Co-trimoxazole (Monograph)

Brand names: Bactrim, Bactrim DS, Septra, Septra DS, Sulfatrim
Drug class: Sulfonamides
- Antiprotozoal Agents
VA class: AM900
CAS number: 8064-90-2

Medically reviewed by Drugs.com on Aug 26, 2024. Written by ASHP.

Introduction

Antibacterial; fixed combination of sulfamethoxazole (intermediate-acting sulfonamide) and trimethoprim; both sulfamethoxazole and trimethoprim are folate-antagonist anti-infectives.^a

Uses for Co-trimoxazole

Acute Otitis Media

Treatment of acute otitis media (AOM) in adults^{† [off-label]} and children caused by susceptible Streptococcus pneumoniae or Haemophilus influenzae¹⁸⁶ ²⁷² ²⁷³ ²⁷⁴ ²⁷⁸ ^a when the clinician makes the judgment that the drug offers some advantage over use of a single anti-infective.^a ¹⁸⁶

Not a drug of first choice; considered an alternative for treatment of AOM, especially for those with type I penicillin hypersensitivity.³²¹ Because amoxicillin-resistant S. pneumoniae frequently are resistant to co-trimoxazole, the drug may not be effective in patients with AOM who fail to respond to amoxicillin.³⁰² ³²¹

Data are limited regarding safety of repeated use of co-trimoxazole in pediatric patients <2 years of age; the drug should not be administered prophylactically or for prolonged periods for treatment of AOM in any age group.¹⁸⁶ ^a

GI Infections

Treatment of travelers’ diarrhea caused by susceptible enterotoxigenic Escherichia coli.¹¹² ¹⁵⁹ ¹⁸¹ ¹⁸² ¹⁸⁶ ²⁴² ²⁵⁶ Replacement therapy with oral fluids and electrolytes may be sufficient for mild to moderate disease;¹¹⁵ ¹⁵⁹ ¹⁸⁰ ¹⁸¹ ²⁴² ²⁵⁶ ²⁵⁷ those who develop diarrhea with ≥3 loose stools in an 8-hour period (especially if associated with nausea, vomiting, abdominal cramps, fever, or blood in the stools) may benefit from short-term anti-infectives.¹¹⁴ ¹¹⁵ ¹⁵⁹ ¹⁸⁰ ²⁴² ²⁵⁹ ³⁰⁶ Fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin) usually drugs of choice when treatment indicated;¹⁵⁹ ¹⁸⁰ ²⁴² ³⁰⁶ co-trimoxazole also has been recommended as an alternative when fluoroquinolones cannot be used (e.g., in children).¹⁵⁹ ²⁴² ³⁰⁶

Prevention of travelers’ diarrhea^{† [off-label]} in individuals traveling forrelatively short periods to areas where enterotoxigenic E. coli and other causative bacterial pathogens (e.g., Shigella) are known to be susceptible to the drug.¹¹³ ¹⁵⁹ ²⁴² CDC and others do not recommend anti-infective prophylaxis in most individuals traveling to areas of risk;¹¹⁴ ¹⁵⁹ ¹⁸⁰ ¹⁹³ ²⁴² ²⁵⁶ ²⁵⁷ ²⁸⁰ ²⁸⁶ the principal preventive measures are prudent dietary practices.¹¹⁴ ¹⁵⁹ ²⁵⁶ ²⁵⁷ If prophylaxis is used (e.g., in immunocompromised individuals such as those with HIV infection), a fluoroquinolone (ciprofloxacin, levofloxacin, ofloxacin, norfloxacin) is preferred.¹⁵⁹ ¹⁸⁰ Resistance to co-trimoxazole is common in many tropical areas.¹⁵⁹

Treatment of enteritis caused by susceptible Shigella flexneri or S. sonnei when anti-infectives are indicated.¹²¹ ¹³⁵ ¹⁸⁶ ²⁸⁶

Treatment of dysentery caused by enteroinvasive E. coli^{† [off-label]} (EIEC).²⁸⁶ AAP suggests that an oral anti-infective (e.g., co-trimoxazole, azithromycin, ciprofloxacin) can be used if the causative organism is susceptible.²⁸⁶

Treatment of diarrhea caused by enterotoxigenic E. coli^{† [off-label]} (ETEC) in travelers to resource-limited countries.²⁸⁶ Optimal therapy not established, but AAP suggests that use of co-trimoxazole, azithromycin, or ciprofloxacin be considered if diarrhea is severe or intractable and if in vitro testing indicates the causative organism is susceptible.²⁸⁶ A parenteral regimen should be used if systemic infection is suspected.²⁸⁶

Role of anti-infectives in treatment of hemorrhagic colitis caused by shiga toxin-producing E. coli^{† [off-label]} (STEC; formerly known as enterohemorrhagic E. coli) is unclear; most experts would not recommend use of anti-infectives in children with enteritis caused by E. coli 0157:H7.²⁸⁶

Treatment of GI infections caused by Yersinia enterocolitica^† or Y. pseudotuberculosis^†.¹²¹ ²⁸⁶ ^d These infections usually are self-limited, but IDSA, AAP, and others recommend anti-infectives for severe infections, when septicemia or other invasive disease occurs, and in immunocompromised patients.²⁸⁶ ^d Other than decreasing the duration of fecal excretion of the organism, a clinical benefit of anti-infectives in management of enterocolitis, pseudoappendicitis syndrome, or mesenteric adenitis caused by Yersinia has not been established.²⁸⁶

Respiratory Tract Infections

Treatment of acute exacerbation of chronic bronchitis caused by susceptible S. pneumoniae or H. influenzae¹³⁵ when the clinician makes the judgment that the drug offers some advantage over use of a single anti-infective.¹⁸⁶

A drug of choice for treatment of upper respiratory tract infections and bronchitis caused by H. influenzae;¹²¹ an alternative to penicillin G or penicillin V for treatment of respiratory tract infections caused by S. pneumoniae.¹²¹

