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INDICATIONS

Tablets and Suspensions

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; trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole; trimethoprim in pediatric patients under two years of age. Sulfamethoxazole; trimethoprim 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, sulfamethoxazole; trimethoprim offers some advantage over the use of a single antimicrobial agent.

Pneumocystis Carinni Pneumonia: For the treatment of documented Pneumocystis carinii pneumonia. For prophylaxis against Pneumocystis carinni pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinni pneumonia.

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.

IV Infusion

Pneumocystis Carinii Pneumonia: Sulfamethoxazole; trimethoprim IV is indicated in the treatment of Pneumocystis carinii pneumonia in pediatric patients and in adults.

Shigellosis: Sulfamethoxazole; trimethoprim IV is indicated in the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei in pediatric patients and adults.

Urinary Tract Infections: Sulfamethoxazole; trimethoprim IV is indicated in the treatment of severe or complicated urinary tract infections due to susceptible strains of Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii and Proteus species when oral administration of sulfamethoxazole; trimethoprim is not feasible and when the organism is not susceptible to single-agent antibacterials effective in the urinary tract.

Although appropriate culture and susceptibility studies should be performed, therapy may be started while awaiting the results of these studies.


DOSAGE AND ADMINISTRATION

Tablets and Suspensions

Contraindicated in pediatric patients less than two months of age.

Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Pediatric Patients

Adults: The usual adult dosage in the treatment of urinary tract infections is one sulfamethoxazole; trimethoprim DS (double strength) tablet, two sulfamethoxazole; trimethoprim tablets, or 4 teaspoonfuls (20 ml) of sulfamethoxazole; trimethoprim suspensions every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.

Pediatric Patients: The recommended dose for pediatric patients with urinary tract infections or acute otitis media is 8 mg/kg trimethoprim and 40 mg/kg sulfamethoxazole per 24 hours, given in 2 divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. TABLE 3 is a guideline for the attainment of this dosage.

 

 

 

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