Drug: Avycaz

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 C7H10 N3O6SNa. 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. Last reviewed on RxList: 3/10/2015
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

The following are discussed in greater detail in the WARNINGS AND PRECAUTIONS section:
  • Decreased Clinical Response in Patients with Baseline CrCL of 30 to 50 mL/min [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Clostridium difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
  • Central Nervous System Reactions [see WARNINGS AND PRECAUTIONS]
  • Development of Drug-Resistant Bacteria [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. AVYCAZ was evaluated in two active-controlled Phase 2 clinical trials, one each in cIAI and cUTI, including pyelonephritis. The Phase 2 trials included a total of 169 adult patients treated with AVYCAZ and 169 patients treated with comparators. Complicated Intra-Abdominal Infections The Phase 2 cIAI trial included 101 adult patients treated with AVYCAZ (2 grams ceftazidime and 0.5 grams avibactam) administered intravenously over 30 minutes every 8 hours plus 500 mg metronidazole administered intravenously over 60 minutes every 8 hours and 102 patients treated with meropenem. The median age of patients treated with AVYCAZ was 41 years (range 18 to 79 years). Patients were predominantly male (69.3%) and Caucasian (55.4%). Patients with an estimated baseline CrCL 50 mL/min or less were excluded. Serious adverse reactions occurred in 9/101 (8.9%) of patients receiving AVYCAZ (with metronidazole) and 11/102 (10.8%) of patients receiving meropenem. The most common adverse reactions leading to discontinuation in patients receiving AVYCAZ were skin and subcutaneous tissue disorders (3%). Adverse reactions occurring in 10% or more of patients receiving AVYCAZ were vomiting and nausea. Increased Mortality In a Phase 3 cIAI trial, death occurred in 2.5% (13/529) of patients who received AVYCAZ/ metronidazole and in 1.5% (8/529) of patients who received meropenem. Among a subgroup of patients with baseline CrCL 30 to 50 mL/min, death occurred in 25.8% (8/31) of patients who received AVYCAZ/metronidazole and in 8.6% (3/35) of patients who received meropenem. Within this subgroup, patients treated with AVYCAZ received a 33% lower daily dose than is currently recommended for patients with CrCL 30 to 50 mL/min [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS]. In patients with normal renal function or mild renal impairment (baseline CrCL greater than 50 mL/min), death occurred in 1.0% (5/498) of patients who received AVYCAZ/metronidazole and in 1.0% (5/494) of patients who received meropenem. The causes of death varied and contributing factors included progression of underlying infection, baseline pathogens isolated that were unlikely to respond to the study drug, and delayed surgical intervention. Complicated Urinary Tract Infections, Including Pyelonephritis The Phase 2 cUTI trial included 68 adult patients treated with AVYCAZ (0.5 grams ceftazidime + 0.125 grams avibactam) administered intravenously over 30 minutes every 8 hours and 67 patients treated with imipenem-cilastatin (0.5 grams intravenously every 6 hours). The dose of AVYCAZ in this trial was lower than the recommended dose [see DOSAGE AND ADMINISTRATION]. Median age of patients treated with AVYCAZ was 47.5 years (range 18 to 85 years). Patients were predominantly female (75%) and Caucasian (58.8%). Patients with CrCL less than 70 mL/min were excluded. Serious