Alternative for treatment of infections caused by Legionella micdadei^† (L. pittsburgensis) or L. pneumophila^†.¹²¹

Urinary Tract Infections (UTIs)

Treatment of UTIs caused by susceptible E. coli, Klebsiella, Enterobacter, Morganella morganii, Proteus mirabilis, or P. vulgaris.¹³⁵ ¹⁸⁶ ^a A drug of choice for empiric treatment of acute uncomplicated UTIs.¹²¹ ¹⁶³

Brucellosis

Treatment of brucellosis^†; alternative when tetracyclines are contraindicated (e.g., children).¹²¹ ²⁸⁶ Used alone or in conjunction with other anti-infectives (e.g., streptomycin or gentamicin and/or rifampin),¹²¹ ²⁸⁶ especially for severe infections or when there are complications (e.g., endocarditis, meningitis, osteomyelitis).²⁸⁶

Burkholderia Infections

Treatment of infections caused by Burkholderia cepacia^†.¹²¹ Co-trimoxazole considered drug of choice; ceftazidime, chloramphenicol, or imipenem are alternatives.¹²¹

Treatment of melioidosis^† caused by susceptible B. pseudomallei; used in multiple-drug regimen with chloramphenicol and doxycycline.¹²¹ Ceftazidime or imipenem monotherapy may be preferred.¹²¹ B. pseudomallei is difficult to eradicate and relapse of melioidosis is common.

Cholera

Treatment of cholera^† caused by Vibrio cholerae.¹²¹ ²³¹ ²⁸⁶ Alternative to tetracyclines; used as an adjunct to fluid and electrolyte replacement in moderate to severe disease.¹²¹ ²³¹ ²⁸⁶

Cyclospora Infections

Treatment of infections caused by Cyclospora cayetanensis^†.¹¹⁹ ¹⁵⁹ ²⁸⁶ ³²⁰ The drug of choice.¹¹⁹ ¹⁵⁹ ²⁸⁶

Granuloma Inguinale (Donovanosis)

Treatment of granuloma inguinale (donovanosis) caused by Calymmatobacterium granulomatis^†.¹¹⁶ ¹²¹ ²⁸⁶ CDC recommends doxycycline or co-trimoxazole.¹¹⁶

Isosporiasis

Treatment of isosporiasis^† caused by Isospora belli.¹¹⁹ ¹²⁰ The drug of choice.¹¹⁹

Listeria Infections

Treatment of infections caused by Listeria monocytogenes^†;¹²¹ ²³² ²³³ ²³⁴ ²³⁵ ²³⁶ ²³⁷ a preferred alternative to ampicillin in penicillin-allergic patients.¹¹⁸ ¹²¹ ²⁸⁶

Mycobacterial Infections

Treatment of cutaneous infections caused by Mycobacterium marinum^†;¹²¹ ^e alternative to minocycline.¹²¹

Nocardia Infections

Treatment of infections caused by Nocardia^†, including N. asteroides, N. brasiliensis, and N. caviae.¹²¹ ²⁸⁶ Drugs of choice are co-trimoxazole¹²¹ ²⁸⁶ or a sulfonamide alone (e.g., sulfisoxazole, sulfamethoxazole).²⁸⁶

Pertussis

Treatment of the catarrhal stage of pertussis^† to potentially ameliorate the disease and reduce its communicability.¹²¹ ¹⁶⁴ ¹⁶⁵ ¹⁶⁶ ¹⁶⁸ ¹⁶⁹ ²⁸⁶ Recommended by CDC, AAP, and others as an alternative to erythromycin.¹²¹ ¹⁶⁴ ²⁸⁶

Prevention of pertussis^† in household and other close contacts (e.g., day-care facility attendees) of patients with the disease.¹⁶⁴ ¹⁶⁵ ¹⁶⁶ ¹⁶⁷ ¹⁶⁸ ²⁵⁵ Alternative to erythromycin.¹⁶⁴ ¹⁶⁵ ¹⁶⁶ ¹⁶⁷ ¹⁶⁸ ²⁵⁵

Plague

Has been used for postexposure prophylaxis of plague^†.¹⁵⁹ ²⁸³ ²⁸⁶ Although recommended by CDC and others for such prophylaxis in infants and children <8 years of age,¹⁵⁹ ²⁸³ ²⁸⁶ efficacy of the drug for prevention of plague is unknown.²⁸⁶ Most experts (e.g., CDC, AAP, the US Working Group on Civilian Biodefense, US Army Medical Research Institute of Infectious Diseases) recommend oral ciprofloxacin or doxycycline for postexposure prophylaxis in adults and most children.²⁸⁶ ³⁰⁹ ³¹⁰ Postexposure prophylaxis recommended after high-risk exposures to plague, including close exposure to individuals with naturally occurring plague, during unprotected travel in active epizootic or epidemic areas, or laboratory exposure to viable Yersinia pestis.¹⁵⁹ ²⁸³ ²⁸⁶ ³⁰⁹ ³¹⁰

Has been used for treatment of plague^†, but appears to be less effective than other anti-infectives used for treatment of the disease (e.g., streptomycin, gentamicin, tetracycline, doxycycline, chloramphenicol).³⁰⁹ ³¹¹ Because of lack of efficacy, some experts state that co-trimoxazole should not be used for the treatment of pneumonic plague.³⁰⁹

Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia

Treatment of Pneumocystis jiroveci (formerly Pneumocystis carinii) pneumonia (PCP).¹¹⁹ ¹³⁵ ¹⁸⁶ ²⁸⁶ ^a Initial drug of choice for most patients with PCP,¹¹⁹ ¹⁷⁰ ²⁸⁶ including HIV-infected individuals.¹⁰⁰ ¹⁰⁴ ¹⁰⁵ ¹⁴⁸ ¹⁴⁹ ¹⁵⁰ ¹⁵¹ ¹⁵² ¹⁵³ ¹⁷⁰ ²⁴¹

