Details
| Stereochemistry | ABSOLUTE |
| Molecular Formula | C30H34ClN7O10S2.2C7H8O3S.H2O |
| Molecular Weight | 1114.633 |
| Optical Activity | UNSPECIFIED |
| Defined Stereocenters | 2 / 2 |
| E/Z Centers | 1 |
| Charge | 0 |
SHOW SMILES / InChI
SMILES
O.CC1=CC=C(C=C1)S(O)(=O)=O.CC2=CC=C(C=C2)S(O)(=O)=O.[H][C@]34SCC(C[N+]6(CCNC(=O)C5=C(Cl)C(O)=C(O)C=C5)CCCC6)=C(N3C(=O)[C@H]4NC(=O)C(=N/OC(C)(C)C(O)=O)\C7=CSC(N)=N7)C([O-])=O
InChI
InChIKey=FNRCOAIUGNUCMQ-PGQCXATESA-N
InChI=1S/C30H34ClN7O10S2.2C7H8O3S.H2O/c1-30(2,28(46)47)48-36-19(16-13-50-29(32)34-16)24(42)35-20-25(43)37-21(27(44)45)14(12-49-26(20)37)11-38(8-3-4-9-38)10-7-33-23(41)15-5-6-17(39)22(40)18(15)31;2*1-6-2-4-7(5-3-6)11(8,9)10;/h5-6,13,20,26H,3-4,7-12H2,1-2H3,(H7-,32,33,34,35,36,39,40,41,42,44,45,46,47);2*2-5H,1H3,(H,8,9,10);1H2/t20-,26-;;;/m1.../s1
Approval Year
Cmax
| Value | Dose | Co-administered | Analyte | Population |
|---|---|---|---|---|
138 mg/L |
2 g 3 times / day multiple, intravenous dose: 2 g route of administration: Intravenous experiment type: MULTIPLE co-administered: |
CEFIDEROCOL unknown | Homo sapiens population: UNHEALTHY age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
|
89.7 mg/L |
2 g single, intravenous dose: 2 g route of administration: Intravenous experiment type: SINGLE co-administered: |
CEFIDEROCOL unknown | Homo sapiens population: HEALTHY age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
AUC
| Value | Dose | Co-administered | Analyte | Population |
|---|---|---|---|---|
1184 mg × h/L |
2 g 3 times / day multiple, intravenous dose: 2 g route of administration: Intravenous experiment type: MULTIPLE co-administered: |
CEFIDEROCOL unknown | Homo sapiens population: UNHEALTHY age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
|
386 mg × h/mL |
2 g single, intravenous dose: 2 g route of administration: Intravenous experiment type: SINGLE co-administered: |
CEFIDEROCOL unknown | Homo sapiens population: HEALTHY age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
Doses
| Dose | Population | Adverse events |
|---|---|---|
2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
Disc. AE: Diarrhea, Drug hypersensitivity... Other AEs: Diarrhea, Infusion site reactions... AEs leading to discontinuation/dose reduction: Diarrhea (0.3%) Other AEs:Drug hypersensitivity (0.3%) Hepatic enzymes increased (0.3%) Death (grade 5, 0.3%) Diarrhea (4%) Sources: Infusion site reactions (4%) Constipation (3%) Rash (3%) Candidiasis (2%) Cough (2%) Elevated liver enzymes (2%) Headache (2%) Hypokalemia (2%) Nausea (2%) Vomiting (2%) Thrombocytosis (<2%) Congestive heart failure (<2%) Bradycardia (<2%) Atrial fibrillation (<2%) Abdominal pain (<2%) Dry mouth (<2%) Stomatitis (<2%) Pyrexia (<2%) Peripheral edema (<2%) Cholelithiasis (<2%) Cholecystitis (<2%) Gallbladder pain (<2%) Drug hypersensitivity (<2%) Clostridium difficile infection (<2%) Prothrombin time prolonged (<2%) Red blood cells urine positive (<2%) Creatine phosphokinase increased (<2%) Decreased appetite (<2%) Hypocalcemia (<2%) Fluid overload (<2%) Dysgeusia (<2%) Seizure (<2%) Dyspnea (<2%) Pleural effusion (<2%) Pruritis (<2%) Insomnia (<2%) Restlessness (<2%) |
1 g 1 times / day single, intravenous Dose: 1 g, 1 times / day Route: intravenous Route: single Dose: 1 g, 1 times / day Sources: |
unhealthy, mean age 60.1 years n = 8 Health Status: unhealthy Condition: Gram-Negative Bacterial Infections Age Group: mean age 60.1 years Sex: M+F Population Size: 8 Sources: |
Disc. AE: Urticaria... AEs leading to discontinuation/dose reduction: Urticaria (12.5%) Sources: |
2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
Disc. AE: Death, Elevated liver enzymes... Other AEs: Elevated liver enzymes, Hypokalemia... AEs leading to discontinuation/dose reduction: Death (grade 5, 26.4%) Other AEs:Elevated liver enzymes Elevated liver enzymes (16%) Sources: Hypokalemia (11%) Diarrhea (9%) Hypomagnesemia (5%) Atrial fibrillation (5%) Thrombocytopenia (<4%) Thrombocytosis (<4%) Myocardial infarction (<4%) Atrial flutter (<4%) Nausea (<4%) Vomiting (<4%) Abdominal pain (<4%) Cholecystitis (<4%) Cholestasis (<4%) Clostridium difficile infection (<4%) Oral candidiasis (<4%) Prothrombin time prolonged (<4%) Activated partial thromboplastin time (<4%) Hypocalcemia (<4%) Hyperkalemia (<4%) Seizure (<4%) Acute interstitial nephritis (<4%) Cough (<4%) Rash (<4%) |
AEs
| AE | Significance | Dose | Population |
|---|---|---|---|
| Diarrhea | 0.3% Disc. AE |
2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Drug hypersensitivity | 0.3% Disc. AE |
