U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ABSOLUTE
Molecular Formula C15H14ClN3O4S.H2O
Molecular Weight 385.8242
Optical Activity UNSPECIFIED
Defined Stereocenters 3 / 3
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of CEFACLOR

SMILES

c1ccc(cc1)[C@]([H])(C(=N[C@]2([H])C(=O)N3C(=C(CS[C@]23[H])Cl)C(=O)O)O)N.O

InChI

InChIKey=WKJGTOYAEQDNIA-IOOZKYRYSA-N
InChI=1S/C15H14ClN3O4S.H2O/c16-8-6-24-14-10(13(21)19(14)11(8)15(22)23)18-12(20)9(17)7-4-2-1-3-5-7;/h1-5,9-10,14H,6,17H2,(H,18,20)(H,22,23);1H2/t9-,10-,14-;/m1./s1

HIDE SMILES / InChI

Molecular Formula H2O
Molecular Weight 18.0153
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Molecular Formula C15H14ClN3O4S
Molecular Weight 367.809
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 3 / 3
E/Z Centers 0
Optical Activity UNSPECIFIED

Description
Curator's Comment:: description was created based on several sources, including: https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50521slr027,50522slr027_cefaclor_lbl.pdf | https://www.ncbi.nlm.nih.gov/pubmed/666290

Cefaclor is a semisynthetic cephalosporin antibiotic for oral administration. As with other cephalosporins, the bactericidal action of Cefaclor results from inhibition of cell-wall synthesis. Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes; Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes; Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes; Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci; Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes. Adverse effects considered to be related to therapy with cefaclor are: Hypersensitivity reactions, Rarely, reversible hyperactivity, agitation, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations, somnolence and diarrhea. Patients receiving Cefaclor may show a false-positive reaction for glucose in the urine with tests that use Benedict's and Fehling's solutions and also with Clinitest® tablets. There have been reports of increased anticoagulant effect when Cefaclor and oral anticoagulants were administered concomitantly.

Approval Year

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Curative
CEFACLOR

Approved Use

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefaclor extended-release tablets USP and other antibacterial drugs, cefaclor extended-release tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The safety and effectiveness of cefaclor extended-release tablets in treating some of the indications and pathogens for which other formulations of cefaclor are approved have NOT been established. When administered at the recommended dosages and durations of therapy, cefaclor extended-release tablets are indicated for the treatment of patients with the following mild to moderate infections when caused by susceptible strains of the designated organisms. (See DOSAGE AND ADMINISTRATION and CLINICAL STUDIES sections.) Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae (excluding ß-lactamase-negative, ampicillin-resistant strains), Moraxella catarrhalis, or Streptococcus pneumoniae. NOTE: In view of the insufficient numbers of isolates of ß-lactamase-producing strains of Haemophilus influenzae that were obtained from clinical trials with cefaclor extended-release tablets for patients with acute bacterial exacerbations of chronic bronchitis or secondary bacterial infections of acute bronchitis, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for bronchitis known, suspected, or considered potentially to be caused by ß-lactamase-producing H. influenzae. Secondary bacterial infections of acute bronchitis due to Haemophilus influenzae (excluding ß-lactamase-negative, ampicillin-resistant strains), Moraxella catarrhalis, or Streptococcus pneumoniae. (See above NOTE.) Pharyngitis and tonsillitis due to Streptococcus pyogenes. NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefaclor extended-release tablets are generally effective in the eradication of S. pyogenes from the oropharynx; however, data establishing the efficacy of cefaclor extended-release tablets for the prophylaxis of subsequent rheumatic fever are not available. Uncomplicated skin and skin and structure infections due to Staphylococcus aureus (methicillin-susceptible only). NOTE: In view of the insufficient numbers of isolates of Streptococcus pyogenes that were obtained from clinical trials with cefaclor extended-release tablets for patients with uncomplicated skin and skin structure infections, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for skin infections known, suspected, or considered potentially to be caused by S. pyogenes.

