{"id":"tazicef","rwe":[{"pmid":"41901706","year":"2026","title":"Fluoroquinolone-Resistant Avian Pathogenic Escherichia coli Isolated from Asymptomatic Broiler Chickens in a Slaughterhouse in Northern Thailand.","finding":"","journal":"Pathogens (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41900883","year":"2026","title":"Chemical Characterization and Evaluation of Antimicrobial, Antioxidant, and Synergistic Activities of Teucrium polium L.: An Integrated Experimental and In Silico Approach.","finding":"","journal":"Pharmaceutics","studyType":"Clinical Study"},{"pmid":"41900863","year":"2026","title":"Accurate and Sensitive UHPLC-Tandem Mass Spectrometry Sequential Methods for Therapeutic Drug Monitoring of Aztreonam/Avibactam in Human Plasma.","finding":"","journal":"Pharmaceutics","studyType":"Clinical Study"},{"pmid":"41900353","year":"2026","title":"Genotypic and Phenotypic Characterization of Cronobacter spp. Strains Isolated from Powdered Milk Formulas and Dairy Production Environments.","finding":"","journal":"Microorganisms","studyType":"Clinical Study"},{"pmid":"41899216","year":"2026","title":"Assessment of Drug Dosing Appropriateness in Hospitalized Chronic Kidney Disease Patients with Cardiovascular Diseases: A Cross-Sectional Study in the Al-Baha Region, Saudi Arabia (2023-2025).","finding":"","journal":"Journal of clinical medicine","studyType":"Clinical Study"}],"_fda":{"id":"6b34b5ad-001f-4c39-8415-a223eb692b46","set_id":"112c5457-8d71-49f5-b531-9761d7d38c93","openfda":{"unii":["9M416Z9QNR"],"route":["INTRAMUSCULAR","INTRAVENOUS"],"rxcui":["1659283","1659287"],"spl_id":["6b34b5ad-001f-4c39-8415-a223eb692b46"],"brand_name":["Ceftazidime"],"spl_set_id":["112c5457-8d71-49f5-b531-9761d7d38c93"],"package_ndc":["25021-127-20","25021-128-50"],"product_ndc":["25021-127","25021-128"],"generic_name":["CEFTAZIDIME"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["CEFTAZIDIME"],"manufacturer_name":["Sagent Pharmaceuticals"],"application_number":["ANDA062640"],"is_original_packager":[true]},"version":"11","warnings":["WARNINGS BEFORE THERAPY WITH CEFTAZIDIME FOR INJECTION IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFTAZIDIME, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBACTERIAL DRUGS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFTAZIDIME FOR INJECTION OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ceftazidime for injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to 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 drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. Elevated levels of ceftazidime in patients with renal insufficiency can lead to seizures, nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia (see PRECAUTIONS )."],"pregnancy":["Pregnancy Teratogenic Effects Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to ceftazidime for injection. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed."],"overdosage":["OVERDOSAGE Ceftazidime overdosage has occurred in patients with renal failure. Reactions have included seizure activity, encephalopathy, asterixis, neuromuscular excitability, and coma. Patients who receive an acute overdosage should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis or peritoneal dialysis may aid in the removal of ceftazidime from the body."],"references":["REFERENCES Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31-41. SAGENT ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in Brazil ©2020 Sagent Pharmaceuticals, Inc. Brands listed are the trademarks of their respective owners. Revised: August 2020 SAGENT Pharmaceuticals ® _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ TEAR AWAY"],"description":["DESCRIPTION Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibacterial drug for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4-thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-, hydroxide, inner salt, [6R-[6α,7β(Z)]]. It has the following structural formula: The molecular formula is C 22 H 22 N 6 O 7 S 2 •5H 2 O, representing a molecular weight of 636.65. Ceftazidime for injection, USP is a sterile, dry-powdered mixture of ceftazidime pentahydrate and sodium carbonate. The sodium carbonate at a concentration of 118 mg/g of ceftazidime activity has been admixed to facilitate dissolution. The total sodium content of the mixture is approximately 54 mg (2.3 mEq)/g of ceftazidime activity. Ceftazidime for injection, USP in sterile crystalline form is supplied in single-dose vials equivalent to 1 g or 2 g of anhydrous ceftazidime. Ceftazidime for injection, USP is a white to cream-colored crystalline powder. Solutions of ceftazidime for injection, USP range in color from light yellow to amber, depending on the diluent and volume used. The pH of freshly constituted solutions usually ranges from 5 to 8. Structural Formula"],"precautions":["PRECAUTIONS General High and prolonged serum ceftazidime concentrations can occur from usual dosages in patients with transient or persistent reduction of urinary output because of renal insufficiency. The total daily dosage should be reduced when ceftazidime is administered to patients with renal insufficiency (see DOSAGE AND ADMINISTRATION ). Elevated levels of ceftazidime in these patients can lead to seizures, nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organisms. As with other antibacterial drugs, prolonged use of ceftazidime may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken. Inducible type I beta-lactamase resistance has been noted with some organisms (e.g., Enterobacter spp., Pseudomonas spp., and Serratia spp.). As with other extended-spectrum beta-lactam antibacterial drugs, resistance can develop during therapy, leading to clinical failure in some cases. When treating infections caused by these organisms, periodic susceptibility testing should be performed when clinically appropriate. If patients fail to respond to monotherapy, an aminoglycoside or similar agent should be considered. Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal and hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated. Ceftazidime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Distal necrosis can occur after inadvertent intra-arterial administration of ceftazidime. Prescribing ceftazidime for injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Information for Patients Patients should be counseled that antibacterial drugs, including ceftazidime for injection, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ceftazidime for injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ceftazidime for injection or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible. Drug Interactions Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibacterial drugs or potent diuretics such as furosemide. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials. Chloramphenicol has been shown to be antagonistic to beta-lactam antibacterial drugs, including ceftazidime, based on in vitro studies and time kill curves with enteric gram-negative bacilli. Due to the possibility of antagonism in vivo , particularly when bactericidal activity is desired, this drug combination should be avoided. Drug/Laboratory Test Interactions The administration of ceftazidime may result in a false-positive reaction for glucose in the urine when using Clinitest ® tablets, Benedict's solution, or Fehling's solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX ® ) be used. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. However, a mouse micronucleus test and an Ames test were both negative for mutagenic effects. Pregnancy Teratogenic Effects Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to ceftazidime for injection. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Ceftazidime is excreted in human milk in low concentrations. Caution should be exercised when ceftazidime is administered to a nursing woman. Pediatric Use See DOSAGE AND ADMINISTRATION . Geriatric Use Of the 2,221 subjects who received ceftazidime in 11 clinical studies, 824 (37%) were 65 and older while 391 (18%) were 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater susceptibility of some older individuals to drug effects cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see DOSAGE AND ADMINISTRATION )."],"how_supplied":["HOW SUPPLIED Ceftazidime for injection, USP in the dry state should be stored at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] and protected from light. Ceftazidime for injection, USP is a white to cream-colored crystalline powder supplied in vials as follows: NDC Ceftazidime for Injection, USP Package Factor 25021-127-20 1 g* Single-Dose Vial 25 vials per carton 25021-128-50 2 g* Single-Dose Vial 10 vials per carton *Equivalent to anhydrous ceftazidime. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex."],"microbiology":["Microbiology Mechanism of Action Ceftazidime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Ceftazidime has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria. Mechanism of Resistance Resistance to ceftazidime is primarily through hydrolysis by beta-lactamase, alteration of penicillin-binding proteins (PBPs), and decreased permeability. Interaction with Other Antimicrobials In an in vitro study, antagonistic effects have been observed with the combination of chloramphenicol and ceftazidime. Ceftazidime has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section: Gram-negative bacteria Citrobacter species Enterobacter species Escherichia coli Klebsiella species Haemophilus influenzae Neisseria meningitidis Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia species Gram-positive bacteria Staphylococcus aureus Streptococcus pneumoniae Streptococcus pyogenes Streptococcus agalactiae Anaerobic bacteria Bacteroides species (Note: many isolates of Bacteroides species are resistant) The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following microorganisms exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for ceftazidime. However, the efficacy of ceftazidime in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials. Gram-negative bacteria Acinetobacter species Citrobacter diversus Citrobacter freundii Providencia species (including Providencia rettgeri ) Salmonella species Shigella species Haemophilus parainfluenzae Morganella morganii Neisseria gonorrhoeae Yersinia enterocolitica Gram-positive bacteria Staphylococcus epidermidis Anaerobic bacteria Clostridium species (Not including Clostridium difficile ) Peptostreptococcus species Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC."],"geriatric_use":["Geriatric Use Of the 2,221 subjects who received ceftazidime in 11 clinical studies, 824 (37%) were 65 and older while 391 (18%) were 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater susceptibility of some older individuals to drug effects cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see DOSAGE AND ADMINISTRATION )."],"pediatric_use":["Pediatric Use See DOSAGE AND ADMINISTRATION ."],"effective_time":"20201005","nursing_mothers":["Nursing Mothers Ceftazidime is excreted in human milk in low concentrations. Caution should be exercised when ceftazidime is administered to a nursing woman."],"adverse_reactions":["ADVERSE REACTIONS Ceftazidime is generally well tolerated. The incidence of adverse reactions associated with the administration of ceftazidime was low in clinical trials. The most common were local reactions following IV injection and allergic and gastrointestinal reactions. Other adverse reactions were encountered infrequently. No disulfiram-like reactions were reported. The following adverse effects from clinical trials were considered to be either related to ceftazidime therapy or were of uncertain etiology: Local Effects, reported in fewer than 2% of patients, were phlebitis and inflammation at the site of injection (1 in 69 patients). Hypersensitivity Reactions, reported in 2% of patients, were pruritus, rash, and fever. Immediate reactions, generally manifested by rash and/or pruritus, occurred in 1 in 285 patients. Toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme have also been reported with cephalosporin antibacterial drugs, including ceftazidime. Angioedema and anaphylaxis (bronchospasm and/or hypotension) have been reported very rarely. Gastrointestinal Symptoms, reported in fewer than 2% of patients, were diarrhea (1 in 78), nausea (1 in 156), vomiting (1 in 500), and abdominal pain (1 in 416). The onset of pseudomembranous colitis symptoms may occur during or after treatment (see WARNINGS ). Central Nervous System Reactions (fewer than 1%) included headache, dizziness, and paresthesia. Seizures have been reported with several cephalosporins, including ceftazidime. In addition, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported in renally impaired patients treated with unadjusted dosing regimens of ceftazidime (see PRECAUTIONS: General ). Less Frequent Adverse Events (fewer than 1%) were candidiasis (including oral thrush) and vaginitis. Hematologic Rare cases of hemolytic anemia have been reported. Laboratory Test Changes noted during clinical trials with ceftazidime were transient and included: eosinophilia (1 in 13), positive Coombs test without hemolysis (1 in 23), thrombocytosis (1 in 45), and slight elevations in one or more of the hepatic enzymes, aspartate aminotransferase (AST, SGOT) (1 in 16), alanine aminotransferase (ALT, SGPT) (1 in 15), LDH (1 in 18), GGT (1 in 19), and alkaline phosphatase (1 in 23). As with some other cephalosporins, transient elevations of blood urea, blood urea nitrogen, and/or serum creatinine were observed occasionally. Transient leukopenia, neutropenia, agranulocytosis, thrombocytopenia, and lymphocytosis were seen very rarely. Postmarketing Experience with Ceftazidime Products In addition to the adverse events reported during clinical trials, the following events have been observed during clinical practice in patients treated with ceftazidime and were reported spontaneously. For some of these events, data are insufficient to allow an estimate of incidence or to establish causation. General Anaphylaxis; allergic reactions, which, in rare instances, were severe (e.g., cardiopulmonary arrest); urticaria; pain at injection site. Hepatobiliary Tract Hyperbilirubinemia, jaundice. Renal and Genitourinary Renal impairment. Cephalosporin-Class Adverse Reactions In addition to the adverse reactions listed above that have been observed in patients treated with ceftazidime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibacterial drugs: Adverse Reactions Colitis, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage. Altered Laboratory Tests Prolonged prothrombin time, false-positive test for urinary glucose, pancytopenia. To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals, Inc. at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ."],"contraindications":["CONTRAINDICATIONS Ceftazidime for injection is contraindicated in patients who have shown hypersensitivity to ceftazidime or the cephalosporin group of antibacterial drugs."],"drug_interactions":["Drug Interactions Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibacterial drugs or potent diuretics such as furosemide. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials. Chloramphenicol has been shown to be antagonistic to beta-lactam antibacterial drugs, including ceftazidime, based on in vitro studies and time kill curves with enteric gram-negative bacilli. Due to the possibility of antagonism in vivo , particularly when bactericidal activity is desired, this drug combination should be avoided."],"how_supplied_table":["
