this Medication Guide before you start taking divalproex sodium
extended-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 extended-release tablets?
Do not stop taking divalproex sodium extended-release tablets without
first talking to your healthcare
provider.
Stopping divalproex sodium extended-release tablets suddenly can cause
serious problems.
Divalproex sodium extended-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 extended-release tablets may harm your unborn baby.
•
If you take divalproex sodium extended-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 (

제품 특성 요약

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, EXTENDED RELEASE
REDPHARM DRUG, INC.
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DIVALPROEX ER 250MG
WARNING: LIFE THREATENING ADVERSE REACTIONS
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 extended-release 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 extended-release 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