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Cephalexin

Rebel Distributors Corp.

Cephalexin Capsules, USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Rx only


CEPHALEXIN DESCRIPTION


1617342


Cephalexin




D

CLINICAL PHARMACOLOGY

Human Pharmacology


Microbiology


In vitro in vitro INDICATIONS AND USAGE

Aerobes, Gram-positive

Staphylococcus aureus

Streptococcus pneumoniae

Streptococcus pyogenes

Aerobes, Gram-negative

Escherichia coli

Haemophilus influenzae

Klebsiella pneumoniae

Moraxella (Branhamella) catarrhalis

Proteus mirabilis

Note —Enterococcus faecalisStreptococcus faecalisEnterobacterMorganella morganiiProteus vulgarisPseudomonasAcinetobacter calcoaceticusStreptococcus pneumoniae



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    

            4-16

   S. aureus         ATCC 29213    

         0.12-0.5
Diffusion techniques — 2,3



   Zone Diameter (mm)    

   Interpretation    

≥18

   Susceptible (S)   

15-17

   Intermediate (I)   

≤14

   Resistant (R)    





           Microorganism    

   Zone Diameter (mm)   

   E. coli             ATCC 25922    

15-21

   S. aureus         ATCC 25923    

29-37

INDICATIONS & USAGE SECTION




Streptococcus pneumoniaeStreptococcus pyogenes

Streptococcus pneumoniaeHaemophilus influenzaeStaphylococcus aureus, Streptococcus pyogenes,Moraxella catarrhalis
 
Staphylococcus aureusStreptococcus pyogenes

Staphylococcus aureus Proteus mirabilis

Escherichia coliProteus mirabilis, Klebsiella 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 C. difficile

C. difficile C. difficile

C. difficileC. difficile

PRECAUTIONS

General
















Information for Patients




Drug Interactions


Metformin max



Probenecid

Drug & Or Laboratory Test Interactions Section


As a result of administration of cephalexin, a false-positive reaction for glucose in the urine may occur. This has been observed with Benedict's and Fehling's solutions and also with Clinitest® tablets.

Carcinogenesis, Mutagenesis, Impairment of Fertility


2

Pregnancy

Teratogenic Effects


Pregnancy Category B 2

Nursing Mothers


Pediatric Use


DOSAGE AND ADMINISTRATION

Geriatric Use




PRECAUTIONS, General

CEPHALEXIN ADVERSE REACTIONS


Gastrointestinal — WARNINGS

Hypersensitivity —





Adverse Reactions

INDICATIONS AND USAGE PRECAUTIONS, General

Altered Laboratory Tests

OVERDOSAGE


Signs and Symptoms

Treatment Physicians' Desk Reference (PDR).







DOSAGE & ADMINISTRATION SECTION




Adults —

Pediatric Patients —





HOW SUPPLIED




                                    250 mg Capsule








                                    500 mg Capsule








Store at

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.


Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited




Rebel Distributors Corp.


Cephalexin

Cephalexin

Cephalexin CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:21695-316(NDC:65862-018)
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
cellulose, microcrystalline
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
GELATIN
MAGNESIUM STEARATE
titanium dioxide
SODIUM LAURYL SULFATE

Product Characteristics

Color Size Imprint Code Shape
white 18 mm A;42;250;mg CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21695-316-20 20 in 1 BOTTLE
2 NDC:21695-316-28 28 in 1 BOTTLE
3 NDC:21695-316-30 30 in 1 BOTTLE
4 NDC:21695-316-40 40 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065253 2005-11-16


Cephalexin

Cephalexin CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:21695-317(NDC:65862-019)
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
cellulose, microcrystalline
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
GELATIN
MAGNESIUM STEARATE
titanium dioxide
SODIUM LAURYL SULFATE

Product Characteristics

Color Size Imprint Code Shape
green (Dark Green Opaque, Light Green Opaque) 21 mm A;43;500;mg CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21695-317-12 12 in 1 BOTTLE
2 NDC:21695-317-14 14 in 1 BOTTLE
3 NDC:21695-317-20 20 in 1 BOTTLE
4 NDC:21695-317-28 28 in 1 BOTTLE
5 NDC:21695-317-30 30 in 1 BOTTLE
6 NDC:21695-317-40 40 in 1 BOTTLE
7 NDC:21695-317-60 60 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065253 2005-11-16


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