NDCCeftazidime for Injection, USPPackage Factor
25021-127-20 1 g* Single-Dose Vial 25 vials per carton
25021-128-50 2 g* Single-Dose Vial 10 vials per carton
"],"general_precautions":["General High and prolonged serum ceftazidime concentrations can occur from usual dosages in patients with transient or persistent reduction of urinary output because of renal insufficiency. The total daily dosage should be reduced when ceftazidime is administered to patients with renal insufficiency (see DOSAGE AND ADMINISTRATION ). Elevated levels of ceftazidime in these patients can lead to seizures, nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organisms. As with other antibacterial drugs, prolonged use of ceftazidime may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken. Inducible type I beta-lactamase resistance has been noted with some organisms (e.g., Enterobacter spp., Pseudomonas spp., and Serratia spp.). As with other extended-spectrum beta-lactam antibacterial drugs, resistance can develop during therapy, leading to clinical failure in some cases. When treating infections caused by these organisms, periodic susceptibility testing should be performed when clinically appropriate. If patients fail to respond to monotherapy, an aminoglycoside or similar agent should be considered. Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal and hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated. Ceftazidime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Distal necrosis can occur after inadvertent intra-arterial administration of ceftazidime. Prescribing ceftazidime for injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria."],"mechanism_of_action":["Mechanism of Action Ceftazidime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Ceftazidime has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria."],"teratogenic_effects":["Teratogenic Effects Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to ceftazidime for injection. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed."],"instructions_for_use":["Ceftazidime for Injection, USP Instructions for Constitution Vials: 1 g IM/IV, 2 g IV Insert the syringe needle through the vial closure and inject the recommended volume of diluent. The vacuum may assist entry of the diluent. Remove the syringe needle. Shake to dissolve; a clear solution will be obtained in 1 to 2 minutes. Invert the vial. Ensuring that the syringe plunger is fully depressed, insert the needle through the vial closure and withdraw the total volume of solution into the syringe (the pressure in the vial may aid withdrawal). Ensure that the needle remains within the solution and does not enter the headspace. The withdrawn solution may contain some bubbles of carbon dioxide. Note: As with the administration of all parenteral products, accumulated gases should be expressed from the syringe immediately before injection of ceftazidime for injection. SAGENT ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in Brazil ©2020 Sagent Pharmaceuticals, Inc. Revised: August 2020 SAGENT Pharmaceuticals ®"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY After IV administration of 500 mg and 1 g doses of ceftazidime over 5 minutes to normal adult male volunteers, mean peak serum concentrations of 45 and 90 mcg/mL, respectively, were achieved. After IV infusion of 500 mg, 1 g, and 2 g doses of ceftazidime over 20 to 30 minutes to normal adult male volunteers, mean peak serum concentrations of 42, 69, and 170 mcg/mL, respectively, were achieved. The average serum concentrations following IV infusion of 500 mg, 1 g, and 2 g doses to these volunteers over an 8-hour interval are given in Table 1 . Table 1. Average Serum Concentrations of Ceftazidime Ceftazidime IV Dose Serum Concentrations (mcg/mL) 0.5 hr 1 hr 2 hr 4 hr 8 hr 500 mg 42 25 12 6 2 1 g 60 39 23 11 3 2 g 129 75 42 13 5 The absorption and elimination of ceftazidime were directly proportional to the size of the dose. The half-life following IV administration was approximately 1.9 hours. Less than 10% of ceftazidime was protein bound. The degree of protein binding was independent of concentration. There was no evidence of accumulation of ceftazidime in the serum in individuals with normal renal function following multiple IV doses of 1 and 2 g every 8 hours for 10 days. Following intramuscular (IM) administration of 500 mg and 1 g doses of ceftazidime to normal adult volunteers, the mean peak serum concentrations were 17 and 39 mcg/mL, respectively, at approximately 1 hour. Serum concentrations remained above 4 mcg/mL for 6 and 8 hours after the IM administration of 500 mg and 1 g doses, respectively. The half-life of ceftazidime in these volunteers was approximately 2 hours. The presence of hepatic dysfunction had no effect on the pharmacokinetics of ceftazidime in individuals administered 2 g intravenously every 8 hours for 5 days. Therefore, a dosage adjustment from the normal recommended dosage is not required for patients with hepatic dysfunction, provided renal function is not impaired. Approximately 80% to 90% of an IM or IV dose of ceftazidime is excreted unchanged by the kidneys over a 24-hour period. After the IV administration of single 500 mg or 1 g doses, approximately 50% of the dose appeared in the urine in the first 2 hours. An additional 20% was excreted between 2 and 4 hours after dosing, and approximately another 12% of the dose appeared in the urine between 4 and 8 hours later. The elimination of ceftazidime by the kidneys resulted in high therapeutic concentrations in the urine. The mean renal clearance of ceftazidime was approximately 100 mL/min. The calculated plasma clearance of approximately 115 mL/min indicated nearly complete elimination of ceftazidime by the renal route. Administration of probenecid before dosing had no effect on the elimination kinetics of ceftazidime. This suggested that ceftazidime is eliminated by glomerular filtration and is not actively secreted by renal tubular mechanisms. Since ceftazidime is eliminated almost solely by the kidneys, its serum half-life is significantly prolonged in patients with impaired renal function. Consequently, dosage adjustments in such patients as described in the DOSAGE AND ADMINISTRATION section are suggested. Therapeutic concentrations of ceftazidime are achieved in the following body tissues and fluids. Table 2. Ceftazidime Concentrations in Body Tissues and Fluids Tissue or Fluid Dose/ Route No. of Patients Time of Sample Post Dose Average Tissue or Fluid Level (mcg/mL or mcg/g) Urine 500 mg IM 6 0 to 2 hr 2,100 2 g IV 6 0 to 2 hr 12,000 Bile 2 g IV 3 90 min 36.4 Synovial fluid 2 g IV 13 2 hr 25.6 Peritoneal fluid 2 g IV 8 2 hr 48.6 Sputum 1 g IV 8 1 hr 9 Cerebrospinal fluid 2 g q8hr IV 5 120 min 9.8 (inflamed meninges) 2 g q8hr IV 6 180 min 9.4 Aqueous humor 2 g IV 13 1 to 3 hr 11 Blister fluid 1 g IV 7 2 to 3 hr 19.7 Lymphatic fluid 1 g IV 7 2 to 3 hr 23.4 Bone 2 g IV 8 0.67 hr 31.1 Heart muscle 2 g IV 35 30 to 280 min 12.7 Skin 2 g IV 22 30 to 180 min 6.6 Skeletal muscle 2 g IV 35 30 to 280 min 9.4 Myometrium 2 g IV 31 1 to 2 hr 18.7 Microbiology Mechanism of Action Ceftazidime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Ceftazidime has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria. Mechanism of Resistance Resistance to ceftazidime is primarily through hydrolysis by beta-lactamase, alteration of penicillin-binding proteins (PBPs), and decreased permeability. Interaction with Other Antimicrobials In an in vitro study, antagonistic effects have been observed with the combination of chloramphenicol and ceftazidime. Ceftazidime has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section: Gram-negative bacteria Citrobacter species Enterobacter species Escherichia coli Klebsiella species Haemophilus influenzae Neisseria meningitidis Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia species Gram-positive bacteria Staphylococcus aureus Streptococcus pneumoniae Streptococcus pyogenes Streptococcus agalactiae Anaerobic bacteria Bacteroides species (Note: many isolates of Bacteroides species are resistant) The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following microorganisms exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for ceftazidime. However, the efficacy of ceftazidime in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials. Gram-negative bacteria Acinetobacter species Citrobacter diversus Citrobacter freundii Providencia species (including Providencia rettgeri ) Salmonella species Shigella species Haemophilus parainfluenzae Morganella morganii Neisseria gonorrhoeae Yersinia enterocolitica Gram-positive bacteria Staphylococcus epidermidis Anaerobic bacteria Clostridium species (Not including Clostridium difficile ) Peptostreptococcus species Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC."],"indications_and_usage":["INDICATIONS AND USAGE Ceftazidime for injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Lower Respiratory Tract Infections, including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas spp.; Haemophilus influenzae, including ampicillin-resistant strains; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis; Escherichia coli; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae; and Staphylococcus aureus (methicillin-susceptible strains). Skin and Skin-Structure Infections caused by Pseudomonas aeruginosa; Klebsiella spp.; Escherichia coli; Proteus spp., including Proteus mirabilis and indole-positive Proteus; Enterobacter spp.; Serratia spp.; Staphylococcus aureus (methicillin-susceptible strains); and Streptococcus pyogenes (group A beta-hemolytic streptococci). Urinary Tract Infections, both complicated and uncomplicated, caused by Pseudomonas aeruginosa; Enterobacter spp.; Proteus spp., including Proteus mirabilis and indole-positive Proteus; Klebsiella spp.; and Escherichia coli. Bacterial Septicemia caused by Pseudomonas aeruginosa, Klebsiella spp., Haemophilus influenzae, Escherichia coli, Serratia spp., Streptococcus pneumoniae, and Staphylococcus aureus (methicillin-susceptible strains). Bone and Joint Infections caused by Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., and Staphylococcus aureus (methicillin-susceptible strains). Gynecologic Infections, including endometritis, pelvic cellulitis, and other infections of the female genital tract caused by Escherichia coli. Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella spp., and Staphylococcus aureus (methicillin-susceptible strains) and polymicrobial infections caused by aerobic and anaerobic organisms and Bacteroides spp. (many strains of Bacteroides fragilis are resistant). Central Nervous System Infections, including meningitis, caused by Haemophilus influenzae and Neisseria meningitidis. Ceftazidime has also been used successfully in a limited number of cases of meningitis due to Pseudomonas aeruginosa and Streptococcus pneumoniae. Ceftazidime for injection, USP may be used alone in cases of confirmed or suspected sepsis. Ceftazidime has been used successfully in clinical trials as empiric therapy in cases where various concomitant therapies with other antibacterial drugs have been used. Ceftazidime for injection, USP may also be used concomitantly with other antibacterial drugs, such as aminoglycosides, vancomycin, and clindamycin; in severe and life-threatening infections; and in the immunocompromised patient. When such concomitant treatment is appropriate, prescribing information in the labeling for the other antibacterial drugs should be followed. The dose depends on the severity of the infection and the patient's condition. