Please wait while the formulary information is being retrieved.
Drug overview for CEFACLOR ER (cefaclor):
Generic name: CEFACLOR (SEF-a-klor)
Drug class: Beta-Lactams
Therapeutic class: Anti-Infective Agents
Cefaclor is a semisynthetic, second generation cephalosporin antibiotic.
Cefaclor is used orally for the treatment of acute otitis media caused by susceptible bacteria; pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A beta-hemolytic streptococci); mild to moderate upper and lower respiratory tract infections (including pneumonia) caused by susceptible bacteria; uncomplicated skin and skin structure infections caused by susceptible bacteria; and urinary tract infections (including pyelonephritis and cystitis) caused by susceptible bacteria. While commercially available cefaclor capsules and oral suspension can be used for any of these infections, safety and efficacy of cefaclor extended-release tablets have been established only for the treatment of mild to moderate respiratory tract infections (i.e., acute exacerbations of chronic bronchitis, secondary infections of acute bronchitis) caused by susceptible bacteria; pharyngitis and tonsillitis caused by S. pyogenes; and mild to moderate uncomplicated skin and skin structure infections caused by susceptible Staphylococcus aureus (methicillin-susceptible (oxacillin-susceptible) strains only).
Generic name: CEFACLOR (SEF-a-klor)
Drug class: Beta-Lactams
Therapeutic class: Anti-Infective Agents
Cefaclor is a semisynthetic, second generation cephalosporin antibiotic.
Cefaclor is used orally for the treatment of acute otitis media caused by susceptible bacteria; pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A beta-hemolytic streptococci); mild to moderate upper and lower respiratory tract infections (including pneumonia) caused by susceptible bacteria; uncomplicated skin and skin structure infections caused by susceptible bacteria; and urinary tract infections (including pyelonephritis and cystitis) caused by susceptible bacteria. While commercially available cefaclor capsules and oral suspension can be used for any of these infections, safety and efficacy of cefaclor extended-release tablets have been established only for the treatment of mild to moderate respiratory tract infections (i.e., acute exacerbations of chronic bronchitis, secondary infections of acute bronchitis) caused by susceptible bacteria; pharyngitis and tonsillitis caused by S. pyogenes; and mild to moderate uncomplicated skin and skin structure infections caused by susceptible Staphylococcus aureus (methicillin-susceptible (oxacillin-susceptible) strains only).
DRUG IMAGES
CEFACLOR ER 500 MG TABLET
The following indications for CEFACLOR ER (cefaclor) have been approved by the FDA:
Indications:
Haemophilus influenzae bronchitis
Moraxella catarrhalis bronchitis
Pharyngitis due to Streptococcus pyogenes
Staphylococcus aureus skin and skin structure infection
Streptococcus pneumoniae bronchitis
Tonsillitis due to Streptococcus pyogenes
Professional Synonyms:
Bronchitis due to B. catarrhalis
Bronchitis due to Branhamella catarrhalis
Bronchitis due to Diplococcus pneumoniae
Bronchitis due to Fraenkel's Pneumococcus
Bronchitis due to Fraenkel-Weichselbaum Pneumococcus
Bronchitis due to H. flu
Bronchitis due to H. influenzae
Bronchitis due to Haemophilus influenzae
Bronchitis due to Hemophilus influenzae
Bronchitis due to influenzae Bacillus
Bronchitis due to M. catarrhalis
Bronchitis due to Moraxella catarrhalis
Bronchitis due to Neisseria catarrhalis
Bronchitis due to Pfeiffer's Bacillus
Bronchitis due to Pneumococcus
Bronchitis due to Pneumonococcus
Bronchitis due to Streptococcus pneumoniae
Epidemic sore throat
Pharyngitis due to group A beta-hemolytic streptococci
Pharyngitis due to Streptococcus epidemicus
Septic sore throat
Skin and skin soft tissue Staphylococcus aureus infection
Streptococcal pharyngitis
Streptococcus pyogenes tonsillitis
Indications:
Haemophilus influenzae bronchitis
Moraxella catarrhalis bronchitis
Pharyngitis due to Streptococcus pyogenes
Staphylococcus aureus skin and skin structure infection
Streptococcus pneumoniae bronchitis
Tonsillitis due to Streptococcus pyogenes
Professional Synonyms:
Bronchitis due to B. catarrhalis
Bronchitis due to Branhamella catarrhalis
Bronchitis due to Diplococcus pneumoniae
Bronchitis due to Fraenkel's Pneumococcus