adverse reactions occurred in 6/68 (8.8%) of patients receiving AVYCAZ and 2/67 (3.0%) of patients receiving imipenem-cilastatin. Two patients prematurely discontinued treatment with AVYCAZ: one due to an accidental overdose and one due to atrial fibrillation. Adverse reactions occurring in 10% or more of patients receiving AVYCAZ were constipation and anxiety. Table 4 lists adverse reactions occurring in 5% or more of patients receiving AVYCAZ in the Phase 2 cIAI trial or the Phase 2 cUTI trial. Table 4: Incidence of Selected Adverse Drug Reactions Occurring in 5% or more of Patients Receiving AVYCAZ in the Phase 2 cIAI Trial or the Phase 2 cUTI Trial
  Phase 2 cIAI Trial Phase 2 cUTI Trial AVYCAZ plus Metronidazole a
(N = 101) Meropenem b
(N = 102) AVYCAZc
(N = 68) Imipenem- Cilastatin d
(N = 67) Gastrointestinal disorders   Vomiting 14% 5% 0% 0%   Nausea 10% 6% 2% 5%   Constipation 4% 1% 10% 3%   Abdominal pain 8% 3% 7% 5%   Upper abdominal pain 1% 0% 7% 2% Investigations   Increased blood alkaline phosphatase  9% 7% 3% 2%   Increased alanine aminotransferase 8% 13% 3% 6% Nervous system disorders   Dizziness 0% 2% 6% 0% Psychiatric disorders   Anxiety 5% 1% 10% 8% a 2.5 grams (2 grams/0.5 grams) intravenously over 30 minutes every 8 hours (with metronidazole 500 mg intravenously every 8 hours)
b 1 gram intravenously over 30 minutes every 8 hours
c 0.625 grams (0.5 grams/0.125 grams) intravenously over 30 minutes every 8 hours
d 0.5 grams intravenously over 30 minutes every 6 hours Other Adverse Reactions of AVYCAZ and Ceftazidime The following selected adverse reactions were reported in AVYCAZ-treated subjects at a rate of less than 5% in the Phase 2 trials and are not described elsewhere in the labeling. Blood and lymphatic disorders -Eosinophilia, Thrombocytopenia Investigations -Increased gamma-glutamyltransferase, Prolonged prothrombin time Metabolism and nutrition disorders -Hypokalemia Renal and urinary disorders -Acute renal failure, Renal impairment Skin and subcutaneous tissue disorders -Rash Additionally, adverse reactions reported with ceftazidime alone that were not reported in AVYCAZ clinical trials are listed below: Blood and lymphatic disorders -Agranulocytosis, Hemolytic anemia, Leukopenia, Lymphocytosis, Neutropenia, Thrombocytosis General disorders and administration site conditions -Infusion site inflammation, Injection site hematoma, Injection site phlebitis, Injection site thrombosis Hepatobiliary disorders – Jaundice Infections and infestations -Candidiasis Investigations -Increased blood lactate dehydrogenase Nervous system disorders -Dysgeusia, Paresthesia Renal and urinary disorders -Tubulointerstitial nephritis Reproductive and breast disorders -Vaginal inflammation Skin and subcutaneous tissue disorders -Angioedema, Erythema multiforme, Pruritis, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Urticaria Laboratory Changes Seroconversion from a negative to a positive direct Coombs' test result occurred in 6/82 (7.3%) of patients receiving AVYCAZ plus metronidazole and 2/84 (2.4%) of patients receiving meropenem in the cIAI trial. Seroconversion from a negative to a positive direct Coombs' test result occurred in 1/52 (1.9%) of patients receiving AVYCAZ and 5/60 (8.3%) of patients receiving imipenem cilastatin in the cUTI trial. No adverse reactions representing hemolytic anemia were reported in any treatment group. Read the Avycaz (ceftazidime-avibactam for injection) Side Effects Center for a complete guide to possible side effectsLearn More »

