BACTRIM DS SUMMARY
BACTRIM™
sulfamethoxazole and trimethoprim DS
(double strength) tablets and tablets USP
BACTRIM (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 Bactrim (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, Bactrim (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.
BACTRIM (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 BACTRIM in pediatric patients under two years of age. BACTRIM 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 BACTRIM offers 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 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.
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NEWS HIGHLIGHTS
Published Studies Related to Bactrim DS (Sulfamethoxazole / Trimethoprim)
Effect of long-term trimethoprim/sulfamethoxazole treatment on resistance and integron prevalence in the intestinal flora: a randomized, double-blind, placebo-controlled trial in children. [2009.05]
OBJECTIVES: The aim of this study was to test the hypothesis that trimethoprim/sulfamethoxazole selects for integron-positive and multidrug-resistant Enterobacteriaceae in the intestinal flora... CONCLUSIONS: Initially, trimethoprim/sulfamethoxazole usage was strongly associated with the appearance of integron-positive (multi)drug-resistant Enterobacteriaceae in the intestinal flora. After prolonged exposure to trimethoprim/sulfamethoxazole, however, this population of Enterobacteriaceae was substituted by a population with non-integron-associated resistance mechanisms. After trimethoprim/sulfamethoxazole was discontinued, susceptibility rates to all antibiotics returned to baseline levels.
Ceftibuten versus trimethoprim-sulfamethoxazole for oral treatment of febrile urinary tract infection in children. [2009.03]
A randomized, open, coordinated multi-center trial compared the bacteriological and clinical efficacy and safety of orally administered ceftibuten and trimethoprim-sulfamethoxazole (TMP-SMX) in children with febrile urinary tract infection (UTI). Children aged 1 month to 12 years presenting with presumptive first-time febrile UTI were eligible for enrolment...
Trimethoprim-sulfamethoxazole in children with chronic otitis media: a randomized comparison of costs and effects. [2008.10]
OBJECTIVE: To study the cost-effectiveness of a 6- to 12-week course of high-dose oral trimethoprim-sulfamethoxazole in children with chronic active otitis media (COM)... CONCLUSION: In children with active COM, direct and indirect costs of a 6- to 12-week course of high-dose oral trimethoprim-sulfamethoxazole are modest in the light of its short-term clinical benefit.
A randomized trial of ceftriaxone versus trimethoprim-sulfamethoxazole to prevent ventriculoperitoneal shunt infection. [2008.04]
BACKGROUND AND PURPOSE: Shunt infection represents a particularly morbid condition, which can also result in mortality. In order to decrease the high morbidity and mortality rates, prevention is an essential step. The purpose of this study was to compare the prophylactic use of ceftriaxone and trimethoprim-sulfamethoxazole (SXT) for the prevention of ventriculoperitoneal (VP) shunt infection... CONCLUSION: Ceftriaxone and SXT showed similar efficacy in preventing shunt infection. Cerebrospinal fluid leakage before or after VP shunt placement and aqueductal stenosis were independent risk factors for meningitis after VP shunt.
Simultaneous determination of sulfamethoxazole and trimethoprim in biological fluids for high-throughput analysis: comparison of HPLC with ultraviolet and tandem mass spectrometric detection. [2008.02.15]
The comparison of two methods based on online solid phase extraction-liquid chromatography with UV (SPE-LC-UV) or mass spectrometry detection (SPE-LC-MS/MS) for the simultaneous quantification of sulfamethoxazole (SMZ) and trimethoprim (TMP) is presented.The method with MS detection in comparison with UV detection proved to be more rugged and was successfully applied to pharmacokinetics studies.
Clinical Trials Related to Bactrim DS (Sulfamethoxazole / Trimethoprim)
Cotrimoxazole Prophylaxis in Severely Malnourished Children [Not yet recruiting]
This trial aims to test the hypothesis that mortality among Kenyan children with severe
malnutrition following initial stabilisation is due to ongoing vulnerability to infectious
disease, and that co-trimoxazole prophylaxis will reduce mortality.
The objective is to conduct a randomized, double blind, placebo-controlled trial of
cotrimoxazole prophylaxis for 6 months among HIV-uninfected children with severe
malnutrition following stabilization. The primary outcome will be survival at one year.
Secondary outcomes are toxicity, survival at two years, growth, hospitalisation and
microbial resistance and ecology.
