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	645.37	29.13	322	3269	310365	63175066
Cross sensitivity reaction	459.27	29.13	83	3508	2079	63483352
Type IV hypersensitivity reaction	441.25	29.13	84	3507	2814	63482617
International normalised ratio fluctuation	416.08	29.13	78	3513	2400	63483031
Bloody discharge	306.22	29.13	56	3535	1495	63483936
Lyme disease	255.91	29.13	55	3536	3394	63482037
Rash maculo-papular	166.75	29.13	64	3527	31832	63453599
Therapeutic product effect incomplete	107.44	29.13	74	3517	124982	63360449
Infection	90.45	29.13	86	3505	229087	63256344
Oedema	70.44	29.13	52	3539	97570	63387861
Drug intolerance	62.89	29.13	82	3509	308579	63176852
Iron deficiency	62.18	29.13	21	3570	7209	63478222
Muscle tension dysphonia	43.97	29.13	8	3583	206	63485225
Platelet count increased	43.96	29.13	21	3570	17690	63467741
Dysphemia	40.65	29.13	12	3579	2663	63482768
Toxic epidermal necrolysis	36.87	29.13	21	3570	25313	63460118
Clostridium difficile infection	36.18	29.13	22	3569	29900	63455531
Urticaria	33.56	29.13	44	3547	165758	63319673
Vomiting	32.03	29.13	86	3505	559531	62925900
Vaccination complication	30.39	29.13	8	3583	1169	63484262
Immunisation reaction	30.01	29.13	7	3584	623	63484808
Oral pruritus	29.31	29.13	9	3582	2282	63483149

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	98.32	28.60	19	982	1378	34954552
Type IV hypersensitivity reaction	91.70	28.60	18	983	1416	34954514
Drug hypersensitivity	47.09	28.60	29	972	80500	34875430
Complex regional pain syndrome	35.51	28.60	7	994	560	34955370
Medical device implantation	28.92	28.60	6	995	620	34955310

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	537.28	27.62	102	4114	3610	79736562
Type IV hypersensitivity reaction	527.63	27.62	102	4114	3979	79736193
Drug hypersensitivity	517.07	27.62	269	3947	298647	79441525
International normalised ratio fluctuation	401.44	27.62	79	4137	3375	79736797
Bloody discharge	297.05	27.62	56	4160	1897	79738275
Lyme disease	261.14	27.62	55	4161	3295	79736877
Rash maculo-papular	170.89	27.62	75	4141	56003	79684169
Therapeutic product effect incomplete	105.84	27.62	75	4141	141570	79598602
Infection	97.21	27.62	89	4127	241623	79498549
Oedema	95.56	27.62	66	4150	119514	79620658
Drug intolerance	75.90	27.62	81	4135	264038	79476134
Iron deficiency	52.00	27.62	20	4196	10634	79729538
Vomiting	41.18	27.62	101	4115	665727	79074445
Platelet count increased	40.61	27.62	21	4195	22385	79717787
Urticaria	39.88	27.62	49	4167	185152	79555020
Toxic epidermal necrolysis	38.84	27.62	26	4190	44555	79695617
Muscle tension dysphonia	32.90	27.62	6	4210	168	79740004

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
203635	RXNORM
C0007537	UMLSCUI
CHEBI:3478	CHEBI
8XI	PDB_CHEM_ID
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
387270009	SNOMEDCT_US
4937008	SNOMEDCT_US
4017534	VANDF
70356-03-5	SECONDARY_CAS_RN
002726	NDDF

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	23594-125	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	23594-250	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	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