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Recommended Dosage The recommended dosage of AVYCAZ is 2.5 grams (2 grams ceftazidime and 0.5 grams avibactam) administered every 8 hours by intravenous (IV) infusion over 2 hours in patients 18 years of age and older. For treatment of cIAI, metronidazole should be given concurrently. The guidelines for dosage of AVYCAZ in patients with normal renal function are listed in Table 1. Table 1: Dosage of AVYCAZ by Indication
Infection Dosage Frequency Infusion Time (hours) Recommended Duration of Total Antimicrobial Treatment Complicated Intra-abdominal Infections [used in combination with metronidazole] 2.5 grams (2 grams/0.5 grams) Every 8 hours 2 5 to14 days Complicated Urinary Tract Infections including Pyelonephritis 2.5 grams (2 grams/0.5 grams) Every 8 hours 2 7 to 14 days Dosage Adjustments In Patients With Renal Impairment The recommended AVYCAZ dosage in patients with varying degrees of renal function is presented in Table 2. For patients with changing renal function, monitor creatinine clearance (CrCL) at least daily and adjust the dosage of AVYCAZ accordingly [see WARNINGS AND PRECAUTIONS, Use In Specific Populations and CLINICAL PHARMACOLOGY]. Table 2: Recommended AVYCAZ Dosage in Patients with Renal Impairment with cUTI or cIAI Estimated Creatinine Clearance (mL/minute)a Recommended Dosage Regimen for AVYCAZ Greater than 50 2.5 grams (2 grams/0.5 grams) intravenously (over 2 hours) every 8 hours 31 to 50 1.25 grams (1 grams/0.25 grams) intravenously (over 2 hours) every 8 hours 16 to 30 0.94 grams (0.75 grams/0.19 grams) intravenously (over 2 hours) every 12 hours 6 to 15b 0.94 grams (0.75 grams/0.19 grams) intravenously (over 2 hours) every 24 hours Less than or equal to 5b 0.94 grams (0.75 grams/0.19 grams) intravenously (over 2 hours) every 48 hours a As calculated using the Cockcroft-Gault formula.
b Both ceftazidime and avibactam are hemodialyzable; thus, administer AVYCAZ after hemodialysis on hemodialysis days. Preparation Of The AVYCAZ Solution For Administration AVYCAZ is supplied as a dry powder, which must be constituted and subsequently diluted, using aseptic technique prior to intravenous infusion.
  1. Constitute the powder in the AVYCAZ vial with 10 mL of one of the following solutions:
    • sterile water for injection, USP
    • 0.9% of sodium chloride injection, USP (normal saline)
    • 5% of dextrose injection, USP
    • all combinations of dextrose injection and sodium chloride injection, USP, containing up to 2.5% dextrose, USP, and 0.45% sodium chloride, USP, or
    • lactated Ringer's injection, USP.
  2. Mix gently. The constituted AVYCAZ solution will have an approximate ceftazidime concentration of 0.167 grams/mL and an approximate avibactam concentration of 0.042 grams/mL.
  3. With the same diluent used for constitution of the powder (except sterile water for injection), dilute the constituted AVYCAZ solution further to achieve a total volume between 50 mL (40 and 10 mg/mL of ceftazidime and avibactam, respectively) to 250 mL (8 and 2 mg/mL of ceftazidime and avibactam, respectively) before infusion.
  4. Mix gently and ensure that the contents are dissolved completely. Visually inspect the diluted AVYCAZ solution (for administration) for particular matter and discoloration prior to administration (the color of the AVYCAZ infusion solution for administration ranges from clear to light yellow).
  5. Use the diluted AVYCAZ solution in the infusion bags within 12 hours when stored at room temperature. The diluted AVYCAZ solution in the infusion bags may be stored under refrigeration at 2 to 8°C (36 to 46°F) up to 24 hours following dilution and use within 12 hours of subsequent storage at room temperature.
Drug Compatibility The AVYCAZ solution for administration at concentrations between 0.008 g/mL ceftazidime + 0.002 g/mL avibactam and 0.04 g/mL ceftazidime + 0.01 g/mL avibactam is compatible with the more commonly used intravenous infusion fluids in infusion bags (including Baxter® Mini-Bag Plus™) such as:
  • 0.9% sodium chloride injection, USP
  • 5% dextrose injection, USP
  • all combinations of dextrose injection and sodium chloride injection, USP, containing up to 2.5% dextrose, USP, and 0.45% sodium chloride, USP
  • lactated ringer's injection, USP, and
  • in Baxter® Mini-Bag Plus™ containing 0.9% sodium chloride injection or 5% dextrose injection.
Compatibility of AVYCAZ solution for administration with other drugs has not been established. Storage Of Constituted Solutions
  • Constituted solutions of AVYCAZ in the infusion bags should be used within 12 hours when stored at room temperature.
  • Constituted solutions of AVYCAZ in the infusion bags may be refrigerated for up to 24 hours following constitution; and then should be used within 12 hours of subsequent storage at room temperature.

