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cefprozil 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antibiotics, cefalosporanic acid derivatives | 556 | 92665-29-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 1 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 4 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.06 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 73 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 42.88 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 90 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 0.21 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 2.90 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.59 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 1.20 hours | Lombardo F, Berellini G, Obach RS |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | -1.726 | Moderate | 0.78 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 0.809 | Moderate | 0.78 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 0.533 | 10^-6 cm/s | Moderate | 0.78 |
| dh-clint | Dog hepatocyte intrinsic clearance | 1.758 | uL/min/10^6 cells | Moderate | 0.78 |
| dppb | Dog plasma protein binding (% unbound) | 60.440 | % | Moderate | 0.78 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 40.500 | % | Moderate | 0.78 |
| herg | hERG pIC50 | 4.638 | pIC50 | Moderate | 0.78 |
| hh-clint | Human hepatocyte intrinsic clearance | 2.518 | uL/min/10^6 cells | Moderate | 0.78 |
| hlm-clint | Human liver microsomal intrinsic clearance | 4.266 | uL/min/mg protein | Moderate | 0.78 |
| hppb | Human plasma protein binding (% unbound) | 42.910 | % | Moderate | 0.78 |
| kinase-safety-class | ACVR2A,ACVR2B,ACVRL1,AURKA,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,ERBB2,GRK2,GRK3,GSK3B,ITK,JAK2,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PIK3CA,PIK3CB,PIM2,PRKDC,SIK2,STK33,SYK,TEK,TGFBR1,TTK | 40 | |||
| kinase-selectivity-class | ACVR2B,AXL,BRAF,CDK4,CDK9,DYRK1B,EIF2AK3,EPHB4,GRK2,JAK2,MAP2K6,MAP3K14,MAPK7,PRKDC,STK33,SYK,TEK,TGFBR1,TTK | 19 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 0.820 | Moderate | 0.78 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 4.102 | Moderate | 0.78 | |
| mppb | Mouse plasma protein binding (% unbound) | 60.710 | Moderate | 0.78 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 1.524 | Moderate | 0.78 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 40.390 | % | Moderate | 0.78 |
| rh-clint | Rat hepatocyte intrinsic clearance | 1.854 | uL/min/10^6 cells | Moderate | 0.78 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 85.450 | % | Moderate | 0.78 |
| rppb | Rat plasma protein binding (% unbound) | 31.470 | % | Moderate | 0.78 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 933.254 | uM | Moderate | 0.78 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 23, 1991 | FDA |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Mouth breathing | 98.39 | 29.38 | 13 | 1311 | 157 | 90626966 |
| Drug hypersensitivity | 67.86 | 29.38 | 55 | 1269 | 463554 | 90163569 |
| Snoring | 49.05 | 29.38 | 12 | 1312 | 5114 | 90622009 |
| Choking | 47.53 | 29.38 | 14 | 1310 | 12019 | 90615104 |
| Sputum discoloured | 44.17 | 29.38 | 15 | 1309 | 20376 | 90606747 |
| Rhinitis allergic | 34.98 | 29.38 | 12 | 1312 | 16773 | 90610350 |
| Urticaria | 33.19 | 29.38 | 31 | 1293 | 312703 | 90314420 |
| Product availability issue | 30.93 | 29.38 | 9 | 1315 | 7395 | 90619728 |
| Tubulointerstitial nephritis and uveitis syndrome | 30.70 | 29.38 | 5 | 1319 | 267 | 90626856 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 74.75 | 24.24 | 62 | 1850 | 454028 | 110133359 |
| Mouth breathing | 73.04 | 24.24 | 11 | 1901 | 296 | 110587091 |
| Sputum discoloured | 51.34 | 24.24 | 19 | 1893 | 27926 | 110559461 |
| Urticaria | 41.15 | 24.24 | 38 | 1874 | 318819 | 110268568 |
| Clostridium difficile colitis | 39.88 | 24.24 | 18 | 1894 | 43760 | 110543627 |
| Oropharyngeal pain | 36.71 | 24.24 | 25 | 1887 | 135251 | 110452136 |
| Snoring | 34.60 | 24.24 | 10 | 1902 | 6774 | 110580613 |
| Choking | 30.43 | 24.24 | 11 | 1901 | 15099 | 110572288 |
| Idiopathic urticaria | 29.49 | 24.24 | 5 | 1907 | 288 | 110587099 |
| Product availability issue | 28.86 | 24.24 | 9 | 1903 | 7881 | 110579506 |
| Tubulointerstitial nephritis and uveitis syndrome | 27.86 | 24.24 | 5 | 1907 | 401 | 110586986 |
| Cough | 26.42 | 24.24 | 36 | 1876 | 461605 | 110125782 |
| Rhinitis allergic | 25.08 | 24.24 | 10 | 1902 | 17912 | 110569475 |
| Heart rate increased | 24.26 | 24.24 | 20 | 1892 | 143814 | 110443573 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J01DC10 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER BETA-LACTAM ANTIBACTERIALS Second-generation cephalosporins |
| FDA CS | M0003827 | Cephalosporins |
| FDA EPC | N0000175488 | Cephalosporin Antibacterial |
| CHEBI has role | CHEBI:36047 | antibacterial drug |
| MeSH PA | D000097902 | beta Lactam Antibiotics |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000900 | Anti-Bacterial Agents |
Related Drugs by ATC class:
J01DC Second-generation cephalosporins 13 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Acute otitis media | indication | 3110003 | |
| Haemophilus Influenzae Acute Otitis Media | indication | 19021002 | |
| Infection of skin AND/OR subcutaneous tissue | indication | 19824006 | |
| Bronchitis | indication | 32398004 | DOID:6132 |
| Streptococcal tonsillitis | indication | 41582007 | |
| Upper respiratory infection | indication | 54150009 | |
| Acute bacterial sinusitis | indication | 75498004 | |
| Tonsillitis | indication | 90176007 | DOID:10456 |
