Valproate Sodium — 100 mg/mL, Injection, tray of 10 × 5 mL single-dose vials

Valproate Sodium — 100 mg/mL, Injection, tray of 10 × 5 mL single-dose 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. Supplied as tray of 10 × 5 mL single-dose vials; NDC 0143-9637-10; manufacturer Hikma Pharmaceuticals USA Inc. Rx only. 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]. 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].

• Active ingredient or product type: VALPROATE SODIUM
• Strength/concentration: 100 mg/mL
• Dosage form and route: Injection, Intravenous
• Exact package presentation: tray of 10 × 5 mL single-dose vials
• NDC/item number: 0143-9637-10
• Manufacturer/labeler: Hikma Pharmaceuticals USA Inc.
• Storage/handling: 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]. 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].
• 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.

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