Bronchitis due to Fraenkel-Weichselbaum Pneumococcus
Bronchitis due to H. flu
Bronchitis due to H. influenzae
Bronchitis due to Haemophilus influenzae
Bronchitis due to Hemophilus influenzae
Bronchitis due to influenzae Bacillus
Bronchitis due to M. catarrhalis
Bronchitis due to Moraxella catarrhalis
Bronchitis due to Neisseria catarrhalis
Bronchitis due to Pfeiffer's Bacillus
Bronchitis due to Pneumococcus
Bronchitis due to Pneumonococcus
Bronchitis due to Streptococcus pneumoniae
Epidemic sore throat
Pharyngitis due to group A beta-hemolytic streptococci
Pharyngitis due to Streptococcus epidemicus
Septic sore throat
Skin and skin soft tissue Staphylococcus aureus infection
Streptococcal pharyngitis
Streptococcus pyogenes tonsillitis
The following dosing information is available for CEFACLOR ER (cefaclor):
Cefaclor is commercially available as the monohydrate; dosage is expressed in terms of anhydrous cefaclor.
The American Academy of Pediatrics (AAP) recommends that pediatric patients beyond the neonatal period receive cefaclor in a dosage of 20-40 mg/kg daily in 2 or 3 equally divided doses for the treatment of mild or moderate infections. The AAP states that the drug is inappropriate for the treatment of severe infections.
A maximum cefaclor dosage of 1 g daily is recommended in pediatric patients.
Modification of usual cefaclor dosage is not necessary in patients with renal impairment; however, close clinical observation and appropriate laboratory tests are recommended in patients with moderate or severe renal impairment since experience in such patients is limited.
The American Academy of Pediatrics (AAP) recommends that pediatric patients beyond the neonatal period receive cefaclor in a dosage of 20-40 mg/kg daily in 2 or 3 equally divided doses for the treatment of mild or moderate infections. The AAP states that the drug is inappropriate for the treatment of severe infections.
A maximum cefaclor dosage of 1 g daily is recommended in pediatric patients.
Modification of usual cefaclor dosage is not necessary in patients with renal impairment; however, close clinical observation and appropriate laboratory tests are recommended in patients with moderate or severe renal impairment since experience in such patients is limited.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CEFACLOR ER 500 MG TABLET | Maintenance | Adults take 1 tablet (500 mg) by oral route every 12 hours with food |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CEFACLOR ER 500 MG TABLET | Maintenance | Adults take 1 tablet (500 mg) by oral route every 12 hours with food |
The following drug interaction information is available for CEFACLOR ER (cefaclor):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Live Typhoid Vaccine/Antimicrobials SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1) CLINICAL EFFECTS: Vaccination may be ineffective. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3) DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3) |
VIVOTIF |
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Fecal Microbiota Spores/Antibiotics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Fecal microbiota spores is a suspension of live bacterial spores, which may be compromised by concurrent use of antibiotics.(1) CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota spores.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota spores. Antibacterial treatment should be completed for 2 to 4 days before initiating treatment with fecal microbiota spores.(1) DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota spores. |
VOWST |
There are 2 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Selected Cephalosporins & Penicillins/Probenecid SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Probenecid impairs the clearance of some cephalosporins and penicillins via inhibition of renal anion transporters in the proximal tubule.(49) It has also been hypothesized that probenecid may affect tissue distribution of cephalosporins.(1-5) CLINICAL EFFECTS: The concurrent administration of probenecid may result in increased maximum concentration (Cmax), area-under-curve (AUC), and half-life of the cephalosporin or penicillin.(49) While this may improve antibiotic efficacy,(46-48) increased levels may also increase the risk for antibiotic-associated nephrotoxicity.