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cefpodoxime proxetil 🐶 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 | 555 | 87239-81-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Prodrug for cefpodoxime
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.40 | g | O |
| 0.40 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.30 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 0 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 17.93 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 52 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 2.286 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 6.295 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 51.642 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 22.751 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 9.110 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 11.090 | % | High | 1 |
| herg | hERG pIC50 | 4.546 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 50.466 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 246.037 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 6.080 | % | High | 1 |
| kinase-safety-class | ACVR2A,ACVR2B,AKT2,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,JAK2,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MARK4,MET,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKDC,STK33,SYK,TEK,TTK | 43 | |||
| kinase-selectivity-class | AXL,BRAF,CDK9,DDR1,EPHB4,GRK2,MAP2K6,MAPK7,STK33,SYK,TEK,TTK | 12 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 19.679 | Moderate | 0.75 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 9.954 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 162.181 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 10.750 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 57.412 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 10.580 | % | High | 1 |
| rat-kpuu-brain | Rat brain Kpuu | 0.065 | % | Moderate | 0.75 |
| rh-clint | Rat hepatocyte intrinsic clearance | 167.109 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 64.850 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 10.190 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 408.319 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 7, 1992 | 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 |
|---|---|---|---|---|---|---|
| Cystitis bacterial | 28.20 | 25.74 | 5 | 1686 | 346 | 90626410 |
| Arthritis reactive | 25.80 | 25.74 | 5 | 1686 | 563 | 90626193 |
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 |
|---|---|---|---|---|---|---|
| Pyrexia | 31.00 | 23.98 | 63 | 2326 | 898202 | 109688708 |
| Clostridium difficile colitis | 27.45 | 23.98 | 15 | 2374 | 43763 | 110543147 |
| Pneumonia | 25.05 | 23.98 | 57 | 2332 | 876657 | 109710253 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J01DD13 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER BETA-LACTAM ANTIBACTERIALS Third-generation cephalosporins |
| ATC | J01DD64 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER BETA-LACTAM ANTIBACTERIALS Third-generation cephalosporins |
| FDA CS | M0003827 | Cephalosporins |
| FDA EPC | N0000175488 | Cephalosporin Antibacterial |
| CHEBI has role | CHEBI:33282 | antibacterial agent |
| CHEBI has role | CHEBI:36047 | antibacterial drug |
| CHEBI has role | CHEBI:50266 | prodrug |
| MeSH PA | D000097902 | beta Lactam Antibiotics |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000900 | Anti-Bacterial Agents |
Related Drugs by ATC class:
J01DD Third-generation cephalosporins 17 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Acute otitis media | indication | 3110003 | |
| Gonorrhea | indication | 15628003 | DOID:7551 |
| Haemophilus Influenzae Acute Otitis Media | indication | 19021002 | |
| Infection of skin AND/OR subcutaneous tissue | indication | 19824006 | |
| Acute gonococcal cervicitis | indication | 20943002 | DOID:10615 |
| Acute gonococcal urethritis | indication | 29864006 | |
| Pneumonia due to Streptococcus | indication | 34020007 | |
| Streptococcal tonsillitis | indication | 41582007 | |
| Gonorrhea of rectum | indication | 42746002 | |
| Bacterial pneumonia | indication | 53084003 | DOID:874 |
| Klebsiella cystitis | indication | 60867007 | |
| Acute maxillary sinusitis | indication | 68272006 | DOID:2050 |
| Haemophilus influenzae pneumonia | indication | 70036007 | |
| Acute bacterial sinusitis | indication | 75498004 | |
| Tonsillitis | indication | 90176007 | DOID:10456 |
| Acute Moraxella catarrhalis bronchitis | indication | 195722003 | |
| Acute bacterial bronchitis | indication | 233598009 | |
| Pneumococcal pneumonia | indication | 233607000 | |
| Escherichia coli urinary tract infection | indication | 301011002 | |
| Proteus urinary tract infection | indication | 301012009 | |
| Streptococcus pyogenes infection | indication | 302809008 | |
| Bacterial urinary infection | indication | 312124009 | |
| Infective otitis media | indication | 312218008 | |
| Pharyngitis | indication | 405737000 | DOID:2275 |
| Infection due to Staphylococcus aureus | indication | 406602003 | |
| Acute exacerbation of chronic bronchitis | indication | 425748003 | |
| Moraxella Catarrhalis Acute Otitis Media | indication | 703469002 | |
| Streptococcus Pneumoniae Bronchitis | indication | ||
| Staphylococcus Saprophyticus Urinary Tract Infection | indication | ||
| Pneumococcal Acute Otitis Media | indication | ||
| Haemophilus Influenzae Chronic Bronchitis | indication | ||
| Blood coagulation disorder | contraindication | 64779008 | DOID:1247 |