Cotrimoxazole has striking protective efficacy against mortality among children with HIV,
despite not altering the underlying immune deficiency. It is hypothesised that
co-trimoxazole prophylaxis will have a similar effect in children immunocompromised because
of severe malnutrition. Worldwide, severe malnutrition is commoner than HIV in childhood and
co-trimoxazole is cheap and widely available, making it easily translatable to policy.
DB289 Versus TMP-SMX for the Treatment of Acute Pneumocystis Jiroveci Pneumonia (PCP) [Suspended]
Impact of Cotrimoxazole Prophylaxis for HIV-Infected Adults on Antifolate Resistance [Completed]
At least three studies in sub-Saharan Africa have demonstrated a decrease in morbidity or
mortality among HIV-infected adults who took daily cotrimoxazole (trimethoprim
sulfamethoxazole) [CTX] prophylaxis. Because of the demonstrated beneficial effect, high
tolerability and low cost of CTX, the United Nations Programme on HIV/AIDS (UNAIDS)
recommends that HIV-infected persons with symptomatic HIV or depressed CD4 counts receive
daily CTX. The effect of this recommendation on subsequent development of antimicrobial
resistance to antifolates among important pathogens needs to be evaluated. The
investigators measured the change in the prevalence of markers of antifolate resistance among
P. falciparum, and the change in the prevalence of CTX resistance among S. pneumoniae, and E.
coli in HIV-infected individuals receiving CTX daily prophylaxis. In addition, the
investigators measured the change in the prevalence of naso-pharyngeal or oro-pharyngeal
carriage of CTX resistant S. pneumoniae among children living in households where an
HIV-infected adult was receiving CTX daily prophylaxis.
Daily Co-Trimoxazole Prophylaxis to Prevent Malaria in Pregnancy [Recruiting]
Malaria is a major contributor of disease burden in Sub-Saharan Africa, and pregnant women
and children are the most vulnerable population. Malaria in pregnancy increases the risks of
abortion, prematurity, maternal anaemia, low birth weight (LBW), perinatal, neonatal and
infant mortality. For prevention and control of malaria in pregnancy, Intermittent Preventive
Treatment (IPT), insecticide treated nets (ITNs) and case management for malaria and anemia
are recommended.
HIV infection in pregnancy increases the risk of malaria, LBW, post-natal mortality and also
of anaemia. In pregnant women, HIV infection decreases the efficacy of IPT with the medicine
sulfadoxine-pyrimethamine (SP), which is the only treatment with proven efficacy and safety
in IPT and is recommended by the World Health Organization (WHO). Unfortunately, there is a
documented increase of resistance to SP, so cotrimoxazole (CTX) could be an alternative:
many studies in Zambia and Uganda demonstrated that it reduces mortality and morbidity in HIV
infected persons, and CTX prophylaxis significantly improves birth outcomes in
immuno-suppressed HIV women. Unfortunately, there is not yet information on its effectiveness
for preventing placental malaria infection, maternal anaemia and LBW. Thus in this study, we
aim to establish the safety and efficacy of daily CTX in preventing malaria infection during
pregnancy and its consequences, both in HIV infected and non-infected pregnant women. This
information is urgently needed to assist to issue guidelines on IPT in pregnancy.
Cotrimoxazole Versus Vancomycin for Invasive Methicillin-resistant Staphylococcus Aureus Infections [Recruiting]
Methicillin-resistant Staphylococcus aureus (SA) is a major pathogen causing mainly
health-care associated infections and, lately, also community acquired infections. Few
treatment choices exist to treat these infections. The currently recommended antibiotics for
these infections are glycopeptides (vancomycin or teicoplanin). Glycopeptide treatment hs
several disadvantages. It is a last resort antibiotic family that should be reserved for the
future; Vancomycin is less effective that beta-lactam drugs for SA infections susceptible to
both agents; treatment can only be given intravenously; and use of vancomycin has led to the
development of SA strains with partial or complete resistance to vancomycin. Cotrimoxazole
is an old antibiotic active against most strains of MRSA, depending on local epidemiology.
Study hypothesis: The purpose of this study is to show that cotrimoxazole is as effective as
treatment with vancomycin for invasive MRSA infections.
We plan a randomized controlled trial comparing treatment with cotrimoxazole vs. vancomycin
for invasive MRSA infections. The primary efficacy outcome we will assess will be
Improvement or cure with or without antibiotic modifications, defined as: survival at 7 days
post randomization with resolution of fever (<38 for two consecutive days) and resolution of
hypotension (>90 systolic without need for vasopressor support); and physician's assessment
that the primary infection was improved or cured. The primary safety outcome will be
all-cause 30-day survival.
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Page last updated: 2009-10-20
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