Avycaz
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FDA Labeling Changes
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Uses
AVYCAZ (ceftazidime-avibactam), in combination with metronidazole, is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Providencia stuartii, Enterobacter cloacae, Klebsiella oxytoca, and Pseudomonas aeruginosa in patients 18 years or older.
As only limited clinical safety and efficacy data for AVYCAZ are currently available, reserve AVYCAZ for use in patients who have limited or no alternative treatment options. [see Clinical Studies (14)].
AVYCAZ (ceftazidime-avibactam) is indicated for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Citrobacter freundii, Proteus spp., and Pseudomonas aeruginosa in patients 18 years or older.
As only limited clinical safety and efficacy data for AVYCAZ are currently available, reserve AVYCAZ for use in patients who have limited or no alternative treatment options .[see Clinical Studies (14)].
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVYCAZ and other antibacterial drugs, AVYCAZ should be used to treat only indicated infections that are proven or strongly suspected to be caused by susceptible 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 [see Dosage and Administration (2.1)].
History
There is currently no drug history available for this drug.
Other Information
AVYCAZ is an antibacterial combination product consisting of the semisynthetic cephalosporin ceftazidime pentahydrate and the beta-lactamase inhibitor avibactam sodium for intravenous administration.
Ceftazidime
Ceftazidime is a semisynthetic, beta-lactam antibacterial drug. It is the pentahydrate of (6R,7R,Z)-7-(2-(2-aminothiazol-4-yl)-2-(2-carboxypropan-2-yloxyimino)acetamido)-8-oxo-3-(pyridinium-1-ylmethyl)-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylate. Its molecular weight is 636.6. The empirical formula is C22H32N6O12S2.
Figure 1 Chemical structure of ceftazidime pentahydrate
Avibactam
Avibactam sodium chemical name is sodium [(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl] sulfate. Its molecular weight is 287.23. The empirical formula is C7H10N3O6SNa.
Figure 2 Chemical structure of avibactam sodium
AVYCAZ is a white to yellow sterile powder consisting of ceftazidime pentahydrate and avibactam sodium packaged in glass vials. The formulation also contains sodium carbonate.
Each AVYCAZ single-dose vial contains 2.635 grams sterile ceftazidime pentahydrate/sodium carbonate equivalent to 2 grams of ceftazidime and 0.551 grams sterile avibactam sodium equivalent to 0.5 grams of avibactam. The sodium carbonate content of the mixture is 239.6 mg/vial. The total sodium content of the mixture is approximately 146 mg (6.4 mEq)/vial.
Sources
Avycaz Manufacturers
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Forest Laboratories, Inc.
![Avycaz (Ceftazidime, Avibactam) Powder, For Solution [Forest Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Avycaz | Meijer Distribution Inc
• do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • do not use dosing cup with other products • dose as follows or as directed by a doctor • mL = milliliterAge
Dose
children 6 years to under 12 years
10 mL every 4 hours
children 4 years to under 6 years
5 mL every 4 hours
children under 4 years
do not use
Other information • each 5 mL contains: sodium 3 mg • do not use if printed neckband is broken or missing • store at 20-25 °C (68-77 °F) • do not refrigerate • dosing cup provided
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