VALPROIC ACID solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Watson Laboratories, Inc.

INN (International Name):

VALPROIC ACID

Sammensætning:

VALPROIC ACID 250 mg in 5 mL

Recept type:

PRESCRIPTION DRUG

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

VALPROIC ACID- VALPROIC ACID SOLUTION
WATSON LABORATORIES, INC.
----------
VALPROIC ACID
ORAL SOLUTION, USP
RX ONLY
REV. 792:03 9/11
50383-792
VALPROIC ACID ORAL SOLUTION, USP
RX ONLY
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 PRODUCTS
ARE USED IN THIS PATIENT GROUP, THEY 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
PRODUCTS
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.
A PATIENT INFORMATION LEAFLET DESCRIBING THE TERATOGEN