VALPROIC ACID capsule VALPROIC ACID capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VALPROIC ACID (UNII: 614OI1Z5WI) (VALPROIC ACID - UNII:614OI1Z5WI)

Available from:

Direct_Rx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

These highlights do not include all the information needed to use VALPROIC ACID CAPSULES safely and effectively. See full prescribing information for VALPROIC ACID CAPSULES. VALPROIC ACID capsules for oral use Initial U.S. Approval: 1978 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 Valproic Acid Capsules are an anti-epileptic drug indicated for: Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and c

Product summary:

Valproic Acid Capsules, USP 250 mg are off-white colored soft gelatin capsules, imprinted with "U-S 250", containing Valproic Acid, USP, and packaged in bottles of 100 capsules . Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VALPROIC ACID- valproic acid capsule
VALPROIC ACID- valproic acid capsule
Direct_Rx
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VALPROIC ACID (val∙pro∙ic acid) CAPSULES, USP
Read this Medication Guide before you start taking valproic acid
capsules 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 valproic
acid capsules?
Do not stop taking valproic acid capsules without first talking to
your healthcare provider.
Stopping valproic acid capsules suddenly can cause serious problems.
Valproic acid capsules 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.
Valproic acid capsules may harm your unborn baby.
If you take valproic acid capsules 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 happen.
Birth defects may occur even in children born to women who are not
taking any medicines and do not have
other risk factors.
Taking folic acid supplem

Summary of Product characteristics

VALPROIC ACID- VALPROIC ACID CAPSULE
VALPROIC ACID- VALPROIC ACID CAPSULE
DIRECT_RX
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VALPROIC ACID
Hepatotoxicity General Population: Hepatic failure resulting in
fatalities has occurred
in patients receiving valproate and its derivatives. These incidents
usually ...
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
valproic acid products are used in this patient group, they 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). Valproic acid is
contraindicated
in patients known to have mitochondrial disorders caused by POLG
mutations and
children under two years of age who are clinically sus