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

Stem definition	Drug id	CAS RN
antibiotics, cefalosporanic acid derivatives	525	53994-73-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: cefaclor alfacet ceclor cephaclor distaclor losefar cefaclor hydrate	Semisynthetic, broad-spectrum antibiotic derivative of CEPHALEXIN. Molecular weight: 367.80 Formula: C15H14ClN3O4S CLOGP: -1.64 LIPINSKI: 0 HAC: 7 HDO: 3 TPSA: 112.73 ALOGS: -3.24 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

cefaclor
alfacet
ceclor
cephaclor
distaclor
losefar
cefaclor hydrate

Semisynthetic, broad-spectrum antibiotic derivative of CEPHALEXIN.

Molecular weight: 367.80
Formula: C15H14ClN3O4S
CLOGP: -1.64
LIPINSKI: 0
HAC: 7
HDO: 3
TPSA: 112.73
ALOGS: -3.24
ROTB: 4

Status: OFP

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)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	8.59 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	52 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	67.97 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	90 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
April 4, 1979	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
Drug hypersensitivity	657.39	28.88	312	2830	274893	56014032
Cross sensitivity reaction	465.93	28.88	83	3059	1942	56286983
Type IV hypersensitivity reaction	452.38	28.88	84	3058	2492	56286433
International normalised ratio fluctuation	406.53	28.88	76	3066	2338	56286587
Bloody discharge	290.66	28.88	53	3089	1412	56287513
Lyme disease	247.72	28.88	52	3090	2906	56286019
Rash maculo-papular	173.79	28.88	64	3078	28843	56260082
Therapeutic product effect incomplete	114.52	28.88	72	3070	105959	56182966
Infection	97.47	28.88	84	3058	200122	56088803
Oedema	79.36	28.88	52	3090	81868	56207057
Drug intolerance	68.86	28.88	79	3063	264739	56024186
Toxic epidermal necrolysis	39.88	28.88	21	3121	22021	56266904
Vomiting	29.62	28.88	77	3065	498151	55790774
Muscle tension dysphonia	29.47	28.88	5	3137	86	56288839

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
Cross sensitivity reaction	98.85	29.97	19	914	1304	31695107
Type IV hypersensitivity reaction	94.52	29.97	18	915	1175	31695236
Drug hypersensitivity	46.54	29.97	28	905	72571	31623840
Complex regional pain syndrome	35.99	29.97	7	926	508	31695903

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
Cross sensitivity reaction	543.92	26.02	102	3653	3376	70921313
Type IV hypersensitivity reaction	542.27	26.02	102	3653	3433	70921256
Drug hypersensitivity	526.76	26.02	261	3494	262198	70662491
International normalised ratio fluctuation	394.69	26.02	77	3678	3142	70921547
Bloody discharge	284.49	26.02	53	3702	1680	70923009
Lyme disease	251.62	26.02	52	3703	2837	70921852
Rash maculo-papular	178.37	26.02	75	3680	50470	70874219
Therapeutic product effect incomplete	112.25	26.02	73	3682	119809	70804880
Oedema	104.18	26.02	66	3689	103515	70821174
Infection	103.60	26.02	87	3668	210698	70713991
Drug intolerance	82.77	26.02	79	3676	225608	70699081
Toxic epidermal necrolysis	41.66	26.02	26	3729	39531	70885158
Vomiting	35.57	26.02	89	3666	593022	70331667
Urticaria	30.10	26.02	40	3715	163009	70761680

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	J01DC04	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER BETA-LACTAM ANTIBACTERIALS Second-generation cephalosporins
CHEBI has role	CHEBI:36047	antibacterial drugs
CHEBI has role	CHEBI:88188	allergenic drug
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents