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftazidime for injection, USP and other antibacterial drugs, ceftazidime for injection, USP should be used only to treat 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."],"information_for_patients":["Information for Patients Patients should be counseled that antibacterial drugs, including ceftazidime for injection, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ceftazidime for injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ceftazidime for injection or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible."],"spl_unclassified_section":["For Intravenous or Intramuscular Use SAGENT ® Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftazidime for injection and other antibacterial drugs, ceftazidime for injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.","COMPATIBILITY AND STABILITY Intramuscular Ceftazidime for injection, when constituted as directed with Sterile Water for Injection, Bacteriostatic Water for Injection, or 0.5% or 1% Lidocaine Hydrochloride Injection, maintains satisfactory potency for 12 hours at room temperature or for 3 days under refrigeration. Solutions in Sterile Water for Injection that are frozen immediately after constitution in the original container are stable for 3 months when stored at -20°C. Once thawed, solutions should not be refrozen. Thawed solutions may be stored for up to 3 hours at room temperature or for 3 days in a refrigerator. Intravenous Ceftazidime for injection, when constituted as directed with Sterile Water for Injection, maintains satisfactory potency for 12 hours at room temperature or for 3 days under refrigeration. Ceftazidime is compatible with the more commonly used IV infusion fluids. Solutions at concentrations between 1 and 40 mg/mL in 0.9% Sodium Chloride Injection; 1/6 M Sodium Lactate Injection; 5% Dextrose Injection; 5% Dextrose and 0.225% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 10% Dextrose Injection; Ringer's Injection, USP; Lactated Ringer's Injection, USP; 10% Invert Sugar in Water for Injection; and NORMOSOL ® -M in 5% Dextrose Injection may be stored for up to 12 hours at room temperature or for 3 days if refrigerated. Ceftazidime for injection is less stable in Sodium Bicarbonate Injection than in other IV fluids. It is not recommended as a diluent. Solutions of ceftazidime for injection in 5% Dextrose Injection and 0.9% Sodium Chloride Injection are stable for at least 6 hours at room temperature in plastic tubing, drip chambers, and volume control devices of common IV infusion sets. Ceftazidime at a concentration of 4 mg/mL has been found compatible for 12 hours at room temperature or for 3 days under refrigeration in 0.9% Sodium Chloride Injection or 5% Dextrose Injection when admixed with: cefuroxime sodium 3 mg/mL, heparin 10 or 50 U/mL, or potassium chloride 10 or 40 mEq/L. Vancomycin solution exhibits a physical incompatibility when mixed with a number of drugs, including ceftazidime. The likelihood of precipitation with ceftazidime is dependent on the concentrations of vancomycin and ceftazidime present. It is therefore recommended, when both drugs are to be administered by intermittent IV infusion, that they be given separately, flushing the IV lines (with 1 of the compatible IV fluids) between the administration of these 2 agents. Note: Parenteral drug products should be inspected visually for particulate matter before administration whenever solution and container permit. As with other cephalosporins, ceftazidime for injection powder, as well as solutions, tend to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Dosage The usual adult dosage is 1 gram administered intravenously or intramuscularly every 8 to 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection, and the condition and renal function of the patient. The guidelines for dosage of ceftazidime for injection are listed in Table 3 . The following dosage schedule is recommended. Table 3. Recommended Dosage Schedule *Although clinical improvement has been shown, bacteriologic cures cannot be expected in patients with chronic respiratory disease and cystic fibrosis. **The higher dose should be reserved for immunocompromised pediatric patients or pediatric patients with cystic fibrosis or meningitis. Dose Frequency Adult Usual recommended dosage 1 gram intravenous or intramuscular every 8 to 12 hours Uncomplicated urinary tract infection 250 mg intravenous or intramuscular every 12 hours Bone and joint infections 2 grams intravenous every 12 hours Complicated urinary tract infections 500 mg intravenous or intramuscular every 8 to 12 hours Uncomplicated pneumonia; mild skin and skin-structure infections 500 mg to 1 gram intravenous or intramuscular every 8 hours Serious gynecological and intra-abdominal infections 2 grams intravenous every 8 hours Meningitis 2 grams intravenous every 8 hours Very severe life-threatening infections, especially in immunocompromised patients 2 grams intravenous every 8 hours Lung infections caused by Pseudomonas spp. in patients with cystic fibrosis with normal renal function* 30 to 50 mg/kg intravenous to a maximum of 6 grams per day every 8 hours Neonates (0 to 4 weeks) 30 mg/kg intravenous every 12 hours Infants and children (1 month to 12 years) 30 to 50 mg/kg intravenous to a maximum of 6 grams per day** every 8 hours Impaired Hepatic Function No adjustment in dosage is required for patients with hepatic dysfunction. Impaired Renal Function Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (glomerular filtration rate [GFR] <50 mL/min), it is recommended that the dosage of ceftazidime be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of ceftazidime may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage. The recommended dosage is presented in Table 4 . Table 4. Recommended Maintenance Dosages of Ceftazidime for Injection in Renal Insufficiency NOTE: If the dose recommended in Table 3 above is lower than that recommended for patients with renal insufficiency as outlined in Table 4 , the lower dose should be used. Creatinine Clearance (mL/min) Recommended Unit Dose of Ceftazidime for Injection Frequency of Dosing 50 to 31 1 gram every 12 hours 30 to 16 1 gram every 24 hours 15 to 6 500 mg every 24 hours less than 5 500 mg every 48 hours When only serum creatinine is available, the following formula (Cockcroft's equation) 1 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function: Males: Creatinine clearance (mL/min) = Weight (kg) x (140 - age) 72 x serum creatinine (mg/dL) Females: 0.85 x male value In patients with severe infections who would normally receive 6 grams of ceftazidime for injection daily were it not for renal insufficiency, the unit dose given in the table above may be increased by 50% or the dosing frequency may be increased appropriately. Further dosing should be determined by therapeutic monitoring, severity of the infection, and susceptibility of the causative organism. In pediatric patients as for adults, the creatinine clearance should be adjusted for body surface area or lean body mass, and the dosing frequency should be reduced in cases of renal insufficiency. In patients undergoing hemodialysis, a loading dose of 1 gram is recommended, followed by 1 gram after each hemodialysis period. Ceftazidime for injection can also be used in patients undergoing intraperitoneal dialysis and continuous ambulatory peritoneal dialysis. In such patients, a loading dose of 1 gram of ceftazidime for injection may be given, followed by 500 mg every 24 hours. In addition to IV use, ceftazidime for injection can be incorporated in the dialysis fluid at a concentration of 250 mg for 2 L of dialysis fluid. Note: Generally, ceftazidime for injection should be continued for 2 days after the signs and symptoms of infection have disappeared, but in complicated infections longer therapy may be required. Administration Ceftazidime for injection may be given intravenously or by deep IM injection into a large muscle mass such as the upper outer quadrant of the gluteus maximus or lateral part of the thigh. Intra-arterial administration should be avoided (see PRECAUTIONS ). Intramuscular Administration For IM administration, ceftazidime for injection should be constituted with one of the following diluents: Sterile Water for Injection, Bacteriostatic Water for Injection, or 0.5% or 1% Lidocaine Hydrochloride Injection. Refer to Table 5 . Intravenous Administration The IV route is preferable for patients with bacterial septicemia, bacterial meningitis, peritonitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or pending. For direct intermittent IV administration, constitute ceftazidime for injection as directed in Table 5 with Sterile Water for Injection. Slowly inject directly into the vein over a period of 3 to 5 minutes or give through the tubing of an administration set while the patient is also receiving one of the compatible IV fluids (see COMPATIBILITY AND STABILITY ). For IV infusion, constitute the 1 gram, or 2 gram vial and add an appropriate quantity of the resulting solution to an IV container with one of the compatible IV fluids listed under the COMPATIBILITY AND STABILITY section. Intermittent IV infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of a solution containing ceftazidime, it is desirable to discontinue the other solution. Table 5. Preparation of Solutions of Ceftazidime for Injection * To obtain a dose of 1 g, withdraw 10 mL from the vial following reconstitution. ** To obtain a dose of 2 g, withdraw 11.5 mL from the vial following reconstitution. Size Amount of Diluent to be Added (mL) Approximate Available Volume (mL) Approximate Ceftazidime Concentration (mg/mL) Intramuscular 1 gram vial 3 3.6 280 Intravenous 1 gram vial 10 10.8* 100 2 gram vial 10 11.5** 170 Discard unused portion. All vials of ceftazidime for injection as supplied are under reduced pressure. When ceftazidime for injection is dissolved, carbon dioxide is released and a positive pressure develops. For ease of use please follow the recommended techniques of constitution described on the detachable Instructions for Constitution section of this insert. Solutions of ceftazidime for injection, like those of most beta-lactam antibacterial drugs, should not be added to solutions of aminoglycoside antibacterial drugs because of potential interaction. However, if concurrent therapy with ceftazidime for injection and an aminoglycoside is indicated, each of these antibacterial drugs can be administered separately to the same patient."],"spl_product_data_elements":["Ceftazidime ceftazidime ceftazidime CEFTAZIDIME ANHYDROUS sodium carbonate Ceftazidime ceftazidime ceftazidime CEFTAZIDIME ANHYDROUS sodium carbonate"],"clinical_pharmacology_table":["
Table 1. Average Serum Concentrations of Ceftazidime
Ceftazidime IV DoseSerum Concentrations (mcg/mL)
0.5 hr1 hr2 hr4 hr8 hr
500 mg 42 25 12 6 2
1 g 60 39 23 11 3
2 g 129 75 42 13 5
","
Table 2. Ceftazidime Concentrations in Body Tissues and Fluids
Tissue or Fluid Dose/ RouteNo. of PatientsTime of Sample Post DoseAverage Tissue or Fluid Level (mcg/mL or mcg/g)
Urine 500 mg IM 6 0 to 2 hr 2,100
2 g IV 6 0 to 2 hr 12,000
Bile 2 g IV 3 90 min 36.4
Synovial fluid 2 g IV 13 2 hr 25.6
Peritoneal fluid 2 g IV 8 2 hr 48.6
Sputum 1 g IV 8 1 hr 9
Cerebrospinal fluid 2 g q8hr IV 5 120 min 9.8
(inflamed meninges) 2 g q8hr IV 6 180 min 9.4
Aqueous humor 2 g IV 13 1 to 3 hr 11
Blister fluid 1 g IV 7 2 to 3 hr 19.7
Lymphatic fluid 1 g IV 7 2 to 3 hr 23.4
Bone 2 g IV 8 0.67 hr 31.1
Heart muscle 2 g IV 35 30 to 280 min 12.7
Skin 2 g IV 22 30 to 180 min 6.6
Skeletal muscle 2 g IV 35 30 to 280 min 9.4
Myometrium 2 g IV 31 1 to 2 hr 18.7
"],"dosage_and_administration_table":["
Table 3. Recommended Dosage Schedule
*Although clinical improvement has been shown, bacteriologic cures cannot be expected in patients with chronic respiratory disease and cystic fibrosis.
**The higher dose should be reserved for immunocompromised pediatric patients or pediatric patients with cystic fibrosis or meningitis.
DoseFrequency
Adult
Usual recommended dosage1 gram intravenous or intramuscularevery 8 to 12 hours
Uncomplicated urinary tract infection 250 mg intravenous or intramuscular every 12 hours
Bone and joint infections 2 grams intravenous every 12 hours
Complicated urinary tract infections 500 mg intravenous or intramuscular every 8 to 12 hours
Uncomplicated pneumonia; mild skin and skin-structure infections 500 mg to 1 gram intravenous or intramuscular every 8 hours
Serious gynecological and intra-abdominal infections 2 grams intravenous every 8 hours
Meningitis 2 grams intravenous every 8 hours
Very severe life-threatening infections, especially in immunocompromised patients 2 grams intravenous every 8 hours
Lung infections caused by Pseudomonas spp. in patients with cystic fibrosis with normal renal function* 30 to 50 mg/kg intravenous to a maximum of 6 grams per day every 8 hours
Neonates (0 to 4 weeks) 30 mg/kg intravenous every 12 hours
Infants and children (1 month to 12 years) 30 to 50 mg/kg intravenous to a maximum of 6 grams per day** every 8 hours
","
Table 4. Recommended Maintenance Dosages of Ceftazidime for Injection in Renal Insufficiency
NOTE: If the dose recommended in Table 3 above is lower than that recommended for patients with renal insufficiency as outlined in Table 4, the lower dose should be used.
Creatinine Clearance (mL/min)Recommended Unit Dose of Ceftazidime for InjectionFrequency of Dosing
50 to 31 1 gram every 12 hours
30 to 16 1 gram every 24 hours
15 to 6 500 mg every 24 hours
less than 5 500 mg every 48 hours
","
Table 5. Preparation of Solutions of Ceftazidime for Injection
* To obtain a dose of 1 g, withdraw 10 mL from the vial following reconstitution.
