Sulfamethoxazole

1): • Treatment and prevention of Pneumocystis jirovecii pneumonitis or “PJP”. • Treatment and prophylaxis of toxoplasmosis. • Treatment of nocardiosis. The following infections may be treated with Co-Trimoxazole where there is bacterial evidence of sensitivity to Co-Trimoxazole and good reason to prefer the combination of antibiotics in Co-Trimoxazole to a single antibiotic: • Acute uncomplicated urinary tract infection.

• Acute otitis media. • Acute exacerbation of chronic bronchitis. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, USP 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 empiric selection of therapy.

Urinary Tract Infections For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella 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 sulfamethoxazole and trimethoprim tablets offer some advantage over the use of other antimicrobial agents.

SEPTRA

Injection and SEPTRA PEDIATRIC ORAL SUSPENSION (sulfamethoxazole and trimethoprim) are indicated for treatment of infections associated with the following gram- positive and gram-negative organisms: Gram-Negative Organisms Haemophilus influenzae Neisseria gonorrhoeae Escherichia coli Klebsiella species Enterobacter (Aerobacter) aerogenes Proteus mirabilis Proteus vulgaris Salmonella species Shigella species Vibrio cholerae Gram-Positive Organisms Streptococcus pyogenes Streptococcus viridans Staphylococcus albus Staphylococcus aureus Diplococcus pneumoniae Other Organisms Brucella melitensis Nocardia asteroides Nocardia brasiliensis Paracoccidioides brasiliensis Pneumocystis jiroveci Streptomyces somaliensis Sensitivity tests should be performed wherever possible to determine choice of therapy.

These tests should be repeated if there is a failure to respond, relapse or early recurrence. SEPTRA Injection and SEPTRA PEDIATRIC ORAL SUSPENSION may be indicated for the following infections when caused by susceptible strains of the above organisms.