VALPROIC ACID capsule, liquid filled

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Rebel Distributors Corp

Designación común internacional (DCI):

valproic acid

Composición:

valproic acid 250 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 FOR STATEMENT REGARDING FATAL HEPATIC DYSFUNCTION. VALPROIC ACID SHOULD NOT BE ADMINISTERED TO PATIENTS WITH HEPATIC DISEASE OR SIGNIFICANT HEPATIC DYSFUNCTION. Valproic acid is contraindicated in patients with known hypersensitivity to the drug. Valproic acid is contraindicated in patients with known urea cycle disorders (see WARNINGS )

Resumen del producto:

Each white, oblong softgel (soft-gelatin capsule) imprinted PA2120, contains 250 mg valproic acid in bottles of 100's.  The softgels should be protected from moisture and humidity and stored between 59-77°F (15-25°C) as per the container label.  Dispense in a tight, light-resistant container as defined in the USP/NF. Maalox® is a registered trademark of Novartis Consumer Health Canada Inc. Titralac TM is a registered trademark of 3M.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

VALPROIC ACID- VALPROIC ACID CAPSULE, LIQUID FILLED
REBEL DISTRIBUTORS CORP
----------
VALPROIC ACID
BOXED WARNING
HEPATOTOXICITY
HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS
RECEIVING VALPROIC ACID. EXPERIENCE HAS INDICATED THAT CHILDREN
UNDER THE AGE OF TWO YEARS ARE AT A CONSIDERABLY INCREASED RISK OF
DEVELOPING FATAL HEPATOTOXICITY, ESPECIALLY THOSE ON MULTIPLE
ANTICONVULSANTS, THOSE WITH CONGENITAL METABOLIC DISORDERS, THOSE
WITH SEVERE SEIZURE DISORDERS ACCOMPANIED BY MENTAL RETARDATION,
AND THOSE WITH ORGANIC BRAIN DISEASE. WHEN VALPROIC ACID IS USED IN
THIS PATIENT GROUP, IT SHOULD BE USED WITH EXTREME CAUTION AND AS A
SOLE AGENT. THE BENEFITS OF THERAPY SHOULD BE WEIGHED AGAINST THE
RISKS. ABOVE THIS AGE GROUP, EXPERIENCE IN EPILEPSY HAS INDICATED THAT
THE INCIDENCE OF FATAL HEPATOTOXICITY DECREASES CONSIDERABLY IN
PROGRESSIVELY OLDER PATIENT GROUPS.
THESE INCIDENTS USUALLY HAVE OCCURRED DURING THE FIRST SIX MONTHS OF
TREATMENT. SERIOUS OR FATAL HEPATOTOXICITY MAY BE PRECEDED BY NON-
SPECIFIC SYMPTOMS SUCH AS MALAISE, WEAKNESS, LETHARGY, FACIAL EDEMA,
ANOREXIA, AND VOMITING. IN PATIENTS WITH EPILEPSY, A LOSS OF SEIZURE
CONTROL MAY ALSO OCCUR. PATIENTS SHOULD BE MONITORED CLOSELY FOR
APPEARANCE OF THESE SYMPTOMS. LIVER FUNCTION TESTS SHOULD BE
PERFORMED PRIOR TO THERAPY AND AT FREQUENT INTERVALS THEREAFTER,
ESPECIALLY DURING THE FIRST SIX MONTHS.
TERATOGENICITY
VALPROATE CAN PRODUCE TERATOGENIC EFFECTS SUCH AS NEURAL TUBE
DEFECTS (E.G., SPINA BIFIDA). ACCORDINGLY, THE USE OF VALPROATE IN
WOMEN
OF CHILDBEARING POTENTIAL REQUIRES THAT THE BENEFITS OF ITS USE BE
WEIGHED AGAINST THE RISK OF INJURY TO THE FETUS. THIS IS ESPECIALLY
IMPORTANT WHEN THE TREATMENT OF A SPONTANEOUSLY REVERSIBLE
CONDITION NOT ORDINARILY ASSOCIATED WITH PERMANENT INJURY OR RISK OF
DEATH (E.G., MIGRAINE) IS CONTEMPLATED. SEE WARNINGS, INFORMATION FOR
PATIENTS.
AN INFORMATION SHEET DESCRIBING THE TERATOGENIC POTENTIAL OF
VALPROATE IS AVAILABLE FOR PATIENTS.
PANCREATITIS
CASES OF LIFE-THREATENING PANCREATITIS HAVE BEE