| legal_CA = <!-- / Schedule I, II, III, IV, V, VI, VII, VIII -->
|fdaLIADAdult======Condition1=====
| legal_UK = <!-- GSL / P / POM / CD / Class A, B, C -->
| legal_US = Rx-only
* Dosing Information
| legal_status =
| routes_of_administration = Oral
:* Dosage
}}
{{SI}}
=====Condition2=====
{{CMG}}
* Dosing Information
:* Dosage
=====Condition3=====
* Dosing Information
:* Dosage
=====Condition4=====
* Dosing Information
:* Dosage
<!--Off-Label Use and Dosage (Adult)-->
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Contraindications-->
|contraindications=* Condition1
<!--Warnings-->
|warnings=* Description
====Precautions====
* Description
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|FDAPregCat=
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
<!--Administration and Monitoring-->
|administration=* Oral
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Description
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
<!--Overdosage-->
|overdose====Acute Overdose===
====Signs and Symptoms====
* Description
====Management====
* Description
===Chronic Overdose===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
<!--Pharmacology-->
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*
<!--Structure-->
|structure=*
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
==Overview==
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
'''Co-trimoxazole''' (abbreviated SXT, TMP-SMX, or TMP-sulfa) is an [[antibiotic]] combination of [[trimethoprim]] and [[sulfamethoxazole]], in the ratio of 1 to 5, used in the treatment of a variety of bacterial infections. The name co-trimoxazole is the [[British Approved Name]], and has been marketed worldwide under many [[trade name]]s including '''Septrin''' ([[GlaxoSmithKline|GSK]]), '''Bactrim''' ([[Hoffmann-La Roche|Roche]]), and various [[generic drug|generic]] preparations. According to the American Hospital Formulary Service, "co-trimoxazole usually is [[bactericidal]]." Other sources list this antibiotic as [[bacteriostatic]].
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
==Synergistic action==
<!--Nonclinical Toxicology-->
Co-trimoxazole exhibits a theoretical, although perhaps not a clinical,<ref>{{cite journal |author=Brumfitt W, Hamilton-Miller JM |title=Limitations of and indications for the use of co-trimoxazole | journal=J Chemother |year=1994 |month=Feb |volume=6 |issue=1 |pages=3-11 |pmid=8071675}}</ref> [[synergy|synergistic]] antibacterial effect when compared to each of its components administered singly. This is because trimethoprim and sulfamethoxazole inhibit successive steps in the [[folic acid|folate]] synthesis pathway (see diagram below). They did not exhibit synergistic effects, due to the requirement of a 1 in 5 ratio, which was observed in the laboratory. However, in clinical situations the ratio in the tissue was observed to be 1 in 20, resulting in no synergy.
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
Sulfamethoxazole acts as a false-substrate inhibitor of [[dihydropteroate synthetase]]. [[Sulfonamides]] such as sulfamethoxazole are analogues of [[para-Aminobenzoic acid|''p''-aminobenzoic acid]] (PABA) and are [[competitive inhibitor]]s of the enzyme; inhibiting the production of [[dihydropteroic acid]].
<!--How Supplied-->
|howSupplied=*
|storage=
|packLabel=
<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
Trimethoprim acts by interfering with the action of bacterial dihydrofolate reductase, inhibiting synthesis of tetrahydrofolic acid.
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
[[Folic acid]] is an essential precursor in the ''[[de novo synthesis|de novo]]'' synthesis of the DNA [[nucleoside]]s [[thymidine]] and [[uridine]]. Bacteria are unable to take up folic acid from the environment (i.e. the infection host) thus are dependent on their own de novo synthesis - inhibition of the enzyme starves the bacteria of two bases necessary for [[DNA replication]] and [[transcription (genetics)|transcription]].
