cephalexin
Cephalexin Capsules, USP To 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.
FULL PRESCRIBING INFORMATION: CONTENTS*
- CEPHALEXIN DESCRIPTION
- CLINICAL PHARMACOLOGY
- CEPHALEXIN INDICATIONS AND USAGE
- CEPHALEXIN CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- CEPHALEXIN ADVERSE REACTIONS
- OVERDOSAGE
- CEPHALEXIN DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- REFERENCES
FULL PRESCRIBING INFORMATION
CEPHALEXIN DESCRIPTION
1617342
D
CLINICAL PHARMACOLOGY
Human Pharmacology
Microbiology
In vitroin vitro INDICATIONS AND USAGE
Staphylococcus aureus
Streptococcus pneumoniae
Streptococcus pyogenes
Escherichia coli
Haemophilus influenzae
Klebsiella pneumoniae
Moraxella (Branhamella) catarrhalis
Proteus mirabilis
NoteEnterococcus faecalisStreptococcus faecalisEnterobacterMorganella morganiiProteus vulgarisPseudomonasAcinetobacter calcoaceticusStreptococcus pneumoniae
Susceptibility Tests
Dilution techniques 1 to 3
| MIC (mcg/mL) | Interpretation | |
|---|---|---|
| ≤ 8 |
Susceptible |
(S) |
| 16 |
Intermediate |
(I) |
| ≥ 32 |
Resistant |
(R) |
| Microorganism | MIC(mcg/mL) |
|---|---|
| E. coli ATCC 25922 |
4 to 16 |
| S. aureus ATCC 29213 |
0.12 to 0.5 |
| Zone Diameter (mm) | Interpretation | |
|---|---|---|
| ≥ 18 |
Susceptible |
(S) |
| 15 to 17 |
Intermediate |
(I) |
| ≤ 14 |
Resistant |
(R) |
| Microorganism | Zone Diameter (mm) |
|---|---|
| E. coli ATCC 25922 |
15 to 21 |
| S. aureus ATCC 25923 |
29 to 37 |
CEPHALEXIN INDICATIONS AND USAGE
Streptococcus pneumoniaeStreptococcus pyogenes
Streptococcus pneumoniaeHaemophilus influenzaeStaphylococcus aureus, Streptococcus pyogenesMoraxella catarrhalis
Staphylococcus aureusStreptococcus pyogenes
Staphylococcus aureusProteus mirabilis
Escherichia coliProteus mirabilisKlebsiella pneumoniae
Note
CEPHALEXIN CONTRAINDICATIONS
WARNINGS
BEFORE THERAPY WITH CEPHALEXIN IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALEXIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEPHALEXIN OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
Clostridium difficile associated diarrhea (CDAD)C. difficile
C. difficileC. difficile
C. difficileC. difficile
PRECAUTIONS
General
Information for Patients
Drug Interactions
Metforminmax
Probenecid
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
see PRECAUTIONS, General
CEPHALEXIN ADVERSE REACTIONS
GastrointestinalSee WARNINGS
Hypersensitivity
Adverse Reactions
see INDICATIONS AND USAGE and PRECAUTIONS, General
Altered Laboratory Tests
OVERDOSAGE
Signs and Symptoms
Treatment Physicians’ Desk ReferencePDR
CEPHALEXIN DOSAGE AND ADMINISTRATION
Adults
Pediatric Patients
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 33261-149-20
Bottle of 28’s NDC 33261-149-28
Bottle of 30’s NDC 33261-149-30
Bottle of 40’s NDC 33261-149-40
Bottle 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 33261-020-20
Bottle of 28’s NDC 33261-020-28
Bottle of 30’s NDC 33261-020-30
Bottle of 40’s NDC 33261-020-40
Bottle of 100’s NDC 33261-020-00
Store 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. 05/2010
PAGPI0001
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