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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]. Drug/Laboratory Test Interactions The administration of ceftazidime may result in a false-positive reaction for glucose in the urine with certain methods. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used. Last reviewed on RxList: 3/10/2015
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Complicated Intra-Abdominal Infections (cIAI) 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]. Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis 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]. Usage 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].

Source: http://www.rxlist.com

AVYCAZ is contraindicated in patients with known serious hypersensitivity to AVYCAZ, avibactam-containing products, ceftazidime, or other members of the cephalosporin class [see WARNINGS AND PRECAUTIONS]. Last reviewed on RxList: 3/10/2015
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

In the event of overdose, discontinue AVYCAZ and institute general supportive treatment. Ceftazidime and avibactam can be removed by hemodialysis. In subjects with ESRD administered 1 gram ceftazidime, the mean total recovery in dialysate following a 4-hour hemodialysis session was 55% of the administered dose. In subjects with ESRD administered 100 mg avibactam, the mean total recovery in dialysate following a 4 hour hemodialysis session started 1 hour after dosing was approximately 55% of the dose. No clinical information is available on the use of hemodialysis to treat AVYCAZ overdosage [see CLINICAL PHARMACOLOGY].

Source: http://www.rxlist.com

Dosage Forms And Strengths AVYCAZ (ceftazidime-avibactam) for injection is supplied as a white to yellow sterile powder in a single use, sterile, clear glass vial containing 2 grams of ceftazidime (equivalent 2.635 grams of ceftazidime pentahydrate/sodium carbonate powder) and 0.5 grams of avibactam (equivalent to 0.551 grams of avibactam sodium). Storage And Handling AVYCAZ for injection is supplied in single use, clear glass vial. 2 grams ceftazidime (equivalent to 2.635 grams of ceftazidime pentahydrate/sodium carbonate) and 0.5 grams avibactam (equivalent to 0.551 grams of avibactam sodium) -individual vial (NDC# 0456-2700-01) and carton containing 10 vials (NDC# 0456-2700-10) Store unconstituted AVYCAZ vials 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. Distributed by: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC Cincinnati, Ohio 45209. Manufactured by: GlaxoSmithKline Manufacturing S.p.A. Verona, 37135 Italy. Revised: Feb 2015 Last reviewed on RxList: 3/10/2015
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Decreased Clinical Response in Patients with Baseline Creatinine Clearance of 30 to 50 mL/min In a Phase 3 cIAI trial, clinical cure rates were lower in a subgroup of patients with baseline CrCL of 30 to 50 mL/min compared to those with CrCL greater than 50 mL/min (Table 3). The reduction in clinical cure rates was more marked in patients treated with AVYCAZ plus metronidazole compared to meropenem-treated patients. Within this subgroup, patients treated with AVYCAZ received a 33% lower daily dose than is currently recommended for patients with CrCL 30 to 50 mL/min. Monitor CrCL at least daily in patients with changing renal function and adjust the dosage of AVYCAZ accordingly [see DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS]. Table 3: Clinical Cure Rate at Test of Cure, by Baseline Renal Function – mMITT Population1
  AVYCAZ + Metronidazole %
(n/N) Meropenem %
(n/N) Normal function / mild impairment (CrCL greater than 50 mL/min) 85% (322/379) 86% (321/373) Moderate impairment (CrCL 30 to 50 mL/min) 45% (14/31) 74% (26/35) 1Microbiological modified intent-to-treat (mMITT) population included patients who had at least one bacterial pathogen at baseline and received at least one dose of study drug. Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with AVYCAZ is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. Exercise caution if this product is to be given to a penicillin or other beta-lactam-allergic patient because cross sensitivity among beta-lactam antibacterial drugs has been established. Discontinue the drug if an allergic reaction to AVYCAZ occurs. Clostridium Difficile-Associated Diarrhea Clostridium difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial drugs, including AVYCAZ, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial drugs alters the normal flora of the colon and may permit overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial drugs. If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued. Manage fluid and electrolyte levels as appropriate, supplement protein intake, monitor antibacterial treatment of C. difficile, and institute surgical evaluation as clinically indicated. Central Nervous System Reactions Seizures, nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported in patients treated with ceftazidime, particularly in the setting of renal impairment. Adjust dosing based on creatinine clearance [see DOSAGE AND ADMINISTRATION]. Development Of Drug-Resistant Bacteria Prescribing AVYCAZ in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria [see INDICATIONS AND USAGE]. