SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP
Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim 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.
Sulfamethoxazole and trimethoprim 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, 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 in pediatric patients under two years of age. Sulfamethoxazole and 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 and trimethoprim offers some advantage over the use of a single antimicrobial agent.
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 and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia.
Traveler's Diarrhea in Adults
For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.
Published Studies Related to Sulfamethoxazole and Trimethoprim (Sulfamethoxazole / Trimethoprim)
Itraconazole vs. trimethoprim-sulfamethoxazole: A comparative cohort study of 200
patients with paracoccidioidomycosis. 
Paracoccidioidomycosis (PCM) is a systemic mycosis endemic to Latin America. Brazil accounts for approximately 80% of cases, where it represents a major
public health issue due to its disabling impact and the number of premature
deaths it causes... Although the results of this study show that
itraconazole was the best treatment option for PCM patients, a double-blind,
randomized, controlled trial is necessary to confirm this conclusion.
Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. [2010.09]
STUDY OBJECTIVE: Community-associated methicillin-resistant Staphylococcus aureus is now the leading cause of uncomplicated skin abscesses in the United States, and the role of antibiotics is controversial. We evaluate whether trimethoprim-sulfamethoxazole reduces the rate of treatment failures during the 7 days after incision and drainage and whether it reduces new lesion formation within 30 days... CONCLUSION: After the incision and drainage of uncomplicated abscesses in adults, treatment with trimethoprim-sulfamethoxazole does not reduce treatment failure but may decrease the formation of subsequent lesions. Copyright (c) 2010 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.
Standard versus newer antibacterial agents in the treatment of severe acute exacerbation of chronic obstructive pulmonary disease: a randomized trial of trimethoprim-sulfamethoxazole versus ciprofloxacin. [2010.07.15]
BACKGROUND. Although the use of antibiotics in the treatment of acute exacerbation of chronic obstructive pulmonary disease (COPD) is largely accepted, controversy remains regarding whether the choice of antibiotic has any impact on outcome.
Trimethopim-sulfamethoxazole compared with benzathine penicillin for treatment of impetigo in Aboriginal children: a pilot randomised controlled trial. [2010.03]
We conducted a pilot randomized controlled trial comparing trimethoprim-sulfamethoxazole to benzathine penicillin for treatment of impetigo in Aboriginal children. Treatment was successful in 7 of 7 children treated with trimethoprim-sulfamethoxazole and 5 of 6 treated with benzathine penicillin.Trimethoprim-sulfamethoxazole achieved microbiological clearance and healing of sores from which beta-hemolytic streptococci and community-associated methicillin-resistant Staphylococcus aureus were initially cultured.
Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated
skin abscesses in patients at risk for community-associated methicillin-resistant
Staphylococcus aureus infection. 
within 30 days... CONCLUSION: After the incision and drainage of uncomplicated abscesses in adults,
Clinical Trials Related to Sulfamethoxazole and Trimethoprim (Sulfamethoxazole / Trimethoprim)
Sulfamethoxazole Drug Interaction Study With MMX� Mesalazine/Mesalamine [Recruiting]
This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole
administered alone & in combination with MMX Mesalazine/mesalamine.
Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS [Completed]
To compare the safety and effectiveness of an investigational drug therapy (trimetrexate plus
leucovorin calcium) with that of conventional therapy (sulfamethoxazole-trimethoprim) in the
treatment of moderately severe Pneumocystis carinii pneumonia (PCP) in patients who have
AIDS, are HIV positive, or are at high risk for HIV infection. New treatments are needed to
reduce the mortality rate from PCP in AIDS patients and to reduce the high relapse rate found
after conventional therapy. Trimetrexate (TMTX) was chosen for this trial because it was
found to be much more potent than sulfamethoxazole/trimethoprim (SMX/TMP) against the PCP
organism in laboratory tests. Also TMTX, in combination with leucovorin (LCV), did not cause
severe toxicity in a preliminary trial. It is believed that TMTX will be more effective in
treating PCP and in preventing a recurrence of PCP.
Effect of Weight and/or Obesity on Sulfamethoxazole and Trimethoprim Concentrations [Recruiting]
This study will find how weight affects the dosing of a drug called sulfamethoxazole and
trimethoprim. Currently, the amount of sulfamethoxazole and trimethoprim a patient receives
is the same regardless of the patient's weight.
All sulfamethoxazole and trimethoprim (Trade name is Bactrim or Septra) medication that you
will receive in this study will be referred to as study medication within this informed
consent form. This drug is a combination of two antibiotics, sulfamethoxazole and
trimethoprim, which belongs to a class of medication known as "sulfones" and is approved by
the US Food and Drug Administration (FDA) for the treatment of a wide variety of bacterial
infections such as ear infections, urinary tract infections, bronchitis, traveler's
diarrhea, and Pneumocystis carinii pneumonia. Sulfamethoxazole and trimethoprim is given
Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis [Completed]
To determine whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces
the incidence of treatment-limiting adverse reactions compared to the routine initiation of
the drugs for Pneumocystis carinii pneumonia (PCP) prophylaxis in HIV-infected patients.
Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP
prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study
in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose
over 2 weeks, no significant adverse reactions have occurred.
Evaluation of the Interaction Between High Dose Sulfamethoxazole/Trimethoprim and Zidovudine [Completed]
To determine if the pharmacokinetics of high doses of zidovudine (AZT) (that is, how fast AZT
reaches the blood, what concentration of AZT is attained in the blood, and how long AZT
remains in the blood) changes from day to day in the same patient. Also to determine whether
the pharmacokinetics of AZT is changed when trimethoprim/sulfamethoxazole (SMX/TMP) is given
at the same time, or whether the pharmacokinetics of SMX/TMP is altered by AZT given at the
AZT has been effective in treating HIV infection in some patients with AIDS, and SMX/TMP is
an antibiotic combination which is useful in preventing or treating Pneumocystis carinii
pneumonia (PCP). It is important to know how drugs interact in patients because addition of a
second drug may change the speed at which a drug is eliminated from the body, and cause
increased toxic effects or decreased therapeutic effects.
Reports of Suspected Sulfamethoxazole and Trimethoprim (Sulfamethoxazole / Trimethoprim) Side Effects
Renal Failure Acute (41),
Stevens-Johnson Syndrome (21),
Pruritus (15), more >>
Page last updated: 2014-11-30