Avycaz ® (ceftazidime-Avibactam)
Historical source. Current clinical review is incomplete. This monograph will be updated in the future.
Avycaz ® (ceftazidime-Avibactam) (opens in a new tab)Original source URL: https://globalrph.com/dilution/avycaz-ceftazidime-and-avibactam/ | Retrieved 2026-11-04
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- https://globalrph.com/dilution/avycaz-ceftazidime-and-avibactam/ (opens in a new tab)
- Source date
- Not established in the retrieved source
- Retrieved
- 2026-11-04T19:44:55.402970+00:00
- Source location
- div.post-content
- Packaged content SHA-256
- 0111ee3c664c000091557ad1b9d5ec5bf27f0876add11916e7f1fbbfbc848ed5
- Original response SHA-256
- 4298438102d8b8587e4ce5aef1272142e5b511fbb0371a633e68334f417a06d1
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- 578e93f0e3f318f89facc399a4e02452c56ef61c4412d242f31309ca786a5392
IV Dilution - AVYCAZ (ceftazidime and avibactam) for injection |
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Usual Diluents Return to article top |
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| NS, D5W | |||||||||||||||||||||||||||||||||||||||
Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate] Return to article top |
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| [2.5 grams] [50 - 250 ml] [120 minutes] (ceftazidime 2 gram and avibactam 0.5 grams) Renal: AVYCAZ is supplied as a dry powder, which must be constituted and subsequently diluted, using aseptic technique prior to intravenous infusion.
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WARNINGS Return to article top |
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| See warnings and precautions below.
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DESCRIPTION Return to article top |
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| Description: AVYCAZ is an antibacterial combination product consisting of the semisynthetic cephalosporin ceftazidime pentahydrate and the beta-lactamase inhibitor avibactam sodium for intravenous administration. Ceftazidime Avibactam |
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CLINICAL PHARMACOLOGY: Return to article top |
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| Mechanism of Action: The ceftazidime component of AVYCAZ is a cephalosporin antibacterial drug with in vitro activity against certain gram-negative and gram-positive bacteria. The bactericidal action of ceftazidime is mediated through binding to essential penicillin-binding proteins (PBPs). The avibactam component of AVYCAZ is a non-beta-lactam beta-lactamase inhibitor that inactivates some beta-lactamases and protects ceftazidime from degradation by certain beta-lactamases. Avibactam does not decrease the activity of ceftazidime against ceftazidime-susceptible organisms. AVYCAZ demonstrated in vitro activity against Enterobacteriaceae in the presence of some beta-lactamases and extended-spectrum beta-lactamases (ESBLs) of the following groups: TEM, SHV, CTX-M, Klebsiella pneumoniae carbapenemase (KPCs), AmpC, and certain oxacillinases (OXA). AVYCAZ also demonstrated in vitro activity against P. aeruginosa in the presence of some AmpC beta-lactamases, and certain strains lacking outer membrane porin (OprD). AVYCAZ is not active against bacteria that produce metallo-beta lactamases and may not have activity against gram-negative bacteria that overexpress efflux pumps or have porin mutations. Resistance Interaction with Other Antimicrobials Activity against Ceftazidime-Nonsusceptible Bacteria in Animal Infection Models Avibactam restored activity of ceftazidime in animal models of infection (e.g. thigh infection, pyelonephritis, systemic infection induced by intraperitoneal injection) caused by ceftazidime non-susceptible beta-lactamase- producing (e.g., ESBL, KPC and AmpC) gram-negative bacteria. Antimicrobial Activity |
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INDICATIONS AND USAGE Return to article top |
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| AVYCAZ is a combination of ceftazidime, a cephalosporin, and avibactam, a beta-lactamase inhibitor, indicated for the treatment of patients 18 years or older with the following infections caused by designated susceptible microorganisms:
Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole (1.1) In the treatment of cUTI, as only limited clinical safety and efficacy data for AVYCAZ are currently available, reserve AVYCAZ for use in patients with cUTI who have limited or no alternative treatment options (1.1, 1.2) To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVYCAZ and other antibacterial drugs, AVYCAZ should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.3) |