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility Ceftazidime and avibactam were each evaluated for mutagenic potential in several in vitro and in vivo assays. Ceftazidime was negative for mutagenicity in a mouse micronucleus test and an Ames test. Avibactam was negative for genotoxicity in the Ames assay, unscheduled DNA synthesis, chromosomal aberration assay, and a rat micronucleus study. Avibactam had no adverse effects on fertility of male and female rats given up to 1 g/kg/day (approximately 20 fold higher than the recommended clinical dose on a body surface area basis). There was a dose-related increase in the percentage of pre-and post-implantation loss relative to controls, resulting in a lower mean litter size at doses 0.5 g/kg and greater with intravenous administration to female rats beginning 2 weeks prior to mating. Use In Specific Populations Pregnancy Pregnancy Category B Animal reproductive toxicity studies have been conducted with ceftazidime and with avibactam. However, there are no adequate and well-controlled studies of AVYCAZ, ceftazidime, or avibactam in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed. Ceftazidime Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and showed no evidence of harm to the fetus due to ceftazidime. Avibactam Avibactam was not teratogenic in rats or rabbits. In the rat, intravenous studies showed no embryofetal toxicity at doses of 1000 mg/kg/day, approximately 9 times the human dose based on exposure (AUC). In a rat pre-and postnatal study at up to 825 mg/kg/day intravenously (11 times the human exposure based on AUC), there were no effects on pup growth and viability. A dose-related increase in the incidence of renal pelvic and ureter dilatation was observed in female weanling pups that was not associated with pathological changes to renal parenchyma or renal function, with renal pelvic dilatation persisting after female weanling pups became adults. Reproductive studies performed during early pregnancy in rabbits showed no effects on embryofetal development at doses of 100 mg/kg, twice the human exposure (AUC). At higher doses, increased post-implantation loss, lower mean fetal weights, delayed ossification of several bones and other anomalies were observed. Nursing Mothers Ceftazidime is excreted in human milk in low concentrations. It is not known whether avibactam is excreted into human milk, although avibactam was shown to be excreted in the milk of rats in a dose dependent manner. Exercise caution if AVYCAZ is to be administered to a nursing woman. Pediatric Use Safety and effectiveness in patients less than 18 years of age have not been established. Geriatric Use Of the 169 patients treated with AVYCAZ in the Phase 2 cIAI and cUTI trials, 18 (10.7%) were 65 years of age and older. Because of limited data, differences in outcomes or specific risks with AVYCAZ cannot be ruled out for patients 65 years of age and older. Ceftazidime and avibactam are excreted primarily by the kidney, and the risk of adverse reactions may be greater in patients with renal impairment. Because elderly patients are more likely to have renal impairment, care should be taken in dose selection in this age group and it may be useful to monitor renal function. Healthy elderly subjects had 17% greater exposure relative to healthy young subjects when administered the same single dose of avibactam, which may have been related to decreased renal function in the elderly subjects. Dosage adjustment for elderly patients should be based on renal function [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY]. Renal Impairment Dosage adjustment is required in patients with moderately or severely impaired renal function (CrCL 50 mL/min or less). For patients with changing renal function, CrCL should be monitored at least daily and dosage of AVYCAZ adjusted accordingly. Both ceftazidime and avibactam are hemodialyzable; thus, AVYCAZ should be administered after hemodialysis on hemodialysis days [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY]. Last reviewed on RxList: 3/10/2015
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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