Sulfamethoxazole and Trimethoprim (Lexi-Drugs)

Pronunciation

(sul fa meth OKS a zole & trye METH oh prim)

Brand Names: US

Bactrim; Bactrim DS; Sulfatrim Pediatric

Brand Names: Canada

APO-Sulfatrim; Protrin DF [DSC]; Septra; Sulfatrim; Sulfatrim DS; Sulfatrim Pediatric; TEVA-Trimel; TEVA-Trimel DS

Dosing: Adult

Note: Weight-based dosing recommendations are based on the trimethoprim (TMP) component. Each double-strength tablet contains TMP 160 mg and sulfamethoxazole (SMX) 800 mg. Each single-strength tablet contains TMP 80 mg and SMX 400 mg. The undiluted IV solution contains TMP 16 mg per mL and SMX 80 mg per mL. IV solutions must be diluted in D5W prior to use. Diluted IV solutions have limited stability and can precipitate unpredictably; refer to a detailed IV compatibility reference.

General dosing guidelines:

Oral: 1 to 2 double-strength tablets every 12 to 24 hours. Note: Serum creatinine and potassium concentrations should be monitored in outpatients receiving high-dose therapy (>5 mg [TMP component]/kg/day) (Gentry 2013).

IV: 8 to 20 mg (TMP component)/kg/day divided every 6 to 12 hours

Bite wound infections, prophylaxis or treatment (animal and human) (alternative agent) (off-label use): Oral: One double-strength tablet twice daily; in combination with an appropriate agent for anaerobic coverage. Duration of treatment for prophylaxis is 3 to 5 days; duration of treatment for established infection varies based on patient-specific factors (Harper 2017; IDSA [Stevens 2014]).

Brain abscess, empyema, and epidural abscess (alternative agent for MRSA) (off-label use): IV: 5 mg (TMP component)/kg/dose every 8 to 12 hours (IDSA [Liu 2011])

Chronic obstructive pulmonary disease, acute exacerbations; uncomplicated (alternative agent for outpatient therapy): Oral: One double-strength tablet every 12 hours for 5 to 7 days (Bartlett 2017; GOLD 2017; Snow 2001)

Diabetic foot infection, mild (MRSA) (off-label use): Oral: Two double-strength tablets twice daily, usually for 1 to 2 weeks (IDSA [Lipsky 2012]; Lipsky 2004). Note: When used as empiric therapy, must be used in combination with other appropriate agents. Some experts also use this agent for selected moderate infections (Lipsky 2012).

Diarrhea, infectious:

Cyclosporiasis (off-label use):

Immunocompromised (AIDSassociated): Limited data available: Oral: One double-strength tablet twice daily for 14 days, followed by secondary prophylaxis with one double-strength tablet 3 times weekly (Pape 1994; Weller 2017).

Immunocompetent: Oral: One double-strength tablet twice daily for 7 to 10 days (CDC 2013; Hoge 1995)

Cystoisosporiasis (isosporiasis) (off-label use):

Immunocompromised (AIDS-associated): Oral, IV: 160 mg (TMP component) twice daily for 7 to 10 days; if symptoms worsen or persist, may increase dose to 160 mg (TMP component) 4 times daily and/or prolong duration to 21 to 28 days. In patients with CD4 <200 cells/mm3, follow treatment with secondary prophylaxis of one double-strength tablet orally 3 times weekly (HHS [OI adult 2017]).

Immunocompetent (usually self-limited; treatment not always indicated): Oral: One double-strength tablet twice daily for 7 to 10 days (CDC 2013)

Shigellosis (widespread resistance [alternative agent if susceptibility is documented]): Oral: One double-strength tablet twice daily for 5 to 7 days (Agha 2017)

Granuloma inguinale (donovanosis) (alternative agent) (off-label use): Oral: One double-strength tablet every 12 hours for at least 3 weeks and until lesions have healed (CDC [Workowski 2015]). Note: If symptoms do not improve within the first few days of therapy, another agent (eg, aminoglycoside) can be added (CDC [Workowski 2015]).

