sulfamethoxazole 800 mg trimethoprim 160 mg oral tablet
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets 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 offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim tablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets are 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 a physician deems that sulfamethoxazole and trimethoprim tablets could offer some advantage over the use of a single antimicrobial agent. Shigellosis For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia For the treatment of documented Pneumocystis jirovecii Pneumonia and for prophylaxis against P. jirovecii Pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii Pneumonia. Traveler's Diarrhea in Adults For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.
aurobindo pharma limited
OVAL WHITE H49
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HOW SUPPLIED
SULFAMETHOXAZOLE AND TRIMETHOPRIM Tablets USP, 400 mg/80 mg are white to off-white circular, beveled edge uncoated tablets, debossed with “H 48” on one side and deep break line on the other side. Bottles of 20 NDC 65862-419-20 Bottles of 100 NDC 65862-419-01 Bottles of 500 NDC 65862-419-05 Bottles of 1,000 NDC 65862-419-99
SULFAMETHOXAZOLE AND TRIMETHOPRIM Tablets USP, 800 mg/160 mg are white to off-white oval, beveled edge uncoated tablets, debossed with “H 49” on one side and deep break line on other side. Bottles of 20 NDC 65862-420-20 Bottles of 100 NDC 65862-420-01 Bottles of 500 NDC 65862-420-05 Bottles of 1,000 NDC 65862-420-99 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [see USP Controlled Room Temperature]. DISPENSE IN TIGHT, LIGHT-RESIStanT CONTAINER.
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