Trimethoprim/sulfamethoxazole explained

Verifiedrevid:388518461
Type:combo
Width:200
Ban:Co-trimoxazole
Component1:Sulfamethoxazole
Class1:Sulfonamide antibiotic
Component2:Trimethoprim
Class2:Dihydrofolate reductase inhibitor
Tradename:Bactrim, Cotrim, Septra, others
Dailymedid:Sulfamethoxazole trimethoprim
Pregnancy Au:C
Pregnancy Au Comment:[1]
Routes Of Administration:oral, intravenous
Atc Prefix:J01
Atc Suffix:EE01
Legal Au:S4
Legal Au Comment:[2] [3]
Legal Ca:Rx-only
Legal Uk:POM
Legal Uk Comment:[4]
Legal Us:Rx-only
Legal Us Comment:[5]
Cas Number:8064-90-2
Pubchem:358641
Chemspiderid:318412
Kegg:D00285
Chebi:3770
Chembl:58061
Synonyms:TMP/SMX, cotrimoxazole

Trimethoprim/sulfamethoxazole, sold under the brand name Bactrim among others, is a fixed-dose combination antibiotic medication used to treat a variety of bacterial infections.[6] It consists of one part trimethoprim to five parts sulfamethoxazole. It is used to treat urinary tract infections, methicillin-resistant Staphylococcus aureus (MRSA) skin infections, travelers' diarrhea, respiratory tract infections, and cholera, among others.[6] It is used both to treat and prevent pneumocystis pneumonia and toxoplasmosis in people with HIV/AIDS and other causes of immunosuppression.[6] It can be given orally (swallowed by mouth) or intravenous infusion (slowly injected into a vein with an IV).[6]

Trimethoprim/sulfamethoxazole is on the World Health Organization's List of Essential Medicines.[7] It is available as a generic medication.[8] In 2021, it was the 122nd most commonly prescribed medication in the United States, with more than 4million prescriptions.[9] [10]

Medical uses

Trimethoprim/sulfamethoxazole generally kills bacteria, by blocking the microorganisms' ability to make and to use folate.

Pneumocystis jirovecii pneumonia

Trimethoprim/sulfamethoxazole (TMP/SMX) is the medicine most commonly used to prevent Pneumocystis jirovecii pneumonia (PCP)[11] People who get Pneumocystis pneumonia have a medical condition that weakens their immune system, like HIV/AIDS, or take medicines (such as corticosteroids) that reduce the body's ability to fight bacterial and viral infections. People with HIV/AIDS are less likely to get Pneumocystis pneumonia as a result of antiretroviral therapy (ART). However, Pneumocystis pneumonia is still a substantial public health problem. Most of what is scientifically known about Pneumocystis pneumonia and its treatment comes from studying people with HIV/AIDS.[11]

Susceptibility

Organisms against which trimethoprim/sulfamethoxazole can be effective include:[12]

The only notable nonsusceptible organisms are Pseudomonas aeruginosa, the mycoplasmae and Francisella tularensis (the causative organism of tularaemia).[13] [14]

Pregnancy and breast feeding

Its use during pregnancy is contraindicated, although it has been placed in Australian pregnancy category C.[12] Its use during the first trimester (during organogenesis) and 12 weeks prior to pregnancy has been associated with an increased risk of congenital malformations, especially malformations associated with maternal folic acid deficiency (which is most likely related to the mechanism of action of co-trimoxazole) such as neural tube defects such as spina bifida, cardiovascular malformations (e.g. Ebstein's anomaly), urinary tract defects, oral clefts, and club foot in epidemiological studies.[12] Its use later on during pregnancy also increases the risk of preterm labour (odds ratio: 1.51) and low birth weight (odds ratio: 1.67).[15] [16] Animal studies have yielded similarly discouraging results.

It appears to be safe for use during breastfeeding as long as the baby is healthy.[17]

Babies

Its use in those less than 2 months of age is not recommended due to the risk of adverse side effects.[18]

Adverse effects

See also: List of side effects of trimethoprim/sulfamethoxazole.

Common side effects include nausea, vomiting, rash, and diarrhea. Severe allergic reactions and Clostridium difficile infection may occasionally occur. Its use in pregnancy is not recommended. It appears to be safe for use during breastfeeding as long as the baby is healthy.