Melioidosis (Burkholderia pseudomallei) infection (off-label use):

Initial intensive therapy (as a potential add-on to primary therapy [ceftazidime or a carbapenem] in focal disease of the CNS, prostate, bone, or other deep-seated infection) (Cheng 2009; Lipsitz 2012): Oral, IV:

40 to 60 kg: 240 mg (TMP component) twice daily

>60 kg: 320 mg (TMP component) twice daily

Eradication therapy (begin after completion of initial intensive therapy) (Cheng 2009; Lipsitz 2012): Oral:

40 to 60 kg: 240 mg (TMP component) twice daily

>60 kg: 320 mg (TMP component) twice daily

Meningitis, bacterial (alternative agent for MRSA, L. monocytogenesE. coli, and other Enterobacteriaceae) (off-label use): IV: 5 mg (TMP component)/kg/dose every 6 to 12 hours (IDSA [Tunkel 2004]; IDSA [Tunkel 2017])

Alternative dosing for MRSA meningitis: 5 mg (TMP component)/kg/dose every 8 to 12 hours (IDSA [Liu 2011])

Nocardiosis (off-label use): Limited data available to guide treatment. Due to concerns for resistance, susceptibility testing should be performed on isolates (CDC 2017).

Cutaneous infections (superficial; no other organ involvement): Oral: 5 to 10 mg (TMP component)/kg/day in 2 divided doses (Spelman 2017)

Pulmonary infection (mild to moderate) (Spelman 2017):

Immunocompetent patients: Oral: 5 to 10 mg (TMP component)/kg/day in 2 divided doses

Immunocompromised patients: IV: 15 mg (TMP component)/kg/day in 3 to 4 divided doses

Pulmonary infection (severe), CNS, disseminated, or multi-site infection: IV: 15 mg (TMP component)/kg/day in 3 to 4 divided doses (Spelman 2017). Note: When used as empiric therapy, must be used in combination with 1 to 2 additional agents. Consult an infectious diseases specialist for specific treatment recommendations.

Duration: Prolonged treatment is required (range: 3 months to ≥1 year [combined parenteral/oral therapy]) (Spelman 2017)

Osteomyelitis due to MRSA (alternative agent) (off-label use): Oral, IV: 4 mg (TMP component)/kg/dose every 12 hours with rifampin (Lalani 2017)

Peritonitis, spontaneous bacterial (prevention) (off-label use):

High-risk patients (eg, hospitalized patients with Child-Pugh class B or C cirrhosis and active GI bleeding): Oral: One double-strength tablet twice daily (Runyon 2017)

Long-term secondary SBP prophylaxis: Oral: One double-strength tablet once daily (Runyon 2017)

Pneumocystis pneumonia:

Prophylaxis, primary and secondary (off-label dose):

HIV-infected: Oral: One double-strength tablet once daily or one single-strength tablet once daily (preferred regimens) or one double-strength tablet 3 times weekly (alternative regimen). Note: In patients also requiring prophylaxis for toxoplasmosis, one double-strength tablet once daily should be used (HHS [OI adult 2017]).

Duration in HIV-infected patients receiving ART: Continue until undetectable viral load and CD4 count >200 cells/mm3 for >3 months (HHS [OI adult 2017]); some experts discontinue primary prophylaxis in patients with CD4 counts between 100 and 200 cells/mm3 who are receiving ART and have had an undetectable viral load for ≥3 to 6 months (HHS [OI adult 2017]; COHERE 2010).

Immunocompromised host, HIV-uninfected (eg, transplant recipients, cancer-related, hematopoietic stem cell transplant [HSCT]) (off-label dose): Oral: One double-strength tablet once daily or one single-strength tablet once daily (preferred regimens); alternatively, one double-strength tablet 3 times weekly (Fishman 2001; Montoya 2001; Tomblyn 2009)

Duration after solid organ transplant (except lung): ≥6 to 12 months and during periods of increased immunosuppression (eg, treatment for acute rejection) (Alexander 2017; Martin 2013)

Duration after lung transplant: Lifelong therapy should be considered (Martin 2013; Palmer 2017)

Duration for cancer-related (including HSCT) in patients at high risk for PCP infection: Based on expert opinion, continue until risk factor(s) for PCP infection are no longer present (Neumann 2013, Thomas 2017). Consult other specialized databases for more detailed information.

Treatment (off-label dose) (HHS [OI adult 2017]; ATS [Limper 2011]; Thomas 2017): Note: Secondary prophylaxis should be initiated immediately upon completion of therapy.