** To obtain a dose of 2 g, withdraw 11.5 mL from the vial following reconstitution.
Size Amount of Diluent to be Added (mL)Approximate Available Volume (mL)Approximate Ceftazidime Concentration (mg/mL)
Intramuscular
1 gram vial 3 3.6 280
Intravenous
1 gram vial 10 10.8* 100
2 gram vial 10 11.5** 170
"],"package_label_principal_display_panel":["PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label NDC 25021-127-20 Single-Dose Vial 1 g per vial Equivalent to 1g of anhydrous ceftazidime CEFTAZIDIME FOR INJECTION, USP Rx only For Intravenous or Intramuscular Use PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label NDC 25021-128-50 Single-Dose Vial 2 g per vial Equivalent to 2 g of anhydrous ceftazidime CEFTAZIDIME FOR INJECTION, USP Rx only For Intravenous Use PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label"],"drug_and_or_laboratory_test_interactions":["Drug/Laboratory Test Interactions The administration of ceftazidime may result in a false-positive reaction for glucose in the urine when using Clinitest ® tablets, Benedict's solution, or Fehling's solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX ® ) be used."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. However, a mouse micronucleus test and an Ames test were both negative for mutagenic effects."]},"tags":[{"label":"ceftazidime","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"J01DD02","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Intramuscular","category":"route"},{"label":"Injection","category":"form"},{"label":"Powder","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Bacterial infection due to Klebsiella pneumoniae","category":"indication"},{"label":"Bacterial meningitis","category":"indication"},{"label":"Bacterial pneumonia","category":"indication"},{"label":"Bacterial septicemia","category":"indication"},{"label":"Bacterial urinary infection","category":"indication"},{"label":"Citrobacter Pneumonia","category":"indication"},{"label":"Pai Holdings Pharm","category":"company"},{"label":"Approved 1980s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"832 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"688 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"540 reports"},{"date":"","signal":"SEPTIC SHOCK","source":"FDA FAERS","actionTaken":"338 reports"},{"date":"","signal":"CONDITION AGGRAVATED","source":"FDA FAERS","actionTaken":"319 reports"},{"date":"","signal":"NEUTROPENIA","source":"FDA FAERS","actionTaken":"318 reports"},{"date":"","signal":"ACUTE KIDNEY INJURY","source":"FDA FAERS","actionTaken":"300 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"298 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"296 reports"},{"date":"","signal":"HYPOTENSION","source":"FDA FAERS","actionTaken":"270 reports"}],"drugInteractions":[{"drug":"Aminoglycoside antibacterial drugs","severity":"Moderate","mechanism":"Potential nephrotoxicity and ototoxicity","management":"Renal function should be carefully monitored, especially with higher aminoglycoside dosages or prolonged therapy","clinicalEffect":"Nephrotoxicity reported with concomitant administration"},{"drug":"Potent diuretics (furosemide)","severity":"Moderate","mechanism":"Potential nephrotoxicity","management":"Renal function should be carefully monitored","clinicalEffect":"Nephrotoxicity reported with concomitant administration"},{"drug":"Chloramphenicol","severity":"High","mechanism":"Antagonistic activity based on in vitro studies and time kill curves","management":"Drug combination should be avoided","clinicalEffect":"Potential antagonism in vivo, particularly when bactericidal activity is desired"}],"commonSideEffects":[{"effect":"Constipation","drugRate":"9.4%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":85,"totalAffected":8,"trialsReporting":1},{"effect":"Sleep disorder","drugRate":"7.1%","organSystem":"Psychiatric disorders","placeboRate":"","totalAtRisk":85,"totalAffected":6,"trialsReporting":1},{"effect":"Nausea","drugRate":"5.9%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":85,"totalAffected":5,"trialsReporting":1},{"effect":"Headache","drugRate":"5.9%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":85,"totalAffected":5,"trialsReporting":1},{"effect":"Insomnia","drugRate":"4.7%","organSystem":"Psychiatric disorders","placeboRate":"","totalAtRisk":85,"totalAffected":4,"trialsReporting":1},{"effect":"Diarrhoea","drugRate":"3.5%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":85,"totalAffected":3,"trialsReporting":1},{"effect":"Infustion site irritation","drugRate":"3.5%","organSystem":"General disorders","placeboRate":"","totalAtRisk":85,"totalAffected":3,"trialsReporting":1},{"effect":"Pyrexia","drugRate":"3.5%","organSystem":"General disorders","placeboRate":"","totalAtRisk":85,"totalAffected":3,"trialsReporting":1},{"effect":"Abdominal pain","drugRate":"2.4%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":85,"totalAffected":2,"trialsReporting":1},{"effect":"Infusion site erythema","drugRate":"2.4%","organSystem":"General disorders","placeboRate":"","totalAtRisk":85,"totalAffected":2,"trialsReporting":1},{"effect":"Infusion site extravasation","drugRate":"2.4%","organSystem":"General disorders","placeboRate":"","totalAtRisk":85,"totalAffected":2,"trialsReporting":1},{"effect":"Infustion site swelling","drugRate":"2.4%","organSystem":"General disorders","placeboRate":"","totalAtRisk":85,"totalAffected":2,"trialsReporting":1},{"effect":"Urinary tract infection","drugRate":"2.4%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":85,"totalAffected":2,"trialsReporting":1},{"effect":"Back pain","drugRate":"2.4%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":85,"totalAffected":2,"trialsReporting":1},{"effect":"Flank pain","drugRate":"2.4%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":85,"totalAffected":2,"trialsReporting":1},{"effect":"Cough","drugRate":"2.4%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":85,"totalAffected":2,"trialsReporting":1},{"effect":"Hypertension","drugRate":"2.4%","organSystem":"Vascular disorders","placeboRate":"","totalAtRisk":85,"totalAffected":2,"trialsReporting":1},{"effect":"Phlebitis","drugRate":"2.4%","organSystem":"Vascular disorders","placeboRate":"","totalAtRisk":85,"totalAffected":2,"trialsReporting":1},{"effect":"Anaemia","drugRate":"1.2%","organSystem":"Blood and lymphatic system disorders","placeboRate":"","totalAtRisk":85,"totalAffected":1,"trialsReporting":1},{"effect":"Abdominal pain upper","drugRate":"1.2%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":85,"totalAffected":1,"trialsReporting":1},{"effect":"Vomiting","drugRate":"1.2%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":85,"totalAffected":1,"trialsReporting":1},{"effect":"Infusion site reaction","drugRate":"1.2%","organSystem":"General disorders","placeboRate":"","totalAtRisk":85,"totalAffected":1,"trialsReporting":1},{"effect":"Hypokalaemia","drugRate":"1.2%","organSystem":"Metabolism and nutrition disorders","placeboRate":"","totalAtRisk":85,"totalAffected":1,"trialsReporting":1},{"effect":"Renal cyst","drugRate":"1.2%","organSystem":"Renal and urinary disorders","placeboRate":"","totalAtRisk":85,"totalAffected":1,"trialsReporting":1},{"effect":"Dyspnoea","drugRate":"1.2%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":85,"totalAffected":1,"trialsReporting":1},{"effect":"Blister","drugRate":"1.2%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":85,"totalAffected":1,"trialsReporting":1},{"effect":"Hypotension","drugRate":"1.2%","organSystem":"Vascular disorders","placeboRate":"","totalAtRisk":85,"totalAffected":1,"trialsReporting":1},{"effect":"Vertigo","drugRate":"0.0%","organSystem":"Ear and labyrinth disorders","placeboRate":"","totalAtRisk":85,"totalAffected":0,"trialsReporting":1},{"effect":"Arteriosclerotic retinopathy","drugRate":"0.0%","organSystem":"Eye disorders","placeboRate":"","totalAtRisk":85,"totalAffected":0,"trialsReporting":1},{"effect":"Retinal degeneration","drugRate":"0.0%","organSystem":"Eye disorders","placeboRate":"","totalAtRisk":85,"totalAffected":0,"trialsReporting":1},{"effect":"Vision blurred","drugRate":"0.0%","organSystem":"Eye disorders","placeboRate":"","totalAtRisk":85,"totalAffected":0,"trialsReporting":1},{"effect":"Visual impairment","drugRate":"0.0%","organSystem":"Eye disorders","placeboRate":"","totalAtRisk":85,"totalAffected":0,"trialsReporting":1},{"effect":"Gingival pain","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":85,"totalAffected":0,"trialsReporting":1},{"effect":"Mouth ulceration","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":85,"totalAffected":0,"trialsReporting":1},{"effect":"Oral pain","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":85,"totalAffected":0,"trialsReporting":1},{"effect":"Chest pain","drugRate":"0.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":85,"totalAffected":0,"trialsReporting":1},{"effect":"Chills","drugRate":"0.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":85,"totalAffected":0,"trialsReporting":1},{"effect":"Feeling abnormal","drugRate":"0.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":85,"totalAffected":0,"trialsReporting":1},{"effect":"Agression","drugRate":"0.0%","organSystem":"Psychiatric disorders","placeboRate":"","totalAtRisk":85,"totalAffected":0,"trialsReporting":1},{"effect":"Depression","drugRate":"0.0%","organSystem":"Psychiatric disorders","placeboRate":"","totalAtRisk":85,"totalAffected":0,"trialsReporting":1},{"effect":"Haematuria","drugRate":"0.0%","organSystem":"Renal and urinary disorders","placeboRate":"","totalAtRisk":85,"totalAffected":0,"trialsReporting":1}],"contraindications":["Hypersensitivity to ceftazidime","Hypersensitivity to cephalosporin group of antibacterial drugs"],"specialPopulations":{"Pregnancy":"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 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. The background risk of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies within the general population. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.","Geriatric use":"Of the 2,221 subjects who received ceftazidime in 11 clinical studies, 824 (37%) were 65 and older while 391 (18%) were 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater susceptibility of some older individuals to drug effects cannot be ruled out.","Paediatric use":"Safety and effectiveness in pediatric patients below the age of months have not been established. Safety and effectiveness in pediatric patients with HABP/VABP have not been established."},"seriousAdverseEvents":[{"event":"Pyelonephritis","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"1.2%"}]},"trials":[],"aliases":[],"company":"Pai Holdings Pharm","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-11-20","unitCost":"$3.8622/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$1,410","description":"CEFTAZIDIME 1 GM VIAL","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Ceftazidime","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:37:18.565003+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Ceftazidime","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:37:27.301472+00:00"},"mechanism":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-21T10:57:20.904469+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:37:25.793117+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-19T23:37:17.191026+00:00"},"pharmacokinetics":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-21T10:57:20.904500+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Ceftazidime","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:37:26.741490+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:37:15.207884+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:37:15.207933+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T23:37:28.432514+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Bacterial penicillin-binding protein inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:37:27.301422+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL44354/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:37:27.216520+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (1 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-21T10:57:21.080571+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA062640","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:37:15.207939+00:00"}},"allNames":"fortaz","offLabel":[],"synonyms":["ceftazidime hydrate","ceftazidime","biotum","cefazid","ceftacidin","ceftazidine","tazicef","tazidime","ceftazidime sodium","ceftazidime pentahydrate"],"timeline":[{"date":"1985-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from COVIS INJECTABLES to Pai Holdings Pharm"},{"date":"1985-07-19","type":"positive","source":"DrugCentral","milestone":"FDA approval (Covis Injectables)"},{"date":"1990-09-27","type":"positive","source":"FDA Orange Book","milestone":"Ceptaz approved — 1GM/VIAL"},{"date":"1992-02-03","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 3 manufacturers approved"},{"date":"2011-06-13","type":"positive","source":"FDA Orange Book","milestone":"Ceftazidime In Dextrose Container approved — EQ 1GM BASE"}],"aiSummary":"Ceftazidime is a third-generation cephalosporin indicated for serious infections caused by susceptible Gram-negative and Gram-positive organisms including Pseudomonas aeruginosa. The drug