País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)
McKesson Contract Packaging
DIVALPROEX SODIUM
VALPROIC ACID 125 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
DIVALPROEX SODIUM- DIVALPROEX SODIUM CAPSULE MCKESSON CONTRACT PACKAGING ---------- 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/ Leia o documento completo