Moderate to severe infection: IV: 15 to 20 mg (TMP component)/kg/day in 3 or 4 divided doses for 21 days; may switch to oral therapy after clinical improvement. Note: Patients with moderate or severe infection (PaO2 <70 mm Hg at room air or alveolar-arterial oxygen gradient ≥35 mm Hg) should receive adjunctive glucocorticoids.

Mild to moderate infection: Oral: 15 to 20 mg (TMP component)/kg/day in 3 divided doses for 21 days or two double-strength tablets 3 times daily.

Prosthetic joint infection (off-label use): Treatment (following pathogen-specific IV therapy in patients undergoing 1-stage exchange or debridement with retention of prosthesis): Oral:

Note: Duration of therapy ranges from a minimum of 3 months to indefinitely, depending on patient specific factors (Berbari 2018).

Staphylococci (methicillin-resistant) and Enterobacteriaceae: One double-strength tablet twice daily. For the first 3 to 6 months of therapy for staphylococcal infections, combine with rifampin (Berbari 2018; IDSA [Osmon 2013]).

Q fever (C. burnetii) (preferred agent for pregnant women ≤32 weeks of gestation; alternative agent for non-pregnant adults) (off-label use): Oral: Acute illness: One double-strength tablet twice daily during pregnancy but not beyond 32 weeks’ gestation; administer with folic acid supplementation. Note: Discontinue therapy for the final 8 weeks of pregnancy due to hyperbilirubinemia risk (CDC [Anderson 2013]).

Septic arthritis (without prosthetic material) due to MRSA (alternative agent following initial IV therapy with an appropriate antibiotic) (off-label use): Oral: Two double-strength tablets twice daily or 4 mg (TMP component)/kg/dose twice daily (maximum: 320 mg [TMP component]/dose) for completion of 3- to 4-week total treatment course (IV and oral) (Goldenberg 2017; IDSA [Liu 2011])

Skin/soft tissue infection, mild to moderate (outpatient treatment) (off-label use): Oral: One to two double-strength tablets twice daily (IDSA [Liu 2011]; IDSA [Stevens 2014]; Miller 2015); treat for 5 to 14 days depending on severity and clinical response (IDSA [Stevens 2014]; Spelman 2018). Note: For empiric therapy of purulent cellulitis, monotherapy with sulfamethoxazole and trimethoprim is appropriate. For empiric therapy of nonpurulent cellulitis, guidelines suggest an additional agent (eg, amoxicillin, cephalexin) for beta-hemolytic streptococci (IDSA [Liu 2011]; IDSA [Stevens 2014]). However, limited data suggest that sulfamethoxazole and trimethoprim is an effective alternative agent for treatment of nonpurulent cellulitis (Bowen 2017; Miller 2015).

Stenotrophomonas maltophilia infections (hospital-acquired pneumonia [HAP], ventilator-associated pneumonia [VAP], bacteremia, or other sites) (off-label use): IV: 15 mg (TMP component)/kg/day in 3 or 4 divided doses. Additional data may be necessary to further define the role of sulfamethoxazole and trimethoprim in this condition (Lewis 2017; Looney 2009)

Toxoplasma gondii encephalitis (AIDS-associated) (off-label use):

Primary prophylaxis: Oral: One double-strength tablet once daily (preferred) or one double-strength tablet 3 times weekly or one single-strength tablet once daily; primary prophylaxis is indicated for T. gondii IgG-positive patients with CD4 count <100 cells/mm3. Continue primary prophylaxis following initiation of ART until CD4 count >200 cells/mm3 for >3 months; some experts discontinue primary prophylaxis in patients with a CD4 count between 100 to 200 cells/mm3 who are receiving ART and have had an undetectable viral load for ≥3 to 6 months (HHS [OI adult 2017]).

Treatment (alternative agent): Oral, IV: 10 mg (TMP component)/kg/day in 2 divided doses for at least 6 weeks; longer duration may be needed if clinical or radiologic disease is extensive or response is incomplete at 6 weeks (HHS [OI adult 2017]).

Secondary prophylaxis (chronic maintenance therapy) (alternative agent): Oral: One double-strength tablet twice daily or, alternatively, one double-strength tablet once daily (lower dose may be associated with increased relapse risk). Continue following initiation of ART until CD4 count >200 cells/mm3 for >6 months (HHS [OI adult 2017]).

