Cefaclor clinical studies
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Clinical Studies
Drug or Laboratory Test Interactions
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies have not been performed to determine potential for carcinogenicity, mutagenicity, or impairment of fertility.
Pregnancy Category: B
Teratogenic Effects
Reproduction studies have been performed in mice and rats at doses up to 12 times the human dose and in ferrets given 3 times the maximum human dose and have revealed no harm to the fetus due to cefaclor. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Labor and Delivery
The effect of cefaclor on labor and delivery is unknown.
Nursing Mothers
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 μg/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.
Pediatric Use
Safety and effectiveness of this product for use in infants less than 1 month of age have not been established.
Geriatric Use
Of the 3703 patients in clinical studies of cefaclor, 594 (16.0%) were 65 and older. No overall differences in safety of 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 (see CLINICAL PHARMACOLOGY), 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 in monitor renal function (see DOSAGE AND ADMINISTRATION).[1]
References
- ↑ publisher = "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/64081_Cefaclor_Approv.pdf" Check
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Adapted from the FDA Package Insert.