Bupivacaine hydrochloride — 125MG, Solution for injection, carton of 10 × 50 mL vials

Bupivacaine hydrochloride — 125MG, Solution for injection, carton of 10 × 50 mL vials

Bupivacaine hydrochloride is a solution for injection for infiltration; perineural use. Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].

• Active ingredient or product type: BUPIVACAINE HYDROCHLORIDE
• Strength/concentration: 125MG
• Dosage form and route: Solution for injection, Infiltration; Perineural
• Exact package presentation: carton of 10 × 50 mL vials
• NDC/item number: 70069-752-10
• Manufacturer: SOMERSET PHARMA
• Storage/handling: Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 ° F to 86 °F). [See USP Controlled Room Temperature.] Bupivacaine hydrochloride injection ―Solutions of bupivacaine hydrochloride injection that do not contain epinephrine may be autoclaved. Protect from light.
• Status: Rx only

Important safety information: Dose-Related Toxicity : Monitor cardiovascular and respiratory vital signs and patient's state of consciousness after injection of bupivacaine hydrochloride injection (5.2) Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use.

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