Urinary tract infection (off-label dose):

Cystitis, acute uncomplicated (empiric use [avoid if resistance prevalence is known to exceed 20% or if used for UTI in previous 3 months] or targeted therapy [if the isolate is known to be susceptible]): Oral: One double-strength tablet twice daily for 3 days (IDSA [Gupta 2011])

Pyelonephritis, acute uncomplicated (outpatient targeted therapy [if the isolate is known to be susceptible]): Oral: One double-strength tablet twice daily for 14 days (IDSA [Gupta 2011]); for women who have a rapid response to treatment, some experts treat for 7 to 10 days (Hooton 2017)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

Manufacturer’s labeling: Oral, IV:

CrCl >30 mL/minute: No dosage adjustment necessary.

CrCl 15 to 30 mL/minute: Administer 50% of recommended dose.

CrCl <15 mL/minute: Use is not recommended and is contraindicated per the manufacturer’s labeling in severe renal disease if renal function cannot be monitored.

Alternative recommendations:

Golightly 2013:

Oral: Note: The following dosage adjustments are based on a usual maintenance dose of 1 double-strength tablet every 12 hours.

GFR 10 to 50 mL/minute: One double-strength tablet once, followed by 1 single-strength tablet every 12 hours.

GFR <10 mL/minute: Avoid use; if necessary, 1 double-strength tablet once, followed by 1 single-strength tablet every 24 hours.

Hemodialysis: One double-strength tablet once, followed by 1 single-strength tablet every 24 hours (dose after hemodialysis on dialysis days)

IV: Note: The following dosage adjustments are based on a usual maintenance dose of 4 to 5 mg (TMP component)/kg every 6 hours.

GFR 10 to 50 mL/minute: 4 to 5 mg (TMP component)/kg every 12 hours

GFR <10 mL/minute: Avoid use; if necessary, 2.5 to 5 mg (TMP component)/kg every 24 hours.

Hemodialysis: 2.5 to 5 mg (TMP component)/kg every 24 hours (dose after hemodialysis on dialysis days)

HHS (OI adult 2017) Pneumocystis pneumonia (PCP), treatment: Note: Renal function may be estimated using the Cockcroft-Gault formula for dosage adjustment purposes.

Oral: Note: The following dosage adjustments are based on a usual maintenance dose of 2 double-strength tablets every 8 hours.

CrCl 10 to 30 mL/minute: Two double-strength tablets every 12 hours

CrCl <10 mL/minute: One double-strength tablet every 12 hours or 2 double-strength tablets every 24 hours

Hemodialysis: Two double-strength tablets once daily (dose after hemodialysis on dialysis days); consider therapeutic drug monitoring to optimize therapy

IV: Note: The following dosage adjustments are based on a usual maintenance dose of 5 mg (TMP component)/kg every 8 hours.

CrCl 10 to 30 mL/minute: 5 mg (TMP component)/kg every 12 hours

CrCl <10 mL/minute: 5 mg (TMP component)/kg every 24 hours

Hemodialysis: 5 mg (TMP component)/kg once daily (dose after hemodialysis on dialysis days); consider therapeutic drug monitoring to optimize therapy

Continuous renal replacement therapy (CRRT) (Heintz 2009; Trotman 2005): Drug clearance is highly dependent on the method of renal replacement, filter type, and flow rate. Appropriate dosing requires close monitoring of pharmacologic response, signs of adverse reactions due to drug accumulation, as well as drug concentrations in relation to target trough (if appropriate). The following are general recommendations only (based on dialysate flow/ultrafiltration rates of 1 to 2 L/hour and minimal residual renal function) and should not supersede clinical judgment:

CVVH/CVVHD/CVVHDF: Oral, IV: 2.5 to 7.5 mg (TMP component)/kg every 12 hours. Note: Dosing regimen dependent on clinical indication. Critically ill patients with P. jiroveciipneumonia receiving CVVHDF may require up to 10 mg (TMP component)/kg every 12 hours (Heintz 2009).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in manufacturer’s labeling. Use with caution; use is contraindicated in cases of marked hepatic damage.