demonstrates bactericidal activity through cell wall inhibition with favorable pharmacokinetics including short half-life and minimal protein binding. Primary risks include hypersensitivity reactions and potential nephrotoxicity when combined with aminoglycosides or diuretics. Ceftazidime remains an important empiric therapy option for severe infections in hospitalized and immunocompromised patients.","brandName":"Fortaz","ecosystem":[{"indication":"Bacterial infection due to Klebsiella pneumoniae","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"azlocillin","slug":"azlocillin","company":"Bayer Pharmaceuticals Corp"},{"name":"aztreonam","slug":"aztreonam","company":"Bristol Myers Squibb"}],"globalPrevalence":null},{"indication":"Bacterial meningitis","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"cefotaxime","slug":"cefotaxime","company":"Sanofi Aventis Us"},{"name":"ceftriaxone","slug":"ceftriaxone","company":""}],"globalPrevalence":null},{"indication":"Bacterial pneumonia","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""}],"globalPrevalence":null},{"indication":"Bacterial septicemia","otherDrugs":[{"name":"Polymyxin B","slug":"polymyxin-b","company":"Monarch Pharms"},{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azlocillin","slug":"azlocillin","company":"Bayer Pharmaceuticals Corp"}],"globalPrevalence":null},{"indication":"Bacterial urinary infection","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"avibactam","slug":"avibactam","company":"Cerexa Inc"}],"globalPrevalence":null},{"indication":"Citrobacter Pneumonia","otherDrugs":[{"name":"gentamicin","slug":"gentamicin","company":"Schering"}],"globalPrevalence":null},{"indication":"Complicated Proteus UTI","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"betaine","slug":"betaine","company":"Rare Dis Therap"},{"name":"cefepime","slug":"cefepime","company":"Hospira Inc"},{"name":"ciprofloxacin","slug":"ciprofloxacin","company":"Bayer Hlthcare"}],"globalPrevalence":null},{"indication":"Complicated UTI with Pseudomonas Aeruginosa","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"betaine","slug":"betaine","company":"Rare Dis Therap"},{"name":"ciprofloxacin","slug":"ciprofloxacin","company":"Bayer Hlthcare"},{"name":"gentamicin","slug":"gentamicin","company":"Schering"}],"globalPrevalence":null}],"mechanism":{"target":"Bacterial cell wall","novelty":"Follow-on","modality":"Beta-lactam antibiotic","drugClass":"Third-generation cephalosporin","explanation":"Ceftazidime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. The drug has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria, providing broader spectrum coverage than earlier generation cephalosporins.","oneSentence":"Bactericidal agent inhibiting bacterial cell wall synthesis with beta-lactamase resistance.","technicalDetail":"Fortaz exerts its antibacterial effect by inhibiting the action of beta-lactamase enzymes and binding to penicillin-binding proteins (PBPs) on the bacterial cell wall, ultimately leading to the disruption of cell wall synthesis and bacterial cell death."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Ceftazidime","title":"Ceftazidime","extract":"Ceftazidime, sold under the brand name Fortaz among others, is a third-generation cephalosporin antibiotic useful for the treatment of a number of bacterial infections. Specifically it is used for joint infections, meningitis, pneumonia, sepsis, urinary tract infections, malignant otitis externa, Pseudomonas aeruginosa infection, and vibrio infection. It is given by injection into a vein, muscle, or eye."},"commercial":{"launchDate":"1985","_launchSource":"DrugCentral (FDA 1985-07-19, COVIS INJECTABLES)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/559","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Ceftazidime","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Ceftazidime","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Ceftazidime","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T02:10:06.231567","_validation":{"fieldsValidated":8,"lastValidatedAt":"2026-04-21T10:57:22.116336+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"cefotaxime","drugSlug":"cefotaxime","fdaApproval":"1981-03-11","genericCount":10,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ceftriaxone","drugSlug":"ceftriaxone","fdaApproval":"1984-12-21","genericCount":26,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"cefmenoxime","drugSlug":"cefmenoxime","fdaApproval":"1987-12-30","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"latamoxef","drugSlug":"latamoxef","fdaApproval":"","relationship":"same-class"},{"drugName":"ceftizoxime","drugSlug":"ceftizoxime","fdaApproval":"1983-09-15","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"cefixime","drugSlug":"cefixime","fdaApproval":"1989-04-28","patentExpiry":"Dec 14, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"cefpiramide","drugSlug":"cefpiramide","fdaApproval":"1989-01-31","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"cefoperazone","drugSlug":"cefoperazone","fdaApproval":"1982-11-18","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"cefpodoxime proxetil","drugSlug":"cefpodoxime-proxetil","fdaApproval":"1992-08-07","genericCount":7,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ceftibuten","drugSlug":"ceftibuten","fdaApproval":"1995-12-20","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"cefdinir","drugSlug":"cefdinir","fdaApproval":"1997-12-04","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"cefditoren pivoxil","drugSlug":"cefditoren-pivoxil","fdaApproval":"2001-08-29","patentStatus":"Unknown","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"ceftazidime","indications":{"approved":[{"name":"Bacterial infection due to Klebsiella pneumoniae","source":"DrugCentral","snomedId":186435004,"regulator":"FDA"},{"name":"Bacterial meningitis","source":"DrugCentral","snomedId":95883001,"regulator":"FDA","eligibility":"Adults and children with normal renal function"},{"name":"Bacterial pneumonia","source":"DrugCentral","snomedId":53084003,"regulator":"FDA","eligibility":"Adults and children with normal renal function"},{"name":"Bacterial septicemia","source":"DrugCentral","snomedId":10001005,"regulator":"FDA"},{"name":"Bacterial urinary infection","source":"DrugCentral","snomedId":312124009,"regulator":"FDA","eligibility":"Adults and children with normal renal function"},{"name":"Citrobacter Pneumonia","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Adults and children with normal renal function"},{"name":"Complicated Proteus UTI","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Adults and children with normal renal function"},{"name":"Complicated UTI with Pseudomonas Aeruginosa","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Adults and children with normal renal function"},{"name":"E. Coli Cervicitis","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Adult women with normal renal function"},{"name":"E. Coli Endometritis","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Adult women with normal renal function"},{"name":"E. Coli Gynecological Infections","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"E. Coli Pelvic Cellulitis","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"E. Coli Pelvic Inflammatory Disease","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"E. Coli Peritonitis","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Ecthyma gangrenosum","source":"DrugCentral","snomedId":17732003,"regulator":"FDA"},{"name":"Endometritis","source":"DrugCentral","snomedId":78623009,"regulator":"FDA"},{"name":"Enterobacter Osteomyelitis","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Enterobacter Pneumonia","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"EnterobacterJoint Infection","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Escherichia coli urinary tract infection","source":"DrugCentral","snomedId":301011002,"regulator":"FDA"},{"name":"Gonococcal meningitis","source":"DrugCentral","snomedId":151004,"regulator":"FDA"},{"name":"H. Influenzae Meningitis","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Haemophilus Septicemia","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Haemophilus influenzae pneumonia","source":"DrugCentral","snomedId":70036007,"regulator":"FDA"},{"name":"Infection due to Enterobacteriaceae","source":"DrugCentral","snomedId":128945009,"regulator":"FDA"},{"name":"Infection due to Escherichia coli","source":"DrugCentral","snomedId":71057007,"regulator":"FDA"},{"name":"Infection due to Staphylococcus aureus","source":"DrugCentral","snomedId":406602003,"regulator":"FDA"},{"name":"Infection of bone","source":"DrugCentral","snomedId":111253001,"regulator":"FDA"},{"name":"Infection of skin AND/OR subcutaneous tissue","source":"DrugCentral","snomedId":19824006,"regulator":"FDA"},{"name":"Infectious disease of abdomen","source":"DrugCentral","snomedId":128070006,"regulator":"FDA"},{"name":"Infectious disorder of joint","source":"DrugCentral","snomedId":363162000,"regulator":"FDA"},{"name":"Inflammatory Disease of Female Pelvic Organs","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Klebsiella Joint Infection","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Klebsiella Pneumoniae Osteomyelitis","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Klebsiella Pneumoniae Peritonitis","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Klebsiella cystitis","source":"DrugCentral","snomedId":60867007,"regulator":"FDA"},{"name":"Lower respiratory tract infection","source":"DrugCentral","snomedId":50417007,"regulator":"FDA"},{"name":"Meningococcal meningitis","source":"DrugCentral","snomedId":192644005,"regulator":"FDA"},{"name":"Neonatal meningitis","source":"DrugCentral","snomedId":276674008,"regulator":"FDA"},{"name":"Osteomyelitis due to Staphylococcus aureus","source":"DrugCentral","snomedId":428783003,"regulator":"FDA"},{"name":"Peritonitis","source":"DrugCentral","snomedId":48661000,"regulator":"FDA"},{"name":"Pneumonia due to Escherichia coli","source":"DrugCentral","snomedId":51530003,"regulator":"FDA"},{"name":"Pneumonia due to Pseudomonas","source":"DrugCentral","snomedId":41381004,"regulator":"FDA"},{"name":"Pneumonia due to Streptococcus","source":"DrugCentral","snomedId":34020007,"regulator":"FDA"},{"name":"Proteus pneumonia","source":"DrugCentral","snomedId":195888009,"regulator":"FDA"},{"name":"Proteus urinary tract infection","source":"DrugCentral","snomedId":301012009,"regulator":"FDA"},{"name":"Pseudomonas Aeruginosa Joint Infection","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Pseudomonas Aeruginosa Osteomyelitis","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Pseudomonas Aeruginosa Urinary Tract Infection","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Rhinoscleroma","source":"DrugCentral","snomedId":72409005,"regulator":"FDA"},{"name":"Sepsis due to Pseudomonas","source":"DrugCentral","snomedId":448813005,"regulator":"FDA"},{"name":"Sepsis due to Staphylococcus aureus","source":"DrugCentral","snomedId":448417001,"regulator":"FDA"},{"name":"Septicemia due to Escherichia coli","source":"DrugCentral","snomedId":9323009,"regulator":"FDA"},{"name":"Septicemia due to Serratia","source":"DrugCentral","snomedId":82091000,"regulator":"FDA"},{"name":"Skin and Skin Structure Proteus Infection","source":"DrugCentral","snomedId":"","regulator":"FDA","usPrevalence":null,"globalPrevalence":251400000,"prevalenceMethod":"curated","prevalenceSource":"Pathogens, 2024 (PMID:39452777)"},{"name":"Skin and Skin Structure Pseudomonas Aeruginosa Infection","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Skin and Skin Structure Serratia Infection","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Staphylococcal pneumonia","source":"DrugCentral","snomedId":22754005,"regulator":"FDA"},{"name":"Staphylococcus Aureus Joint Infection","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Staphylococcus Peritonitis","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Streptococcal septicemia","source":"DrugCentral","snomedId":29577008,"regulator":"FDA"},{"name":"Streptococcus pyogenes infection","source":"DrugCentral","snomedId":302809008,"regulator":"FDA"},{"name":"Urinary tract infection caused by Klebsiella","source":"DrugCentral","snomedId":369001000119100,"regulator":"FDA"}],"offLabel":[{"name":"Diabetic Foot Infection","source":"DrugCentral","drugName":"Ceftazidime","evidenceCount":43,"evidenceLevel":"moderate"},{"name":"Infection by Yersinia enterocolitica","source":"DrugCentral","drugName":"Ceftazidime","evidenceCount":34,"evidenceLevel":"moderate"},{"name":"Melioidosis","source":"DrugCentral","drugName":"Ceftazidime","evidenceCount":402,"evidenceLevel":"strong"},{"name":"Pseudomonas Respiratory Tract Infection in Cystic Fibrosis","source":"DrugCentral","drugName":"Ceftazidime","evidenceCount":89,"evidenceLevel":"strong"},{"name":"Pseudotuberculosis","source":"DrugCentral","drugName":"Ceftazidime","evidenceCount":4,"evidenceLevel":"emerging"},{"name":"Pyrexia of unknown origin","source":"DrugCentral","drugName":"Ceftazidime","evidenceCount":64,"evidenceLevel":"strong"},{"name":"Ventilator-acquired pneumonia","source":"DrugCentral","drugName":"Ceftazidime","evidenceCount":215,"evidenceLevel":"strong"}],"pipeline":[]},"currentOwner":"Pai Holdings