| Acute Moraxella catarrhalis bronchitis | indication | 195722003 | |
| Acute bacterial bronchitis | indication | 233598009 | |
| Streptococcus pyogenes infection | indication | 302809008 | |
| Infective otitis media | indication | 312218008 | |
| Infection due to Staphylococcus aureus | indication | 406602003 | |
| Acute exacerbation of chronic bronchitis | indication | 425748003 | |
| Moraxella Catarrhalis Acute Otitis Media | indication | 703469002 | |
| Pneumococcal Acute Otitis Media | indication | ||
| Streptococcus Pneumoniae Bronchitis | indication | ||
| Haemophilus Influenzae Chronic Bronchitis | indication | ||
| Streptococcus Pneumoniae Chronic Bronchitis | indication | ||
| Moraxella Catarrhalis Chronic Bronchitis | indication | ||
| Haemophilus Influenzae Bronchitis | indication | ||
| Pyrexia of unknown origin | off-label use | 7520000 | |
| Acute nephropathy | contraindication | 58574008 | |
| Factor II deficiency | contraindication | 73975000 | |
| Pseudomembranous enterocolitis | contraindication | 397683000 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 2.7 | acidic |
| pKa2 | 9.72 | acidic |
| pKa3 | 7.63 | Basic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Penicillin-binding protein 1A | Enzyme | WOMBAT-PK |
External reference:
| ID | Source |
|---|---|
| 4020058 | VUID |
| N0000148083 | NUI |
| D00261 | KEGG_DRUG |
| 121123-17-9 | SECONDARY_CAS_RN |
| 19552 | RXNORM |
| C0053882 | UMLSCUI |
| CHEBI:3506 | CHEBI |
| CHEMBL5314373 | ChEMBL_ID |
| CHEMBL3301800 | ChEMBL_ID |
| DB01150 | DRUGBANK_ID |
| D000097670 | MESH_DESCRIPTOR_UI |
| 62977 | PUBCHEM_CID |
| 12219 | IUPHAR_LIGAND_ID |
| 4W0459ZA4V | UNII |
| 4382 | MMSL |
| 73619 | MMSL |
| d00073 | MMSL |
| 003623 | NDDF |
| 387538005 | SNOMEDCT_US |
| 96054007 | SNOMEDCT_US |
| 4020058 | VANDF |
| 4W0459ZA4V | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Cefprozil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-1077 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 25 sections |
| Cefprozil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-1078 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 25 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 16714-396 | POWDER, FOR SUSPENSION | 125 mg | ORAL | ANDA | 25 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 16714-397 | POWDER, FOR SUSPENSION | 250 mg | ORAL | ANDA | 25 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 16714-398 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 25 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 16714-399 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 25 sections |
| Cefprozil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-1188 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 26 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 50090-1710 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 25 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 50090-1739 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 24 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 50090-3226 | POWDER, FOR SUSPENSION | 250 mg | ORAL | ANDA | 25 sections |
| CEFPROZIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52959-300 | TABLET | 500 mg | ORAL | ANDA | 14 sections |
| CEFPROZIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53217-031 | TABLET | 500 mg | ORAL | ANDA | 14 sections |
| CEFPROZIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-5756 | TABLET | 500 mg | ORAL | ANDA | 14 sections |
| Cefprozil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-5757 | POWDER, FOR SUSPENSION | 250 mg | ORAL | ANDA | 14 sections |
| CEFPROZIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55648-712 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 20 sections |
| CEFPROZIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55648-713 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 20 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 57237-034 | POWDER, FOR SUSPENSION | 125 mg | ORAL | ANDA | 25 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 57237-035 | POWDER, FOR SUSPENSION | 250 mg | ORAL | ANDA | 25 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 57237-036 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 24 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 57237-037 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 24 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 65862-068 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 24 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 65862-069 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 24 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 65862-099 | POWDER, FOR SUSPENSION | 125 mg | ORAL | ANDA | 25 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 65862-100 | POWDER, FOR SUSPENSION | 250 mg | ORAL | ANDA | 25 sections |
| CEFPROZIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67296-0590 | TABLET | 500 mg | ORAL | ANDA | 24 sections |
| Cefprozil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67296-1180 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 14 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 67877-243 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 23 sections |
| Cefprozil | Human Prescription Drug Label | 1 | 67877-244 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 23 sections |
| CEFPROZIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68180-273 | POWDER, FOR SUSPENSION | 250 mg | ORAL | ANDA | 23 sections |
| CEFPROZIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68180-401 | POWDER, FOR SUSPENSION | 125 mg | ORAL | ANDA | 24 sections |