Septra (Trimethoprim / Sulfamethoxazole) - Summary

SEPTRA SUMMARY

SEPTRA (trimethoprim and sulfamethoxazole) is a synthetic antibacterial combination product.

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

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.

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

See all Septra indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Septra (Trimethoprim / Sulfamethoxazole)

Clindamycin versus trimethoprim-sulfamethoxazole for uncomplicated skin infections. [2015]
community-acquired methicillin-resistant Staphylococcus aureus (MRSA) is unclear... CONCLUSIONS: We found no significant difference between clindamycin and TMP-SMX,

Itraconazole vs. trimethoprim-sulfamethoxazole: A comparative cohort study of 200 patients with paracoccidioidomycosis. [2014]
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.

Short- and long-term cure rates of short-duration trimethoprim-sulfamethoxazole treatment in female dogs with uncomplicated bacterial cystitis. [2014]
BACKGROUND: Long-duration beta-lactam antibiotics are used for empirical treatment in female dogs with uncomplicated bacterial cystitis. However, women with bacterial cystitis are treated with short-duration potentiated sulfonamides because longer courses of beta-lactams result in lower cure and higher recurrence rates...

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.

more studies >>

Clinical Trials Related to Septra (Trimethoprim / Sulfamethoxazole)

Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With Cotrimoxazole [Recruiting]
First study to test the validity of the treatment of idiopathic pulmonary fibrosis, which causes inflammation and fibrosis (scarring) of the lung tissue, with cotrimoxazole. Cotrimoxazole may improve the clinical course of the disease through eradication of Pneumocystis jiroveci colonization and other mechanisms as inhibiting the activation of alveolar macrophages and producing alterations in the surfactant system which favours the persistent activation of the inflammatory response and the development of pulmonary fibrosis.

Safety of Cotrimoxazole in HIV- and HAART-exposed Infants [Completed]

Cotrimoxazole Versus Amoxicillin in the Treatment of Community Acquired Pneumonia in Children Aged 2-59 Months [Completed]
The investigators hypothesized that Oral amoxicillin (25mg/kg/dose bid) given to children aged 2-59 months with pneumonia, would lead to better clinical outcome on day three in 89. 9% of the children compared to 77. 0% of children receiving oral cotrimoxazole (8 mg/kg/dose trimethoprim, 40 mg/kg/dose sulphamethoxazole). A double blind randomized controlled trial was conducted in the Assessment Center of Mulago Hospital. Children with non-severe pneumonia were randomized to receive either oral amoxicillin (25 mg/kg/dose) or cotrimoxazole (trimethoprim 8 mg/kg and sulphamethoxazole 40 mg/kg) and followed up on day 3 and 5 of treatment. The primary outcome measures were normalization of respiratory rate by day 3 of treatment. Secondary outcome measures were antimicrobial susceptibility to cotrimoxazole and amoxicillin.

PK of Clindamycin and Trimethoprim-sulfamethoxazole in Infants and Children [Not yet recruiting]
Developmental changes in physiology during childhood influence drug dosing. Failure to account for these changes leads to improper dosing, which is associated with decreased drug efficacy and safety in children. Population physiologically-based pharmacokinetic (PBPK) modeling offers the opportunity to predict optimal drug dosing based on physiologic parameters adjusted for developmental changes. PBPK models are mathematical constructs that incorporate physiologic processes with drug characteristics and genetic variances to characterize the dose-exposure relationship across the age continuum. These models integrate drug-specific (e. g., metabolism, protein binding) and systems-specific (e. g., organ size, blood flow) information to predict the effect of different factors (e. g., age, genetic variants, disease) on drug exposure. By accounting for these factors and using data from clinical trials to confirm the modeling, PBPK models can reduce the number of children needed for clinical trials while maximizing dose-based efficacy and safety. This trial will evaluate a platform to prospectively validate population PBPK models in children. The study drugs, clindamycin and Bactrim (aka TMP-SMX), are ideal candidates to evaluate population PBPK models in children due to their differing physico-chemical properties and elimination pathways. In addition, a trial of clindamycin and TMP-SMX has broad clinical applicability, as both drugs are among the most commonly used agents to treat gram-positive infections in infants and children.

Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients [Completed]
The primary aim of this study is to quantify the effectiveness of Bactrim as additional therapy for the treatment of uncomplicated cellulitis in adults, by comparing: standard therapy plus Bactrim, versus standard therapy plus placebo. The primary hypothesis of this study is that, in light of increasing CA-MRSA prevalence, subjects treated with standard therapy plus Bactrim will have higher cure rates than those treated with standard therapy plus placebo.

more trials >>

Reports of Suspected Septra (Trimethoprim / Sulfamethoxazole) Side Effects

Drug Hypersensitivity (28),  Malaise (11),  Pain (10),  Hypersensitivity (9),  Skin Exfoliation (8),  Pneumonia (8),  Rash (8),  Sepsis (8),  Confusional State (7),  Osteomyelitis (7), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Septra review by 57 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		urinary infection
Dosage & duration:		one tablet taken twice a day for the period of about 2 weeks
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		The urinary tract infection which causing frequent urination and a lot of discomfort was completely cleared up after I took this drug. This drug has been effective for me on more than one occasion.
Side effects:		I did not have any side effects that I am aware of.
Comments:		I took two tablets of bactrim 2x per day with a glass of water. I was careful to drink plenty of water throughout the day.

Septra review by 48 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		urinary tract infection
Dosage & duration:		tablet taken daily for the period of 7 days
Other conditions:		none
Other drugs taken:		0
		Reported Results
Benefits:		eliminated urinary tract infection symptoms
Side effects:		mood changes, headaches,
Comments:		I had to finally stop before the end of the dose- I just was not myself. I understand that this drug has been banned in the UK due to the side effects.

Septra review by 48 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		urinary tract infection
Dosage & duration:		tablet taken daily for the period of 7 days
Other conditions:		none
Other drugs taken:		0
		Reported Results
Benefits:		eliminated urinary tract infection symptoms
Side effects:		mood changes, headaches,
Comments:		I had to finally stop before the end of the dose- I just was not myself. I understand that this drug has been banned in the UK due to the side effects.