Prevention of initial episodes of PCP (primary prophylaxis) in immunocompromised individuals at increased risk, including HIV-infected individuals.¹¹⁹ ¹⁵¹ ¹⁵⁵ ¹⁵⁶ ¹⁵⁷ ¹⁸⁶ ¹⁹⁹ ²⁰² ²⁰³ ²²⁷ ²²⁸ ²⁴⁰ ²⁴¹ ²⁶¹ ²⁶² ²⁸⁰ ²⁸⁶ ^a Drug of choice.¹¹⁹ ²⁶¹ ²⁶² ²⁸⁶ up to 14

Long-term suppressive or chronic maintenance therapy (secondary prophylaxis) to prevent recurrence following an initial PCP episode in immunocompromised patients, including HIV-infected individuals.¹¹⁹ ¹⁹⁹ ²⁰² ²⁰³ ²²⁷ ²²⁸ ²⁴¹ ²⁶² ²⁸⁰ ²⁸⁶ Drug of choice.¹¹⁹ ²⁸⁰ ²⁸⁶

Toxoplasmosis

Prevention of toxoplasmosis^† encephalitis (primary prophylaxis) in HIV-infected adults, adolescents, and children who are seropositive for Toxoplasma IgG antibody.¹¹⁹ ²⁸⁰ Drug of choice.²⁸⁰

Not recommended for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) to prevent recurrence of toxoplasmosis encephalitis; regimen of choice for secondary prophylaxis of toxoplasmosis is sulfadiazine and pyrimethamine (with leucovorin).²⁸⁰

Typhoid Fever and Other Salmonella Infections

Alternative for treatment of typhoid fever^† (enteric fever) caused by susceptible Salmonella typhi.¹²¹ ²⁸⁶ Drugs of choice are fluoroquinolones and third generation cephalosporins (e.g., ceftriaxone, cefotaxime);¹²¹ ²⁸⁶ consider that multidrug-resistant strains of S. typhi (strains resistant to ampicillin, amoxicillin, chloramphenicol, and/or co-trimoxazole) reported with increasing frequency.¹²¹ ²⁸⁶

Alternative for treatment of gastroenteritis caused by nontyphoidal Salmonella^†.¹²¹ ²⁸⁶

Wegener’s Granulomatosis

Treatment of Wegener’s granulomatosis^†.¹²² ¹²³ ¹³³ ¹⁴⁶ ¹⁴⁷ ²⁰⁷ ^c Effect on long-term morbidity and mortality unclear, but may prevent relapse and reduce need for cytotoxic (e.g., cyclophosphamide) and corticosteroid therapy in some patients.¹²² ¹²³ ¹³³ ¹⁴⁶ ¹⁴⁷ ²⁰⁷ ^c

Whipple’s Disease

Treatment of Whipple’s disease^† caused by Tropheryma whippelii.¹²¹ Alternative or follow-up to penicillin G.¹²¹

Co-trimoxazole Dosage and Administration

Administration

Administer orally^a or by IV infusion.¹³⁵ Do not administer by rapid IV infusion or injection¹³⁵ and do not administer IM.¹³⁵

An adequate fluid intake should be maintained during co-trimoxazole therapy to prevent crystalluria and stone formation.¹³⁵ ^a

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Dilution

Co-trimoxazole concentrate for injection must be diluted prior to IV infusion.¹³⁵

Each 5 mL of the concentrate for injection containing 80 mg of trimethoprim should be added to 125 mL of 5% dextrose in water.¹³⁵ In patients in whom fluid intake is restricted, each 5 mL of the concentrate may be added to 75 mL of 5% dextrose in water.¹³⁵

Rate of Administration

IV solutions should be infused over a period of 60–90 minutes.¹³⁵

Dosage

Available as fixed combination containing sulfamethoxazole and trimethoprim; dosage expressed as both the sulfamethoxazole and trimethoprim content or as the trimethoprim content.¹³⁵ ^a ^b

Pediatric Patients

Acute Otitis Media

Oral

Children ≥2 months of age: 8 mg/kg of trimethoprim and 40 mg/kg of sulfamethoxazole daily in 2 divided doses every 12 hours.^a Usual duration is 10 days.^a

GI Infections

Shigella Infections

Oral

Children ≥2 months of age: 8 mg/kg of trimethoprim and 40 mg/kg of sulfamethoxazole daily in 2 divided doses every 12 hours.^a Usual duration is 5 days.^a

Children ≥2 months of age: 8–10 mg/kg of trimethoprim daily (as co-trimoxazole) in 2–4 equally divided doses given for 5 days.¹³⁵

Urinary Tract Infections (UTIs)

Oral

Children ≥2 months of age: 8 mg/kg of trimethoprim and 40 mg/kg of sulfamethoxazole daily in 2 divided doses every 12 hours.^a Usual duration is 10 days.^a

Severe UTIs

Children ≥2 months of age: 8–10 mg/kg of trimethoprim daily (as co-trimoxazole) in 2–4 equally divided doses given for up to 14 days.¹³⁵

Brucellosis†

Oral

10 mg/kg daily (up to 480 mg daily) of trimethoprim (as co-trimoxazole) in 2 divided doses for 4–6 weeks.²⁸⁶

Cholera†

Oral

4–5 mg/kg of trimethoprim (as co-trimoxazole) twice daily given for 3 days.²⁸³ ²⁸⁶

Cyclospora Infections†

Oral

5 mg/kg of trimethoprim and 25 mg/kg of sulfamethoxazole twice daily given for 7–10 days.¹¹⁹ HIV-infected patients may require higher dosage and longer treatment.¹¹⁹

