VALPROIC ACID solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Valproic Acid (UNII: 614OI1Z5WI) (Valproic Acid - UNII:614OI1Z5WI)

Available from:

Precision Dose Inc.

INN (International Name):

Valproic Acid

Composition:

Valproic Acid 500 mg in 10 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, 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 bipolar disorder who a

Product summary:

Valproic Acid Oral Solution, USP is available as a clear, cherry-flavored red oral solution containing the equivalent of 250 mg of valproic acid per 5 mL as the sodium salt. NDC 68094-193-61 5 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-193-62 5 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-701-61 10 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-701-62 10 mL per unit dose cup Thirty (30) cups per shipper RECOMMENDED STORAGE Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VALPROIC ACID- VALPROIC ACID SOLUTION
Precision Dose Inc.
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MEDICATION GUIDE
VALPROIC ACID ORAL SOLUTION
Read this Medication Guide before you start taking valproic acid oral
solution 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 oral solution?
Do not stop taking valproic acid oral solution without first talking
to your healthcare provider.
Stopping valproic acid oral solution suddenly can cause serious
problems.
Valproic acid oral solution 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 oral solution may harm your unborn baby.
•
If you take valproic acid oral solution 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 ris

Summary of Product characteristics

VALPROIC ACID- VALPROIC ACID SOLUTION
PRECISION DOSE INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALPROIC ACID ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
VALPROIC ACID ORAL
SOLUTION.
VALPROIC ACID ORAL SOLUTION, USP
INITIAL U.S. APPROVAL: 1978
WARNINGS: 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)
RECENT MAJOR CHANGES
Boxed Warning, Fetal Risk
2/2019
Indications and Usage, Important Limitations (1.2)
2/2019
Contraindications (4)
2/2019
Warnings and Precautions, Use in Women of Childbearing Potential (5.4)
2/2019
INDICATIONS AND USAGE
Valproic Acid Oral Solution 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 Oral Solution 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
Oral Solution: 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) (