(4) PREDISPOSING FACTORS: Underlying renal dysfunction may increase the risk for nephrotoxicity. PATIENT MANAGEMENT: In patients receiving the combination to improve antibiotic efficacy, monitor for antibiotic adverse effects and consider monitoring renal function. In patients receiving probenecid therapy to prevent or treat hyperuricemia, exposure to the antibiotic will be increased. A decrease in antibiotic dose or frequency may be required. The US manufacturer of piperacillin-tazobactam states probenecid should not be coadministered with piperacillin-tazobactam unless the benefit outweighs the risk.(50) DISCUSSION: Concurrent use of probenecid with a cephalosporin or penicillin may cause an increase in the Cmax, AUC, and an increased elimination half life of the antibiotic.(6-8,49) This may be beneficial or necessary in difficult to treat infections,(46-48) but an increased risk for adverse effects should be expected. Antibiotics not dose adjusted for concurrent use with probenecid may be associated with an increased risk for adverse effects, such as nephrotoxicity. Probenecid administered concurrently with piperacillin-tazobactam prolongs the half-life of piperacillin by 21% and tazobactam by 71%. In a study in 8 healthy males, concurrent administration of probenecid (1 g) with piperacillin (1 g IM) increased piperacillin's Cmax and AUC by 30% and 60%. Renal clearance was reduced by 40%.(51) The cephalosporins affected by probenecid include cefazolin,(9-11) cephacetrile,(12,13) cephaloglycin,(14,15) cephalexin,(16-21) cephradine, (22-23) cefoxitin,(24-28) cefadroxil(29), cefaclor,(23) cefamandole,(30) ceftizoxime,(31,32) cefuroxime,(33,34) cefprozil,(35) cefonicid,(36) cefmetazole,(37) cefmenoxime,(38) and cefditoren.(39) Probenecid has been shown not to affect moxalactam,(4,40,41) ceforanide, (4,42), cefoperazone, ceftazidime(4,34,43) or ceftriaxone.(4) |
PROBENECID, PROBENECID-COLCHICINE |
| Selected Cephalosporins/Aluminum; Magnesium Compounds SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Aluminum and magnesium containing antacids may form chelation complexes with some cephalosporins, preventing their absorption.(1,2) CLINICAL EFFECTS: Simultaneous administration of an aluminum and/or magnesium containing antacid with some cephalosporins may result in decreased levels and effectiveness of the cephalosporin.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of cefdinir recommends that cefdinir be taken at least 2 hours before or after an aluminum and/or magnesium containing antacid.(1) It would be prudent to separate the administration of cefaclor by at least this amount of time as well.(2) DISCUSSION: Simultaneous administration of cefdinir (300 mg) with Maalox TC (30 ml) decreased cefdinir area-under-curve (AUC) and maximum concentration (Cmax) by 40%.(1) In a study in 15 healthy subjects, simultaneous administration of cefaclor advanced formulation (500 mg) with Maalox TC decreased the extent of cefaclor absorption.(2) |
ALUMINUM HYDROXIDE, CLENPIQ, KAOLIN, MAGNESIUM CHLORIDE, MAGNESIUM OXIDE, MAGNESIUM SULFATE |
The following contraindication information is available for CEFACLOR ER (cefaclor):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Clostridioides difficile infection |
There are 0 moderate contraindications.
The following adverse reaction information is available for CEFACLOR ER (cefaclor):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 14 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Serum sickness |
None. |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Clostridioides difficile infection Drug fever Erythema Erythema multiforme Hemolytic anemia Hypoprothrombinemia Kidney disease with reduction in glomerular filtration rate (GFr) Pruritus of skin Seizure disorder Skin rash Stevens-johnson syndrome |
There are 6 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Vulvovaginal candidiasis |
Abdominal pain with cramps Diarrhea Nausea Oral candidiasis Vomiting |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for CEFACLOR ER (cefaclor):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Reproduction studies in mice, rats, and ferrets using doses up to 3-5 times the maximum human dosage (1500 mg daily) based on mg/m2 have not revealed evidence of harm to the fetus. There are no adequate and controlled studies using cefaclor in pregnant women or during labor and delivery, and the drug should be used during pregnancy only when clearly needed.