Dosing: Pediatric

Note: Dosage recommendations are based on the trimethoprim (TMP) component:

General dosing, susceptible infection: Infants ≥2 months, Children, and Adolescents: Oral, IV: 6 to 12 mg TMP/kg/day in divided doses every 12 hours; maximum single dose: 160 mg TMP/dose (Red Book [AAP 2015])

Catheter (peritoneal dialysis); exit-site or tunnel infection: Limited data available: Infants, Children, and Adolescents: Oral: 5 to 10 mg TMP/kg/dose once daily; maximum dose: 80 mg TMP/dose (ISPD [Warady 2012])

Cyclosporiasis: Limited data available: Infants ≥2 months, Children, and Adolescents: Oral: 8 to 10 mg TMP/kg/day in divided doses twice daily for 7 to 10 days; maximum single dose: 160 mg TMP (Red Book [AAP 2015])

Meningitis: Infants ≥2 months, Children, and Adolescents: IV: 10 to 20 mg TMP/kg/day divided every 6 to 12 hours for 7 to 21 days; duration dependent on the pathogen and clinical course (Tunkel 2004)

MRSA, community-acquired mild to moderate skin/soft tissue infection: Infants ≥2 months, Children, and Adolescents: Oral: 8 to 12 mg TMP/kg/day in divided doses every 12 hours (Liu 2011); alternatively, use of 20 mg TMP/kg/day in divided doses every 6 hours has been reported (Long 2012). If using empirically, consider addition of group A streptococcal coverage.

Otitis media, acute: Infants ≥2 months, Children, and Adolescents: Oral: 6 to 10 mg TMP/kg/day in divided doses every 12 hours for 10 days. Note: Due to resistance of S. pneumoniae, should not be used in patients that fail first-line amoxicillin therapy (AAP [Lieberthal 2013]).

Pneumocystis jirovecii pneumonia (PCP) (HIV-exposed/-positive):

Prophylaxis:

Infants (at least 4 weeks of age) and Children: Oral: 5 to 10 mg TMP/kg/day or 150 mg TMP/m2/day; dose may be given as a single daily dose or in divided doses every 12 hours given 2 to 3 days per week on consecutive days or alternating days; maximum daily dose: TMP 320 mg/day (HHS [OI pediatric 2016])

Adolescents: Oral: 80 to 160 mg TMP daily or alternatively, 160 mg TMP 3 times weekly (HHS [OI adult 2017]):

Treatment:

Infants >2 months and Children: Initial: IV: 15 to 20 mg TMP/kg/day in divided doses every 6 hours for 21 days; as acute pneumonitis subsides in patients with mild to moderate disease and no malabsorption issues nor diarrhea, may transition to oral therapy of same daily dose (15 to 20 mg/kg/day TMP) administered in divided doses 3 or 4 times daily (HHS [OI pediatric 2016])

Adolescents (HHS [OI adult 2017]):

Mild to moderate: Oral: 15 to 20 mg TMP/kg/day in 3 divided doses for 21 days or alternatively, 320 mg TMP 3 times daily for 21 days

Moderate to severe: Initial: IV: 15 to 20 mg TMP/kg/day in 3 to 4 divided doses for 21 days; may switch to oral after clinical improvement

Q-Fever (Coxiella burnetii); mild infection (doxycycline therapeutic failure): Limited data available, dose should be based on severity of illness: Children <8 years: Oral: Usual dose range: 8 to 10 mg TMP/kg/day in divided doses twice daily for 14 days; a wider dose range of 4 to 20 mg TMP/kg/day divided twice daily has been suggested to address varying degrees of severity; however, reported pediatric efficacy experience (eg, case series) are lacking; monitor patients receiving doses at the high and low end of the range closely for efficacy and possible adverse effects (Bradley 2017; CDC 2013)

Shigellosis: Infants ≥2 months, Children, and Adolescents: Note: Due to reported widespread resistance empiric therapy with sulfamethoxazole and trimethoprim is not recommended (CDC-NARMS 2010; WHO 2005)

Oral:

Manufacturer’s labeling: 8 mg TMP/kg/day in divided doses every 12 hours for 5 days; maximum single dose: 160 mg TMP

Alternate dosing: IDSA recommendations for infectious diarrhea: 10 mg TMP/kg/day in divided doses every 12 hours for 3 days (for immunocompetent patients) or 7 to 10 days (for immunocompromised patients); maximum single dose: 160 mg TMP (Guerrant 2001)