Launch Date

1.03109761E12
Curative
CEFACLOR

Approved Use

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefaclor extended-release tablets USP and other antibacterial drugs, cefaclor extended-release tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The safety and effectiveness of cefaclor extended-release tablets in treating some of the indications and pathogens for which other formulations of cefaclor are approved have NOT been established. When administered at the recommended dosages and durations of therapy, cefaclor extended-release tablets are indicated for the treatment of patients with the following mild to moderate infections when caused by susceptible strains of the designated organisms. (See DOSAGE AND ADMINISTRATION and CLINICAL STUDIES sections.) Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae (excluding ß-lactamase-negative, ampicillin-resistant strains), Moraxella catarrhalis, or Streptococcus pneumoniae. NOTE: In view of the insufficient numbers of isolates of ß-lactamase-producing strains of Haemophilus influenzae that were obtained from clinical trials with cefaclor extended-release tablets for patients with acute bacterial exacerbations of chronic bronchitis or secondary bacterial infections of acute bronchitis, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for bronchitis known, suspected, or considered potentially to be caused by ß-lactamase-producing H. influenzae. Secondary bacterial infections of acute bronchitis due to Haemophilus influenzae (excluding ß-lactamase-negative, ampicillin-resistant strains), Moraxella catarrhalis, or Streptococcus pneumoniae. (See above NOTE.) Pharyngitis and tonsillitis due to Streptococcus pyogenes. NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefaclor extended-release tablets are generally effective in the eradication of S. pyogenes from the oropharynx; however, data establishing the efficacy of cefaclor extended-release tablets for the prophylaxis of subsequent rheumatic fever are not available. Uncomplicated skin and skin and structure infections due to Staphylococcus aureus (methicillin-susceptible only). NOTE: In view of the insufficient numbers of isolates of Streptococcus pyogenes that were obtained from clinical trials with cefaclor extended-release tablets for patients with uncomplicated skin and skin structure infections, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for skin infections known, suspected, or considered potentially to be caused by S. pyogenes.

Launch Date

1.03109761E12
Curative
CEFACLOR

Approved Use

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefaclor extended-release tablets USP and other antibacterial drugs, cefaclor extended-release tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The safety and effectiveness of cefaclor extended-release tablets in treating some of the indications and pathogens for which other formulations of cefaclor are approved have NOT been established. When administered at the recommended dosages and durations of therapy, cefaclor extended-release tablets are indicated for the treatment of patients with the following mild to moderate infections when caused by susceptible strains of the designated organisms. (See DOSAGE AND ADMINISTRATION and CLINICAL STUDIES sections.) Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae (excluding ß-lactamase-negative, ampicillin-resistant strains), Moraxella catarrhalis, or Streptococcus pneumoniae. NOTE: In view of the insufficient numbers of isolates of ß-lactamase-producing strains of Haemophilus influenzae that were obtained from clinical trials with cefaclor extended-release tablets for patients with acute bacterial exacerbations of chronic bronchitis or secondary bacterial infections of acute bronchitis, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for bronchitis known, suspected, or considered potentially to be caused by ß-lactamase-producing H. influenzae. Secondary bacterial infections of acute bronchitis due to Haemophilus influenzae (excluding ß-lactamase-negative, ampicillin-resistant strains), Moraxella catarrhalis, or Streptococcus pneumoniae. (See above NOTE.) Pharyngitis and tonsillitis due to Streptococcus pyogenes. NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefaclor extended-release tablets are generally effective in the eradication of S. pyogenes from the oropharynx; however, data establishing the efficacy of cefaclor extended-release tablets for the prophylaxis of subsequent rheumatic fever are not available. Uncomplicated skin and skin and structure infections due to Staphylococcus aureus (methicillin-susceptible only). NOTE: In view of the insufficient numbers of isolates of Streptococcus pyogenes that were obtained from clinical trials with cefaclor extended-release tablets for patients with uncomplicated skin and skin structure infections, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for skin infections known, suspected, or considered potentially to be caused by S. pyogenes.