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
==Clinical indications==
<!--Look-Alike Drug Names-->
Co-trimoxazole was claimed to be more effective than either of its components individually in treating bacterial infections, although this was later disputed.<ref>{{cite journal |author=Brumfitt W, Hamilton-Miller JM |title=Reassessment of the rationale for the combinations of sulphonamides with diaminopyrimidines | journal=J Chemother |year=1993 |month=Dec |volume=5 |issue=6 |pages=465-9 |pmid=8195839}}</ref> Along with its associated greater incidence of adverse effects including allergic responses (see below), its widespread use has been restricted in many countries to very specific circumstances where its improved efficacy is demonstrated.<ref>{{cite journal |author= |title=Co-trimoxazole use restricted |journal=Drug Ther Bull |year=1995 |month=Dec | volume=33 |issue=12 |pages=92-3 |pmid=8777892 |url=}}</ref> It may be effective in a variety of upper and lower [[respiratory tract]] infections, [[renal]] and [[urinary tract infection]]s, [[gastrointestinal tract]] infections, skin and wound infections, [[septicaemia]]s and other infections caused by sensitive organisms.
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
Specific indications for its use include: (Rossi, 2004)
<!--Drug Shortage Status-->
*treatment and prophylaxis of pneumonia caused by ''[[Pneumocystis jirovecii]]'' (formerly identified as ''P. carinii'') (Commmonly seen in immunocompromised patients including those suffering from [[HIV]]/[[AIDS]])
*prophylaxis of cerebral [[toxoplasmosis]] in [[HIV]] patients
{{LabelImage
*[[Whipple's disease]]
|fileName={{PAGENAME}}11.png
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
<!--Pill Image-->
==Safety==
There has been some concern about its use, however, since it has been associated with both frequent mild allergic reactions and serious adverse effects including [[Stevens-Johnson syndrome]], [[myelosuppression]], [[mydriasis]], [[agranulocytosis]], as well as severe liver damage (cholostatic hepatosis, hepatitis, liver necrosis, fulminant liver failure) and renal impairment up to acute renal failure and anuria. These side-effects are seen especially in the elderly and may be fatal. (Joint Formulary Committee, 2004).
The folic acid is likely not the best option for the treatment of some adverse effects with associated with TMP-SMX, a better treatment is probably administration of [[Folinic acid|folinic acid]]
In some countries, co-trimoxazole has been withdrawn due to these toxic effects.
Thus the current [[United Kingdom|British]] Committee on Safety of Medicines (CSM) guidelines recommend limiting its use to:
<!--Label Display Image-->
*[[Pneumocystis pneumonia]]
*[[Toxoplasmosis]] and [[nocardiosis]]
*acute exacerbations of chronic bronchitis and infections of the urinary tract where there is good rationale for use
*acute [[otitis media]] in children where there is good rationale
==References==
* Rossi S, editor. [[Australian Medicines Handbook]] 2004. Adelaide: Australian Medicines Handbook; 2004. ISBN 0-9578521-4-2.
* [[British National Formulary]], 51st edition (April 20, 2006). London: British Medical Association and Royal Pharmaceutical Society of Great Britain; 2006. ISBN 0853696683
* [http://briandeer.com/bactrim-septra.htm briandeer.com] Newspaper campaign over adverse events; 1994-
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Black Box Warning
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
Sulfamethoxazole-Trimethoprim (injection) is a that is FDA approved for the of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
Dosing Information
Dosage
Condition2
Dosing Information
Dosage
Condition3
Dosing Information
Dosage
Condition4
Dosing Information
Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Sulfamethoxazole-Trimethoprim (injection) in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Sulfamethoxazole-Trimethoprim (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Sulfamethoxazole-Trimethoprim (injection) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Sulfamethoxazole-Trimethoprim (injection) in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Sulfamethoxazole-Trimethoprim (injection) in pediatric patients.
Contraindications
Condition1
Warnings
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Sulfamethoxazole-Trimethoprim (injection) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Sulfamethoxazole-Trimethoprim (injection) in the drug label.
There is limited information regarding Patient Counseling Information of Sulfamethoxazole-Trimethoprim (injection) in the drug label.
Precautions with Alcohol
Alcohol-Sulfamethoxazole-Trimethoprim (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
01.png){kind=link}