IV: 8 to 10 mg TMP/kg/day in divided doses every 6, 8, or 12 hours for up to 5 days

Toxoplasmosis (HIV-exposed/infected):

Prophylaxis, primary:

Infants ≥2 months and Children: Oral: 150 mg TMP/m2/day; dose may be administered as a single daily dose (preferred) or in divided doses every 12 hours; alternatively, may also be given 3 times weekly for 3 consecutive or alternating days (HHS [OI pediatric 2016])

Adolescents: Oral: 160 mg TMP daily (preferred) or 160 mg TMP 3 times weekly or 80 mg TMP daily (HHS [OI adult 2017])

Treatment, encephalitis: Adolescents: Oral, IV: 10 mg/kg/day TMP in two divided doses for at least 6 weeks; longer duration may be required in some patients; following treatment all patients should receive chronic maintenance therapy daily (HHS [OI adult 2017])

Secondary prophylaxis (chronic suppressive therapy, alternative regimen): Note: Only use when pyrimethamine is unavailable or not tolerated:

Infants and Children: Oral: 150 mg TMP/m2/day once daily (HHS [OI pediatric 2016])

Adolescents: Maintenance therapy; postencephalitis treatment: Oral: 160 mg TMP once or twice daily: May discontinue when asymptomatic and CD4 count >200 cells/mm3for >6 months in response to ART. Note: Once-daily dosing may be associated with an increased risk of relapse; if used, a gradual transition (eg, follow acute treatment with 4 to 6 weeks of 160 mg TMP twice daily before lowering to once-daily dosing) may be beneficial (HHS [OI adult 2017])

Urinary tract infection:

Treatment:

Oral:

Infants and Children 2 to 24 months: 6 to 12 mg TMP/kg/day in divided doses every 12 hours for 7 to 14 days (AAP 2011)

Children >24 months and Adolescents: 8 mg TMP/kg/day in divided doses every 12 hours for 3 days; longer duration may be required in some patients; maximum single dose: 160 mg TMP

IV: Infants ≥2 months, Children, and Adolescents: 8 to 10 mg TMP/kg/day in divided doses every 6, 8, or 12 hours for up to 14 days with serious infections

Prophylaxis: Infants ≥2 months, Children, and Adolescents: Oral: 2 mg TMP/kg/dose once daily (Mattoo 2007; Red Book [AAP 2012])

Dosing: Renal Impairment: Pediatric

Manufacturer’s labeling: Infants ≥2 months, Children, and Adolescents: Oral, IV:

CrCl >30 mL/minute: No adjustment required.

CrCl 15 to 30 mL/minute: Administer 50% of recommended dose.

CrCl <15 mL/minute: Use is not recommended.

Alternative recommendations:

Children and Adolescents (Veltri 2004): Note: Renally adjusted dose recommendations are based on doses of 3 to 5 mg/kg/dose every 12 hours. IV, Oral:

CrCl 10 to 50 mL/minute/1.73 m2: 3 to 5 mg TMP/kg/dose every 18 hours

CrCl <10 mL/minute/1.73 m2: 3 to 5 mg TMP/kg/dose every 24 hours

Hemodialysis: 3 to 5 mg TMP/kg/dose every 24 hours; administer 2.5 mg TMP/kg/dose after each dialysis session

CRRT (CAVH/CVVH/CAVHD/CVVHD):

Combined dialysis flow + ultrafiltration rate <1,500 mL/m2/hour: 3 to 5 mg TMP/kg/dose every 18 hours

Combined dialysis flow + ultrafiltration rate ≥ 1,500 mL/m2/hour: 4 to 5 mg TMP/kg/dose every 18 hours

Pneumocystis jirovecii pneumonia (PCP):

Treatment (Veltri 2004):

Children: Note: Renally adjusted dose recommendations are based on doses of 5 mg/kg/dose every 6 hours. IV, Oral:

CrCl 10 to 50 mL/minute/1.73 m2: 5 mg TMP/kg/dose every 8 hours

CrCl <10 mL/minute/1.73 m2: 5 mg TMP/kg/dose every 12 hours

Hemodialysis: 5 mg/kg/dose every 12 hours; administer 2.5 mg TMP/kg/dose after each dialysis session

