cefepime 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antibiotics, cefalosporanic acid derivatives	535	88040-23-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: cefepime dihydrochloride hydrate cefepime cefepime hydrochloride cefimen tsefepim cefepime HCl	A fourth-generation cephalosporin antibacterial agent that is used in the treatment of infections, including those of the abdomen, urinary tract, respiratory tract, and skin. It is effective against PSEUDOMONAS AERUGINOSA and may also be used in the empiric treatment of FEBRILE NEUTROPENIA. Molecular weight: 480.56 Formula: C19H24N6O5S2 CLOGP: -4.87 LIPINSKI: 1 HAC: 11 HDO: 2 TPSA: 150.04 ALOGS: -4.49 ROTB: 7 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

cefepime dihydrochloride hydrate
cefepime
cefepime hydrochloride
cefimen
tsefepim
cefepime HCl

A fourth-generation cephalosporin antibacterial agent that is used in the treatment of infections, including those of the abdomen, urinary tract, respiratory tract, and skin. It is effective against PSEUDOMONAS AERUGINOSA and may also be used in the empiric treatment of FEBRILE NEUTROPENIA.

Molecular weight: 480.56
Formula: C19H24N6O5S2
CLOGP: -4.87
LIPINSKI: 1
HAC: 11
HDO: 2
TPSA: 150.04
ALOGS: -4.49
ROTB: 7

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
4	g	P

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	99 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
EoM (Fraction excreted unchanged in urine)	85 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
CL (Clearance)	2.20 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.90 hours	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.78 %	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.28 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Jan. 18, 1996	FDA	HOSPIRA INC

FDA Adverse Event Reporting System (Female)

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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
Encephalopathy	462.19	18.80	217	16214	38403	63434188
Acute kidney injury	337.13	18.80	376	16055	263039	63209552
Febrile neutropenia	294.20	18.80	244	16187	118205	63354386
Neurotoxicity	239.25	18.80	107	16324	16883	63455708
Drug reaction with eosinophilia and systemic symptoms	219.15	18.80	126	16305	33710	63438881
Status epilepticus	208.31	18.80	94	16337	15139	63457452
Multiple organ dysfunction syndrome	172.95	18.80	132	16299	56620	63415971
Cytokine release syndrome	160.51	18.80	77	16354	14237	63458354
Myoclonus	144.22	18.80	74	16357	15794	63456797
Sepsis	143.44	18.80	187	16244	152936	63319655

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FDA Adverse Event Reporting System (Male)

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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
Encephalopathy	248.14	16.07	191	21117	35128	34900495
Acute kidney injury	247.87	16.07	561	20747	304427	34631196
Neurotoxicity	192.78	16.07	126	21182	17884	34917739
Cytokine release syndrome	178.97	16.07	132	21176	22745	34912878
Febrile neutropenia	172.39	16.07	303	21005	136546	34799077
Drug reaction with eosinophilia and systemic symptoms	163.83	16.07	146	21162	32866	34902757
Septic shock	131.68	16.07	189	21119	71645	34863978
Respiratory failure	102.67	16.07	213	21095	108359	34827264
Multiple organ dysfunction syndrome	102.03	16.07	174	21134	76392	34859231
Pyrexia	89.49	16.07	420	20888	332593	34603030

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FDA Adverse Event Reporting System (Geriatric)

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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
Encephalopathy	641.01	15.98	390	35219	67007	79641772
Acute kidney injury	540.85	15.98	887	34722	518517	79190262
Neurotoxicity	415.02	15.98	228	35381	32290	79676489
Febrile neutropenia	393.00	15.98	499	35110	230500	79478279
Drug reaction with eosinophilia and systemic symptoms	351.41	15.98	264	35345	63980	79644799
Cytokine release syndrome	336.01	15.98	206	35403	35792	79672987
Septic shock	238.65	15.98	284	35325	122517	79586262
Multiple organ dysfunction syndrome	213.98	15.98	266	35343	119980	79588799
Status epilepticus	210.19	15.98	134	35475	24907	79683872
Myoclonus	190.90	15.98	131	35478	27529	79681250

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	J01DE01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER BETA-LACTAM ANTIBACTERIALS Fourth-generation cephalosporins
ATC	J01RA06	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE COMBINATIONS OF ANTIBACTERIALS Combinations of antibacterials
CHEBI has role	CHEBI:36047	antibacterial drugs
FDA CS	M0003827	Cephalosporins
FDA EPC	N0000175488	Cephalosporin Antibacterial
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Infection due to Pseudomonas aeruginosa	indication	11218009
Pneumonia due to Streptococcus	indication	34020007
Pneumonia due to Pseudomonas	indication	41381004
Bacterial pneumonia	indication	53084003	DOID:874
Klebsiella cystitis	indication	60867007
Infectious disease of abdomen	indication	128070006
Bacterial infection due to Klebsiella pneumoniae	indication	186435004
Bacterial peritonitis	indication	197171003
Pneumococcal pneumonia	indication	233607000
Escherichia coli urinary tract infection	indication	301011002

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.32	acidic
pKa2	13.31	acidic
pKa3	3.1	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Bacterial penicillin-binding protein	Enzyme		PBPA_ECOLI PBPB_ECOLI DACC_ECOLI PBP2_ECOLI FTSI_ECOLI DACA_ECOLI DACB_ECOLI	INHIBITOR				CHEMBL	CHEMBL

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External reference:

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ID	Source
9WT	PDB_CHEM_ID
004974	NDDF
004975	NDDF
10772	IUPHAR_LIGAND_ID
116681	MMSL
123171-59-5	SECONDARY_CAS_RN
20481	RXNORM
370370003	SNOMEDCT_US
370371004	SNOMEDCT_US
4020908	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Cefepime	HUMAN PRESCRIPTION DRUG LABEL	1	0338-1301	INJECTION, SOLUTION	1 g	INTRAVENOUS	NDA	28 sections
Cefepime	HUMAN PRESCRIPTION DRUG LABEL	1	0338-1301	INJECTION, SOLUTION	1 g	INTRAVENOUS	NDA	28 sections
Cefepime	HUMAN PRESCRIPTION DRUG LABEL	1	0338-1301	INJECTION, SOLUTION	1 g	INTRAVENOUS	NDA	28 sections
Cefepime	HUMAN PRESCRIPTION DRUG LABEL	1	0338-1301	INJECTION, SOLUTION	1 g	INTRAVENOUS	NDA	28 sections
Cefepime	HUMAN PRESCRIPTION DRUG LABEL	1	0409-9566	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	27 sections
Cefepime	HUMAN PRESCRIPTION DRUG LABEL	1	0409-9566	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	27 sections
Cefepime	HUMAN PRESCRIPTION DRUG LABEL	1	0409-9735	INJECTION, POWDER, FOR SOLUTION	2 g	INTRAVENOUS	ANDA	27 sections
Cefepime	HUMAN PRESCRIPTION DRUG LABEL	1	0409-9735	INJECTION, POWDER, FOR SOLUTION	2 g	INTRAVENOUS	ANDA	27 sections
cefepime	HUMAN PRESCRIPTION DRUG LABEL	1	25021-121	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	29 sections
cefepime	HUMAN PRESCRIPTION DRUG LABEL	1	25021-121	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	29 sections

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