Because low concentrations of cefaclor (0.16-0.21 mcg/mL) have been detected in milk following a single 500-mg oral dose of the drug, cefaclor should be used with caution in nursing women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for CEFACLOR ER (cefaclor):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for CEFACLOR ER (cefaclor)'s list of indications:
| Haemophilus influenzae bronchitis | |
| J20.1 | Acute bronchitis due to hemophilus influenzae |
| Moraxella catarrhalis bronchitis | |
| B96.89 | Other specified bacterial agents as the cause of diseases classified elsewhere |
| J20.8 | Acute bronchitis due to other specified organisms |
| Pharyngitis due to streptococcus pyogenes | |
| J02.0 | Streptococcal pharyngitis |
| Staphylococcus aureus skin and skin structure infection | |
| B95.6 | Staphylococcus aureus as the cause of diseases classified elsewhere |
| H60.1 | Cellulitis of external ear |
| H60.10 | Cellulitis of external ear, unspecified ear |
| H60.11 | Cellulitis of right external ear |
| H60.12 | Cellulitis of left external ear |
| H60.13 | Cellulitis of external ear, bilateral |
| J34.0 | Abscess, furuncle and carbuncle of nose |
| L02 | Cutaneous abscess, furuncle and carbuncle |
| L02.0 | Cutaneous abscess, furuncle and carbuncle of face |
| L02.02 | Furuncle of face |
| L02.03 | Carbuncle of face |
| L02.1 | Cutaneous abscess, furuncle and carbuncle of neck |
| L02.12 | Furuncle of neck |
| L02.13 | Carbuncle of neck |
| L02.2 | Cutaneous abscess, furuncle and carbuncle of trunk |
| L02.22 | Furuncle of trunk |
| L02.221 | Furuncle of abdominal wall |
| L02.222 | Furuncle of back [any part, except buttock] |
| L02.223 | Furuncle of chest wall |
| L02.224 | Furuncle of groin |
| L02.225 | Furuncle of perineum |
| L02.226 | Furuncle of umbilicus |
| L02.229 | Furuncle of trunk, unspecified |
| L02.23 | Carbuncle of trunk |
| L02.231 | Carbuncle of abdominal wall |
| L02.232 | Carbuncle of back [any part, except buttock] |
| L02.233 | Carbuncle of chest wall |
| L02.234 | Carbuncle of groin |
| L02.235 | Carbuncle of perineum |
| L02.236 | Carbuncle of umbilicus |
| L02.239 | Carbuncle of trunk, unspecified |
| L02.3 | Cutaneous abscess, furuncle and carbuncle of buttock |
| L02.32 | Furuncle of buttock |
| L02.33 | Carbuncle of buttock |
| L02.4 | Cutaneous abscess, furuncle and carbuncle of limb |
| L02.42 | Furuncle of limb |
| L02.421 | Furuncle of right axilla |
| L02.422 | Furuncle of left axilla |
| L02.423 | Furuncle of right upper limb |
| L02.424 | Furuncle of left upper limb |
| L02.425 | Furuncle of right lower limb |
| L02.426 | Furuncle of left lower limb |
| L02.429 | Furuncle of limb, unspecified |
| L02.43 | Carbuncle of limb |
| L02.431 | Carbuncle of right axilla |
| L02.432 | Carbuncle of left axilla |
| L02.433 | Carbuncle of right upper limb |
| L02.434 | Carbuncle of left upper limb |
| L02.435 | Carbuncle of right lower limb |
| L02.436 | Carbuncle of left lower limb |
| L02.439 | Carbuncle of limb, unspecified |
| L02.5 | Cutaneous abscess, furuncle and carbuncle of hand |
| L02.52 | Furuncle hand |
| L02.521 | Furuncle right hand |
| L02.522 | Furuncle left hand |
| L02.529 | Furuncle unspecified hand |
| L02.53 | Carbuncle of hand |