Granuloma Inguinale (Donovanosis)†

Oral

Adolescents: 160 mg of trimethoprim and 800 mg of sulfamethoxazole twice daily given for ≥3 weeks or until all lesions have healed completely;¹¹⁶ consider adding IV aminoglycoside (e.g., gentamicin) if improvement is not evident within the first few days of therapy and in HIV-infected patients.¹¹⁶

Relapse can occur 6–18 months after apparently effective treatment.¹¹⁶

Isosporiasis†

Oral

5 mg/kg of trimethoprim and 25 mg/kg of sulfamethoxazole twice daily.¹¹⁹ Usual duration of treatment is 10 days; higher dosage or more prolonged treatment necessary in immunocompromised patients.¹¹⁹

Pertussis†

Oral

8 mg/kg of trimethoprim and 40 mg/kg of sulfamethoxazole daily in 2 divided doses.¹⁶⁴ ²⁸⁶ Usual duration is 14 days for treatment or prevention.¹⁶⁴ ²²² ²²³ ²²⁴ ²²⁵ ²²⁶ ²⁸⁶

Plague†

Postexposure Prophylaxis†

Oral

Children ≥2 months of age: 320–640 mg of trimethoprim (as co-trimoxazole) daily in 2 divided doses given for 7 days.²⁸³ Alternatively, 8 mg/kg daily of trimethoprim (as co-trimoxazole) in 2 divided doses given for 7 days.²⁸³

Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia

Treatment

Oral

Children ≥2 months of age: 15–20 mg/kg of trimethoprim and 75–100 mg/kg of sulfamethoxazole daily in 3 or 4 divided doses.¹¹⁹ ²⁸⁶ ^a Usual duration is 14–21 days.¹¹⁹ ²⁸⁶ ^a

Children ≥2 months of age: 15–20 mg/kg of trimethoprim daily (as co-trimoxazole) in 3 or 4 equally divided doses.¹¹⁹ ¹³⁵ ²⁸⁶ Usual duration is 14–21 days.¹¹⁹ ²⁸⁶ ^a

Primary Prophylaxis in Infants and Children

Oral

150 mg/m² of trimethoprim and 750 mg/m² of sulfamethoxazole daily in 2 divided doses given on 3 consecutive days each week.¹¹⁹ ¹⁸⁶ ²⁸⁰ ²⁸⁶ ^a Total daily dose should not exceed 320 mg of trimethoprim and 1.6 g of sulfamethoxazole.^a

Alternatively, 150 mg/m² of trimethoprim and 750 mg/m² of sulfamethoxazole can be administered as a single dose 3 times each week on consecutive days, in 2 divided doses daily 7 days each week, or in 2 divided daily doses given 3 times each week on alternate days.²⁸⁰ ²⁸⁶

CDC, USPHS/IDSA, AAP, and others recommend that primary prophylaxis be initiated in all infants born to HIV-infected women starting at 4–6 weeks of age, regardless of their CD4⁺ T-cell count.²⁸⁰ ²⁸² ²⁸⁶ Infants who are first identified as being HIV-exposed after 6 weeks of age should receive primary prophylaxis beginning at the time of identification.²⁸²

Primary prophylaxis should be continued until 12 months of age in all HIV-infected infants and infants whose infection status has not yet been determined;²⁸⁰ ²⁸² it can be discontinued in those found not to be HIV-infected.²⁸⁰ ²⁸²

The need for subsequent prophylaxis should be based on age-specific CD4⁺ T-cell count thresholds.²⁸⁰ ²⁸² In HIV-infected children 1–5 years of age, primary prophylaxis should be initiated if CD4⁺ T-cell counts are <500/mm³ or CD4⁺ percentage is <15%.²⁸⁰ ²⁸² In HIV-infected children 6–12 years of age, primary prophylaxis should be initiated if CD4⁺ T-cell counts are <200/mm³ or CD4⁺ percentage is <15%.²⁸⁰ ²⁸²

The safety of discontinuing prophylaxis in HIV-infected children receiving potent antiretroviral therapy has not been extensively studied.²⁸⁰

Prevention of Recurrence (Secondary Prophylaxis) in Infants and Children

Oral

150 mg/m² of trimethoprim and 750 mg/m² of sulfamethoxazole daily in 2 divided doses given on 3 consecutive days each week.¹¹⁹ ¹⁸⁶ ²⁸⁰ ^a Total daily dose should not exceed 320 mg of trimethoprim and 1.6 g of sulfamethoxazole.^a

Alternatively, 150 mg/m² of trimethoprim and 750 mg/m² of sulfamethoxazole can be administered as a single daily dose given for 3 consecutive days each week, in 2 divided doses daily, or in 2 divided daily doses given 3 times a week on alternate days.²⁸⁰

The safety of discontinuing secondary prophylaxis in HIV-infected children receiving potent antiretroviral therapy has not been extensively studied.²⁸⁰ Children who have a history of PCP should receive life-long suppressive therapy to prevent recurrence.²⁸⁰

Primary and Secondary Prophylaxis in Adolescents

Oral

Dosage for primary or secondary prophylaxis against P. jiroveci pneumonia in adolescents and criteria for initiation or discontinuance of such prophylaxis in this age group are the same as those recommended for adults.²⁸⁰ (See Adult Dosage under Dosage and Administration.)

Toxoplasmosis†

Primary Prophylaxis in Infants and Children†

Oral

150 mg/m² of trimethoprim and 750 mg/m² of sulfamethoxazole daily in 2 divided doses.²⁸⁰

The safety of discontinuing toxoplasmosis prophylaxis in HIV-infected children receiving potent antiretroviral therapy has not been extensively studied.²⁸⁰

Primary Prophylaxis in Adolescents†

Oral

Dosage for primary prophylaxis against toxoplasmosis in adolescents and criteria for initiation or discontinuance of such prophylaxis in this age group are the same as those recommended for adults.²⁸⁰ (See Adult Dosage under Dosage and Administration.)

