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:

PAI Holdings, LLC

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 Precautions (5.1) for statement regarding fatal hepatic dysfunction. Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipola

Product samenvatting:

Valproic Acid Oral Solution USP is available as a red, cherry flavored oral solution containing the equivalent of 250 mg valproic acid per 5 mL as the sodium salt and supplied in the following oral dosage forms: NDC 0121-0675-16: 16 fl oz (473 mL) bottle, in a case of 6 bottles. NDC 0121-0675-85: 16 fl oz (473 mL) bottle, in a case of 12 bottles. NDC 0121-4675-05:  5 mL unit dose cup. Case contains 40 unit-dose cups of 5 mL (NDC 0121-4675-40), packaged in 4 trays of 10 unit-dose cups each and 100 unit-dose cups of 5 mL (NDC 0121-4675-00), packaged in 10 trays of 10 unit-dose cups each. NDC 0121-1350-10:  10 mL unit dose cup. Case contains 100 unit-dose cups of 10 mL (NDC 0121-1350-00), packaged in 10 trays of 10 unit-dose cups each. STORAGE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

VALPROIC ACID- VALPROIC ACID SOLUTION
PAI Holdings, LLC
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MEDICATION GUIDE
VALPROIC ACID ORAL SOLUTION USP
(VAL-pro-IC)
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:
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: In some cases, liver
damage may continue despite stopping the drug.
•
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
2. 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 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.
Decreased hearing or hearing loss
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

Productkenmerken

VALPROIC ACID- VALPROIC ACID SOLUTION
PAI HOLDINGS, LLC
----------
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: 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 is indicated for:
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)
DOSAGE AND ADMINISTRATION
Valproic acid is intended for oral administration. (2.1)
Simple and Complex Absence Seizures: Start at 10 to 15 mg/kg/day,
increasing at 1 week intervals by 5
to 10 mg/kg/week until seizure control or limiting side effects (2.1)
Safety of doses above 60 mg/kg/day is not established (2.1, 2.2)
DOSAGE FORMS AND STRENGTHS
Valproic acid oral solution USP: Equivalent of 250 mg valproic acid
per 5 mL as the sodium salt (3)
CONTRAINDICATIONS
Hepatic disease or significant hepatic dysfunction (4, 5.1)
Known mitochondrial disorders caused by mutations in mitochondrial DNA
polymerase γ (POLG) (4, 5.1)
Suspected POLG-related disorder in children under two years of age (4,
5.1)
Known hypersensitivity to the drug (4, 5.12)
Urea cycle disorders (4, 5.6)
Prophylaxis of migraine headaches: Pregnant women, women of
childbearing potential