KEFLEX CEPHALEXIN

Get an overview of KEFLEX (cephalexin capsule), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in KEFLEX can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as KEFLEX.

Drug Basics

Brand Name: KEFLEX

Generic Name: CEPHALEXIN

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: CAPSULE

Data Current As Of: 2019-12-30

indications & usage

KEFLEX is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria:

  • Respiratory tract infection (1.1)
  • Otitis media (1.2)
  • Skin and skin structure infections (1.3)
  • Bone infections (1.4)
  • Genitourinary tract infections (1.5)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of KEFLEX and other antibacterial drugs, KEFLEX should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6)

respiratory tract infections

KEFLEX is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes.

otitis media

KEFLEX is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis.

skin & skin structure infections

KEFLEX is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.

bone infections

KEFLEX is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis.

genitourinary tract infections

KEFLEX is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.

usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of KEFLEX and other antibacterial drugs, KEFLEX should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

drug interactions

  • Metformin: increased metformin concentrations. Monitor for hypoglycemia. (7.1)
  • Probenecid- The renal excretion of KEFLEX is inhibited by probenecid. Co-administration of probenecid with KEFLEX is not recommended. (7.2)
  • Administration of KEFLEX may result in a false-positive reaction for glucose in the urine. (7.3)

metformin

Administration of KEFLEX with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin.

Careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking KEFLEX and metformin [see Clinical Pharmacology (12.3)].

probenecid

The renal excretion of KEFLEX is inhibited by probenecid. Co-administration of probenecid with KEFLEX is not recommended.

interaction with laboratory or diagnostic testing

A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict's solution or Fehling's solution.

patient counseling information

Allergic Reactions

Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask the patient about any previous hypersensitivity reactions to KEFLEX, other beta-lactams (including cephalosporins) or other allergens (5.1)

Diarrhea

Advise patients that diarrhea is a common problem caused by antibacterial drugs and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, advise patients to contact their healthcare provider.

Antibacterial Resistance

Counsel patients that antibacterial drugs including KEFLEX, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When KEFLEX is prescribed to treat a bacterial infection, tell patients that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by KEFLEX or other antibacterial drugs in the future.

Manufactured in Austria for:
Pragma Pharmaceuticals, LLC
Distributed by: Fera Pharmaceuticals, LLC
Locust Valley, N.Y. 11560

Pragma ®

PPI-011

Principal Display Panel - 250 mg Bottle Label

NDC 58463-011-01

KEFLEX ®

Cephalexin Capsules, USP

250 mg

100 Capsules

Rx only

Pragma ®

kef01 0004 02.jpg

Principal Display Panel - 500 mg Bottle Label

NDC 58463-012-01

KEFLEX ®

Cephalexin Capsules, USP

500 mg

100 Capsules

Rx only

Pragma ®

kef01 0004 03.jpg

Principal Display Panel - 750 mg Bottle Label

NDC 58463-013-50

KEFLEX ®

Cephalexin Capsules, USP

750 mg

50 Capsules

Rx only

Pragma ®

kef01 0004 04.jpg

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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