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:

Eywa Pharma Inc

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 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 o

Product summary:

Valproic acid is available as white to off-white soft gelatin capsules of 250 mg valproic acid, bearing imprint ST-l for product identification, in bottles of 100 capsules (NDC: 71930-057-12). Store capsules at 59 to 77°F (15 to 25°C)

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Eywa Pharma Inc
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SPL MEDGUIDE SECTION
MEDICATION GUIDE
Valproic acid (val·pro·ic acid) 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 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 not
taking any medicines and do not have
ot

Summary of Product characteristics

VALPROIC ACID - VALPROIC ACID CAPSULE
EYWA PHARMA INC
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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
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
malformation, 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
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 PO LG-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 contraception (4, 8.1)
WA