Adults

GI Infections

Treatment of Travelers’ Diarrhea

Oral

160 mg of trimethoprim and 800 mg of sulfamethoxazole every 12 hours given for 3–5 days.¹¹² ¹⁸³ ¹⁸⁶ ²⁴² ²⁵⁶ ²⁵⁷ ³⁰⁶ ^a A single 320-mg dose of trimethoprim (as co-trimoxazole) also has been used.²⁴² ³⁰⁶

Prevention of Travelers’ Diarrhea

Oral

160 mg of trimethoprim and 800 mg of sulfamethoxazole once daily during the period of risk.²⁵⁶ ²⁵⁷ Use of anti-infectives for prevention of travelers’ diarrhea generally is discouraged.¹¹² ¹⁸⁰ ¹⁸⁶ ²⁴² ²⁵⁶ ²⁵⁷ ³⁰⁶

Shigella Infections

Oral

160 mg of trimethoprim and 800 mg of sulfamethoxazole every 12 hours given for 5 days.^a

8–10 mg/kg of trimethoprim daily (as co-trimoxazole) in 2–4 equally divided doses given for 5 days.¹³⁵

Respiratory Tract Infections

Acute Exacerbations of Chronic Bronchitis

Oral

160 mg of trimethoprim and 800 mg of sulfamethoxazole every 12 hours given for 14 days.^a

Urinary Tract Infections (UTIs)

Oral

160 mg of trimethoprim and 800 mg of sulfamethoxazole every 12 hours.^a

Usual duration of treatment is 10–14 days.^a A 3-day regimen may be effective for acute, uncomplicated cystitis in women.¹²¹ ¹⁶³

Severe UTIs

8–10 mg/kg of trimethoprim daily (as co-trimoxazole) in 2–4 equally divided doses given for up to 14 days.¹³⁵

Cholera†

Oral

160 mg of trimethoprim and 800 mg of sulfamethoxazole every 12 hours given for 3 days.²³¹

Cyclospora Infections†

Oral

160 mg of trimethoprim and 800 mg of sulfamethoxazole twice daily given for 7–10 days.¹¹⁹ HIV-infected patients may require higher dosage and longer-term treatment.¹¹⁹

Granuloma Inguinale (Donovanosis)†

Oral

160 mg of trimethoprim and 800 mg of sulfamethoxazole twice daily given for ≥3 weeks or until all lesions have healed completely;¹¹⁶ consider adding IV aminoglycoside (e.g., gentamicin) if improvement is not evident within the first few days of therapy and in HIV-infected patients.¹¹⁶

Relapse can occur 6–18 months after apparently effective treatment.¹¹⁶

Isosporiasis†

Oral

160 mg of trimethoprim and 800 mg of sulfamethoxazole twice daily.¹¹⁹ Usual duration of treatment is 10 days; higher dosage or more prolonged treatment necessary in immunocompromised patients.¹¹⁹

Mycobacterial Infections†

Mycobacterium marinum Infections

Oral

160 mg of trimethoprim and 800 mg of sulfamethoxazole twice daily given for ≥3 months recommended by ATS for treatment of cutaneous infections.^c A minimum of 4–6 weeks of treatment usually is necessary to determine whether the infection is responding.^c

Pertussis†

Oral

320 mg of trimethoprim (as co-trimoxazole) daily in 2 divided doses.¹⁶⁴ ¹⁶⁶ ¹⁶⁸ Usual duration is 14 days for treatment or prevention.¹⁶⁴ ²²² ²²³ ²²⁴ ²²⁵ ²²⁶ ²⁸⁶

Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia

Treatment

Oral

15–20 mg/kg of trimethoprim and 75–100 mg/kg of sulfamethoxazole daily in 3 or 4 divided doses.¹¹⁹ ¹⁷⁰ ¹⁸⁶ ^a Usual duration is 14–21 days.¹¹⁹ ^a

15–20 mg/kg of trimethoprim daily in 3 or 4 equally divided doses every 6 or 8 hours given for up to 14 days.¹³⁵ Some clinicians recommend 15 mg/kg of trimethoprim and 75 mg/kg of sulfamethoxazole daily in 3 or 4 divided doses for 14–21 days.¹¹⁹

Primary Prophylaxis

Oral

160 mg of trimethoprim and 800 mg of sulfamethoxazole once daily.¹¹⁹ ¹⁸⁶ ²²⁷ ²⁴⁰ ²⁴¹ ²⁴³ ²⁸⁰ ^a Alternatively, 80 mg of trimethoprim and 400 mg of sulfamethoxazole can be given once daily.¹¹⁹ ²⁸⁰

Initiate primary prophylaxis in patients with CD4⁺ T-cell counts <200/mm³ or a history of oropharyngeal candidiasis.²⁸⁰ Also consider primary prophylaxis if CD4⁺ T-cell percentage is <14% or there is a history of an AIDS-defining illness.²⁸⁰

Primary prophylaxis can be discontinued in adults and adolescents responding to potent antiretroviral therapy who have a sustained (≥3 months) increase in CD4⁺ T-cell counts from <200/mm³ to >200/mm³.¹⁹⁹ ²⁸⁰ ²⁸¹ ²⁸⁷ ³¹² ³¹³ ³¹⁴ ³¹⁵ ³¹⁶ However, it should be restarted if CD4⁺ T-cell count decreases to <200/mm³.²⁸⁰

Prevention of Recurrence (Secondary Prophylaxis)

Oral

160 mg of trimethoprim and 800 mg of sulfamethoxazole once daily.¹¹⁹ ²⁸⁰ Alternatively, 80 mg of trimethoprim and 400 mg of sulfamethoxazole can be given once daily.¹¹⁹ ²⁸⁰