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CONTRAINDICATIONS Return to article top |
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| Contraindications: AVYCAZ is contraindicated in patients with known serious hypersensitivity to the components of AVYCAZ (ceftazidime and avibactam), avibactam-containing products, or other members of the cephalosporin class |
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PRECAUTIONS Return to article top |
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| WARNINGS AND PRECAUTIONS:
Decreased efficacy in patients with baseline CrCl of 30 to less than or equal to 50 mL/ min. Monitor CrCl at least daily in patients with changing renal function and adjust the dose of AVYCAZ accordingly. (5.1) |
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ADVERSE REACTIONS Return to article top |
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| ADVERSE REACTIONS:
The most common adverse reactions in cIAI (>=/ 5%, when used with metronidazole) are diarrhea, nausea and vomiting. In cUTI, the most common adverse reactions (>=10%) are constipation and anxiety. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Forest Laboratories, LLC, at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION. Revised: 6/2016 See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide. |
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DOSAGE AND ADMINISTRATION Return to article top |
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2.1 Recommended DosageThe recommended dosage of AVYCAZ is 2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams) administered every 8 hours by intravenous (IV) infusion over 2 hours in patients 18 years of age and older in patients with normal renal function. For treatment of cIAI, metronidazole should be given concurrently. The guidelines for dosage of AVYCAZ in patients with creatinine clearance [CrCl] greater than 50 mL/min are listed in Table 1.
2.2 Dosage Adjustments in Patients with Renal ImpairmentSeparate renal reference: Open Renal Dosing Master (opens in a new tab)The recommended AVYCAZ dosage in patients with varying degrees of renal function is presented in Table 2. For patients with changing renal function, monitor CrCl at least daily and adjust the dosage of AVYCAZ accordingly [see Warnings and Precautions (5.1), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.3 Preparation of the AVYCAZ Solution for AdministrationAVYCAZ is supplied as a dry powder, which must be constituted and subsequently diluted, using aseptic technique prior to intravenous infusion.
2.4 Drug CompatibilityThe AVYCAZ solution for administration at the range of diluted concentrations of ceftazidime 0.008 g/mL and avibactam 0.002 g/mL to ceftazidime 0.04 g/mL and avibactam 0.01 g/mL is compatible with the more commonly used intravenous infusion fluids in infusion bags (including Baxter® Mini-Bag Plus™) such as:
Compatibility of AVYCAZ solution for administration with other drugs has not been established. 2.5 Storage of Constituted SolutionsUpon constitution with appropriate diluent, the constituted AVYCAZ solution may be held for no longer than 30 minutes prior to transfer and dilution in a suitable infusion bag. Following dilution of the constituted solutions with the appropriate diluents, AVYCAZ solutions in the infusion bags are stable for 12 hours when stored at room temperature. Following dilution of the constituted solutions with the appropriate diluents, AVYCAZ solutions in the infusion bags may also be refrigerated at 2 to 8°C (36 to 46°F) for up to 24 hours; and then should be used within 12 hours of subsequent storage at room temperature. |
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HOW SUPPLIED Return to article top |
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| DOSAGE FORMS AND STRENGTHS: AVYCAZ 2.5 grams (ceftazidime and avibactam) for injection is supplied in single-dose, clear glass vial containing: ceftazidime 2 grams (equivalent to 2.635 grams of ceftazidime pentahydrate/sodium carbonate) and avibactam 0.5 grams (equivalent to 0.551 grams of avibactam sodium). Vials are supplied as individual vial (NDC# 0456-2700-01) and in cartons containing 10 vials (NDC# 0456-2700-10) |
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Storage and Stability Return to article top |
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| AVYCAZ vials should be stored at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Protect from light. Store in carton until time of use. | |||||||||||||||||||||||||||||||||||||||