Launch Date

1.03109761E12
Curative
CEFACLOR

Approved Use

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefaclor extended-release tablets USP and other antibacterial drugs, cefaclor extended-release tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The safety and effectiveness of cefaclor extended-release tablets in treating some of the indications and pathogens for which other formulations of cefaclor are approved have NOT been established. When administered at the recommended dosages and durations of therapy, cefaclor extended-release tablets are indicated for the treatment of patients with the following mild to moderate infections when caused by susceptible strains of the designated organisms. (See DOSAGE AND ADMINISTRATION and CLINICAL STUDIES sections.) Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae (excluding ß-lactamase-negative, ampicillin-resistant strains), Moraxella catarrhalis, or Streptococcus pneumoniae. NOTE: In view of the insufficient numbers of isolates of ß-lactamase-producing strains of Haemophilus influenzae that were obtained from clinical trials with cefaclor extended-release tablets for patients with acute bacterial exacerbations of chronic bronchitis or secondary bacterial infections of acute bronchitis, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for bronchitis known, suspected, or considered potentially to be caused by ß-lactamase-producing H. influenzae. Secondary bacterial infections of acute bronchitis due to Haemophilus influenzae (excluding ß-lactamase-negative, ampicillin-resistant strains), Moraxella catarrhalis, or Streptococcus pneumoniae. (See above NOTE.) Pharyngitis and tonsillitis due to Streptococcus pyogenes. NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefaclor extended-release tablets are generally effective in the eradication of S. pyogenes from the oropharynx; however, data establishing the efficacy of cefaclor extended-release tablets for the prophylaxis of subsequent rheumatic fever are not available. Uncomplicated skin and skin and structure infections due to Staphylococcus aureus (methicillin-susceptible only). NOTE: In view of the insufficient numbers of isolates of Streptococcus pyogenes that were obtained from clinical trials with cefaclor extended-release tablets for patients with uncomplicated skin and skin structure infections, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for skin infections known, suspected, or considered potentially to be caused by S. pyogenes.

Launch Date

1.03109761E12
Curative
CEFACLOR

Approved Use

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefaclor extended-release tablets USP and other antibacterial drugs, cefaclor extended-release tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The safety and effectiveness of cefaclor extended-release tablets in treating some of the indications and pathogens for which other formulations of cefaclor are approved have NOT been established. When administered at the recommended dosages and durations of therapy, cefaclor extended-release tablets are indicated for the treatment of patients with the following mild to moderate infections when caused by susceptible strains of the designated organisms. (See DOSAGE AND ADMINISTRATION and CLINICAL STUDIES sections.) Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae (excluding ß-lactamase-negative, ampicillin-resistant strains), Moraxella catarrhalis, or Streptococcus pneumoniae. NOTE: In view of the insufficient numbers of isolates of ß-lactamase-producing strains of Haemophilus influenzae that were obtained from clinical trials with cefaclor extended-release tablets for patients with acute bacterial exacerbations of chronic bronchitis or secondary bacterial infections of acute bronchitis, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for bronchitis known, suspected, or considered potentially to be caused by ß-lactamase-producing H. influenzae. Secondary bacterial infections of acute bronchitis due to Haemophilus influenzae (excluding ß-lactamase-negative, ampicillin-resistant strains), Moraxella catarrhalis, or Streptococcus pneumoniae. (See above NOTE.) Pharyngitis and tonsillitis due to Streptococcus pyogenes. NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefaclor extended-release tablets are generally effective in the eradication of S. pyogenes from the oropharynx; however, data establishing the efficacy of cefaclor extended-release tablets for the prophylaxis of subsequent rheumatic fever are not available. Uncomplicated skin and skin and structure infections due to Staphylococcus aureus (methicillin-susceptible only). NOTE: In view of the insufficient numbers of isolates of Streptococcus pyogenes that were obtained from clinical trials with cefaclor extended-release tablets for patients with uncomplicated skin and skin structure infections, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for skin infections known, suspected, or considered potentially to be caused by S. pyogenes.

