VALPROIC- valproic acid capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ATLANTIC BIOLOGICALS CORP.

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, neurodevelopment 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

Product summary:

Valproic Acid Capsules, USP, 250 mg. Each off-white colored soft gelatin capsule is imprinted with VALPROIC 250 and made available in bottles of 100 capsules (NDC 0591-4012-01). Store capsules at controlled room temperature 15° to 30°C (59° to 86°F), see USP. Dispense in tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VALPROIC- VALPROIC ACID CAPSULE, LIQUID FILLED
ATLANTIC BIOLOGICALS CORP.
----------
MEDICATION GUIDE
Valproic Acid(val-prō-ik a-sǝd) Capsules
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 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.
Decreased hearing or hearing loss can also happen.
•
Birth defects may occur even in children born to women who are not
taking a

Summary of Product characteristics

VALPROIC- VALPROIC ACID CAPSULE, LIQUID FILLED
ATLANTIC BIOLOGICALS CORP.
----------
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.
VALPROIC ACID CAPSULES, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1978
WARNINGS: LIFE THREATENING ADVERSE REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
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)
RECENT MAJOR CHANGES
Boxed Warning, Hepatotoxicity, General Population 12/2019
Medication Guide
12/2019
INDICATIONS AND USAGE
Valproic Acid is an anti-epileptic drug 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
Capsules: 250 mg valproic acid (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