Application Nr Approved Date Route Status External Links
ANDA065498 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Piperacillin And Tazobactam For Injection Is A Combination Product Consisting Of A Penicillin-Class Antibacterial, Piperacillin, And A Β-Lactamase Inhibitor, Tazobactam, Indicated For The Treatment Of Patients With Moderate To Severe Infections Caused By Susceptible Isolates Of The Designated Bacteria In The Conditions Listed Below. Piperacillin And Tazobactam For Injection Is A Combination Penicillin-Class Antibacterial And Β-Lactamase Inhibitor Indicated For Treatment Of: Intra-Abdominal Infections ( 1.1 ) Skin And Skin Structure Infections ( 1.2 ) Female Pelvic Infections ( 1.3 ) Community-Acquired Pneumonia ( 1.4 ) Nosocomial Pneumonia ( 1.5 ) Usage ( 1.6 ) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Piperacillin And Tazobactam For Injection And Other Antibacterial Drugs, Piperacillin And Tazobactam For Injection Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Bacteria. ( 1.6 ) 1.1 Intra-Abdominal Infections Appendicitis (complicated By Rupture Or Abscess) And Peritonitis Caused By Β-Lactamase Producing Isolates Of Escherichia Coli Or The Following Members Of The Bacteroides Fragilis Group: B. Fragilis, B. Ovatus, B. Thetaiotaomicron, Or B. Vulgatus . The Individual Members Of This Group Were Studied In Fewer Than 10 Cases. 1.2 Skin And Skin Structure Infections Uncomplicated And Complicated Skin And Skin Structure Infections, Including Cellulitis, Cutaneous Abscesses And Ischemic/diabetic Foot Infections Caused By Β-Lactamase Producing Isolates Of Staphylococcus Aureus . 1.3 Female Pelvic Infections Postpartum Endometritis Or Pelvic Inflammatory Disease Caused By Β-Lactamase Producing Isolates Of Escherichia Coli . 1.4 Community-Acquired Pneumonia Community-Acquired Pneumonia (moderate Severity Only) Caused By Β-Lactamase Producing Isolates Of Haemophilus Influenzae . 1.5 Nosocomial Pneumonia Nosocomial Pneumonia (moderate To Severe) Caused By Β-Lactamase Producing Isolates Of Staphylococcus Aureus And By Piperacillin/tazobactam-Susceptible Acinetobacter Baumannii, Haemophilus Influenzae, Klebsiella Pneumoniae, And Pseudomonas Aeruginosa (nosocomial Pneumonia Caused By P. Aeruginosa Should Be Treated In Combination With An Aminoglycoside) [see Dosage And Administration ( 2 )] . 1.6 Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Piperacillin And Tazobactam For Injection And Other Antibacterial Drugs, Piperacillin And Tazobactam For Injection Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Bacteria. When Culture And Susceptibility Information Are Available, They Should Be Considered In Selecting Or Modifying Antibacterial Therapy. In The Absence Of Such Data, Local Epidemiology And Susceptibility Patterns May Contribute To The Empiric Selection Of Therapy.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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