Cephalexin description, usages, side effects, indications, overdosage, supplying and lots more!

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Cephalexin

Gen-Source Rx
Aurobindo Pharma Limited

Cephalexin Capsules, USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION


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 techniques2,3


   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

CEPHALEXIN INDICATIONS AND USAGE




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/Laboratory Test Interactions


®

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).







CEPHALEXIN DOSAGE AND ADMINISTRATION




Adults — 








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.











PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg (100 Capsule Bottle)


NDC 52343-002-01
Cephalexin Capsules, USP
500 mg
Rx only            100 Capsules
Gen-Source Rx
Cephalexin

Cephalexin

Cephalexin CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52343-001
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
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
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:52343-001-01 100 in 1 BOTTLE
2 NDC:52343-001-05 500 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:52343-002
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
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
GELATIN
MAGNESIUM STEARATE
titanium dioxide
SODIUM LAURYL SULFATE

Product Characteristics

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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52343-002-01 100 in 1 BOTTLE
2 NDC:52343-002-05 500 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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Be sure to consult your doctor before taking any medication!
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