2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Hepatic enzymes increased | 0.3% Disc. AE |
2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Candidiasis | 2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Cough | 2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Elevated liver enzymes | 2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Headache | 2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Hypokalemia | 2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Nausea | 2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Vomiting | 2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Constipation | 3% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Rash | 3% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Diarrhea | 4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Infusion site reactions | 4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Abdominal pain | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Atrial fibrillation | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Bradycardia | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Cholecystitis | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Cholelithiasis | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Clostridium difficile infection | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Congestive heart failure | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Creatine phosphokinase increased | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Decreased appetite | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Drug hypersensitivity | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Dry mouth | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Dysgeusia | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Dyspnea | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Fluid overload | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Gallbladder pain | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Hypocalcemia | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Insomnia | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Peripheral edema | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Pleural effusion | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Prothrombin time prolonged | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Pruritis | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Pyrexia | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Red blood cells urine positive | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Restlessness | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Seizure | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Stomatitis | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Thrombocytosis | <2% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Death | grade 5, 0.3% Disc. AE |
2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, 18 to 93 years n = 300 Health Status: unhealthy Condition: Complicated Urinary Tract Infections Age Group: 18 to 93 years Sex: M+F Population Size: 300 Sources: |
| Urticaria | 12.5% Disc. AE |
1 g 1 times / day single, intravenous Dose: 1 g, 1 times / day Route: intravenous Route: single Dose: 1 g, 1 times / day Sources: |
unhealthy, mean age 60.1 years n = 8 Health Status: unhealthy Condition: Gram-Negative Bacterial Infections Age Group: mean age 60.1 years Sex: M+F Population Size: 8 Sources: |
| Hypokalemia | 11% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Elevated liver enzymes | 16% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Atrial fibrillation | 5% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Hypomagnesemia | 5% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Diarrhea | 9% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Abdominal pain | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Activated partial thromboplastin time | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Acute interstitial nephritis | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Atrial flutter | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Cholecystitis | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Cholestasis | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Clostridium difficile infection | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Cough | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Hyperkalemia | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Hypocalcemia | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Myocardial infarction | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Nausea | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Oral candidiasis | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Prothrombin time prolonged | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Rash | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Seizure | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Thrombocytopenia | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Thrombocytosis | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Vomiting | <4% | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Elevated liver enzymes | Disc. AE | 2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
