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P - Caution when used during pregnancy
L - Caution when used during lactation
LI - Lab*
Cefaclor, also known as cefachlor or cefaclorum (brand names Ceclor, Distaclor, Keflor, Raniclor), is a second-generation cephalosporin antibiotic used to treat certain infections caused by bacteria such as pneumonia and ear, lung, skin, throat, and urinary tract infections.
Cefaclor binds to one or more of the penicillin-binding proteins (PBPs) which inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death. It has bactericidal activity against gm-ve bacteria including E. coli, S. pneumoniae, N. gonorrhoea, P. mirabilis and H. influenzae.
Absorption: Well absorbed from the GIT (oral); rate but not extent of absorption is altered by food.
Distribution: Widely distributed; crosses the placenta and enters breast milk (low concentrations). Protein-binding: 25%
Excretion: Via the urine by the kidneys within 8 hrs (as 85% unchanged); the greater part of the dose within 2 hrs. Elimination half-life: 0.5-1 hr, slightly prolonged in renal impairment. May be removed by haemodialysis.
Information Not Available
Allergic reactions; diarrhoea, nausea, vomiting; candidiasis, eosinophilia; elevated transaminases.
Potentially Fatal: Anaphylactic reaction; pseudomembranous colitis.
Response to therapy
Monitor patient's response to therapy. Notify health care provider if infection does not improve or appears to worsen.
Monitor patient for GI, DERM, and general body side effects, and signs of superinfection. Inform health care provider if noted and significant. Immediately report severe diarrhea, diarrhea containing blood or pus, or severe abdominal cramping.
Reactions range from mild to life-threatening. Administer drug with caution to penicillin-sensitive patients because of possible cross-reactivity.
Use drug with caution in patients with renal impairment. Dosage adjustment based on renal function may be required.
May result in bacterial or fungal overgrowth of nonsusceptible microorganisms.
Consider in patients in whom diarrhea develops.
Severe renal impairment; history of allergy to penicillin; pregnancy, lactation.
Probenecid slows tubular excretion.
Potentially Fatal: May enhance nephrotoxicity of aminoglycosides and furosemide. Bleeding may occur if taken with anticoagulants.
Food Interactions: Plasma levels slightly reduced.
Urinary tract infections, Upper and lower respiratory tract infections, Skin infections, Otitis media
Adult: As monohydrate: 250-500 mg every 8 hr. Max: 4 g daily.
Child: >1 mth: 20 mg/kg daily in 3 divided doses, increased to 40 mg/kg daily if necessary, <1 yr: 62.5 mg tid, 1-5 yr: 125 mg tid, >5 yr: 250 mg tid.
May be taken with or without food.
Caution when used during pregnancy.
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Caution when used during lactation.
Small amounts of cefaclor have been detected in mother’s milk following administration of single 500 mg doses. Average levels were 0.18, 0.20, 0.21, and 0.16 mcg/mL at 2, 3, 4, and 5 hours respectively. Trace amounts were detected at 1 hour. The effect on nursing infants is not known. Caution should be exercised when cefaclor is administered to a nursing woman.
Safety and effectiveness of this product for use in pediatric patients less than 1 month of age have not been established.
Of the 3703 patients in clinical studies of cefaclor, 594 (16.0%) were 65 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function
Known hypersensitivity to cephalosporins.
Oral: Store at 15-30°C.
Oral: Store at 15-30°C.