Brand Name
Cefaclor
View Brand InformationFDA approval date: September 26, 2002
Classification: Cephalosporin Antibacterial
Form: Tablet, Suspension, Capsule
What is Cefaclor?
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. Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae. NOTE: In view of the insufficient numbers of isolates of ß-lactamase-producing isolates of Haemophilus influenzae that were obtained from clinical trials with cefaclor extended-release tablets for patients with acute bacterial exacerbations of chronic 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. 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 . 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.
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Brand Information
Cefaclor (Cefaclor)
1DESCRIPTION
Cefaclor, USP is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C
Each 250-mg capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) of anhydrous cefaclor and inactive ingredients: magnesium stearate, sodium starch glycolate, lactose monohydrate, talc. The 250 mg capsule shell contains gelatin, titanium dioxide, FD & C Blue No. 1, FD & C Red No. 3, and imprinting ink components: shellac, strong ammonia solution, potassium hydroxide, black iron oxide, .dehydrated alcohol, isopropyl alcohol, butyl alcohol and propylene glycol.
Each 500-mg capsule contains cefaclor monohydrate equivalent to 500 mg (1.36 mmol) of anhydrous cefaclor and inactive ingredients: magnesium stearate, sodium starch glycolate, lactose monohydrate, talc. The 500 mg capsule shell contains gelatin, titanium dioxide, FD & C Blue No. 1, FD & C Red No. 3, FD & C Yellow No. 6, FD & C Red No. 40, and imprinting ink components: shellac, strong ammonia solution, titanium dioxide, FD & C Blue No. 1 aluminum lake, dehydrated alcohol, isopropyl alcohol, butyl alcohol and propylene glycol.
2CLINICAL PHARMACOLOGY
Cefaclor is well absorbed after oral administration to fasting subjects. Total absorption is the same whether the drug is given with or without food; however, when it is taken with food, the peak concentration achieved is 50% to 75% of that observed when the drug is administered to fasting subjects and generally appears from three fourths to 1 hour later. Following administration of 250-mg, 500-mg, and 1-g doses to fasting subjects, average peak serum levels of approximately 7, 13, and 23 mcg/mL respectively were obtained within 30 to 60 minutes. Approximately 60% to 85% of the drug is excreted unchanged in the urine within 8 hours, the greater portion being excreted within the first 2 hours. During this 8-hour period, peak urine concentrations following the 250-mg, 500-mg and 1-g doses were approximately 600, 900 and 1,900 mc
2.1Microbiology
Mechanism of Action
As with other cephalosporins, the bactericidal action of cefaclor results from inhibition of cell-wall synthesis.
As with other cephalosporins, the bactericidal action of cefaclor results from inhibition of cell-wall synthesis.
Mechanism of Resistance
Resistance to cefaclor is primarily through hydrolysis of beta-lactamases, alteration of penicillin-binding proteins (PBPs) and decreased permeability.
Antibacterial Activity
Cefaclor has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.
Cefaclor has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.
Gram-positive Bacteria
Staphylococcus aureus (methicillin susceptible only)
Coagulase negative staphylococci (methicillin susceptible only)
Streptococcus pneumoniae
Streptococcus pyogenes (group A β-hemolytic streptococci)
Gram-negative Bacteria
Escherichia coli
Haemophilus influenzae (excluding β-lactamase-negative, ampicillin-resistant strains)
Klebsiella spp.
Proteus mirabilis
Escherichia coli
Haemophilus influenzae (excluding β-lactamase-negative, ampicillin-resistant strains)
Klebsiella spp.
Proteus mirabilis
The following
Gram-negative Bacteria
Citrobacter diversus
Moraxella catarrhalis
Neisseria gonorrhoeae
Citrobacter diversus
Moraxella catarrhalis
Neisseria gonorrhoeae
Anaerobic Bacteria
Bacteroides spp.
Peptococcus spp.
Peptostreptococcus spp.
Propionibacterium acnes
Bacteroides spp.
Peptococcus spp.
Peptostreptococcus spp.
Propionibacterium acnes
Susceptibility Testing
For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.
For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.
3INDICATIONS AND USAGE
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
Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains.
Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae,and Streptococcus pyogenes
Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains.
Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes
Note:Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present.
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
Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsule and other antibacterial drugs, Cefaclor Capsule 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.
