Piperacillin And Tazobactam

Piperacillin And Tazobactam

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FDA Labeling Changes

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Uses

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.

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)].

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 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.

History

There is currently no drug history available for this drug.

Other Information

Piperacillin and tazobactam for injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the β-lactamase inhibitor tazobactam sodium for intravenous administration.

Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin.  The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazinecarboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.  The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5.  The chemical structure of piperacillin sodium is:

Chemical Structure

Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone.  Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide.  The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3.  The chemical structure of tazobactam sodium is:

Chemical Structure

Piperacillin and tazobactam for injection, piperacillin/tazobactam parenteral combination, is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials.  The product does not contain excipients or preservatives.

Each piperacillin and tazobactam for injection 2.25 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam.  Each vial contains 4.7 mEq (108 mg) of sodium.

Each piperacillin and tazobactam for injection 3.375 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam.  Each vial contains 7.0 mEq (162 mg) of sodium.

Each piperacillin and tazobactam for injection 4.5 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam.  Each vial contains 9.4 mEq (216 mg) of sodium.

Piperacillin and tazobactam for injection is a monosodium salt of piperacillin and a monosodium salt of tazobactam containing a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product.

Piperacillin And Tazobactam Manufacturers


  • Fresenius Kabi Usa, Llc
    Piperacillin And Tazobactam (Piperacillin Sodium,tazobactam Sodium) Injection, Powder, For Solution [Fresenius Kabi Usa, Llc]
  • Fresenius Kabi Usa, Llc
    Piperacillin And Tazobactam (Piperacillin Sodium And Tazobactam Sodium) Injection, Powder, For Solution [Fresenius Kabi Usa, Llc]
  • Fresenius Kabi Usa, Llc
    Piperacillin And Tazobactam (Piperacillin Sodium And Tazobactam Sodium) Injection, Powder, For Solution [Fresenius Kabi Usa, Llc]
  • App Pharmaceuticals, Llc
    Piperacillin And Tazobactam (Piperacillin Sodium,tazobactam Sodium) Injection, Powder, For Solution [App Pharmaceuticals, Llc]
  • App Pharmaceuticals, Llc
    Piperacillin And Tazobactam (Piperacillin Sodium,tazobactam Sodium) Injection, Powder, For Solution [App Pharmaceuticals, Llc]
  • Wg Critical Care, Llc
    Piperacillin And Tazobactam (Piperacillin Sodium,tazobactam Sodium) Injection, Powder, For Solution [Wg Critical Care, Llc]
  • Wg Critical Care, Llc
    Piperacillin And Tazobactam Injection, Powder, For Solution [Wg Critical Care, Llc]
  • Cardinal Health
    Piperacillin And Tazobactam (Piperacillin Sodium,tazobactam Sodium) Injection, Powder, For Solution [Cardinal Health]
  • Auromedics Pharma Llc
    Piperacillin And Tazobactam (Piperacillin Sodium And Tazobactam Sodium) Injection, Powder, Lyophilized, For Solution [Auromedics Pharma Llc]
  • Hospira, Inc
    Piperacillin And Tazobactam Injection, Powder, Lyophilized, For Solution [Hospira, Inc]
  • Hospira, Inc
    Piperacillin And Tazobactam Injection, Powder, Lyophilized, For Solution [Hospira, Inc]
  • Hospira, Inc
    Piperacillin And Tazobactam Injection, Powder, Lyophilized, For Solution [Hospira, Inc]
  • Hospira, Inc
    Piperacillin And Tazobactam Injection, Powder, Lyophilized, For Solution [Hospira, Inc]
  • Sandoz Inc
    Piperacillin And Tazobactam Injection, Powder, Lyophilized, For Solution [Sandoz Inc]
  • Sandoz Inc
    Piperacillin And Tazobactam (Piperacillin Sodium And Tazobactam Sodium) Injection, Powder, For Solution [Sandoz Inc]
  • Apotex Corporation
    Piperacillin And Tazobactam Injection, Powder, For Solution [Apotex Corporation]
  • Apotex Corporation
    Piperacillin And Tazobactam Injection, Powder, For Solution [Apotex Corporation]
  • Agila Specialties Private Limited
    Piperacillin And Tazobactam Injection, Powder, For Solution [Agila Specialties Private Limited]
  • Mylan Institutional Llc
    Piperacillin And Tazobactam Injection, Powder, For Solution [Mylan Institutional Llc ]

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