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ceftaroline fosamil 🐶 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 | 4169 | 402741-13-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Ceftaroline is a cephalosporin antibacterial drug with in vitro activity against Gram-positive and -negative bacteria. The bactericidal action of ceftaroline is mediated through binding to essential penicillin-binding proteins (PBPs). Ceftaroline is bactericidal against S. aureus due to its affinity for PBP2a and against Streptococcus pneumoniae due to its affinity for PBP2x.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 1.20 | g | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 0.53 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 83.60 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.80 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 0.09 hours | Lombardo F, Berellini G, Obach RS |
| BA (Bioavailability) | 0 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 29, 2010 | FDA | CEREXA |
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 |
|---|---|---|---|---|---|---|
| Off label use | 61.15 | 59.79 | 52 | 523 | 1102200 | 89525672 |
FDA Adverse Event Reporting System (Male)
| 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 |
|---|---|---|---|---|---|---|
| Off label use | 91.62 | 36.61 | 83 | 731 | 638252 | 41982269 |
| Eosinophilia | 68.09 | 36.61 | 25 | 789 | 32874 | 42587647 |
| Agranulocytosis | 47.94 | 36.61 | 19 | 795 | 30593 | 42589928 |
| Neutropenia | 38.27 | 36.61 | 31 | 783 | 199400 | 42421121 |
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 |
|---|---|---|---|---|---|---|
| Off label use | 92.41 | 40.24 | 92 | 1017 | 1500093 | 109088097 |
| Neutropenia | 89.47 | 40.24 | 52 | 1057 | 374568 | 110213622 |
| Eosinophilia | 81.43 | 40.24 | 28 | 1081 | 57908 | 110530282 |
| Agranulocytosis | 64.64 | 40.24 | 24 | 1085 | 61736 | 110526454 |
| Drug ineffective | 44.15 | 40.24 | 64 | 1045 | 1520476 | 109067714 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J01DI02 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER BETA-LACTAM ANTIBACTERIALS Other cephalosporins and penems |
| FDA CS | M0003827 | Cephalosporins |
| FDA EPC | N0000175488 | Cephalosporin Antibacterial |
| MeSH PA | D000097902 | beta Lactam Antibiotics |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000900 | Anti-Bacterial Agents |
| CHEBI has role | CHEBI:33281 | antimicrobial agent |
| CHEBI has role | CHEBI:36047 | antibacterial drug |
| CHEBI has role | CHEBI:50266 | prodrug |
| CHEBI has role | CHEBI:33282 | antibacterial agent |
| CHEBI has role | CHEBI:35441 | antiinfective agent |
| CHEBI has role | CHEBI:67079 | anti-inflammatory agent |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:49103 | drug metabolite |
Related Drugs by ATC class:
J01DI Other cephalosporins and penems 5 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Pneumonia due to Escherichia coli | indication | 51530003 | |
| Haemophilus influenzae pneumonia | indication | 70036007 | |
| Infection due to Escherichia coli | indication | 71057007 | |
| Rhinoscleroma | indication | 72409005 | DOID:11336 |
| Bacterial infection due to Klebsiella pneumoniae | indication | 186435004 | |
| Pneumococcal pneumonia | indication | 233607000 | |
| Streptococcus pyogenes infection | indication | 302809008 | |
| Infection due to Staphylococcus aureus | indication | 406602003 | |
| Pneumonia due to Staphylococcus aureus | indication | 441658007 | |
| Skin and Skin Structure Streptococcus Agalactiae Infection | indication | ||
| Hemolytic anemia | contraindication | 61261009 | DOID:583 |
| Impaired renal function disorder | contraindication | 197663003 | |
| 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 | 2.48 | acidic |
| pKa2 | 2.96 | acidic |
| pKa3 | 7.53 | acidic |
| pKa4 | 13.05 | acidic |
| pKa5 | 2.0 | Basic |
| pKa6 | 0.14 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 400MG/VIAL | TEFLARO | ABBVIE | N200327 | Oct. 29, 2010 | RX | POWDER | INTRAVENOUS | 8247400 | Feb. 10, 2031 | METHOD OF TREATING BACTERIAL INFECTIONS |
| 600MG/VIAL | TEFLARO | ABBVIE | N200327 | Oct. 29, 2010 | RX | POWDER | INTRAVENOUS | 8247400 | Feb. 10, 2031 | METHOD OF TREATING BACTERIAL INFECTIONS |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial penicillin-binding protein | Enzyme | INHIBITOR | CHEMBL | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4030298 | VUID |
| N0000182256 | NUI |
| D08884 | KEGG_DRUG |
| 229016-73-3 | SECONDARY_CAS_RN |
| 400827-55-6 | SECONDARY_CAS_RN |
| 4030297 | VANDF |
| 4030298 | VANDF |
| 4030305 | VANDF |
| C2001525 | UMLSCUI |
| CHEBI:70714 | CHEBI |
| 1W8 | PDB_CHEM_ID |
| CHEMBL501122 | ChEMBL_ID |
| CHEMBL3544973 | ChEMBL_ID |
| D000097583 | MESH_DESCRIPTOR_UI |
| DB06590 | DRUGBANK_ID |
| 10899 | IUPHAR_LIGAND_ID |
| 8827 | INN_ID |
| 7P6FQA5D21 | UNII |
| 9852981 | PUBCHEM_CID |
| 1040004 | RXNORM |
| 177759 | MMSL |
| 27590 | MMSL |
| 401240 | MMSL |
| d07706 | MMSL |
| 013547 | NDDF |
| 013548 | NDDF |
| 702414006 | SNOMEDCT_US |
| 702415007 | SNOMEDCT_US |
| 714785008 | SNOMEDCT_US |
| C2001521 | UMLSCUI |
| CHEMBL4594371 | ChEMBL_ID |
| 189345-04-8 | SECONDARY_CAS_RN |
| H36Z0FHR8K | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Teflaro | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0456-0400 | POWDER, FOR SOLUTION | 400 mg | INTRAVENOUS | NDA | 28 sections |
| Teflaro | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0456-0400 | POWDER, FOR SOLUTION | 400 mg | INTRAVENOUS | NDA | 28 sections |
| Teflaro | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0456-0600 | POWDER, FOR SOLUTION | 600 mg | INTRAVENOUS | NDA | 28 sections |
| Teflaro | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0456-0600 | POWDER, FOR SOLUTION | 600 mg | INTRAVENOUS | NDA | 28 sections |
| Ceftaroline Fosamil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-6124 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 400 mg | INTRAVENOUS | ANDA | 25 sections |
| Ceftaroline Fosamil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-6125 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 600 mg | INTRAVENOUS | ANDA | 25 sections |