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:

Upsher-Smith Laboratories, LLC

INN (International Name):

valproic acid

Composition:

valproic acid 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Valproic acid capsules are 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 capsules are 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 b

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 (NDC 0832-0310-11). 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
Upsher-Smith Laboratories, LLC
----------
MEDICATION GUIDE
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. Decreased hearing or hearing loss can
also happen.
•
Birth defects may occur even in children born to women who are no

Summary of Product characteristics

VALPROIC ACID- VALPROIC ACID CAPSULE
UPSHER-SMITH LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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 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 capsules are 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 migraine headaches: Pregnant women, women of
childbearing potential not using
effective contracep