CEPHALEXIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)

Available from:

Northwind Pharmaceuticals

INN (International Name):

CEPHALEXIN

Composition:

CEPHALEXIN ANHYDROUS 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cephalexin Capsules USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.) Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherich

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEPHALEXIN- CEPHALEXIN CAPSULE
NORTHWIND PHARMACEUTICALS
----------
CEPHALEXIN 500 MG
INDICATIONS AND USAGE
Cephalexin Capsules USP are indicated for the treatment of the
following infections when caused by
susceptible strains of the designated microorganisms:
Respiratory tract infections caused by Streptococcus pneumoniae and
Streptococcus pyogenes.
(Penicillin is the usual drug of choice in the treatment and
prevention of streptococcal infections,
including the prophylaxis of rheumatic fever. Cephalexin is generally
effective in the eradication of
streptococci from the nasopharynx; however, substantial data
establishing the efficacy of cephalexin in
the subsequent prevention of rheumatic fever are not available at
present.)
Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae,
Staphylococcus aureus,
Streptococcus pyogenes, and Moraxella catarrhalis.
Skin and skin structure infections caused by Staphylococcus aureus
and/or Streptococcus pyogenes.
Bone infections caused by Staphylococcus aureus and/or Proteus
mirabilis.
Genitourinary tract infections, including acute prostatitis, caused by
Escherichia coli, Proteus mirabilis,
and Klebsiella pneumoniae.
Note – Culture and susceptibility tests should be initiated prior to
and during therapy. Renal function
studies should be performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cephalexin
capsules and other antibacterial drugs, cephalexin capsules should be
used only to treat or prevent
infections that are proven or strongly suspected to be caused by
susceptible bacteria. When culture and
susceptibility information are available, they 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.
CONTRAINDICATIONS
Cephalexin is contraindicated in patients with known allergy to the
cephalosporin group of antibiotics.
WARNINGS
BEFORE THERAPY WITH CEPHALEXIN IS