Ceftazidime-avibactam
Limited reviewed summaryFull monograph review pending
Historical dilution reference. Verify the preparation against the label for the product in hand.
Original GlobalRPh article: Avycaz ® (ceftazidime-Avibactam) (opens in a new tab)Original source URL: https://globalrph.com/dilution/avycaz-ceftazidime-and-avibactam/ Retrieved 2026-11-04
Historical source details
Original publication date: unavailable in the retrieved article.
Source location and file checksums
- Original source URL
- 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
- Source body SHA-256
- 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. | |||||||||||||||||||||||||||||||||||||||
Reviewed product information
Avycaz single-dose vial, ceftazidime 2 g and avibactam 0.5 g, adult IV infusion.
Use the dose-specific U.S. dilution instructions in section 2.4, Table 5. In that table only the full 2.5 g dose can be diluted to 250 mL.
Preparation sources checked 2026-11-13.
Reconstitution
Use 10 mL sterile water for injection as one labeled reconstitution option. The vial yields about 12 mL and requires further dilution.
Sources and exact locations
Claim ID: IVR-70-CEFTAZIDIME-AVIBACTAM-001
Review basis: Separately authored institutional guidance
Source 1
AVYCAZ U.S. prescribing information (opens in a new tab)
Exact location: 2. 4 Preparation of the AVYCAZ Solution for Administration (SPL section 3c36fc38-637a-42d9-beb1-5c0ee044feda)
Publisher: DailyMed / Allergan, Inc.
Source family: U.S. product prescribing information
Retrieved: 2026-11-13T14:23:03.546273+00:00
Source 2
Galway adult IV guide: Ceftazidime-avibactam (opens in a new tab)
Exact location: Reconstitution
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals Medicines Information
Retrieved: 2026-11-13T14:23:07.470053+00:00
Separately edited hospital guidance may draw on product labeling. Only overlapping preparation steps are used.
Dose Withdrawal
For a prescribed 2.5 g adult dose, withdraw the entire vial (about 12 mL). For 1.25 g, withdraw 6 mL.
Sources and exact locations
Claim ID: IVR-70-CEFTAZIDIME-AVIBACTAM-002
Review basis: Separately authored institutional guidance
Source 1
AVYCAZ U.S. prescribing information (opens in a new tab)
Exact location: 2. 4 Preparation of the AVYCAZ Solution for Administration (SPL section 3c36fc38-637a-42d9-beb1-5c0ee044feda)
Publisher: DailyMed / Allergan, Inc.
Source family: U.S. product prescribing information
Retrieved: 2026-11-13T14:23:03.546273+00:00
Source 2
Galway adult IV guide: Ceftazidime-avibactam (opens in a new tab)
Exact location: Methods of intravenous administration, 2.5 g and 1.25 g rows
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals Medicines Information
Retrieved: 2026-11-13T14:23:07.470053+00:00
Separately edited hospital guidance may draw on product labeling. Only overlapping preparation steps are used.
Dilution And Infusion
After water reconstitution, 0.9% sodium chloride or 5% dextrose may be used to dilute the adult dose. Infuse over 2 hours.
Sources and exact locations
Claim ID: IVR-70-CEFTAZIDIME-AVIBACTAM-003
Review basis: Separately authored institutional guidance
Source 1
AVYCAZ U.S. prescribing information (opens in a new tab)
Exact location: 2. 4 Preparation of the AVYCAZ Solution for Administration (SPL section 3c36fc38-637a-42d9-beb1-5c0ee044feda); 2.1 Recommended Dosage in Adult Patients (SPL section c6c61617-e0cd-4345-8f5d-c34e4683b59a)
Publisher: DailyMed / Allergan, Inc.
Source family: U.S. product prescribing information
Retrieved: 2026-11-13T14:23:03.546273+00:00
Source 2
Galway adult IV guide: Ceftazidime-avibactam (opens in a new tab)
Exact location: Infusion fluids and Methods of intravenous administration
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals Medicines Information
Retrieved: 2026-11-13T14:23:07.470053+00:00
Separately edited hospital guidance may draw on product labeling. Only overlapping preparation steps are used.
Product identifiers and clinical review status
Selected prescribing information available. Full monograph review pending.
Selected product identity
Matched to U.S. product NDC 0456-2700 for the preparation statements shown.
View product identifiers and primary-label provenance
- Selected product scope
- Avycaz single-dose vial, ceftazidime 2 g and avibactam 0.5 g, adult IV infusion.
- Labeler
- Allergan, Inc.
- Application number(s)
- NDA206494
- NDC(s)
- 0456-2700-01; 0456-2700-10
- DailyMed Set ID
- d9c2803f-dc9c-4b19-b4a3-8303bc8c15fd
- SPL version
- 25
- Label printed revision date
- Not established
- SPL effective date
- 2025-04-30
- Retrieved
- 2026-11-13T14:23:03.546273+00:00
- Downloaded XML SHA-256
- 04c1e43db0be258682dbbef20d204ca4f94ce4f0367103e9d79595fb5d2ee07e
What remains to be completed
- Extract and verify presentation-specific IV preparation.
- Complete indication- and age-specific dosing, incompatibility, monitoring and stability review.
- Assess any proposed compounding BUD for the exact formulation, concentration, container and conditions.
Open the original GlobalRPh site monograph (historical; not revalidated) (opens in a new tab)