Initiate long-term suppressive therapy or chronic maintenance therapy (secondary prophylaxis) in those with a history of P. jiroveci pneumonia to prevent recurrence.²⁸⁰

Discontinuance of secondary prophylaxis is recommended in those who have a sustained (≥3 months) increase in CD4⁺ T-cell counts to >200/mm³ since such prophylaxis appears to add little benefit in terms of disease prevention and discontinuance reduces the medication burden, the potential for toxicity, drug interactions, selection of drug-resistant pathogens, and cost.²⁸⁰

Reinitiate secondary prophylaxis if CD4⁺ T-cell count decreases to <200/mm³ or if P. jiroveci pneumonia recurs at a CD4⁺ T-cell >200/mm³.²⁸⁰ It probably is prudent to continue secondary prophylaxis for life in those who had P. jiroveci episodes when they had CD4⁺ T-cell counts >200/mm³.²⁸⁰

Toxoplasmosis†

Primary Prophylaxis

Oral

160 mg of trimethoprim and 800 mg of sulfamethoxazole once daily.²⁸⁰ Alternatively, 80 mg of trimethoprim and 400 mg of sulfamethoxazole may be used.²⁸⁰

Initiate primary prophylaxis against toxoplasmosis in HIV-infected adults and adolescents who are seropositive for Toxoplasma IgG antibody and have CD4⁺ T-cell counts <100/mm³.²⁸⁰

Consideration can be given to discontinuing primary prophylaxis in adults and adolescents who have a sustained (≥3 months) increase in CD4⁺ T-cell counts to >200/mm³ since such prophylaxis appears to add little benefit in terms of disease prevention for toxoplasmosis, and discontinuance reduces the pill burden, the potential for toxicity, drug interactions, selection of drug-resistant pathogens, and cost.²⁸⁰

Reinitiate primary prophylaxis against toxoplasmosis if CD4⁺ T-cell count decreases to <100–200/mm³.²⁸⁰

Wegener’s Granulomatosis†

Oral

160 mg of trimethoprim and 800 mg of sulfamethoxazole twice daily.^c

Special Populations

Renal Impairment

In patients with Cl_cr 15–30 mL/minute, use 50% of usual dosage.¹³⁵ ^a

Use not recommended in those with Cl_cr <15 mL/minute.¹³⁵ ^a

Geriatric Patients

No dosage adjustments except those related to renal impairment.¹³⁵ (See Renal Impairment under Dosage and Administration.)

Cautions for Co-trimoxazole

Contraindications

Known hypersensitivity to sulfonamides or trimethoprim.¹³⁵ ^a
Documented megaloblastic anemia due to folate deficiency.¹³⁵ ^a
Children <2 months of age, pregnant women at term, and nursing women.¹³⁵ ^a

Warnings/Precautions

Warnings

Severe Reactions related to the Sulfonamide Component

Severe (sometimes fatal) reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias, have been reported with sulfonamides.¹³⁵ ^a

Rash, sore throat, fever, arthralgia, pallor, purpura, or jaundice may be early indications of serious reactions.¹³⁵ ^a Discontinue co-trimoxazole at the first appearance of rash or any sign of adverse reactions.¹³⁵ ^a

Superinfection/Clostridium difficile-associated Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.¹³⁵ ^a Institute appropriate therapy if superinfection occurs.¹³⁵ ^a

Treatment with anti-infectives may permit overgrowth of clostridia.¹³⁵ ^a Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.¹³⁵ ^a

Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone.¹³⁵ ^a Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) recommended if colitis is severe.¹³⁵ ^a

Sensitivity Reactions

Hypersensitivity Reactions

Cough, shortness of breath, and pulmonary infiltrates are hypersensitivity reactions of the respiratory tact that have been reported with sulfonamides.¹³⁵ ^a

Use with caution in patients with severe allergy or bronchial asthma.^a

Sulfite Sensitivity

Concentrate for injection contains a sulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.¹³⁵

General Precautions

Patients with Folate Deficiency or G6PD Deficiency

Hemolysis may occur in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency; this effect may be dose-related.^a

Use with caution in patient with possible folate deficiency (e.g., geriatric patients, chronic alcoholics, patients receiving anticonvulsant therapy, patients with malabsorption syndrome, patients with malnutrition).¹³⁵ ^a

Patients with Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia

HIV-infected patients with Pneumocystis jiroveci pneumonia may have an increased incidence of adverse effects during co-trimoxazole therapy (particularly rash, fever, leukopenia, increased liver enzymes) compared with HIV-seronegative patients.¹³⁵ ^a The incidence of hyperkalemia and hyponatremia also may be increased in HIV-infected patients.¹³⁵ ^a

Adverse effects generally are less severe in those receiving co-trimoxazole for prophylaxis rather than treatment.^a

A history of mild intolerance to co-trimoxazole in HIV-infected patients does not appear to predict intolerance to subsequent use of the drug for secondary prophylaxis.^a However, use of the drug should be reevaluated in patients who develop rash or any sign of adverse reaction.^a

Concomitant use of leucovorin and co-trimoxazole for acute treatment of P. jiroveci pneumonia in HIV-infected patients has been associated with increased rates of treatment failure and morbidity.^a

Laboratory Monitoring

Perform CBCs frequently during co-trimoxazole therapy; discontinue the drug if a significant reduction in any formed blood element occurs.¹³⁵ ^a

Perform urinalysis with careful microscopic examination and renal function tests during co-trimoxazole therapy, especially in patients with impaired renal function.¹³⁵ ^a

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of co-trimoxazole and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.^b

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.¹³⁵

Because S. pyogenes (group A β-hemolytic streptococci) may not be eradicated by co-trimoxazole, do not use the drug for treatment of infections caused by this organism since it cannot prevent sequelae such as rheumatic fever.¹³⁵ ^a

