cephalexin

CEPHALEXIN INDICATIONS AND USAGE

CEPHALEXIN 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

CEPHALEXIN ADVERSE REACTIONS

OVERDOSAGE

CEPHALEXIN 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.

NDC 62756-293-88
Cephalexin Capsules, USP
250 mg
Rx only
100 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 500 MG

NDC 62756-294-88
Cephalexin Capsules, USP
500 mg
Rx only
100 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES LTD.

cephalexin cephalexin CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:62756-293 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEPHALEXIN CEPHALEXIN ANHYDROUS 250 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE D&C YELLOW NO. 10 FD&C YELLOW NO. 6 FD&C GREEN NO. 3 SODIUM LAURYL SULFATE GELATIN titanium dioxide Product Characteristics Color Size Imprint Code Shape WHITE (opaque white) 18 mm 293;293 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62756-293-88 100 in 1 BOTTLE 2 NDC:62756-293-13 500 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062791 2010-06-21

cephalexin cephalexin CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:62756-294 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEPHALEXIN CEPHALEXIN ANHYDROUS 500 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE D&C YELLOW NO. 10 FD&C YELLOW NO. 6 FD&C GREEN NO. 3 SODIUM LAURYL SULFATE GELATIN titanium dioxide FD&C BLUE NO. 1 Product Characteristics Color Size Imprint Code Shape GREEN (opaque light green) 22 mm 294;294 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62756-294-88 100 in 1 BOTTLE 2 NDC:62756-294-13 500 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062791 2010-06-21