SEPTRA SUMMARY
SEPTRA (trimethoprim and sulfamethoxazole) is a synthetic antibacterial combination product.
SEPTRA is indicated for the following:
Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Kelbsiella
species,
Enterobacter
species,
Morganella morganii, Proteus mirabilis,
and
Proteus vulgaris.
It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of
Streptococcus pneumoniae
or
Haemophilus influenzae
when, in the judgment of the physician, SEPTRA offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of SEPTRA in pediatric patients under two years of age. SEPTRA is not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of
Streptococcus pneumoniae
or
Haemophilus influenzae
when, in the judgment of the physician, SEPTRA offers some advantage over the use of a single antimicrobial agent.
Travelers' Diarrhea in Adults: For the treatment of travelers' diarrhea due to susceptible strains of enterotoxigenic
E. coli.
Shigellosis: For the treatment of enteritis caused by susceptible strains of
Shigella flexneri
and
Shigella sonnei
when antibacterial therapy is indicated.
Pneumocystis Carinii Pneumonia: For the treatment of documented
Pneumocystis carinii
pneumonia. For prophylaxis against
Pneumocystis carinii
pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing
Pneumocystis carinii
pneumonia.
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