Launch Date

1.03109761E12
Curative
CEFACLOR

Approved Use

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefaclor extended-release tablets USP and other antibacterial drugs, cefaclor extended-release tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The safety and effectiveness of cefaclor extended-release tablets in treating some of the indications and pathogens for which other formulations of cefaclor are approved have NOT been established. When administered at the recommended dosages and durations of therapy, cefaclor extended-release tablets are indicated for the treatment of patients with the following mild to moderate infections when caused by susceptible strains of the designated organisms. (See DOSAGE AND ADMINISTRATION and CLINICAL STUDIES sections.) Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae (excluding ß-lactamase-negative, ampicillin-resistant strains), Moraxella catarrhalis, or Streptococcus pneumoniae. NOTE: In view of the insufficient numbers of isolates of ß-lactamase-producing strains of Haemophilus influenzae that were obtained from clinical trials with cefaclor extended-release tablets for patients with acute bacterial exacerbations of chronic bronchitis or secondary bacterial infections of acute bronchitis, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for bronchitis known, suspected, or considered potentially to be caused by ß-lactamase-producing H. influenzae. Secondary bacterial infections of acute bronchitis due to Haemophilus influenzae (excluding ß-lactamase-negative, ampicillin-resistant strains), Moraxella catarrhalis, or Streptococcus pneumoniae. (See above NOTE.) Pharyngitis and tonsillitis due to Streptococcus pyogenes. NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefaclor extended-release tablets are generally effective in the eradication of S. pyogenes from the oropharynx; however, data establishing the efficacy of cefaclor extended-release tablets for the prophylaxis of subsequent rheumatic fever are not available. Uncomplicated skin and skin and structure infections due to Staphylococcus aureus (methicillin-susceptible only). NOTE: In view of the insufficient numbers of isolates of Streptococcus pyogenes that were obtained from clinical trials with cefaclor extended-release tablets for patients with uncomplicated skin and skin structure infections, it was not possible to adequately evaluate the effectiveness of cefaclor extended-release tablets for skin infections known, suspected, or considered potentially to be caused by S. pyogenes.

Launch Date

1.03109761E12
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
17.3 μg/mL
250 mg single, oral
dose: 250 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CEFACLOR plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
17.5 μg × h/mL
250 mg single, oral
dose: 250 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CEFACLOR plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
0.6 h
250 mg single, oral
dose: 250 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CEFACLOR plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
Doses

Doses

DosePopulationAdverse events​
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Condition: infections
Age Group: adult
Sources:
Other AEs: Hypersensitivity...
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
n = 200
Health Status: unhealthy
Condition: infections
Age Group: adult
Population Size: 200
Sources:
Other AEs: Creatinine serum increased...
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
n = 40
Health Status: unhealthy
Condition: infections
Age Group: adult
Population Size: 40
Sources:
Other AEs: Aspartate aminotransferase increased, ALT increased...
Other AEs:
Aspartate aminotransferase increased (1 patient)
ALT increased (1 patient)
Sources:
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
n = 50
Health Status: unhealthy
Condition: infections
Age Group: adult
Population Size: 50
Sources:
Other AEs: Eosinophilia, Pruritus genital...
Other AEs:
Eosinophilia (1 patient)
Pruritus genital (1 patient)
Moniliasis (1 patient)
Vaginitis (1 patient)
Sources:
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
n = 500
Health Status: unhealthy
Condition: infections
Age Group: adult
Population Size: 500
Sources:
Other AEs: Alkaline phosphatase increased, Blood urea increased...
Other AEs:
Alkaline phosphatase increased (1 patient)
Blood urea increased (1 patient)
Sources:
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
n = 70
Health Status: unhealthy
Condition: infections
Age Group: adult
Population Size: 70
Sources:
Other AEs: Diarrhea...
20 mg/kg/day 3 times / day steady, oral
Dose: 20 mg/kg/day, 3 times / day
Route: oral
Route: steady
Dose: 20 mg/kg/day, 3 times / day
Sources:
unhealthy, pediatric
Health Status: unhealthy
Condition: infections
Age Group: pediatric
Sources:
Other AEs: Reaction serum sickness-like...
AEs

