VALPROIC ACID- valproic acid solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Cardinal Health

INN (Algemene Internationale Benaming):

VALPROIC ACID

Samenstelling:

VALPROIC ACID 250 mg in 5 mL

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Valproic acid is 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. Valproic acid is 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 which 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. See Warnings and Precaution (5.1) for statement regarding fatal hepatic dysfunction. Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the man

Product samenvatting:

Valproic Acid Oral Solution USP is available as a red, cherry flavored solution containing the equivalent of 250 mg valproic acid per 5 mL as the sodium salt in 5 mL unit dose containers, available overbagged with 5 cups per bag, NDC 55154-9430-5.. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Repackaged By: Cardinal Health Zanesville, OH 43701 L37248870715

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

VALPROIC ACID- VALPROIC ACID SOLUTION
Cardinal Health
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MEDICATION GUIDE
VALPROIC ACID ORAL SOLUTION USP
Read this Medication Guide before you start taking valproic acid 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?
Do not stop taking valproic acid without first talking to your
healthcare provider.
Stopping valproic acid suddenly can cause serious problems.
Valproic acid can cause serious side effects, including:
•
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.
•
Valproic acid may harm your unborn baby.
•
If you take valproic acid during pregnancy for any medical condition,
your baby is at risk for
serious birth defects. The most common birth defects with valproic
acid 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 children born to women who are not
taking any medicines
and do not have other risk factors.
•
Taking folic acid supplements before getting pregnant and during early
pregnancy can lower
the chance of having a baby with a neural tube defect.
•
If you take valproic acid dur

Productkenmerken

VALPROIC ACID- VALPROIC ACID SOLUTION
CARDINAL HEALTH
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALPROIC ACID SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VALPROIC ACID ORAL SOLUTION USP.
VALPROIC ACID ORAL SOLUTION, USP
INITIAL U.S. APPROVAL: 2000
WARNINGS: LIFE THREATENING ADVERSE REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
•
•
•
RECENT MAJOR CHANGES
Boxed Warning, Hepatotoxicity
10/2013
Boxed Warning, Fetal Risk
10/2013
Indications and Usage, Important Limitations (1.2)
10/2013
Contraindications, Known or Suspected Mitochondrial Disorders (4)
10/2013
Warnings and Precautions, Hepatotoxicity (5.1)
10/2013
Warnings and Precautions, Birth Defects (5.2)
10/2013
Warnings and Precautions, Decreased IQ (5.3)
10/2013
Warnings and Precautions, Use in Women of Childbearing Potential (5.4)
10/2013
Warnings and Precautions, Brain Atrophy (5.7)
10/2013
INDICATIONS AND USAGE
Valproic acid is an anti-epileptic drug indicated for:
•
DOSAGE AND ADMINISTRATION
Valproic acid is intended for oral administration. (2.1)
•
•
DOSAGE FORMS AND STRENGTHS
Valproic acid oral solution USP: Equivalent of 250 mg valproic acid
per 5 mL as the sodium salt
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
Hepatotoxicity, including fatalities, usually during 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)
Monotherapy and adjunctive therapy of complex partial seizures; sole
and adjunctive therapy of simple and complex
absence seizures; adjunctive therapy in patients with multiple seizure
types that include absence seizures (1)
Simple and Complex Absence Se