| Factor II deficiency | contraindication | 73975000 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Pseudomembranous enterocolitis | contraindication | 397683000 |
🐶 Veterinary Drug Use
| Species | Use | Relation |
|---|---|---|
| Dogs | Skin infections caused by Staphylococcus intermedius | Indication |
| Dogs | Skin infections caused by Staphylococcus aureus | Indication |
| Dogs | Skin infections caused by Streptococcus canis | Indication |
| Dogs | Skin infections caused by Escherchia coli | Indication |
| Dogs | Skin infections caused by Pasteurella multocida | Indication |
| Dogs | Skin infections caused by Proteus mirabilis | Indication |
🐶 Veterinary products
| Product | Applicant | Ingredients |
|---|---|---|
| Simplicef | Zoetis Inc. | 1 |
| Cefpodoxime Proxetil Tablets | Dechra Veterinary Products LLC | 1 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 3.1 | Basic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| 4020567 | VUID |
| N0000148269 | NUI |
| D00920 | KEGG_DRUG |
| 20489 | RXNORM |
| C0108938 | UMLSCUI |
| CHEMBL1201016 | ChEMBL_ID |
| D000097627 | MESH_DESCRIPTOR_UI |
| 2TB00A1Z7N | UNII |
| 6526396 | PUBCHEM_CID |
| DB01416 | DRUGBANK_ID |
| 4381 | MMSL |
| 57686 | MMSL |
| d00095 | MMSL |
| 387534007 | SNOMEDCT_US |
| 96049003 | SNOMEDCT_US |
| 96050003 | SNOMEDCT_US |
| C0055011 | UMLSCUI |
| CHEMBL1672 | ChEMBL_ID |
| 80210-62-4 | SECONDARY_CAS_RN |
| 6335986 | PUBCHEM_CID |
| 10780 | IUPHAR_LIGAND_ID |
| 6123 | INN_ID |
| 4020567 | VANDF |
| D000097623 | MESH_DESCRIPTOR_UI |
| 7R4F94TVGY | UNII |
| 003727 | NDDF |
| 003728 | NDDF |
| CHEBI:3504 | CHEBI |
| 2TB00A1Z7N | INXIGHT DRUGS |
| 7R4F94TVGY | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Cefpodoxime Proxetil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-5438 | TABLET, FILM COATED | 100 mg | ORAL | ANDA | 26 sections |
| Cefpodoxime Proxetil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-5439 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 26 sections |
| CEFPODOXIME PROXETIL | Human Prescription Drug Label | 1 | 16714-394 | TABLET, FILM COATED | 100 mg | ORAL | ANDA | 24 sections |
| CEFPODOXIME PROXETIL | Human Prescription Drug Label | 1 | 16714-395 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 24 sections |
| Cefpodoxime Proxetil | Human Prescription Drug Label | 1 | 16714-402 | GRANULE, FOR SUSPENSION | 50 mg | ORAL | ANDA | 24 sections |
| Cefpodoxime Proxetil | Human Prescription Drug Label | 1 | 16714-403 | GRANULE, FOR SUSPENSION | 100 mg | ORAL | ANDA | 24 sections |
| Cefpodoxime Proxetil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-083 | TABLET, FILM COATED | 100 mg | ORAL | ANDA | 23 sections |
| Cefpodoxime Proxetil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-084 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 23 sections |
| CEFPODOXIME PROXETIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55289-393 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 23 sections |
| Cefpodoxime Proxetil | Human Prescription Drug Label | 1 | 64980-402 | GRANULE, FOR SUSPENSION | 50 mg | ORAL | ANDA | 23 sections |
| Cefpodoxime Proxetil | Human Prescription Drug Label | 1 | 64980-403 | GRANULE, FOR SUSPENSION | 100 mg | ORAL | ANDA | 23 sections |
| CEFPODOXIME PROXETIL | Human Prescription Drug Label | 1 | 65862-095 | TABLET, FILM COATED | 100 mg | ORAL | ANDA | 23 sections |
| CEFPODOXIME PROXETIL | Human Prescription Drug Label | 1 | 65862-096 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 23 sections |
| Cefpodoxime Proxetil | Human Prescription Drug Label | 1 | 65862-140 | GRANULE, FOR SUSPENSION | 50 mg | ORAL | ANDA | 24 sections |
| Cefpodoxime Proxetil | Human Prescription Drug Label | 1 | 65862-141 | GRANULE, FOR SUSPENSION | 100 mg | ORAL | ANDA | 24 sections |
| Cefpodoxime Proxetil | Human Prescription Drug Label | 1 | 67877-559 | TABLET, FILM COATED | 100 mg | ORAL | ANDA | 23 sections |
| Cefpodoxime Proxetil | Human Prescription Drug Label | 1 | 67877-560 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 23 sections |
| Cefpodoxime Proxetil | Human Prescription Drug Label | 1 | 67877-878 | TABLET, FILM COATED | 100 mg | ORAL | ANDA | 23 sections |
| Cefpodoxime Proxetil | Human Prescription Drug Label | 1 | 67877-879 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 23 sections |
| CEFPODOXIME PROXETIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68071-2742 | TABLET, FILM COATED | 100 mg | ORAL | ANDA | 24 sections |
| Cefpodoxime Proxetil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68071-3441 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 23 sections |
| Cefpodoxime Proxetil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68071-3616 | TABLET, FILM COATED | 100 mg | ORAL | ANDA | 23 sections |
| CEFPODOXIME PROXETIL | Human Prescription Drug Label | 1 | 69043-006 | TABLET, FILM COATED | 100 mg | ORAL | ANDA | 24 sections |
| CEFPODOXIME PROXETIL | Human Prescription Drug Label | 1 | 69043-007 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 24 sections |
| Cefpodoxime Proxetil | Human Prescription Drug Label | 1 | 69292-514 | TABLET, FILM COATED | 100 mg | ORAL | ANDA | 23 sections |
| Cefpodoxime Proxetil | Human Prescription Drug Label | 1 | 69292-516 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 23 sections |
| Cefpodoxime Proxetil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70518-4676 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 23 sections |