Continuous renal replacement therapy (CRRT): CAVH/CVVH/CAVHD/CVVHD: 5 mg TMP/kg/dose every 8 hours

Adolescents (HHS [OI adult 2016]): IV, Oral:

CrCl 10 to 30 mL/minute: 5 mg TMP/kg/dose IV every 12 hours or 320 mg TMP orally every 12 hours

CrCl <10 mL/minute: 5 mg TMP/kg/dose IV every 24 hours or 160 mg TMP orally every 12 hours or 320 mg TMP orally every 24 hours

Hemodialysis: 5 mg TMP/kg/dose IV or 320 mg TMP orally; administer dose after dialysis on dialysis days

Prophylaxis (Masur 2002): Adolescents: Oral:

CrCl 15 to 30 mL/minute: 40 mg or 80 mg TMP daily or 80 mg TMP 3 times weekly

CrCl <15 mL/minute: 40 mg or 80 mg TMP daily or 80 mg TMP 3 times weekly. While the guidelines do acknowledge the alternative of giving 80 mg TMP daily, this may be inadvisable in the uremic/ESRD patient.

Hemodialysis: 40 mg or 80 mg TMP after each dialysis session

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution; use is contraindicated in cases of marked hepatic damage.

Use: Labeled Indications

Oral: Treatment of urinary tract infections due to Escherichia coliKlebsiella and Enterobacter spp, Morganella morganiiProteus mirabilis, and Proteus vulgaris; acute otitis media; acute exacerbations of COPD due to susceptible strains of Haemophilus influenzae or Streptococcus pneumoniae; treatment and prophylaxis of Pneumocystis pneumonia (PCP); traveler’s diarrhea due to enterotoxigenic E. coli; treatment of shigellosis caused by Shigella flexneri or Shigella sonnei

IV: Treatment of Pneumocystis pneumonia (PCP); treatment of shigellosis caused by S. flexneri or S. sonnei; treatment of severe or complicated UTIs due to E. coli, Klebsiella and Enterobacter spp, M. morganii, P. mirabilis, and P. vulgaris

Use: Off-Label: Adult

  Bite wound infections (animal and human bites)Level of Evidence [C, G]

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), sulfamethoxazole and trimethoprim, in combination with an appropriate agent for anaerobic coverage, is an effective and recommended alternative for the prophylaxis and treatment of animal bite wounds.

Clinical experience suggests the utility of sulfamethoxazole and trimethoprim as an alternative agent for the prophylaxis and treatment of human bite wounds Ref.

  Brain abscess, empyema, and epidural abscess (methicillin-resistant Staphylococcus aureus)Level of Evidence [G]

IDSA guidelines cite limited data evaluating the effectiveness of sulfamethoxazole and trimethoprim in the treatment of brain abscess, subdural empyema, and epidural abscess caused by methicillin-resistant Staphylococcus aureus (MRSA). However, the guidelines support the initial use and evaluation of vancomycin treatment; if vancomycin is contraindicated or resistance is expected, use of linezolid or sulfamethoxazole and trimethoprim should be considered as alternative therapy. Sulfamethoxazole and trimethoprim can be given as a single agent or in combination with rifampin. Access Full Off-Label Monograph

  CyclosporiasisLevel of Evidence [B, G]

Data from a randomized, double-blind, placebo-controlled trial in immunocompetent patients Ref and a prospective cohort study in patients with HIV Ref support the use of sulfamethoxazole and trimethoprim in the treatment of cyclosporiasis.

Based on the Centers for Disease Control and Prevention (CDC) recommendations for the treatment for cyclosporiasis, sulfamethoxazole and trimethoprim is the preferred treatment for cyclosporiasis (immunocompetent or HIV-infected patients).

  Cystoisosporiasis (Isosporiasis)Level of Evidence [G]

Based on the US Department of Health and Human Services (HHS) guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents, sulfamethoxazole and trimethoprim is an effective and recommended agent for treatment or chronic suppressive therapy (secondary prophylaxis) of Isospora belli infection in adolescent and adult HIV-infected patients.

Based on the CDC recommendations for the treatment for cystoisosporiasis, sulfamethoxazole and trimethoprim is the preferred treatment for Cystoisospora belli (Isospora belli) in immunocompetent (when treatment is indicated) or immunosuppressed patients (expert consultation is recommended).

