Cephalexin Capsules, USPTo reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
CLINICAL PHARMACOLOGY
Human Pharmacology
Microbiology
Susceptibility Tests
| ≤ 8 | Susceptible | (S) |
| 16 | Intermediate | (I) |
| ≥ 32 | Resistant | (R) |
| E. coli ATCC 25922 | 4 to 16 |
| S. aureus ATCC 29213 | 0.12 to 0.5 |
| ≥ 18 | Susceptible | (S) |
| 15 to 17 | Intermediate | (I) |
| ≤ 14 | Resistant | (R) |
| E. coli ATCC 25922 | 15 to 21 |
| S. aureus ATCC 25923 | 29 to 37 |
INDICATIONS AND USAGE
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
General
Information for Patients
Drug Interactions
Drug / Laboratory Test Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Lifetime studies in animals have not been performed to evaluate the carcinogenic potential of cephalexin. Tests to determine the mutagenic potential of cephalexin have not been performed. In male and female rats, fertility and reproductive performance were not affected by cephalexin oral doses up to 1.5 times the highest recommended human dose based upon mg/m2.
Pregnancy
Teratogenic effects — Pregnancy Category B — Reproduction studies have been performed on mice and rats using oral doses of cephalexin monohydrate 0.6 and 1.5 times the maximum daily human dose (66 mg/kg/day) based upon mg/m2, and have revealed no harm to the fetus. 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.
Nursing Mothers
The excretion of cephalexin in human milk increased up to 4 hours after a 500 mg dose; the drug reached a maximum level of 4 mcg/mL, then decreased gradually, and had disappeared 8 hours after administration. Caution should be exercised when cephalexin capsules, USP is administered to a nursing woman.
Pediatric Use
The safety and effectiveness of cephalexin capsules, USP in pediatric patients was established in clinical trials for the dosages described in the DOSAGE AND ADMINISTRATION section. In these trials, pediatric patients may have received cephalexin capsules. Cephalexin capsules should only be used in children and adolescents capable of ingesting the capsule.
Geriatric Use
ADVERSE REACTIONS
OVERDOSAGE
DOSAGE AND ADMINISTRATION
HOW SUPPLIED
REFERENCES
- National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically — Fourth Edition. Approved Standard NCCLS Document M7 - A4, Vol. 17, No. 2, NCCLS, Wayne, PA, January, 1997.
- National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests — Sixth Edition. Approved Standard NCCLS Document M2 - A6, Vol. 17, No. 1, NCCLS, Wayne, PA, January, 1997.
- National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Susceptibility Testing — Eighth Informational Supplement. Approved Standard NCCLS Document M100 - S8, Vol. 18, No. 1, NCCLS, Wayne, PA, January, 1998.