Pharm","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"cefotaxime","brandName":"cefotaxime","genericName":"cefotaxime","approvalYear":"1981","relationship":"same-class"},{"drugId":"ceftriaxone","brandName":"ceftriaxone","genericName":"ceftriaxone","approvalYear":"1984","relationship":"same-class"},{"drugId":"cefmenoxime","brandName":"cefmenoxime","genericName":"cefmenoxime","approvalYear":"1987","relationship":"same-class"},{"drugId":"latamoxef","brandName":"latamoxef","genericName":"latamoxef","approvalYear":"","relationship":"same-class"},{"drugId":"ceftizoxime","brandName":"ceftizoxime","genericName":"ceftizoxime","approvalYear":"1983","relationship":"same-class"},{"drugId":"cefixime","brandName":"cefixime","genericName":"cefixime","approvalYear":"1989","relationship":"same-class"},{"drugId":"cefpiramide","brandName":"cefpiramide","genericName":"cefpiramide","approvalYear":"1989","relationship":"same-class"},{"drugId":"cefoperazone","brandName":"cefoperazone","genericName":"cefoperazone","approvalYear":"1982","relationship":"same-class"},{"drugId":"cefpodoxime-proxetil","brandName":"cefpodoxime proxetil","genericName":"cefpodoxime proxetil","approvalYear":"1992","relationship":"same-class"},{"drugId":"ceftibuten","brandName":"ceftibuten","genericName":"ceftibuten","approvalYear":"1995","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07494981","phase":"","title":"Individualized Precision Therapy With Ceftazidime and Avibactam Guided by PK/PD in Geriatric Populations","status":"NOT_YET_RECRUITING","sponsor":"Chinese PLA General Hospital","startDate":"2026-03-25","conditions":["Ceftazidime-avibactam"],"enrollment":150,"completionDate":"2030-12-31"},{"nctId":"NCT04948463","phase":"PHASE4","title":"Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia","status":"COMPLETED","sponsor":"Murdoch Childrens Research Institute","startDate":"2021-11-15","conditions":["Febrile Neutropenia"],"enrollment":55,"completionDate":"2025-12-17"},{"nctId":"NCT06406114","phase":"PHASE2","title":"Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing","status":"RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2025-05-05","conditions":["Drug Allergy","Cephalosporin Allergy","Drug Hypersensitivity","Antibiotic Allergy","Beta Lactam Adverse Reaction","Drug-Induced Anaphylaxis","Cephalosporin Reaction"],"enrollment":300,"completionDate":"2028-12-31"},{"nctId":"NCT07478484","phase":"PHASE4","title":"Different Administration Regimens of CAZ-AVI in Combination With ATM for the Treatment of CR-GNB","status":"RECRUITING","sponsor":"Jing Zhou","startDate":"2026-03-31","conditions":["Ceftazidime-avibactam","Aztreonam","Gram-negative Bacterial Infection","Metallo-β-lactamase-producing","Carbapenem-resistant"],"enrollment":144,"completionDate":"2028-01-31"},{"nctId":"NCT04961580","phase":"","title":"PK/PD of Ceftazidime Avitbatan Sodium in Children With Severe Infection","status":"RECRUITING","sponsor":"Children's Hospital of Fudan University","startDate":"2022-10-01","conditions":["Sepsis","Antibiotic Reaction"],"enrollment":30,"completionDate":"2026-12-31"},{"nctId":"NCT07431307","phase":"PHASE2","title":"Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex","status":"NOT_YET_RECRUITING","sponsor":"BioVersys AG","startDate":"2026-07","conditions":["Ventilator Associated Bacterial Pneumonia (VABP)","Hospital Acquired Bacterial Pneumonia (HABP)","Blood Stream Infection","Meningitis, Bacterial","Ventriculitis, Infectious"],"enrollment":120,"completionDate":"2028-07"},{"nctId":"NCT07327619","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP","status":"RECRUITING","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2026-01-22","conditions":["Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia"],"enrollment":420,"completionDate":"2028-10"},{"nctId":"NCT07311343","phase":"PHASE4","title":"Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia","status":"RECRUITING","sponsor":"Beijing Tiantan Hospital","startDate":"2026-01-07","conditions":["Hemorrhage","Pneumonia"],"enrollment":440,"completionDate":"2027-10-31"},{"nctId":"NCT07369518","phase":"","title":"Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae","status":"NOT_YET_RECRUITING","sponsor":"Sohag University","startDate":"2026-01","conditions":["ISOLATION OF KLEB. by Culture on macConkey Agar","Antibiotic Sensitivity Testing of Different Antibiotics According to Clsi 25","Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae","Detection of Resistance Gene in Isolates Using Conventional Pcr","Detection of Some Virulence Genes Using Conventional Pcr"],"enrollment":100,"completionDate":"2026-12"},{"nctId":"NCT07318584","phase":"PHASE2","title":"Cefotetan Therapy for Escherichia Coli Infections","status":"NOT_YET_RECRUITING","sponsor":"Oregon Health and Science University","startDate":"2026-03","conditions":["E Coli Infection","ESBL Producing E.Coli"],"enrollment":84,"completionDate":"2028-08"},{"nctId":"NCT06717594","phase":"","title":"PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE","status":"RECRUITING","sponsor":"IRCCS Azienda Ospedaliero-Universitaria di Bologna","startDate":"2023-12-01","conditions":["Gram Negative Infections","Antimicrobial Resistance (AMR)"],"enrollment":60,"completionDate":"2026-04-30"},{"nctId":"NCT07085624","phase":"NA","title":"Early Optimization of Ceftazidime Regimen in Critical Care","status":"NOT_YET_RECRUITING","sponsor":"Centre Hospitalier Universitaire de Saint Etienne","startDate":"2026-01","conditions":["Infection in ICU","Sepsis","Septic Shock","Pseudomonas Aeruginosa Infection"],"enrollment":128,"completionDate":"2026-11"},{"nctId":"NCT01543334","phase":"","title":"Antibiotic Concentrations Among Critically Ill Patients","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Nīmes","startDate":"2012-03","conditions":["Administration of Antibiotics in Intensive Care Units"],"enrollment":98,"completionDate":"2012-04-01"},{"nctId":"NCT06864585","phase":"","title":"A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan","status":"NOT_YET_RECRUITING","sponsor":"Pfizer","startDate":"2026-03-15","conditions":["Infectious Diseases"],"enrollment":59,"completionDate":"2029-03-30"},{"nctId":"NCT07204522","phase":"","title":"Efficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients.","status":"RECRUITING","sponsor":"Shanxi Bethune Hospital","startDate":"2025-09-22","conditions":["Febrile Neutropenia"],"enrollment":20,"completionDate":"2027-09-22"},{"nctId":"NCT07063095","phase":"PHASE3","title":"A Combination Therapy With Ceftazidime and Fosfomycin Will be Compared to Ceftazidime Alone in Hospitalized Adult Patients With Suspected Severe Gram-negative Bacterial Infections","status":"RECRUITING","sponsor":"Angela HUTTNER","startDate":"2025-08-25","conditions":["Gram Negative Infections","Sepsis and Septic Shock"],"enrollment":100,"completionDate":"2026-12"},{"nctId":"NCT07160569","phase":"","title":"Microbiological and Clinical Characteristics of Severe Infections Caused by Carbapenem-Resistant Enterobacterales","status":"NOT_YET_RECRUITING","sponsor":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","startDate":"2025-09-01","conditions":["Carbapenem-Resistant Enterobacteriaceae Infection"],"enrollment":100,"completionDate":"2026-08-31"},{"nctId":"NCT05487586","phase":"","title":"Real-World Study of Ceftazidime Avibactam in China","status":"TERMINATED","sponsor":"Pfizer","startDate":"2022-10-20","conditions":["Hospital Acquired Pneumonia","Ventilator Acquired Pneumonia","Complicated Intra Abdominal Infections"],"enrollment":220,"completionDate":"2024-07-11"},{"nctId":"NCT05733104","phase":"","title":"A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea","status":"RECRUITING","sponsor":"Pfizer","startDate":"2024-02-19","conditions":["Complicated Intra-abdominal Infection","Complicated Urinary Tract Infection","Hospital-acquired Pneumonia"],"enrollment":600,"completionDate":"2029-09-28"},{"nctId":"NCT05977868","phase":"PHASE4","title":"Comparing Oral Versus Parenteral Antimicrobial Therapy","status":"TERMINATED","sponsor":"West Virginia University","startDate":"2023-08-04","conditions":["Endovascular Infection","Bone and Joint Infection","Skin and Soft Tissue Infection","Pulmonary Infection","Gastrointestinal Infection","Genitourinary Infection"],"enrollment":94,"completionDate":"2025-02-14"},{"nctId":"NCT07016165","phase":"PHASE4","title":"Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies","status":"RECRUITING","sponsor":"Gadjah Mada University","startDate":"2025-06-01","conditions":["Neutropenic Fever","Acute Lymphoblastic Leukemia","Acute Myeloblastic Leukemia","Non Hodgkin Lymphoma"],"enrollment":120,"completionDate":"2025-12-31"},{"nctId":"NCT05413343","phase":"","title":"Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"First Affiliated Hospital of Zhejiang University","startDate":"2021-06-01","conditions":["Severe Sepsis"],"enrollment":30,"completionDate":"2025-10-31"},{"nctId":"NCT07089186","phase":"PHASE3","title":"Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections","status":"RECRUITING","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2025-04-12","conditions":["Hospital-acquired Bacterial Pneumonia (HABP)","Ventilator-associated Bacterial Pneumonia (VABP)","Complicated Intra-abdominal Infection (cIAI)","Complicated Urinary Tract Infection (cUTI)","Bloodstream Infection (BSI)"],"enrollment":80,"completionDate":"2027-04"},{"nctId":"NCT06112938","phase":"","title":"Alternative Treatment Strategies for Stenotrophomonas Maltophilia Pneumonia","status":"COMPLETED","sponsor":"Methodist Health System","startDate":"2022-07-21","conditions":["Stenotrophomonas Maltophilia Infection"],"enrollment":110,"completionDate":"2025-07-14"},{"nctId":"NCT06368804","phase":"PHASE2","title":"Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis","status":"RECRUITING","sponsor":"Centre Hospitalier Intercommunal Creteil","startDate":"2024-09-15","conditions":["Bronchiectasis"],"enrollment":196,"completionDate":"2028-09-15"},{"nctId":"NCT07026253","phase":"","title":"Comparative Analysis of Delirium in Older Adults Treated With Ceftazidime, Cefepime, or Ceftriaxone","status":"RECRUITING","sponsor":"Alexandria University","startDate":"2024-10-01","conditions":["Delirium"],"enrollment":120,"completionDate":"2025-12"},{"nctId":"NCT07004049","phase":"PHASE4","title":"Optimising TREATment for Severe Gram-Negative Bacterial Infections","status":"RECRUITING","sponsor":"National University of Singapore","startDate":"2025-04-21","conditions":["Bloodstream Infection","Ventilator Associated Bacterial Pneumonia","Hospital Acquired Bacterial Pneumonia","Carbapenem Resistant Bacterial Infection","Multidrug Resistance"],"enrollment":600,"completionDate":"2028-12-31"},{"nctId":"NCT06992102","phase":"","title":"Clinical Study on the Treatment of Lower Respiratory Tract Infection With Pseudomonas Aeruginosa by Ceftazidime and Avibatam","status":"COMPLETED","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2022-01-01","conditions":["MDRPA"],"enrollment":500,"completionDate":"2025-01-01"},{"nctId":"NCT03790631","phase":"","title":"The OPTIMAL TDM Study: Determining Optimal Beta-lactam Plasma Concentrations Through Therapeutic Drug Monitoring","status":"COMPLETED","sponsor":"University of Geneva, Switzerland","startDate":"2019-01-14","conditions":["Beta-lactam Antibiotics","Therapeutic Drug Monitoring","Toxicity","Efficacy","Imipenem","Meropenem","Piperacillin","Flucloxacillin","Amoxicillin","Ceftazidime","Cefepime"],"enrollment":771,"completionDate":"2023-12-31"},{"nctId":"NCT06051513","phase":"NA","title":"Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection","status":"RECRUITING","sponsor":"Southeast University, China","startDate":"2023-11-27","conditions":["Carbapenem-Resistant Enterobacteriaceae Infection"],"enrollment":404,"completionDate":"2025-12-31"},{"nctId":"NCT06967376","phase":"EARLY_PHASE1","title":"The Role of Adjuvant Corneal Crosslinking in the Management of Infective Keratitis","status":"COMPLETED","sponsor":"Research Institute of Ophthalmology, Egypt","startDate":"2018-05-21","conditions":["Infective Keratitis"],"enrollment":40,"completionDate":"2022-02-03"},{"nctId":"NCT06939829","phase":"PHASE4","title":"A Multicenter Clinical Study on the Continuous vs. Intermittent Infusion of Ceftazidime-Avibactam in Critically Ill Patients With Severe Infections","status":"NOT_YET_RECRUITING","sponsor":"Southeast University, China","startDate":"2025-05-01","conditions":["Patients With Critically Ill Infections"],"enrollment":1200,"completionDate":"2027-12-31"},{"nctId":"NCT06811727","phase":"PHASE4","title":"CONTinuous Infusion Versus Intermittent Dosing of ceftaZidime/AVIbactam in Critically Ill Patients","status":"NOT_YET_RECRUITING","sponsor":"Ivan Šitum, MD","startDate":"2025-05-01","conditions":["Severe Infection"],"enrollment":140,"completionDate":"2027-08-01"},{"nctId":"NCT02526004","phase":"NA","title":"Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results Stratified","status":"COMPLETED","sponsor":"University College Cork","startDate":"2013-10-01","conditions":["Cystic Fibrosis"],"enrollment":223,"completionDate":"2018-06-30"},{"nctId":"NCT04077996","phase":"NA","title":"Treatment of Peritonitis in Automated Peritoneal Dialysis","status":"COMPLETED","sponsor":"Universidad de Colima","startDate":"2019-07-01","conditions":["Secondary