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cephalexin

Sun Pharmaceutical Industries Limited

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*




FULL PRESCRIBING INFORMATION

CEPHALEXIN DESCRIPTION


1617342


cephalexin




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
Diffusion techniques 2,3



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














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.

Caraco Pharmaceutical Laboratories, Ltd.



Sun Pharmaceutical Industries Ltd.





PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 250 MG

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

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


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