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

Disease	Relation	SNOMED_ID	DOID
Infection of skin AND/OR subcutaneous tissue	indication	19824006
Pneumonia due to Streptococcus	indication	34020007
Streptococcal tonsillitis	indication	41582007
Lower respiratory tract infection	indication	50417007
Upper respiratory infection	indication	54150009
Urinary tract infectious disease	indication	68566005
Haemophilus influenzae pneumonia	indication	70036007
Tonsillitis	indication	90176007	DOID:10456
Acute Moraxella catarrhalis bronchitis	indication	195722003
Acute bacterial bronchitis	indication	233598009
Pneumonia	indication	233604007	DOID:552
Streptococcus pyogenes infection	indication	302809008
Infective otitis media	indication	312218008
Pharyngitis	indication	405737000	DOID:2275
Infection due to Staphylococcus aureus	indication	406602003
Moraxella Catarrhalis Chronic Bronchitis	indication
Haemophilus Influenzae Bronchitis	indication
Haemophilus Influenzae Chronic Bronchitis	indication
Streptococcus Pneumoniae Bronchitis	indication
Streptococcus Pneumoniae Chronic Bronchitis	indication
Pyrexia of unknown origin	off-label use	7520000
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	2.02	acidic
pKa2	13.93	acidic
pKa3	7.67	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	UniProt	Action	Type	Activity value (-log[M])	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
Penicillin-binding protein 1A	Enzyme	PBPA_CLOPE				WOMBAT-PK
Streptokinase A	Enzyme	STRP_STRP1		EC50	6.33	WOMBAT-PK

External reference:

ID	Source
4017534	VUID
N0000145917	NUI
D00256	KEGG_DRUG
70356-03-5	SECONDARY_CAS_RN
203635	RXNORM
4017534	VANDF
C0007537	UMLSCUI
CHEBI:3478	CHEBI
CHEMBL680	ChEMBL_ID
CHEMBL1201018	ChEMBL_ID
DB00833	DRUGBANK_ID
D002433	MESH_DESCRIPTOR_UI
51039	PUBCHEM_CID
10897	IUPHAR_LIGAND_ID
69K7K19H4L	UNII
4368	MMSL
862	MMSL
871	MMSL
d00081	MMSL
002726	NDDF
387270009	SNOMEDCT_US
4937008	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1087	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	ANDA	24 sections
CEFACLOR	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9985	CAPSULE	250 mg	ORAL	ANDA	20 sections
CEFACLOR	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9986	CAPSULE	500 mg	ORAL	ANDA	20 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	16571-070	SUSPENSION	125 mg	ORAL	ANDA	23 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	16571-071	SUSPENSION	250 mg	ORAL	ANDA	23 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	16571-072	SUSPENSION	375 mg	ORAL	ANDA	23 sections
CEFACLOR	HUMAN PRESCRIPTION DRUG LABEL	1	21695-782	SUSPENSION	250 mg	ORAL	ANDA	21 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	23594-125	FOR SUSPENSION	125 mg	ORAL	ANDA	24 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	23594-250	FOR SUSPENSION	250 mg	ORAL	ANDA	24 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	23594-375	FOR SUSPENSION	375 mg	ORAL	ANDA	24 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	50090-1602	CAPSULE	500 mg	ORAL	ANDA	23 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	54868-3478	CAPSULE	250 mg	ORAL	ANDA	13 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	54868-3511	CAPSULE	500 mg	ORAL	ANDA	13 sections
CEFACLOR	HUMAN PRESCRIPTION DRUG LABEL	1	59115-071	CAPSULE	500 mg	ORAL	ANDA	21 sections
CEFACLOR	HUMAN PRESCRIPTION DRUG LABEL	1	59115-072	CAPSULE	250 mg	ORAL	ANDA	21 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	61442-171	CAPSULE	250 mg	ORAL	ANDA	23 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	61442-172	CAPSULE	500 mg	ORAL	ANDA	23 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	61442-173	SUSPENSION	125 mg	ORAL	ANDA	23 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	61442-174	SUSPENSION	187 mg	ORAL	ANDA	23 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	61442-175	SUSPENSION	250 mg	ORAL	ANDA	23 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	61442-176	SUSPENSION	375 mg	ORAL	ANDA	23 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	63629-1007	CAPSULE	250 mg	ORAL	ANDA	23 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	63629-1008	CAPSULE	500 mg	ORAL	ANDA	23 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	68289-003	CAPSULE	500 mg	ORAL	ANDA	23 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	68289-004	CAPSULE	250 mg	ORAL	ANDA	23 sections
Cefaclor	HUMAN PRESCRIPTION DRUG LABEL	1	81948-6250	SUSPENSION	250 mg	ORAL	ANDA	22 sections