Peritonitis"],"enrollment":64,"completionDate":"2022-08-30"},{"nctId":"NCT04278404","phase":"","title":"Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","status":"RECRUITING","sponsor":"Duke University","startDate":"2020-03-05","conditions":["Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Primary Hyperaldosteronism","Edema","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","Down Syndrome"],"enrollment":5000,"completionDate":"2027-09"},{"nctId":"NCT06818565","phase":"NA","title":"Comparison of Efficacy and Safety of Ceftazidime Avibactam Versus Extended Infusions of High Dose Meropenem in Patients of ACLF With Nosocomial Infections.","status":"NOT_YET_RECRUITING","sponsor":"Institute of Liver and Biliary Sciences, India","startDate":"2025-02-10","conditions":["Acute-On-Chronic Liver Failure"],"enrollment":150,"completionDate":"2026-12-31"},{"nctId":"NCT06044272","phase":"","title":"Antimicrobial Resistance in Hospitals From Meta, Colombia","status":"COMPLETED","sponsor":"Hospital Departamental de Villavicencio","startDate":"2023-09-01","conditions":["Increased Drug Resistance"],"enrollment":10000,"completionDate":"2024-06-30"},{"nctId":"NCT06729619","phase":"","title":"Concentration Monitoring of Anti-infective Drugs in Human Cerebrospinal Fluid and Its Clinical Application","status":"ACTIVE_NOT_RECRUITING","sponsor":"Xueyan Cui","startDate":"2024-06-03","conditions":["Intracranial Infection","Central Infection"],"enrollment":200,"completionDate":"2027-12-31"},{"nctId":"NCT06419296","phase":"","title":"Mortality of MBL-producing Enterobacteriaceae Bacteremias with the Combined Use of Ceftazidime-avibactam and Aztreonam Vs. Other Active Antibiotics. a Multicenter Target Trial Emulation.","status":"COMPLETED","sponsor":"Hospital Italiano de Buenos Aires","startDate":"2024-06-01","conditions":["Bacteremia"],"enrollment":265,"completionDate":"2024-11-19"},{"nctId":"NCT04882085","phase":"PHASE4","title":"Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults","status":"COMPLETED","sponsor":"Pfizer","startDate":"2021-08-26","conditions":["Urinary Tract Infection","Acute Pyelonephritis","Hospital Acquired Pneumonia","Ventilator-associated Pneumonia","Bacteremia","Intra-abdominal Infection"],"enrollment":60,"completionDate":"2023-08-31"},{"nctId":"NCT06651047","phase":"","title":"PK/PD Analysis of Ceftazidime/Avibactam or Cefiderocol With or Without Fosfomycin for the Treatment of Difficult To-treat Gram-negative Infections","status":"RECRUITING","sponsor":"University of Bologna","startDate":"2024-07-09","conditions":["Gram Negative Infection","Antimicrobial Resistance (AMR)"],"enrollment":120,"completionDate":"2025-09-30"},{"nctId":"NCT06633718","phase":"PHASE3","title":"Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI","status":"NOT_YET_RECRUITING","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2024-10-31","conditions":["Intra-abdominal Infections"],"enrollment":786,"completionDate":"2027-05-30"},{"nctId":"NCT04774094","phase":"PHASE4","title":"Efficacy and Safety of Ceftazidime-Avibactam (CAZ-AVI) in Chinese Participants With HAP (Including VAP)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2021-05-21","conditions":["Hospital-Acquired Pneumonia"],"enrollment":235,"completionDate":"2023-05-04"},{"nctId":"NCT04785924","phase":"PHASE4","title":"Imipenem/Cilastatin/Relebactam (IMI/REL) in Treatment of CRE Infections","status":"WITHDRAWN","sponsor":"Wake Forest University Health Sciences","startDate":"2021-06-07","conditions":["Carbapenem-Resistant Enterobacteriaceae Infection","KPC","Gram-Negative Bacterial Infections","Antibiotic Resistant Infection"],"enrollment":0,"completionDate":"2023-01-12"},{"nctId":"NCT04628572","phase":"","title":"Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections","status":"COMPLETED","sponsor":"Pfizer","startDate":"2021-01-29","conditions":["Gram Negative Infections"],"enrollment":189,"completionDate":"2022-03-11"},{"nctId":"NCT06539663","phase":"PHASE2,PHASE3","title":"The Role of OmniLenz® in the Treatment of Small Corneal Perforations Secondary to Exposure Keratitis in ICU Patients","status":"COMPLETED","sponsor":"Farwaniya Hospital","startDate":"2022-04-10","conditions":["Corneal Perforation","Exposure Keratitis","Infectious Keratitis"],"enrollment":5,"completionDate":"2024-04-10"},{"nctId":"NCT06528028","phase":"PHASE4","title":"Relationship Between Different Administration Regimens of Ceftazidime/Avibactam and Clinical Outcomes","status":"RECRUITING","sponsor":"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","startDate":"2024-07-01","conditions":["Anti-Infective Agent"],"enrollment":140,"completionDate":"2025-07-30"},{"nctId":"NCT05786495","phase":"NA","title":"Short Antibiotic Treatment in High Risk Febrile Neutropenia","status":"RECRUITING","sponsor":"University Health Network, Toronto","startDate":"2023-10-01","conditions":["Febrile Neutropenia"],"enrollment":80,"completionDate":"2026-02-28"},{"nctId":"NCT05566665","phase":"","title":"Nosocomial Infections in ECMO Patients","status":"RECRUITING","sponsor":"Policlinico Hospital","startDate":"2023-01-01","conditions":["Acute Respiratory Distress Syndrome","Nosocomial Infection","Extracorporeal Membrane Oxygenation Complication"],"enrollment":200,"completionDate":"2026-12-31"},{"nctId":"NCT03923426","phase":"","title":"Real-World Observational Study Of Zavicefta to Characterize Use Patterns","status":"COMPLETED","sponsor":"Pfizer","startDate":"2018-11-27","conditions":["Infection"],"enrollment":572,"completionDate":"2022-03-28"},{"nctId":"NCT05048693","phase":"","title":"Use of New Antibiotics in Sweden","status":"COMPLETED","sponsor":"Uppsala University","startDate":"2021-11-01","conditions":["Multi-antibiotic Resistance"],"enrollment":41,"completionDate":"2023-12-30"},{"nctId":"NCT05258851","phase":"PHASE3","title":"Ceftazidime-Avibactam Use in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections","status":"TERMINATED","sponsor":"King Faisal Specialist Hospital & Research Center","startDate":"2022-06-01","conditions":["Carbapenem-Resistant Enterobacteriaceae Infection"],"enrollment":29,"completionDate":"2024-01-28"},{"nctId":"NCT06422533","phase":"NA","title":"Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia in Hemato-oncological Patients","status":"RECRUITING","sponsor":"Instituto Nacional de Cancerologia de Mexico","startDate":"2023-11-07","conditions":["Hematologic Neoplasms","Neutropenia"],"enrollment":226,"completionDate":"2025-08-30"},{"nctId":"NCT04192994","phase":"NA","title":"Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis","status":"COMPLETED","sponsor":"Federal University of São Paulo","startDate":"2019-01-01","conditions":["Endophthalmitis"],"enrollment":25,"completionDate":"2023-12-01"},{"nctId":"NCT04319328","phase":"","title":"Is Cefazolin, Ceftazidime and Ciprofloxacin Dosing Optimal in Hemodialysis Patients?","status":"COMPLETED","sponsor":"University of Manitoba","startDate":"2019-10-18","conditions":["Hemodialysis Complication","Infectious Disease","End Stage Renal Disease"],"enrollment":40,"completionDate":"2024-04-30"},{"nctId":"NCT04126031","phase":"PHASE2","title":"Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.","status":"TERMINATED","sponsor":"Pfizer","startDate":"2020-01-14","conditions":["Gram-negative Bacterial Infection"],"enrollment":48,"completionDate":"2022-12-30"},{"nctId":"NCT04927312","phase":"PHASE3","title":"Study to Assess Efficacy and Safety of PF-06947386 in Japanese Adult Patients With Complicated Intra-abdominal Infection","status":"COMPLETED","sponsor":"Pfizer","startDate":"2021-10-01","conditions":["Complicated Intra-abdominal Infection"],"enrollment":60,"completionDate":"2022-09-15"},{"nctId":"NCT05926063","phase":"PHASE4","title":"Stopping Antibiotics After 3 Days for the Treatment of High-risk FEbrile Neutropenia","status":"RECRUITING","sponsor":"Universitaire Ziekenhuizen KU Leuven","startDate":"2024-02-26","conditions":["Neutropenia, Febrile"],"enrollment":410,"completionDate":"2026-07"},{"nctId":"NCT05979545","phase":"PHASE4","title":"EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics","status":"RECRUITING","sponsor":"National University of Singapore","startDate":"2023-12-12","conditions":["Blood Stream Infections","Ventilator Associated Pneumonia","Healthcare Associated Infection","Carbapenem-Resistant Enterobacteriaceae Infection","Hospital-acquired Pneumonia"],"enrollment":1900,"completionDate":"2026-12-31"},{"nctId":"NCT01785641","phase":"NA","title":"Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients","status":"COMPLETED","sponsor":"Chulalongkorn University","startDate":"2012-12","conditions":["Peritonitis"],"enrollment":300,"completionDate":"2013-12"},{"nctId":"NCT05105035","phase":"PHASE2","title":"Oral ARV-1801 Given in Combination With Intravenous Ceftazidime or Meropenem for Treatment of Melioidosis in Hospitalized Patients","status":"COMPLETED","sponsor":"Arrevus Inc.","startDate":"2022-06-14","conditions":["Melioidosis"],"enrollment":125,"completionDate":"2023-10-10"},{"nctId":"NCT03897582","phase":"","title":"Beta-Lactams Dosing In Pneumonia in ICU in Patients Treated by Continuous Renal Replacement Therapy: the BLIPIC Study","status":"RECRUITING","sponsor":"Centre Hospitalier de Valenciennes","startDate":"2019-02-22","conditions":["Beta-lactam","Continuous Renal Replacement Therapy","Pneumonia","Antibiotic"],"enrollment":65,"completionDate":"2026-05-31"},{"nctId":"NCT05971537","phase":"PHASE4","title":"Clinical Trial on Antibiotic-Lock in Tenckhoff Catheter for Relasping and Repeat Peritonitis","status":"RECRUITING","sponsor":"Alice Ho Miu Ling Nethersole Hospital","startDate":"2023-06-15","conditions":["Peritoneal Dialysis-associated Peritonitis"],"enrollment":46,"completionDate":"2026-10"},{"nctId":"NCT05655689","phase":"","title":"The Antibiogram and Outcomes of Antimicrobial Regimens in Microbial Keratitis: A Prospective Cohort Study","status":"COMPLETED","sponsor":"Alexandria University","startDate":"2021-12-31","conditions":["Bacterial Keratitis","Fungal Keratitis","Mixed Bacterial and Fungal Keratitis","Microbial Keratitis"],"enrollment":123,"completionDate":"2023-01-01"},{"nctId":"NCT06210542","phase":"","title":"Precise Treatment of Ceftazidime-Avibactam in Patients With CRO Infections Under the Guidance of TDM and PPK Model","status":"NOT_YET_RECRUITING","sponsor":"Sichuan Provincial People's Hospital","startDate":"2024-01","conditions":["ECMO","Carbapenem-Resistant Enterobacteriaceae Infection"],"enrollment":50,"completionDate":"2026-12"},{"nctId":"NCT04033029","phase":"","title":"Antibiotic Plasma Concentrations During Continuous Renal Replacement Therapy With a High Adsorption Membrane (oXiris®)","status":"COMPLETED","sponsor":"Hospital Universitari de Bellvitge","startDate":"2021-01-01","conditions":["Hemodiafiltration","Sepsis","Acute Kidney Injury"],"enrollment":20,"completionDate":"2023-06-30"},{"nctId":"NCT05862402","phase":"PHASE4","title":"Dose Optimization by Pharmacokinetic/Pharmacodynamic of Antibiotics to Improve Clinical Outcome of Carbapenem Resistant Klebsiella Pneumoniae Bloodstream Infections in Critically Ill Patients at Phramongkutklao Hospital","status":"UNKNOWN","sponsor":"Phramongkutklao College of Medicine and Hospital","startDate":"2023-05-07","conditions":["Carbapenem Resistant Klebsiella Pneumoniae"],"enrollment":76,"completionDate":"2024-06-30"},{"nctId":"NCT03439124","phase":"PHASE3","title":"Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia","status":"COMPLETED","sponsor":"Basilea Pharmaceutica","startDate":"2017-11-27","conditions":["Community-acquired Pneumonia (CAP)","Hospital-acquired Pneumonia (HAP)"],"enrollment":138,"completionDate":"2020-03-16"},{"nctId":"NCT04035369","phase":"NA","title":"Endophthalmitis Post Intravitreal Injections","status":"UNKNOWN","sponsor":"Unity Health Toronto","startDate":"2020-03-01","conditions":["Endophthalmitis"],"enrollment":310,"completionDate":"2024-07"},{"nctId":"NCT05850871","phase":"NA","title":"Drug Resistance Mechanism of Enterobacteriaceae and Its Strategies","status":"UNKNOWN","sponsor":"Qianfoshan Hospital","startDate":"2023-01-06","conditions":["Carbapenem-Resistant Enterobacteriaceae Infection"],"enrollment":427,"completionDate":"2025-01-31"},{"nctId":"NCT03147807","phase":"NA","title":"BetaLACTA® Test for Early De-escalation of Empirical Carbapenems in Pulmonary, Urinary and Bloodstream Infections in ICU","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2017-10-20","conditions":["Pneumonia","Urinary Tract Infections","Bloodstream Infection"],"enrollment":75,"completionDate":"2019-10-20"},{"nctId":"NCT03909698","phase":"","title":"Antibiotic Dosing in Patients on Intermittent Hemodialysis","status":"COMPLETED","sponsor":"University Hospital, Ghent","startDate":"2016-09-15","conditions":["Kidney Failure, Chronic","Antibiotics","Hemodialysis"],"enrollment":150,"completionDate":"2022-03-31"},{"nctId":"NCT03881800","phase":"","title":"Ceftazidime in Burn Children","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2020-02-19","conditions":["Burned Children","Ceftazidime Treatment"],"enrollment":3,"completionDate":"2020-11-11"},{"nctId":"NCT04040621","phase":"PHASE1","title":"Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia","status":"TERMINATED","sponsor":"Pfizer","startDate":"2020-06-15","conditions":["Hospitalized Children With Suspected