Piperacillin

Piperacillin and Tazobactam for Injection (sterile piperacillin sodium/tazobactam sodium) is indicated for the treatment of patients with systemic and/or local bacterial infections, caused by piperacillin resistant, piperacillin/tazobactam susceptible, ß-lactamase producing strains of the designated microorganisms in the specified conditions listed below: a) INTRA-ABDOMINAL INFECTIONS Appendicitis (complicated by rupture or abscess) and peritonitis caused by piperacillin resistant, ß-lactamase producing strains of Escherichia coli or members of the Bacteroides fragilis group.

b) SKIN AND SKIN STRUCTURE INFECTIONS Uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscess, acute ischemic/diabetic foot infections caused by piperacillin resistant ß-lactamase producing strains of Staphylococcus aureus (not methicillin- resistant strains).

c) GYNECOLOGICAL INFECTIONS Postpartum endometritis or pelvic inflammatory disease caused by piperacillin resistant, ß-lactamase producing strains of Escherichia coli. d) COMMUNITY-ACQUIRED LOWER RESPIRATORY TRACT INFECTIONS Community- acquired pneumonia (moderate severity only) caused by piperacillin resistant, ß- lactamase producing strains of Haemophilus influenzae.

1): Adults and adolescents – Severe pneumonia including hospital-acquired and ventilator-associated pneumonia – Complicated urinary tract infections (including pyelonephritis) – Complicated intra-abdominal infections – Complicated skin and soft tissue infections (including diabetic foot infections) Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.

Piperacillin/Tazobactam may be used in the management of neutropenic patients with fever suspected to be due to a bacterial infection.

Note:

Use for bacteraemia due to extended-beta-lactamase (ESBL) producing E. coli and K. 1. Children 2 to 12 years of age – Complicated intra-abdominal infections Piperacillin/Tazobactam may be used in the management of neutropenic children with fever suspected to be due to a bacterial infection.

5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection, USP and other antibacterial drugs, Piperacillin and Tazobactam for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

1 Intra-abdominal Infections Piperacillin and tazobactam for injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of appendicitis (complicated by rupture or abscess) and peritonitis caused by beta-lactamase producing isolates of Escherichia coli or the following members of the Bacteroides fragilis group: B.

fragilis, B. ovatus, B. thetaiotaomicron, or B. vulgatus. 2 Nosocomial Pneumonia Piperacillin and tazobactam for injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of nosocomial pneumonia (moderate to severe) caused by beta-lactamase producing isolates of Staphylococcus aureus and by piperacillin and tazobactam-susceptible Acinetobacter baumannii , Haemophilus influenzae , Klebsiella pneumoniae , and Pseudomonas aeruginosa (Nosocomial pneumonia caused by P.