4CONTRAINDICATION
Cefaclor is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
5WARNINGS
BEFORE THERAPY WITH CEFACLOR IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFACLOR, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG β-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY.
IF AN ALLERGIC REACTION TO CEFACLOR OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
Antibiotics, including cefaclor, should be administered cautiously to any patient who has demonstrated some form of allergy, particularly to drugs.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefaclor, and has ranged in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug effective against
6ADVERSE REACTIONS
Adverse effects considered to be related to therapy with cefaclor are listed below:
Hypersensitivity reactions have been reported in about 1.5% of patients and include morbilliform eruptions (1 in 100). Pruritus, urticaria, and positive Coombs' tests each occur in less than 1 in 200 patients.
Cases of
More severe hypersensitivity reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and anaphylaxis have been reported rarely. Anaphylactoid events may be manifested by solitary symptoms, including angioedema, asthenia, edema (including face and limbs), dyspnea, paresthesias, syncope, hypotension, or vasodilatation. Anaphylaxis may be more common in patients with a history of penicillin allergy.
Rarely, hypersensitivity symptoms may persist for several months.
Gastrointestinal symptoms occur in about 2.5% of patients and include diarrhea (1 in 70).
Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (see
Other effects considered related to therapy included eosinophilia (1 in 50 patients), genital pruritus, moniliasis or vaginitis (about 1 in 50 patients), and, rarely, thrombocytopenia or reversible interstitial nephritis.
Causal Relationship Uncertain –
CNS ─ Rarely, reversible hyperactivity, agitation, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations, and somnolence have been reported.
Transitory abnormalities in clinical laboratory test results have been reported. Although they were of uncertain etiology, they are listed below to serve as alerting information for the physician.
Hepatic ─ Slight elevations of AST, ALT, or alkaline phosphatase values (1 in 40).
Hematopoietic ─ As has also been reported with other β-lactam antibiotics, transient lymphocytosis, leukopenia, and, rarely, hemolytic anemia, aplastic anemia, agranulocytosis, and reversible neutropenia of possible clinical significance.
There have been rare reports of increased prothrombin time with or without clinical bleeding in patients receiving cefaclor and Coumadin
Renal ─ Slight elevations in BUN or serum creatinine (less than 1 in 500) or abnormal urinalysis (less than 1 in 200).
6.1Cephalosporin-class Adverse Reactions
In addition to the adverse reactions listed above that have been observed in patients treated with cefaclor, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: fever, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, hemorrhage, false positive test for urinary glucose, elevated bilirubin, elevated LDH, and pancytopenia.
Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated (see
7DOSAGE AND ADMINISTRATION
Cefaclor is administered orally.
Adults ─ 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.
Pediatric Patients ─ The usual recommended daily dosage for pediatric patients is 20 mg/kg/day in divided doses every 8 hours. In more serious infections, otitis media, and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day.
Cefaclor may be administered in the presence of impaired renal function. Under such a condition, the dosage usually is unchanged (see
In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cefaclor should be administered for at least 10 days.
8HOW SUPPLIED
Cefaclor Capsule USP 250 mg (blue cap and pink body hard gelatin capsule containing white to slightly yellowish powder imprinted with ”KRC” on both capsule cap and capsule body) contains cefaclor USP (monohydrate) equivalent to 250 mg anhydrous cefaclor.
Bottle of 30 NDC 61442-171-30
Bottle of 100 NDC 61442-171-01
Bottle of 500 NDC 61442-171-05
Cefaclor Capsule USP 500 mg (blue cap and orange body hard gelatin capsule containing white to slightly yellowish powder imprinted with “KRC500” on both capsule cap and capsule body) contains cefaclor USP (monohydrate) equivalent to 500 mg anhydrous cefaclor.
Bottle of 30 NDC 61442-172-30
Bottle of 100 NDC 61442-172-01
Bottle of 500 NDC 61442-172-05
Store at 20 - 25℃ (68 to 77℉) [See USP Controlled Room Temperature].
Manufactured by:
Yung Shin Pharmaceutical Ind. Co., Ltd.
Tachia, Taichung 43769
TAIWAN
Yung Shin Pharmaceutical Ind. Co., Ltd.
Tachia, Taichung 43769
TAIWAN
Distributed by:
5922 Farnsworth Court,
Carlsbad, CA 92008, USA
Revised: 02/18