| Death | grade 5, 26.4% Disc. AE |
2 g 3 times / day multiple, intravenous Recommended Dose: 2 g, 3 times / day Route: intravenous Route: multiple Dose: 2 g, 3 times / day Sources: |
unhealthy, median age - 67 years n = 148 Health Status: unhealthy Condition: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Age Group: median age - 67 years Sex: M+F Population Size: 148 Sources: |
Overview
| CYP3A4 | CYP2C9 | CYP2D6 | hERG |
|---|---|---|---|
Drug as perpetrator
| Target | Modality | Activity | Metabolite | Clinical evidence |
|---|---|---|---|---|
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| no | ||||
| yes | no (co-administration study) Comment: The results from a clinical drug-drug interaction study indicate that cefiderocol had no clinically meaningful effects on the PK of furosemide (substrate for OAT1 and OAT3), metformin (for OCT1, OCT2, and MATE2- K), and rosuvastatin (for OATP1B3). Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209445Orig1s000MultidisciplineR.pdf#page=64 Page: 64.0 |
|||
| yes | no (co-administration study) Comment: The results from a clinical drug-drug interaction study indicate that cefiderocol had no clinically meaningful effects on the PK of furosemide (substrate for OAT1 and OAT3), metformin (for OCT1, OCT2, and MATE2- K), and rosuvastatin (for OATP1B3). Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209445Orig1s000MultidisciplineR.pdf#page=64 Page: 64.0 |
|||
| yes | no (co-administration study) Comment: The results from a clinical drug-drug interaction study indicate that cefiderocol had no clinically meaningful effects on the PK of furosemide (substrate for OAT1 and OAT3), metformin (for OCT1, OCT2, and MATE2- K), and rosuvastatin (for OATP1B3). Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209445Orig1s000MultidisciplineR.pdf#page=64 Page: 64.0 |
|||
| yes | no (co-administration study) Comment: The results from a clinical drug-drug interaction study indicate that cefiderocol had no clinically meaningful effects on the PK of furosemide (substrate for OAT1 and OAT3), metformin (for OCT1, OCT2, and MATE2- K), and rosuvastatin (for OATP1B3). Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209445Orig1s000MultidisciplineR.pdf#page=64 Page: 64.0 |
|||
| yes | no (co-administration study) Comment: The results from a clinical drug-drug interaction study indicate that cefiderocol had no clinically meaningful effects on the PK of furosemide (substrate for OAT1 and OAT3), metformin (for OCT1, OCT2, and MATE2- K), and rosuvastatin (for OATP1B3). Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209445Orig1s000MultidisciplineR.pdf#page=64 Page: 64.0 |
|||
| yes | no (co-administration study) Comment: The results from a clinical drug-drug interaction study indicate that cefiderocol had no clinically meaningful effects on the PK of furosemide (substrate for OAT1 and OAT3), metformin (for OCT1, OCT2, and MATE2- K), and rosuvastatin (for OATP1B3). Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209445Orig1s000MultidisciplineR.pdf#page=64 Page: 64.0 |
Drug as victim
| Target | Modality | Activity | Metabolite | Clinical evidence |
|---|---|---|---|---|
| yes | ||||
| yes | ||||
| yes | ||||
| yes | ||||
| yes | ||||
| yes |
Tox targets
| Target | Modality | Activity | Metabolite | Clinical evidence |
|---|---|---|---|---|
| Name | Type | Language | ||
|---|---|---|---|---|
|
Common Name | English |
| Code System | Code | Type | Description | ||
|---|---|---|---|---|---|
|
1883830-01-0
Created by
admin on Sat Dec 16 11:36:54 GMT 2023 , Edited by admin on Sat Dec 16 11:36:54 GMT 2023
|
PRIMARY | |||
|
137321962
Created by
admin on Sat Dec 16 11:36:54 GMT 2023 , Edited by admin on Sat Dec 16 11:36:54 GMT 2023
|
PRIMARY | |||
|
3HA30AS289
Created by
admin on Sat Dec 16 11:36:54 GMT 2023 , Edited by admin on Sat Dec 16 11:36:54 GMT 2023
|
PRIMARY |
ACTIVE MOIETY
SUBSTANCE RECORD
