VALPROIC ACID capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

valproic acid (UNII: 614OI1Z5WI) (valproic acid - UNII:614OI1Z5WI)

Dostupné z:

Aphena Pharma Solutions - Tennessee, LLC

INN (Medzinárodný Name):

valproic acid

Zloženie:

valproic acid 250 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Valproic Acid Capsules, USP 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, USP 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, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless th

Prehľad produktov:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. 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 0832-1008-11). Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container with a child-resistant closure.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

VALPROIC ACID- VALPROIC ACID CAPSULE
Aphena Pharma Solutions - Tennessee, LLC
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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. The most common birth defects with
valproic acid capsules
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 can 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 supplements before getting pregnant and during ea

Súhrn charakteristických

VALPROIC ACID- VALPROIC ACID CAPSULE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALPROIC ACID CAPSULES, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALPROIC ACID
CAPSULES, USP.
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 05/2013
Boxed Warning, Fetal Risk 05/2013
Indications and Usage, Important Limitations (1.2) 05/2013
Contraindications, Known or Suspected Mitochondrial Disorders (4)
05/2013
Warnings and Precautions, Hepatotoxicity (5.1) 05/2013
Warnings and Precautions, Birth Defects (5.2) 05/2013
Warnings and Precautions, Decreased IQ (5.3) 05/2013
Warnings and Precautions, Use in Women of Childbearing Potential (5.4)
05/2013
Warnings and Precautions, Brain Atrophy (5.7) 05/2013
INDICATIONS AND USAGE
Valproic Acid Capsules, USP are 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 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)