DIVALPROEX SODIUM capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)

Предлага се от:

McKesson Contract Packaging

INN (Международно Name):

DIVALPROEX SODIUM

Композиция:

VALPROIC ACID 125 mg

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

DIVALPROEX SODIUM- DIVALPROEX SODIUM CAPSULE
MCKESSON CONTRACT PACKAGING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIVALPROEX SODIUM CAPSULES (SPRINKLE)
(DIVALPROEX SODIUM USP EQUIVALENT TO 125 MG OF VALPROIC ACID) SAFELY
AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR DIVALPROEX SODIUM APSULES
(SPRINKLE) (DIVALPROEX SODIUM USP EQUIVALENT
TO 125 MG OF VALPROIC ACID).
INITIAL U.S. APPROVAL: 1989
DIVALPROEX SODIUM CAPSULES (SPRINKLE) (DIVALPROEX SODIUM USP
EQUIVALENT TO 125 MG OF VALPROIC ACID)
WARNING: 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 ARE AT CONSIDERABLY HIGHER RISK OF FATAL HEPATOTOXICITY.
MONITOR PATIENTS CLOSELY, AND
PERFORM LIVER FUNCTION TESTS PRIOR TO THERAPY AND AT FREQUENT
INTERVALS THEREAFTER (5.1)
TERATOGENICITY, INCLUDING NEURAL TUBE DEFECTS (5.2)
PANCREATITIS, INCLUDING FATAL HEMORRHAGIC CASES (5.3)
RECENT MAJOR CHANGES
Warnings and Precautions (5.8, 5.10, 5.12, 5.13, 5.14) 3/2008
Pediatric Use 8.4 3/2008
INDICATIONS AND USAGE
Monotherapy and adjunctive therapy of complex partial seizures and
simple and complex absence seizures; adjunctive
therapy in patients with multiple seizure types that include absence
seizures (1) (2)
DOSAGE AND ADMINISTRATION
Divalproex sodium capsules (sprinkle) may be swallowed whole or the
contents may be sprinkled on soft food. The
drug/food mixture should be swallowed immediately (avoid chewing)
Safety of doses above 60 mg/kg/day is not established (2.1, 2.2)
Complex Partial Seizures: Start at 10 to 15 mg/kg/day, increasing at 1
week intervals by 5 to 10 mg/kg/day to achieve
optimal clinical response; if response is not satisfactory, check
valproate plasma level; see full prescribing information
for conversion to monotherapy (2.1)
Absence Seizures: Start at 15 mg/kg/day, increasing at 1 week
intervals by 5 to 10 mg/kg/