Valproate Sodium — 500MG/5ML, Injection, carton of 10 × 5 mL vials

Valproate Sodium — 500MG/5ML, Injection, carton of 10 × 5 mL vials

Valproate Sodium is a injection for intravenous use. 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 ) 1.1 Epilepsy 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 tr

• Active ingredient or product type: VALPROATE SODIUM
• Strength/concentration: 500MG/5ML
• Dosage form and route: Injection, Intravenous
• Exact package presentation: carton of 10 × 5 mL vials
• NDC/item number: 0143-9785-10
• Manufacturer: HIKMA PHARMACEUTICALS USA INC
• Storage/handling: Store vials at 20º to 25ºC (68º to 77ºF) with excursions between 15º and 30ºC (59º and 86ºF) [See USP Controlled Room Temperature].
• Status: Rx only

Important safety information: Hepatotoxicity; evaluate high risk populations and monitor serum liver tests ( 5.1 ) Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable ( 5.2 , 5.3 , 5.4 ) Pancreatitis; Valproate Sodium Injectio

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.