Refer to the “Also Known As” section to reference different products that include the same medication as KEFLEX.
Brand Name: KEFLEX
Generic Name: CEPHALEXIN
Drug Type: HUMAN PRESCRIPTION DRUG
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.
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.
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.
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.
- 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)
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)].
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
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)
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.
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
Principal Display Panel - 250 mg Bottle Label
Cephalexin Capsules, USP
Principal Display Panel - 500 mg Bottle Label
Cephalexin Capsules, USP
Principal Display Panel - 750 mg Bottle Label
Cephalexin Capsules, USP
also known as