Specific Populations

Pregnancy

Category C.¹³⁵ ^a

Because sulfonamides may cause kernicterus in neonates, co-trimoxazole is contraindicated in pregnant women at term.¹³⁵ ^a

Lactation

Both sulfamethoxazole and trimethoprim distributed into milk.^a Co-trimoxazole contraindicated in nursing women.¹³⁵ ^a

Pediatric Use

Safety and efficacy not established in children <2 months of age.¹³⁵ ^a

Geriatric Use

Geriatric patients may be at increased risk of severe adverse reactions, particularly if they have impaired hepatic and/or renal function or are receiving concomitant drug therapy.¹³⁵ ^a

The most frequent adverse reactions in geriatric patients are severe skin reactions, generalized bone marrow suppression, or a specific decrease in platelets (with or without purpura).¹³⁵ ^a Those receiving concurrent therapy with a diuretic (principally thiazides) are at increased risk of thrombocytopenia with purpura.¹³⁵ ^a

Dosage adjustments are necessary based on age-related decreases in renal function.^a

Hepatic Impairment

Use with caution in patients with impaired hepatic function.¹³⁵ ^a

Renal Impairment

Use reduced dosage in patients with Cl_cr 15–30 mL/minute.¹³⁵ ^a

Do not use in patients with Cl_cr <15 mL/minute.¹³⁵ ^a

Common Adverse Effects

GI effects (nausea, vomiting, anorexia); dermatologic and sensitivity reactions (rash, urticaria).¹³⁵ ^b

Drug Interactions

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Amantadine	Toxic delirium reported in an individual who received amantadine and co-trimoxazole concomitantly¹⁸⁶
Antidepressants, tricyclics	Possible decreased efficacy of the tricyclic antidepressant¹⁸⁶
Cyclosporine	Reversible nephrotoxicity reported in renal transplant recipients receiving cyclosporine and co-trimoxazole concomitantly¹⁸⁶
Digoxin	Possible increased digoxin concentrations, especially in geriatric patients¹⁸⁶	Monitor serum digoxin concentrations in patients receiving co-trimoxazole concomitantly¹⁸⁶
Diuretics	Possible increased incidence of thrombocytopenia and purpura if certain diuretics (principally thiazides) are used concomitantly, especially in geriatric patients¹³⁵ ^a
Hypoglycemic agents, oral	Possible potentiation of hypoglycemic effects¹⁸⁶
Indomethacin	Possible increased sulfamethoxazole concentrations¹⁸⁶
Methotrexate	Co-trimoxazole can displace methotrexate from plasma protein-binding sites resulting in increased free methotrexate concentrations¹³⁵ ^a ^b Possible interference with serum methotrexate assays if competitive protein binding technique is used with a bacterial dihydrofolate reductase as the binding protein; interference does not occur if methotrexate is measured using radioimmunoassay¹³⁵ ^a	Use caution if methotrexate and co-trimoxazole used concomitantly^b
Phenytoin	Co-trimoxazole may inhibit metabolism and increase half-life of phenytoin¹³⁵ ¹⁸⁶ ^a	Monitor for possible increased phenytoin effects¹³⁵ ¹⁸⁶ ^a
Pyrimethamine	Megaloblastic anemia reported when co-trimoxazole used concomitantly with pyrimethamine dosages >25 mg weekly (for malaria prophylaxis)¹⁸⁶
Tests for creatinine	Possible interference with Jaffe alkaline picrate assay resulting in falsely elevated creatinine concentrations¹³⁵ ^a
Warfarin	Possible inhibition of warfarin clearance and prolonged PT¹³⁵ ^a ^b	Monitor PT closely and adjust warfarin dosage if co-trimoxazole used concomitantly¹³⁵ ^a ^b

Co-trimoxazole Pharmacokinetics

Absorption

Bioavailability

Sulfamethoxazole and trimethoprim are rapidly and well absorbed from the GI tract following oral administration of the fixed combination preparation (co-trimoxazole).^a ^b Peak serum concentrations of both sulfamethoxazole and trimethoprim are attained within 1–4 hours.^a ^b

Co-trimoxazole contains a 1:5 ratio of trimethoprim to sulfamethoxazole, but the trimethoprim:sulfamethoxazole ratio in serum after administration of the fixed-combination preparation is about 1:20 at steady-state.^b

Distribution

Extent

Widely distributed into body tissues and fluids, including sputum, aqueous humor, middle ear fluid, bronchial secretions, prostatic fluid, vaginal fluid, and bile.^a ^b

In patients with uninflamed meninges, trimethoprim and sulfamethoxazole concentrations in CSF are about 50 and 40%, respectively, of concurrent serum concentrations.^b

Both sulfamethoxazole and trimethoprim readily cross the placenta and are distributed into milk.^a ^b

Plasma Protein Binding

Sulfamethoxazole is approximately 70% and trimethoprim is approximately 44% bound to plasma proteins.^a ^b Presence of sulfamethoxazole decreases protein binding of trimethoprim.^a

Elimination

Metabolism

Both sulfamethoxazole and trimethoprim are metabolized in the liver.^b

Elimination Route

Both sulfamethoxazole and trimethoprim are rapidly excreted in urine by glomerular filtration and active tubular secretion.^a ^b In adults with normal renal function, approximately 45–85% of a sulfamethoxazole dose and 50–67% of a trimethoprim dose are excreted in urine.^a ^b

Only small amounts of trimethoprim are excreted in feces via biliary elimination.^b

Half-life

Serum half-lives of sulfamethoxazole and trimethoprim are approximately 10–13 and 8–11 hours, respectively, in adults with normal renal function.^a ^b

Special Populations

Patients with impaired renal function: Half-lives of both sulfamethoxazole and trimethoprim may be prolonged.^a ^b

In adults with Cl_cr≤10 mL/minute, serum half-life of trimethoprim may increase to >26 hours.^b In adults with chronic renal failure, sulfamethoxazole half-life may be 3 times that in patients with normal renal function.^b