Contraindications

Contraindications include the following:[12]

Interactions

Its use is advised against in people being concomitantly treated with:[12] [2] [4] [19] [20]

Overdose

Likely signs of toxicity include:[2]

The recommended treatment for overdose includes:[2]

Alkalinisation of the urine may reduce the toxicity of sulfamethoxazole, but it may increase the toxic effects of trimethoprim.[2]

Pharmacology

The synergy between trimethoprim and sulfamethoxazole was first described in the late 1960s.[23] [24] [25] Trimethoprim and sulfamethoxazole have a greater effect when given together than when given separately, because they inhibit successive steps in the folate synthesis pathway. They are given in a one-to-five ratio in their tablet formulations so that when they enter the body their concentration in the blood and tissues is roughly one-to-twenty — the exact ratio required for a peak synergistic effect between the two.

Sulfamethoxazole, a sulfonamide, induces its therapeutic effects by interfering with the de novo (that is, from within the cell) synthesis of folate inside microbial organisms such as protozoa, fungi and bacteria. It does this by competing with p-aminobenzoic acid (PABA) in the biosynthesis of dihydrofolate.

Trimethoprim serves as a competitive inhibitor of dihydrofolate reductase (DHFR), hence inhibiting the de novo synthesis of tetrahydrofolate, the biologically active form of folate.

Tetrahydrofolate is crucial in the synthesis of purines, thymidine, and methionine which are needed for the production of DNA and proteins[26] during bacterial replication.

The effects of trimethoprim causes a backlog of dihydrofolate (DHF) and this backlog can work against the inhibitory effect the drug has on tetrahydrofolate biosynthesis. This is where the sulfamethoxazole comes in; its role is in depleting the excess DHF by preventing it from being synthesised in the first place.

Co-trimoxazole was claimed to be more effective than either of its components individually in treating bacterial infections, although this was later disputed.[27] [28]

Excretion
1-4 20 66% 8-10 Renal
1-4 130 42-45% 10 Renal

Society and culture

Legal status

Indication! scope="col"

FDA-labelled indication?
TGA-labelled indication?
MHRA-labelled indication?		Literature support
Clinical trials are lacking.
Prophylaxis in HIV-infected individuals Effective in one Ugandan study on morbidity, mortality, CD4-cell count, and viral load in HIV infection.[29]
Clinical trials have confirmed its efficacy in chronic active otitis media[30] and acute otitis media.[31]
Travellers' diarrhoea, treatment & prophylaxis Clinical trials have confirmed its efficacy as a treatment for travellers' diarrhoea.[32] [33] [34]
Clinical trials have confirmed its efficacy in this indication.[35]
Bacterial infections
At least one clinical trial supports its use in this indication.[36]
Well-designed clinical trials are lacking.
Clinical trials have confirmed its efficacy, with or without adjunctive doxycycline; although, co-trimoxazole alone seems preferable.[37] [38] [39]
Pertussis (whooping cough) One cochrane review supports its efficacy in preventing the spread of pertussis.[40]
Generally accepted treatment for shigellosis.[41] A recent Cochrane review found that while it is an effective treatment for shigellosis it also produces more significant adverse effects than other antibiotic drugs.[42]
Staphylococcus aureus infections In vitro and in vivo activity against both non-resistant and methicillin-resistant Staphylococcus aureus (MRSA) infections.[43] [44] [45] [46] [47] [48] [49]
In vitro and in vivo activity against both nonresistant and MDR strains of TB.[50] [51] [52]
Co-trimoxazole is the recommended standard treatment for whipple's disease in some treatment protocols.[53] [54] [55]
Fungal and protozoal infections
Clinical trials have confirmed its use in this indication.[56]
Clinical trials have confirmed its efficacy in both the treatment and prevention of malaria.[57]
Its use as a prophylactic treatment is supported by one clinical trial involving children with acute lymphoblastic leukaemia.[58] Other than this and one other clinical trial into its efficacy as a treatment for pneumocystis pneumonia,[59] data on its use in both the treatment and prevention of pneumocystis pneumonia is significantly lacking.
Clinical trials have confirmed its prophylactic and therapeutic utility in cases of toxoplasmosis.[60] [61] [62] [63] [64] [65]

Brand names

Trimethoprim/sulfamethoxazole may be abbreviated as SXT, SMZ-TMP, TMP-SMX, TMP-SMZ, or TMP-sulfa. The generic British Approved Name (BAN) Co-trimoxazole is used for trimethoprim/sulfamethoxazole manufactured and sold by many different companies.[66]

The following list of brand names is incomplete:

Economics

Trimethoprim/sulfamethoxazole is relatively inexpensive as of 2019.[70]

