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

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

Cephalexin capsules, USP, are available in:  The 250 mg cephalexin capsules, USP are a white to off white powder filled into size 2 capsules (opaque dark green cap and opaque white body) that are imprinted with “293” in edible black ink on cap and body. They are available as follows:  Bottle of 20’s NDC 33261-149-20Bottle of 28’s NDC 33261-149-28Bottle of 30’s NDC 33261-149-30Bottle of 40’s NDC 33261-149-40Bottle of 100’s NDC 33261-149-00  The 500 mg cephalexin capsules, USP are a white to off white powder filled into size 0 capsules (opaque dark green cap and opaque light green body) that are imprinted with “294” in edible black ink on cap and body.  They are available as follows:  Bottle of 20’s NDC 33261-020-20Bottle of 28’s NDC 33261-020-28Bottle of 30’s NDC 33261-020-30Bottle of 40’s NDC 33261-020-40Bottle of 100’s NDC 33261-020-00Store at 25°C (77°F); excursions permitted to 15‑30°C (59‑86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

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.

Distributed by:Caraco Pharmaceutical Laboratories, Ltd.1150 Elijah McCoy Drive, Detroit, MI 48202 Manufactured by:Sun Pharmaceutical Industries Ltd.Acme Plaza, Andheri-Kurla Road,Andheri (East), Mumbai - 400 059, India

Repackaged By:Aidarex Pharmaceuticals, LLC.Corona, CA 92880 ISS. 05/2010PAGPI0001