Stability

Storage

Oral

Tablets

15–25°C;^a protect from light.^a

Suspension

15–25°C;^a protect from light.^a

Parenteral

Concentrate for Injection

5–25°C;¹³⁵ do not refrigerate.¹³⁵

Following dilution in 125 or 100 mL of 5% dextrose in water, use within 6 or 4 hours, respectively.¹³⁵ If diluted in 75 mL of 5% dextrose in water, use within 2 hours.¹³⁵

Compatibility

Parenteral

Solution CompatibilityHID

Compatible
Dextrose 5% in sodium chloride 0.45%
Ringer’s injection, lactated
Sodium chloride 0.45%
Variable
Dextrose 5% in water
Sodium chloride 0.9%

Drug Compatibility

Admixture CompatibilityHID
Incompatible
Fluconazole
Linezolid
Verapamil HCl

Y-Site CompatibilityHID
Compatible
Acyclovir sodium
Aldesleukin
Allopurinol sodium
Amifostine
Amphotericin B cholesteryl sulfate complex
Anidulafungin
Atracurium besylate
Aztreonam
Bivalirudin
Ceftaroline fosamil
Cyclophosphamide
Dexmedetomidine HCl
Diltiazem HCl
Docetaxel
Doxorubicin HCl liposome injection
Enalaprilat
Esmolol HCl
Etoposide phosphate
Fenoldopam mesylate
Filgrastim
Fludarabine phosphate
Gallium nitrate
Gemcitabine HCl
Granisetron HCl
Hetastarch in lactated electrolyte injection (Hextend)
Hydromorphone HCl
Labetalol HCl
Lorazepam
Magnesium sulfate
Melphalan HCl
Meperidine HCl
Morphine sulfate
Nicardipine HCl
Pancuronium bromide
Pemetrexed disodium
Piperacillin sodium-tazobactam sodium
Remifentanil HCl
Sargramostim
Tacrolimus
Teniposide
Thiotepa
Vecuronium bromide
Zidovudine
Incompatible
Caspofungin acetate
Fluconazole
Midazolam HCl
Vinorelbine tartrate
Variable
Cisatracurium besylate
Foscarnet sodium

Actions and Spectrum

A fixed combination of sulfamethoxazole and trimethoprim; both drugs are folate-antagonists and sequentially inhibit enzymes of the folic acid pathway in susceptible bacteria.^b
Sulfamethoxazole inhibits formation of dihydrofolic acid from p-aminobenzoic acid and trimethoprim inhibits formation of tetrahydrofolic acid (the metabolically active form of folic acid).^b
Sulfamethoxazole is bacteriostatic and trimethoprim usually is bactericidal; the fixed combination generally is bactericidal when synergism is achieved.^b
Susceptibility to trimethoprim is more critical to efficacy of co-trimoxazole than susceptibility to sulfamethoxazole.^b Co-trimoxazole is active against many organisms resistant to sulfamethoxazole but susceptible to trimethoprim.^b
Spectrum of activity includes many gram-positive and -negative aerobic bacteria and some protozoa.^b Inactive against most anaerobic bacteria and inactive against fungi and viruses.^b
Gram-positive aerobes: Active against Staphylococcus aureus (including penicillinase-producing strains), Streptococcus pneumoniae, S. pyogenes (group A β-hemolytic streptococci), and some strains of enterococci (e.g., Enterococcus faecalis).^a ^b Also active against Nocardia,^b but Bacillus anthracis may be resistant.³⁰⁷ ³⁰⁸
Gram-negative aerobes: Active against Acinetobacter, Enterobacter, Escherichia coli, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Salmonella, and Shigella.^a ^b Also active against Haemophilus influenzae (including ampicillin-resistant strains), H. ducreyi, and Neisseria gonorrhoeae.^a ^b Pseudomonas aeruginosa is resistant.^a
Other organisms: Active in vitro and in vivo against Pneumocystis jiroveci (Pneumocystis carinii).^b Most anaerobes, including Bacteroides and Clostridium, are resistant.^b
Resistance to co-trimoxazole has been reported in some Enterobacteriaceae and H. influenzae.^b

Advice to Patients

Importance of completing full course of therapy, even if feeling better after a few days.^a
Advise patients to maintain an adequate fluid intake to prevent crystalluria and stone formation.¹³⁵ ^a
Importance of discontinuing drug and informing clinician if rash or any sign of adverse reaction (sore throat, fever, arthralgia, pallor, purpura, jaundice) occurs.¹³⁵ ^a
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, and any concomitant illnesses.^a
Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed.^a
Importance of advising patients of other important precautionary information.^a (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Co-trimoxazole
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Suspension	Trimethoprim 40 mg/5 mL and Sulfamethoxazole 200 mg/5 mL*	Septra Suspension	Monarch
			Septra Grape Suspension	Monarch
			Sulfatrim Pediatric Suspension	Alpharma
			Sulfatrim Suspension	Alpharma
	Tablets	Trimethoprim 80 mg and Sulfamethoxazole 400 mg*	Bactrim (scored)	Women First HealthCare
			Septra (scored)	Monarch
			Sulfamethoxazole and Trimethoprim Tablets
		Trimethoprim 160 mg and Sulfamethoxazole 800 mg*	Bactrim DS	Women First HealthCare
			Septra DS (scored)	Monarch
Parenteral	For injection concentrate, for IV infusion	Trimethoprim 16 mg/mL and Sulfamethoxazole 80 mg/mL	Sulfamethoxazole and Trimethoprim Concentrate for Injection

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

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a. Monarch Pharmaceuticals. Septra tablets, DS (double strength) tablets, suspension, and grape suspension prescribing information. Bristol, TN; 2000 Feb.

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HID. Trissel LA. Handbook on injectable drugs. 17th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2013:1107-13.

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