Ceftazidime, Avibactam
Generic Name: ceftazidime, avibactam
Brand Names:
Avycaz
11 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 Ceftazidime is a semisynthetic, beta-lactam antibacterial drug. It is the pentahydrate of (6 R ,7 R , 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.
Overview
11 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 Ceftazidime is a semisynthetic, beta-lactam antibacterial drug. It is the pentahydrate of (6 R ,7 R , 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.
Uses
1 INDICATIONS AND USAGE AVYCAZ is a combination of ceftazidime, a cephalosporin, and avibactam, a beta-lactamase inhibitor, indicated for the treatment of the following infections caused by designated susceptible Gram-negative microorganisms in adult and pediatric patients (at least 31 weeks gestational age): Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole ( 1.1 ) Complicated Urinary Tract Infections (cUTI), including Pyelonephritis ( 1.2 ) Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) ( 1.3 ) 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 or prevent infections that are proven or strongly su...
Dosage
2 DOSAGE AND ADMINISTRATION Dosage of AVYCAZ in Adult Patients with Creatinine Clearance ( CrCl ) greater than 50 mL/min ( 2.1 ) Infection Dose Frequency Infusion Time cIAI * , cUTI including Pyelonephritis, and HABP/VABP AVYCAZ 2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams) Every 8 hours 2 hours * Used in conjunction with metronidazole 0.5 g intravenously every 8 hours in adult cIAI patients Dosage of AVYCAZ in Pediatric Patients aged 2 years to less than 18 years with Estimated Glomerular Filtration Rate (eGFR) greater than 50 mL/min/1.73 m 2 and in Pediatric Patients less than 2 years of age without Renal Impairment ( 2.2 ) Infection Age Range Dose Infusion Time/ Frequency cIAI * , cUTI including Pyelonephritis, HABP/VABP 2 years to less than 18 years AVYCAZ 62.5 mg/kg to a max...
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [ see Warnings and Precautions ( 5.2 ) ] Clostridi oid e s difficile -Associated Diarrhea [ see Warnings and Precautions ( 5.3 ) ] Central Nervous System Reactions [ see Warnings and Precautions ( 5.4 ) ] Adult Patients : The most common adverse reactions in cIAI (≥ 5%, when used with metronidazole) patients are diarrhea, nausea and vomiting. The most common adverse reactions (3%) in cUTI patients are diarrhea and nausea. The most common adverse reactions (≥ 5%) in HABP/VABP patients were diarrhea and vomiting.
Interactions
7 DRUG INTERACTIONS 7.1 Probenecid In vitro , avibactam is a substrate of OAT1 and OAT3 transporters which might contribute to the active uptake from the blood compartment, and thereby its excretion. As a potent OAT inhibitor, probenecid inhibits OAT uptake of avibactam by 56% to 70% in vitro and, therefore, has the potential to decrease the elimination of avibactam when co-administered. Because a clinical interaction study of AVYCAZ or avibactam alone with probenecid has not been conducted, co-administration of AVYCAZ with probenecid is not recommended [ see Clinical Pharmacology ( 12.3 ) ] . 7.2 Drug/Laboratory Test Interactions The administration of ceftazidime may result in a false-positive reaction for glucose in the urine with certain methods.
Warnings
5 WARNINGS AND PRECAUTIONS Decreased Clinical Response in A dult cIAI P atients with B aseline CrC l of 30 to L ess T han or E qual to 50 mL/ min : Monitor CrCl at least daily in adult and pediatric patients with changing renal function and adjust the dosage of AVYCAZ accordingly. ( 5.1 ) Hypersensitivity R eactions : Includes anaphylaxis and serious skin reactions. Cross sensitivity may occur in patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue AVYCAZ. ( 5.2 ) Clostrid io i des difficile -associated D iarrhea (CDAD) : CDAD has been reported with nearly all systemic antibacterial agents, including AVYCAZ. Evaluate if diarrhea occurs. 4 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 [see Warnings and Precautions ( 5.2 )] .
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of AVYCAZ, ceftazidime, or avibactam in pregnant women. Neither ceftazidime nor avibactam were teratogenic in rats at doses 40 and 9 times the recommended human clinical dose. In the rabbit, at twice the exposure as seen at the human clinical dose, there were no effects on embryofetal development with avibactam. The background risk of major birth defects and miscarriage for the indicated population is unknown.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING AVYCAZ 2.5 grams (ceftazidime and avibactam) for injection is supplied as a white to yellow sterile powder for constitution in single-dose, clear glass vial containing: ceftazidime 2 grams and avibactam 0.5 grams. Vials are supplied as individual vial (NDC # 0456-2700-01) and in cartons containing 10 vials (NDC # 0456-2700-10).
Frequently Asked Questions
What is Ceftazidime, Avibactam used for?▼
1 INDICATIONS AND USAGE AVYCAZ is a combination of ceftazidime, a cephalosporin, and avibactam, a beta-lactamase inhibitor, indicated for the treatment of the following infections caused by designated susceptible Gram-negative microorganisms in adult and pediatric patients (at least 31 weeks gestational age): Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole ( 1.1 ) Complicated Urinary Tract Infections (cUTI), including Pyelonephritis ( 1.2 ) Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) ( 1.3 ) 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 or prevent infections that are proven or strongly su...
What are the side effects of Ceftazidime, Avibactam?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [ see Warnings and Precautions ( 5.2 ) ] Clostridi oid e s difficile -Associated Diarrhea [ see Warnings and Precautions ( 5.3 ) ] Central Nervous System Reactions [ see Warnings and Precautions ( 5.4 ) ] Adult Patients : The most common adverse reactions in cIAI (≥ 5%, when used with metronidazole) patients are diarrhea, nausea and vomiting. The most common adverse reactions (3%) in cUTI patients are diarrhea and nausea. The most common adverse reactions (≥ 5%) in HABP/VABP patients were diarrhea and vomiting.
Can I take Ceftazidime, Avibactam during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of AVYCAZ, ceftazidime, or avibactam in pregnant women. Neither ceftazidime nor avibactam were teratogenic in rats at doses 40 and 9 times the recommended human clinical dose. In the rabbit, at twice the exposure as seen at the human clinical dose, there were no effects on embryofetal development with avibactam. The background risk of major birth defects and miscarriage for the indicated population is unknown.
What are the important warnings for Ceftazidime, Avibactam?▼
5 WARNINGS AND PRECAUTIONS Decreased Clinical Response in A dult cIAI P atients with B aseline CrC l of 30 to L ess T han or E qual to 50 mL/ min : Monitor CrCl at least daily in adult and pediatric patients with changing renal function and adjust the dosage of AVYCAZ accordingly. ( 5.1 ) Hypersensitivity R eactions : Includes anaphylaxis and serious skin reactions. Cross sensitivity may occur in patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue AVYCAZ. ( 5.2 ) Clostrid io i des difficile -associated D iarrhea (CDAD) : CDAD has been reported with nearly all systemic antibacterial agents, including AVYCAZ. Evaluate if diarrhea occurs. 4 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 [see Warnings and Precautions ( 5.2 )] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.