or Confirmed Nosocomial Pneumonia"],"enrollment":4,"completionDate":"2021-05-07"},{"nctId":"NCT03978091","phase":"PHASE1,PHASE2","title":"A Trial to Evaluate the Pharmacokinetics and Safety of AVYCAZ(R) in Combination With Aztreonam","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2019-07-09","conditions":["Bacterial Infection"],"enrollment":48,"completionDate":"2020-11-23"},{"nctId":"NCT02840136","phase":"NA","title":"LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients","status":"TERMINATED","sponsor":"University Ghent","startDate":"2016-02","conditions":["Cystic Fibrosis"],"enrollment":40,"completionDate":"2017-09-01"},{"nctId":"NCT02287493","phase":"","title":"Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)","status":"COMPLETED","sponsor":"Universitätsklinikum Hamburg-Eppendorf","startDate":"2013-07","conditions":["Replacement Therapy, Renal"],"enrollment":35,"completionDate":"2016-12"},{"nctId":"NCT03790176","phase":"PHASE1","title":"ZAVI APD ELF Protocol v2.2","status":"UNKNOWN","sponsor":"Markus Zeitlinger","startDate":"2018-10-01","conditions":["Peritonitis","Pneumonia"],"enrollment":20,"completionDate":"2022-12"},{"nctId":"NCT04167228","phase":"","title":"Impact of Ceftazidime / Avibactam Treatment vs Better Available Therapy on Mortality of Patients With Infections Caused by Carbapenem-resistant Enterobacteria","status":"COMPLETED","sponsor":"Maimónides Biomedical Research Institute of Córdoba","startDate":"2019-10-01","conditions":["Carbapenem-Resistant Enterobacteriaceae Infection"],"enrollment":348,"completionDate":"2021-05-05"},{"nctId":"NCT04879030","phase":"PHASE2,PHASE3","title":"Combination Antibiotic Therapy Compared to Monotherapy in the Treatment of Acute COPD","status":"COMPLETED","sponsor":"Haiphong University of Medicine and Pharmacy","startDate":"2020-01-01","conditions":["COPD Exacerbation Acute"],"enrollment":170,"completionDate":"2020-12-30"},{"nctId":"NCT04771884","phase":"","title":"Population Pharmacokinetics of Commonly Used Antimicrobial Agents in Children of Bacterial Meningitis With Augmented Renal Clearance","status":"UNKNOWN","sponsor":"Shandong University","startDate":"2020-10-01","conditions":["Bacterial Meningitis","Augmented Renal Clearance"],"enrollment":300,"completionDate":"2026-03-20"},{"nctId":"NCT02099240","phase":"EARLY_PHASE1","title":"Patients Response to Early Switch To Oral:Osteomyelitis Study","status":"TERMINATED","sponsor":"Julio Ramirez","startDate":"2014-03-06","conditions":["Osteomyelitis"],"enrollment":11,"completionDate":"2018-11-07"},{"nctId":"NCT04358991","phase":"","title":"Pharmacokinetics of Ceftazidime-avibactam Among Critically-ill Patients Receiving CVVHDF","status":"COMPLETED","sponsor":"University of Pittsburgh","startDate":"2017-01-01","conditions":["Bacterial Infections"],"enrollment":20,"completionDate":"2019-12-31"},{"nctId":"NCT02795949","phase":"PHASE3","title":"Study on Reduced Antibiotic Treatment vs Broad Spectrum Betalactam in Patients With Bacteremia by Enterobacteriaceae","status":"COMPLETED","sponsor":"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla","startDate":"2016-10","conditions":["Enterobacteriaceae Infections"],"enrollment":344,"completionDate":"2020-01"},{"nctId":"NCT03776409","phase":"","title":"Safety and Efficacy of Vancomycin Plus Beta-lactams","status":"COMPLETED","sponsor":"First Affiliated Hospital Xi'an Jiaotong University","startDate":"2018-12-12","conditions":["Critical Illness"],"enrollment":700,"completionDate":"2020-05-30"},{"nctId":"NCT04402359","phase":"","title":"Usage of Meropenem/Gentamicin Versus Ceftazidime/Avibactam in ARDS","status":"COMPLETED","sponsor":"King Abdul Aziz Specialist Hospital","startDate":"2018-07-05","conditions":["Ventilator Associated Pneumonia"],"enrollment":200,"completionDate":"2019-12-30"},{"nctId":"NCT03941951","phase":"NA","title":"Study to Optimize the Use of New Antibiotics","status":"UNKNOWN","sponsor":"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla","startDate":"2019-07-09","conditions":["Bacterial Infections","Fungal Infection"],"enrollment":900,"completionDate":"2022-12-31"},{"nctId":"NCT04367974","phase":"","title":"Clinical Pharmacokinetic Study of Ceftazidime and Cefazolin","status":"UNKNOWN","sponsor":"Fifth Affiliated Hospital, Sun Yat-Sen University","startDate":"2020-06-01","conditions":["CAPD-related Peritonitis"],"enrollment":20,"completionDate":"2022-05-01"},{"nctId":"NCT02787057","phase":"NA","title":"Vancomycin Plus Moxifloxacin Versus Vancomycin Plus Ceftazidime for the Treatment of Peritoneal Dialysis (PD)-Related Peritonitis","status":"COMPLETED","sponsor":"Peking University First Hospital","startDate":"2012-11","conditions":["Peritoneal Dialysis Associated Peritonitis"],"enrollment":80,"completionDate":"2016-04"},{"nctId":"NCT04187755","phase":"PHASE4","title":"Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever","status":"COMPLETED","sponsor":"Indonesia University","startDate":"2019-03-01","conditions":["Neutropenia, Febrile","Leukemia","Pediatric Cancer","Antibiotic Reaction"],"enrollment":72,"completionDate":"2019-07-31"},{"nctId":"NCT02593201","phase":"PHASE4","title":"The Efficacy of Prolonged Antibiotic Therapy for the Prevention of Relapsing Peritonitis in Peritoneal Dialysis Patients With High Dialysis Effluent Bacterial DNA Fragment Levels","status":"COMPLETED","sponsor":"Chinese University of Hong Kong","startDate":"2016-02-26","conditions":["Peritoneal Dialysis"],"enrollment":358,"completionDate":"2019-06-30"},{"nctId":"NCT02894684","phase":"PHASE4","title":"Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis","status":"COMPLETED","sponsor":"Liverpool Heart and Chest Hospital NHS Foundation Trust","startDate":"2017-01","conditions":["Cystic Fibrosis","Infection","Pseudomonas"],"enrollment":16,"completionDate":"2019-09"},{"nctId":"NCT01601093","phase":"PHASE2","title":"Study on Ceftazidime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection","status":"SUSPENDED","sponsor":"Xiangbei Welman Pharmaceutical Co., Ltd","startDate":"2011-11","conditions":["Respiratory Tract Infections","Urinary Tract Infections"],"enrollment":288,"completionDate":"2022-12-15"},{"nctId":"NCT03960905","phase":"","title":"A Study the Population Pharmacokinetics of Children of Infectious Disease in Central Nervous System","status":"UNKNOWN","sponsor":"Wei Zhao","startDate":"2019-01-01","conditions":["Central Nervous System Infection"],"enrollment":800,"completionDate":"2020-12-31"},{"nctId":"NCT03243864","phase":"","title":"Study of Ceftazidime-Avibactam Blood Concentrations in Intensive Care Unit Patients With Renal Failure Requiring Continuous Dialysis","status":"UNKNOWN","sponsor":"Temple University","startDate":"2017-03-13","conditions":["Renal Failure","Bacterial Infections","Critical Illness"],"enrollment":10,"completionDate":"2020-10-21"},{"nctId":"NCT02822950","phase":"PHASE1","title":"A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients","status":"COMPLETED","sponsor":"Michigan State University","startDate":"2017-01","conditions":["Pharmacokinetics of Avycaz in ICU Patients"],"enrollment":10,"completionDate":"2017-12"},{"nctId":"NCT03754387","phase":"NA","title":"Antibiotic Therapy vs Laparscopic Appendectomy in Pediatric Chronic Appendicitis","status":"UNKNOWN","sponsor":"Zunyi Medical College","startDate":"2019-01-01","conditions":["Chronic Appendicitis"],"enrollment":200,"completionDate":"2022-01-01"},{"nctId":"NCT02504827","phase":"PHASE4","title":"Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis","status":"COMPLETED","sponsor":"University of Southern California","startDate":"2015-09","conditions":["Cystic Fibrosis"],"enrollment":12,"completionDate":"2016-10"},{"nctId":"NCT03404739","phase":"PHASE2,PHASE3","title":"Single- Versus Multiple-dose Antimicrobial Prophylaxis for The Prevention of Infectious Complications Associated With Peroral Endoscopic Myotomy(POEM) for Achalasia","status":"UNKNOWN","sponsor":"Shanghai Zhongshan Hospital","startDate":"2017-10-01","conditions":["Esophageal Achalasia"],"enrollment":666,"completionDate":"2019-01"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Intramuscular","formulation":"Injection, Powder","formulations":[{"form":"INJECTION, POWDER, FOR SOLUTION","route":"INTRAMUSCULAR","productName":"TAZICEF"},{"form":"INJECTION, POWDER, FOR SOLUTION","route":"INTRAMUSCULAR","productName":"FORTAZ"},{"form":"INJECTION, POWDER, FOR SOLUTION","route":"INTRAVENOUS","productName":"Ceftazidime"},{"form":"INJECTION, POWDER, FOR SOLUTION","route":"INTRAVENOUS","productName":"TAZICEF"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Ceftazidime and Dextrose"},{"form":"POWDER, FOR SOLUTION","route":"INTRAVENOUS","productName":"AVYCAZ"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000145931","MMSL":"1047","NDDF":"002735","UNII":"9M416Z9QNR","VUID":"4017550","CHEBI":"CHEBI:3508","VANDF":"4017550","RXNORM":"203418","UMLSCUI":"C0007559","chemblId":"CHEMBL44354","ChEMBL_ID":"CHEMBL44354","KEGG_DRUG":"D00921","DRUGBANK_ID":"DB00438","PUBCHEM_CID":"5481173","SNOMEDCT_US":"36893000","IUPHAR_LIGAND_ID":"10762","SECONDARY_CAS_RN":"73547-61-2","MESH_DESCRIPTOR_UI":"D002442"},"formularyStatus":[],"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"1985-","companyName":"Covis Injectables","relationship":"Original Developer"},{"period":"present","companyName":"Pai Holdings Pharm","relationship":"Current Owner"}],"pharmacokinetics":{"tmax":"Approximately 1 hour (IM)","halfLife":"1.9 hours (IV); approximately 2 hours (IM)","clearance":"Approximately 80% to 90% of IM or IV dose","excretion":"Renal excretion (80-90% of dose)","metabolism":"","proteinBinding":"Less than 10%","bioavailability":"","volumeOfDistribution":""},"publicationCount":13681,"therapeuticAreas":["Metabolic"],"atcClassification":{"source":"DrugCentral","atcCode":"J01DD02","allCodes":["J01DD02","J01DD52"]},"biosimilarFilings":[],"originalDeveloper":"Covis Injectables","recentPublications":[{"date":"2026 Feb 27","pmid":"41901706","title":"Fluoroquinolone-Resistant Avian Pathogenic Escherichia coli Isolated from Asymptomatic Broiler Chickens in a Slaughterhouse in Northern Thailand.","journal":"Pathogens (Basel, Switzerland)"},{"date":"2026 Mar 23","pmid":"41900883","title":"Chemical Characterization and Evaluation of Antimicrobial, Antioxidant, and Synergistic Activities of Teucrium polium L.: An Integrated Experimental and In Silico Approach.","journal":"Pharmaceutics"},{"date":"2026 Mar 19","pmid":"41900863","title":"Accurate and Sensitive UHPLC-Tandem Mass Spectrometry Sequential Methods for Therapeutic Drug Monitoring of Aztreonam/Avibactam in Human Plasma.","journal":"Pharmaceutics"},{"date":"2026 Mar 6","pmid":"41900353","title":"Genotypic and Phenotypic Characterization of Cronobacter spp. Strains Isolated from Powdered Milk Formulas and Dairy Production Environments.","journal":"Microorganisms"},{"date":"2026 Mar 17","pmid":"41899216","title":"Assessment of Drug Dosing Appropriateness in Hospitalized Chronic Kidney Disease Patients with Cardiovascular Diseases: A Cross-Sectional Study in the Al-Baha Region, Saudi Arabia (2023-2025).","journal":"Journal of clinical medicine"}],"companionDiagnostics":[],"genericManufacturers":6,"_genericFilersChecked":true,"structuredTrialResults":[{"hr":"6.8","nctId":"NCT00921024","phase":"PHASE2","pValue":"","ciLower":"","ciUpper":"","endpoint":"Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population","enrollment":129}],"genericManufacturerList":["Acs Dobfar","Aurobindo Pharma Ltd","Glaxosmithkline","Hospira","Lilly","Wockhardt"],"status":"approved","companyName":"Pai Holdings Pharm","companyId":"pai-holdings-pharm","modality":"Small molecule","firstApprovalDate":"1985","enrichmentLevel":5,"visitCount":8,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1992-11-09T00:00:00.000Z","mah":"HOSPIRA","brand_name_local":null,"application_number":"ANDA062662"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2005-11-28T00:00:00.000Z","mah":"HOSPIRA","brand_name_local":null,"application_number":"ANDA064032"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2012-03-16T00:00:00.000Z","mah":"ACS DOBFAR","brand_name_local":null,"application_number":"ANDA062640"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2017-01-26T00:00:00.000Z","mah":"ABBVIE","brand_name_local":null,"application_number":"NDA206494"},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"pricingByCountry":[{"country_code":"Un","currency":"USD","price_amount":"1410.00","price_per":"year","price_type":"NADAC","annual_cost_usd":null,"reimbursement_status":null},{"country_code":"UN","currency":"USD","price_amount":"1410.00","price_per":"year","price_type":"NADAC","annual_cost_usd":null,"reimbursement_status":null},{"country_code":"UN","currency":"USD","price_amount":"1410.00","price_per":"year","price_type":"NADAC","annual_cost_usd":null,"reimbursement_status":null},{"country_code":"UN","currency":"USD","price_amount":"1410.00","price_per":"year","price_type":"NADAC","annual_cost_usd":null,"reimbursement_status":null},{"country_code":"UN","currency":"USD","price_amount":"1410.00","price_per":"year","price_type":"NADAC","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":5,"withResults":1},"validation":{"fieldsValidated":8,"lastValidatedAt":"2026-04-21T10:57:22.116336+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}