| L02.531 | Carbuncle of right hand |
| L02.532 | Carbuncle of left hand |
| L02.539 | Carbuncle of unspecified hand |
| L02.6 | Cutaneous abscess, furuncle and carbuncle of foot |
| L02.62 | Furuncle of foot |
| L02.621 | Furuncle of right foot |
| L02.622 | Furuncle of left foot |
| L02.629 | Furuncle of unspecified foot |
| L02.63 | Carbuncle of foot |
| L02.631 | Carbuncle of right foot |
| L02.632 | Carbuncle of left foot |
| L02.639 | Carbuncle of unspecified foot |
| L02.8 | Cutaneous abscess, furuncle and carbuncle of other sites |
| L02.82 | Furuncle of other sites |
| L02.821 | Furuncle of head [any part, except face] |
| L02.828 | Furuncle of other sites |
| L02.83 | Carbuncle of other sites |
| L02.831 | Carbuncle of head [any part, except face] |
| L02.838 | Carbuncle of other sites |
| L02.9 | Cutaneous abscess, furuncle and carbuncle, unspecified |
| L02.92 | Furuncle, unspecified |
| L02.93 | Carbuncle, unspecified |
| L03.01 | Cellulitis of finger |
| L03.011 | Cellulitis of right finger |
| L03.012 | Cellulitis of left finger |
| L03.019 | Cellulitis of unspecified finger |
| L03.03 | Cellulitis of toe |
| L03.031 | Cellulitis of right toe |
| L03.032 | Cellulitis of left toe |
| L03.039 | Cellulitis of unspecified toe |
| L03.1 | Cellulitis and acute lymphangitis of other parts of limb |
| L03.11 | Cellulitis of other parts of limb |
| L03.111 | Cellulitis of right axilla |
| L03.112 | Cellulitis of left axilla |
| L03.113 | Cellulitis of right upper limb |
| L03.114 | Cellulitis of left upper limb |
| L03.115 | Cellulitis of right lower limb |
| L03.116 | Cellulitis of left lower limb |
| L03.119 | Cellulitis of unspecified part of limb |
| L03.2 | Cellulitis and acute lymphangitis of face and neck |
| L03.21 | Cellulitis and acute lymphangitis of face |
| L03.211 | Cellulitis of face |
| L03.22 | Cellulitis and acute lymphangitis of neck |
| L03.221 | Cellulitis of neck |
| L03.3 | Cellulitis and acute lymphangitis of trunk |
| L03.31 | Cellulitis of trunk |
| L03.311 | Cellulitis of abdominal wall |
| L03.312 | Cellulitis of back [any part except buttock] |
| L03.313 | Cellulitis of chest wall |
| L03.314 | Cellulitis of groin |
| L03.315 | Cellulitis of perineum |
| L03.316 | Cellulitis of umbilicus |
| L03.317 | Cellulitis of buttock |
| L03.319 | Cellulitis of trunk, unspecified |
| L03.8 | Cellulitis and acute lymphangitis of other sites |
| L03.81 | Cellulitis of other sites |
| L03.811 | Cellulitis of head [any part, except face] |
| L03.818 | Cellulitis of other sites |
| L03.9 | Cellulitis and acute lymphangitis, unspecified |
| L03.90 | Cellulitis, unspecified |
| L08.89 | Other specified local infections of the skin and subcutaneous tissue |
| L08.9 | Local infection of the skin and subcutaneous tissue, unspecified |
| N48.22 | Cellulitis of corpus cavernosum and penis |
| Streptococcus pneumoniae bronchitis | |
| B95.3 | Streptococcus pneumoniae as the cause of diseases classified elsewhere |
| J20.2 | Acute bronchitis due to streptococcus |
| Tonsillitis due to streptococcus pyogenes | |
| J03.0 | Streptococcal tonsillitis |
| J03.00 | Acute streptococcal tonsillitis, unspecified |
| J03.01 | Acute recurrent streptococcal tonsillitis |
Formulary Reference Tool