AEs

AESignificanceDosePopulation
Hypersensitivity 1.5%
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Condition: infections
Age Group: adult
Sources:
Creatinine serum increased 1 patient
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
n = 200
Health Status: unhealthy
Condition: infections
Age Group: adult
Population Size: 200
Sources:
ALT increased 1 patient
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
n = 40
Health Status: unhealthy
Condition: infections
Age Group: adult
Population Size: 40
Sources:
Aspartate aminotransferase increased 1 patient
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
n = 40
Health Status: unhealthy
Condition: infections
Age Group: adult
Population Size: 40
Sources:
Eosinophilia 1 patient
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
n = 50
Health Status: unhealthy
Condition: infections
Age Group: adult
Population Size: 50
Sources:
Moniliasis 1 patient
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
n = 50
Health Status: unhealthy
Condition: infections
Age Group: adult
Population Size: 50
Sources:
Pruritus genital 1 patient
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
n = 50
Health Status: unhealthy
Condition: infections
Age Group: adult
Population Size: 50
Sources:
Vaginitis 1 patient
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
n = 50
Health Status: unhealthy
Condition: infections
Age Group: adult
Population Size: 50
Sources:
Alkaline phosphatase increased 1 patient
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
n = 500
Health Status: unhealthy
Condition: infections
Age Group: adult
Population Size: 500
Sources:
Blood urea increased 1 patient
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
n = 500
Health Status: unhealthy
Condition: infections
Age Group: adult
Population Size: 500
Sources:
Diarrhea 1 patient
250 mg 3 times / day steady, oral
Dose: 250 mg, 3 times / day
Route: oral
Route: steady
Dose: 250 mg, 3 times / day
Sources:
unhealthy, adult
n = 70
Health Status: unhealthy
Condition: infections
Age Group: adult
Population Size: 70
Sources:
Reaction serum sickness-like 0.5%
20 mg/kg/day 3 times / day steady, oral
Dose: 20 mg/kg/day, 3 times / day
Route: oral
Route: steady
Dose: 20 mg/kg/day, 3 times / day
Sources:
unhealthy, pediatric
Health Status: unhealthy
Condition: infections
Age Group: pediatric
Sources:
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG

OverviewOther

Other InhibitorOther SubstrateOther Inducer






Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
yes [Ki 1150 uM]
yes [Ki 65 uM]
Drug as victim
Sourcing

