País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
VALPROATE SODIUM (UNII: 5VOM6GYJ0D) (VALPROIC ACID - UNII:614OI1Z5WI)
Hikma Pharmaceuticals USA Inc.
VALPROATE SODIUM
VALPROIC ACID 100 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Valproate Sodium Injection is indicated as an intravenous alternative in patients for whom oral administration of valproate products is temporarily not feasible in the following conditions: Valproate Sodium Injection 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. Valproate Sodium Injection is also indicated for use as sole and adjunctive therapy in the treatment of patients with simple and complex absence seizures, and adjunctively in patients with multiple seizure types that 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 AND PRECAUTIONS (5.1) for statement regarding fatal hepatic dysfunction. Because of the risk to the fetus
Valproate Sodium Injection, USP, equivalent to 100 mg of valproic acid per mL, is a clear, colorless solution in 5 mL single dose vials, available in trays of 10 vials (NDC 0143-9637-10). Recommended storage: Store vials at 20° to 25°C (68° to 77°F) with excursions between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature]. No preservatives have been added. Unused portion of container should be discarded.
Abbreviated New Drug Application
VALPROATE SODIUM- VALPROATE SODIUM INJECTION HIKMA PHARMACEUTICALS USA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VALPROATE SODIUM INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALPROATE SODIUM INJECTION, USP. VALPROATE SODIUM INJECTION, USP FOR INTRAVENOUS INJECTION INITIAL U.S. APPROVAL: 1996 WARNING: LIFE THREATENING ADVERSE REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ HEPATOTOXICITY, INCLUDING FATALITIES, USUALLY DURING THE FIRST 6 MONTHS OF TREATMENT. CHILDREN UNDER THE AGE OF TWO YEARS AND PATIENTS WITH MITOCHONDRIAL DISORDERS ARE AT HIGHER RISK. MONITOR PATIENTS CLOSELY, AND PERFORM SERUM LIVER TESTING PRIOR TO THERAPY AND AT FREQUENT INTERVALS THEREAFTER (5.1) FETAL RISK, PARTICULARLY NEURAL TUBE DEFECTS, OTHER MAJOR MALFORMATIONS, AND DECREASED IQ (5.2, 5.3, 5.4) PANCREATITIS, INCLUDING FATAL HEMORRHAGIC CASES (5.5) INDICATIONS AND USAGE Valproate Sodium Injection is indicated as an intravenous alternative in patients in whom oral administration of valproate products is temporarily not feasible in the following conditions: 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) DOSAGE AND ADMINISTRATION Valproate Sodium Injection is intended for intravenous use only. Epilepsy Complex Partial Seizures in Adults and Children 10 years of age or older: Initial dose is 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response. Maximum recommended dose is 60 mg/kg/day (2.1). Simple and Complex Absence Seizures: Initial dose is 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response. Maximum recommended dose is 60 mg/kg/day (2.1). DOSAGE FORMS AND STRENGTHS Injection: 100 mg per mL in a 5 mL single dose vial (3) CONTRAINDICATIONS Hepatic d Leer el documento completo