Notes and References

  1. Web site: Sulfamethoxazole / trimethoprim Use During Pregnancy . Drugs.com . 8 March 2019 . 15 April 2020 . 6 September 2015 . https://web.archive.org/web/20150906073951/http://www.drugs.com/pregnancy/sulfamethoxazole-trimethoprim.html . live .
  2. Web site: Bactrim DS tablet blister pack . Therapeutic Goods Administration (TGA) . 28 December 2021 . 29 December 2021 . https://web.archive.org/web/20211229045805/https://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=162563 . live .
  3. Web site: TGA eBS - Product and Consumer Medicine Information Licence. 29 December 2021. 29 December 2021. https://web.archive.org/web/20211229045813/https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2021-PI-01633-1. live.
  4. Web site: Co-Trimoxazole 80 mg/400 mg Tablets - Summary of Product Characteristics (SmPC) . (emc) . 1 August 2021 . 28 December 2021 . 29 December 2021 . https://web.archive.org/web/20211229045804/https://www.medicines.org.uk/emc/product/6999/smpc . live .
  5. Web site: Bactrim DS- sulfamethoxazole and trimethoprim tablet Bactrim- sulfamethoxazole and trimethoprim tablet . DailyMed . 28 December 2021 . 29 December 2021 . https://web.archive.org/web/20211229045803/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62 . live .
  6. Web site: Co-trimoxazole. The American Society of Health-System Pharmacists . 1 August 2015. live. https://web.archive.org/web/20150906003435/http://www.drugs.com/monograph/co-trimoxazole.html . 6 September 2015.
  7. Book: ((World Health Organization)) . The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023) . 2023 . 10665/371090 . World Health Organization . World Health Organization . Geneva . WHO/MHP/HPS/EML/2023.02 . free .
  8. Book: Hamilton R . Tarascon Pocket Pharmacopoeia 2015 Deluxe Lab-Coat Edition. 2015. Jones & Bartlett Learning. 9781284057560. 105.
  9. Web site: The Top 300 of 2021 . ClinCalc . 14 January 2024 . 15 January 2024 . https://web.archive.org/web/20240115223848/https://clincalc.com/DrugStats/Top300Drugs.aspx . live .
  10. Web site: Sulfamethoxazole; Trimethoprim - Drug Usage Statistics . ClinCalc . 14 January 2024.
  11. Web site: 13 October 2021. Pneumocystis pneumonia. 30 December 2021. U.S. Centers for Disease Control and Prevention (CDC). 26 July 2021. https://web.archive.org/web/20210726083526/https://www.cdc.gov/fungal/diseases/pneumocystis-pneumonia/index.html. live.
  12. Web site: trimethoprim/sulfamethoxazole (Rx). Medscape Reference. 13 January 2014. live. https://web.archive.org/web/20140116124927/http://reference.medscape.com/drug/bactrim-trimethoprim-sulfamethoxazole-342543#showall. 16 January 2014.
  13. Web site: Tularemia. Infectious Disease Epidemiology Section. Louisiana Office of Public Health. 17 July 2011. 12 February 2014. live. https://web.archive.org/web/20140223030105/http://new.dhh.louisiana.gov/assets/oph/Center-PHCH/Center-CH/infectious-epi/EpiManual/TularemiaManual.pdf. 23 February 2014.
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  17. Web site: Sulfamethoxazole / trimethoprim Pregnancy and Breastfeeding Warnings. live. https://web.archive.org/web/20150906073951/http://www.drugs.com/pregnancy/sulfamethoxazole-trimethoprim.html. 6 September 2015. 31 August 2015. An extensive systematic review of sulfonamide usage near term and during breastfeeding found no side effects in infants; the authors concluded that use of this combination drug during breastfeeding presents no risk of neonatal kernicterus... LactMed: Use is considered acceptable when breastfeeding healthy, full-term infants after the newborn period.
  18. Web site: Drugs & Medications. WebMD. 19 April 2019. 19 April 2019. https://web.archive.org/web/20190419210051/https://www.webmd.com/drugs/2/drug-5530/bactrim-ds-oral/details/list-sideeffects. live.
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  26. Web site: Tetrahydrofolic acid. PubChem . U.S. National Library of Medicine . 26 February 2018. 26 February 2018. https://web.archive.org/web/20180226151952/https://pubchem.ncbi.nlm.nih.gov/compound/tetrahydrofolate#section=Drug-and-Medication-Information. live.
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