VALPROIC ACID capsule liquid filled

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

McKesson Packaging Services Business Unit of McKesson Corporation

INN (Международно Name):

VALPROIC ACID

Композиция:

VALPROIC ACID 250 mg

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

VALPROIC ACID- VALPROIC ACID CAPSULE, LIQUID FILLED
MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION
----------
VALPROIC ACID CAPSULES, USP
250 MG
RX ONLY
BOX 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
CAPSULES, USP 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.
AN INFORMATION SHEET DESCRIBING THE TERATOGENIC POTENT