Sourcing

Vendor/AggregatorIDURL
PubMed

PubMed

TitleDatePubMed
Levofloxacin: an updated review of its use in the treatment of bacterial infections.
2002
Immunoglobulin E binding determinants on beta-lactam drugs.
2002 Aug
[Antibacterial activity of cefpodoxime against clinical isolates in 2000 and 2001].
2002 Dec
An unusual abdominal mass in a renal transplant recipient.
2002 Dec
Comparative efficacy and safety of 5-day cefaclor and 10-day amoxycillin treatment of group A streptococcal pharyngitis in children.
2002 Jul
Effect of a short course of clarithromycin therapy on sputum production in patients with chronic airway hypersecretion.
2002 Jul
Antibacterial activity of oral antibiotics against community-acquired respiratory pathogens from three European countries.
2002 Jul
[Microbiological and clinical studies of Haemophilus influenzae isolated at Kitakyushu Municipal Medical Center from 1996 through 1999].
2002 Jun
The fecal microflora of 1-3-month-old infants during treatment with eight oral antibiotics.
2002 Jun
Susceptibility change to antibiotics of Staphylococcus aureus strains isolated from skin infections between July 1994 and November 2000.
2002 Jun
Trends in antimicrobial susceptibility of the Streptococcus milleri group.
2002 Jun
[Urinary antimicrobial prophylaxis].
2002 May
beta-Lactam allergenic determinants: fine structural recognition of a cross-reacting determinant on benzylpenicillin and cephalothin.
2002 Nov
A case of purpuric drug eruption due to cefaclor.
2002 Nov
An evaluation of cefaclor in Pakistani children with pharyngotonsillitis.
2002 Oct
[Antimicrobial susceptibility of Streptococcus pneumoniae and Haemophilus influenzae isolated in major hospitals in Nagano Prefecture].
2002 Oct
Cefaclor induced serum sickness like reaction.
2002 Oct
Mycobacterium bohemicum cervical lymphadenitis.
2002 Oct
The Italian Epidemiological Survey 1997-1999. Antimicrobial susceptibility data of Haemophilus influenzae, Haemophilus parainfluenzae and Moraxella catarrhalis in Italy.
2002 Oct
Natural antibiotic susceptibility of Enterobacter amnigenus, Enterobacter cancerogenus, Enterobacter gergoviae and Enterobacter sakazakii strains.
2002 Sep
Antimicrobial resistance amongst isolates of Streptococcus pyogenes and Staphylococcus aureus in the PROTEKT antimicrobial surveillance programme during 1999-2000.
2002 Sep
Antimicrobial action of Nitens mouthwash (cetyltrimethylammonium naproxenate) on multiple isolates of pharyngeal microbes: a controlled study against chlorhexidine, benzydamine, hexetidine, amoxicillin, amoxicillin-clavulanate, clarithromycin, and cefaclor.
2002 Sep
Synthesis and biological activity of tris- and tetrakiscatecholate siderophores based on poly-aza alkanoic acids or alkylbenzoic acids and their conjugates with beta-lactam antibiotics.
2003
Drainage of liver abscess via laparoscopic trocar with local anesthesia.
2003 Apr
Natural antimicrobial susceptibilities of strains of 'unusual' Serratia species: S. ficaria, S. fonticola, S. odorifera, S. plymuthica and S. rubidaea.
2003 Apr
Serotype distribution and antimicrobial resistance patterns in Streptococcus pneumoniae isolates from hospitalized pediatric patients with respiratory infections in Shanghai, China.
2003 Aug
Modelling and analysing exchangeable binary data with random cluster sizes.
2003 Aug 15
Natural antibiotic susceptibility of Proteus spp., with special reference to P. mirabilis and P. penneri strains.
2003 Feb
Low plasma cefaclor levels in cystectomized bladder cancer patients with various types of urinary diversion.
2003 Feb
Life-threatening infantile diarrhea from fluoroquinolone-resistant Salmonella enterica typhimurium with mutations in both gyrA and parC.
2003 Feb
[In vitro sensitivity to antimicrobial agents of Haemophilus influenzae strains isolated from clinical specimens].
2003 Jan
[Antibiotic resistance and serotype distribution of Streptococcus pneumoniae strains isolated from patients at Hacettepe University Medical Faculty].
2003 Jan
A case of baboon syndrome associated with group a streptococcal infection.
2003 Jan
Etiology of acute otitis media in childhood and evaluation of two different protocols of antibiotic therapy: 10 days cefaclor vs. 3 days azitromycin.
2003 Jan
Effect of extended-spectrum beta-lactamases on the susceptibility of Haemophilus influenzae to cephalosporins.
2003 Jan
Sensitive determination of a beta-lactam antibiotic, cefaclor by liquid chromatography with chemiluminescence detection.
2003 Jan 15
Determination of cefaclor in human plasma by a sensitive and specific liquid chromatographic-tandem mass spectrometric method.
2003 Jan 25
Natural antibiotic susceptibility of strains of Serratia marcescens and the S. liquefaciens complex: S. liquefaciens sensu stricto, S. proteamaculans and S. grimesii.
2003 Jul
Antimicrobial resistance in Gram-negative bacteria from Intensive Care Units and Urology Services. A nationwide study in The Netherlands 1995-2000.
2003 Jun
Reactive metabolites and adverse drug reactions: clinical considerations.
2003 Jun
How can we predict bacterial eradication?
2003 Mar
A comparative study of cefaclor vs amoxicillin/clavulanate in pediatric pharyngotonsillitis.
2003 Mar
[Sensitivity of Haemophilus influenzae isolates in Spain to 17 oral antibiotics].
2003 Mar
Effect of computerised prescribing on use of antibiotics.
2003 Mar 3
Surveillance of antibiotic resistance in clinical isolates of Streptococcus pneumoniae collected in Belgium during winter 2000-2001.
2003 Mar-Apr
[Report of questionnaire survey for methicillin-resistant Staphylococcus aureus and penisillin-resistant Streptococcus pneumoniae between 1998 and 2000 in the Kinki district].
2003 May
Antibiotic prophylaxis by low-dose cefaclor in children with vesicoureteral reflux.
2003 May
Rapid and sensitive high-performance liquid chromatographic determination of four cephalosporin antibiotics in pharmaceuticals and body fluids.
2003 May 5
[Hypersensitivity reactions to beta-lactam antibiotics in childhood].
2003 May-Jun
Diversity of ampicillin-resistance genes in Haemophilus influenzae in Japan and the United States.
2003 Spring
Patents

Sample Use Guides

The usual adult dosage is 250 mg every 8 hours. For more severe infections (such as pneumonia) or those caused by less susceptible organisms, doses may be doubled.
Route of Administration: Oral
In Vitro Use Guide
Cefaclor inhibits the gram-negative bacteria. At a level of 12.5 ug/ml, 73% of the E. coli, 90% of the Salmonella, 55% of the Shigella, 77% of the Citrobacter, 91% of the Klebsiella, and 75% of the P. mirabilis isolates were inhibited. However, only 18% of the Enterobacter, 3% of the Serratia, 9% of the Proteus morganii, and 16% of the Providencia strains, and less than 10% of the Proteus vulgaris, Proteus rettgeri, and Bacteroides fragilis isolates, were inhibited. All Pseudomonas strains were as resistant to cefaclor as they were to available cephalosporins.
Substance Class Chemical
Created
by admin
on Fri Jun 25 21:01:29 UTC 2021
Edited
by admin
on Fri Jun 25 21:01:29 UTC 2021
Record UNII
69K7K19H4L
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
CEFACLOR
EP   MART.   ORANGE BOOK   USAN   USP   USP-RS   VANDF  
USAN  
Official Name English
COMPOUND 99638
Code English
J01DC04
Code English
CEFACLOR MONOHYDRATE [VANDF]
Common Name English
(6R,7R)-7-((R)-2-AMINO-2-PHENYLACETAMIDO)-3-CHLORO-8-OXO-5-THIA-1-AZABICYCLO(4.2.0)OCT-2-ENE-2-CARBOXYLIC ACID MONOHYDRATE
Systematic Name English
CEFACLOR [VANDF]
Common Name English
CEFACLOR MONOHYDRATE [WHO-DD]
Common Name English
CECLOR
Brand Name English
CEFACLOR MONOHYDRATE [MI]
Common Name English
CEFACLOR MONOHYDRATE
MI   VANDF   WHO-DD  
Common Name English
COMPOUND-99638
Code English
CEFACLOR [USAN]
Common Name English
CEFACLOR [USP-RS]
Common Name English
CEFACLOR [ORANGE BOOK]
Common Name English
CEFACLOR [MART.]
Common Name English
CEFACLOR [EP MONOGRAPH]
Common Name English
3-CHLORO-7-D-(2-PHENYLGLYCINAMIDO)-3-CEPHEM-4-CARBOXYLIC ACID MONOHYDRATE
Common Name English
CEFACLOR [USP]
Common Name English
NSC-757422
Code English
5-THIA-1-AZABICYCLO(4.2.0)OCT-2-ENE-2-CARBOXYLIC ACID, 7-((AMINOPHENYLACETYL)AMINO)-3-CHLORO-8-OXO-, MONOHYDRATE, (6R-(6.ALPHA.,7.BETA.(R*)))-
Common Name English
RANICLOR
Brand Name English
Classification Tree Code System Code
WHO-VATC QJ01DC04
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
NDF-RT N0000175488
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
NCI_THESAURUS C357
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
WHO-ATC J01DC04
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
LIVERTOX 158
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
Code System Code Type Description
DRUG BANK
DB00833
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
PRIMARY
WIKIPEDIA
CEFACLOR
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
PRIMARY
PUBCHEM
51038
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
PRIMARY
EVMPD
SUB13271MIG
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
PRIMARY
ChEMBL
CHEMBL680
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
PRIMARY
FDA UNII
69K7K19H4L
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
PRIMARY
NCI_THESAURUS
C28911
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
PRIMARY
DRUG CENTRAL
525
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
PRIMARY
CAS
70356-03-5
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
PRIMARY
LACTMED
Cefaclor
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
PRIMARY
USP_CATALOG
1096906
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
PRIMARY USP-RS
MERCK INDEX
M3184
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
PRIMARY Merck Index
MESH
D002433
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
PRIMARY
RXCUI
2176
Created by admin on Fri Jun 25 21:01:29 UTC 2021 , Edited by admin on Fri Jun 25 21:01:29 UTC 2021
PRIMARY RxNorm
Related Record Type Details
BINDER->LIGAND
BINDING
PARENT -> SALT/SOLVATE
TRANSPORTER -> INHIBITOR
Related Record Type Details
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Biological Half-life PHARMACOKINETIC