  Diabetic foot infectionLevel of Evidence [G]

According to IDSA guidelines, sulfamethoxazole and trimethoprim is a reasonable treatment option for mild diabetic foot infections. Access Full Off-Label Monograph

  Granuloma inguinale (Donovanosis)Level of Evidence [G]

Based on the CDC sexually transmitted diseases treatment guidelines, sulfamethoxazole and trimethoprim is an effective and recommended alternative agent in the treatment of granuloma inguinale.

  Head lice (Pediculosis capitis)Level of Evidence [C, G]

Most sulfamethoxazole and trimethoprim trials for the treatment of head lice studied the drug in addition to standard treatment. There is little evidence to support treatment with sulfamethoxazole and trimethoprim as a single agent for head lice infestation, but it may have some benefit when used as part of combination therapy. Current guidelines do not recommend the use of sulfamethoxazole and trimethoprim for head lice infestation if other options are available. Access Full Off-Label Monograph

  Melioidosis (Burkholderia pseudomallei) infectionLevel of Evidence [G]

An HHS Workshop on treatment of and postexposure prophylaxis for Burkholderia pseudomallei and B. mallei infection suggests the use of sulfamethoxazole and trimethoprim as a potential addition to initial intensive therapy (with ceftazidime or a carbapenem) in focal disease of the CNS, prostate, bone, or other deep-seated infection, and as eradication therapy (initiated after completion of initial intensive therapy) Ref.

  Meningitis, bacterialLevel of Evidence [G]

Based on the IDSA guidelines for the management of bacterial meningitis and health care-associated ventriculitis and meningitis, sulfamethoxazole and trimethoprim is an effective and recommended alternative agent for the treatment of meningitis due to MRSA, Listeria monocytogenes, E. coli, and other susceptible Enterobacteriaceae.

  NocardiosisLevel of Evidence [C]

Data from a limited number of patients studied suggest that sulfamethoxazole and trimethoprim may be beneficial for the treatment of nocardiosis (as monotherapy or combination therapy, depending on severity of infection) Ref.

Clinical experience also suggests the utility of sulfamethoxazole and trimethoprim in the treatment of nocardiosis Ref.

  OsteomyelitisLevel of Evidence [G]

According to IDSA and SIMIT guidelines, sulfamethoxazole and trimethoprim, in combination with rifampin, is a reasonable treatment option for MRSA osteomyelitis. Access Full Off-Label Monograph

  Peritonitis, spontaneous bacterial (prevention)Level of Evidence [B, G]

Data from controlled trials support use of sulfamethoxazole and trimethoprim as primary long-term prophylaxis in cirrhotic patients with low protein ascites with or without renal or liver impairment, or as secondary long-term prophylaxis in patients who have experienced a prior SBP episode.

According to AASLD and EASL guidelines, long-term prophylaxis with daily sulfamethoxazole and trimethoprim should be considered as secondary prophylaxis in patients who have experienced a prior SBP episode, and as primary prophylaxis in cirrhotic patients with low protein ascites. Increasing bacterial resistance rates to antibiotics used in the treatment and prevention of SBP have been documented; therefore, local epidemiological patterns should be considered, and use of antibiotic prophylaxis should be restricted to patients at high risk of SBP. Access Full Off-Label Monograph

  Prosthetic joint infectionLevel of Evidence [C, G]

Data from a limited number of patients in a prospective, consecutive, therapeutic case series with no control group suggest that sulfamethoxazole and trimethoprim may be beneficial for the treatment of prosthetic joint infection Ref. Additional data may be necessary to further define the role of sulfamethoxazole/trimethoprim in the treatment of this condition.

Based on the IDSA clinical practice guideline for the diagnosis and management of prosthetic joint infection, sulfamethoxazole and trimethoprim is an effective and recommended agent for treatment and chronic oral antimicrobial suppression of prosthetic joint infection due to staphylococci (methicillin-resistant) or Enterobacteriaceae, after completion of pathogen-specific parenteral therapy in patients undergoing 1-stage exchange or debridement with retention of prosthesis.

  Q fever (Coxiella burnetii)Level of Evidence [G]

Based on the CDC diagnosis and management of Q fever guidelines, sulfamethoxazole and trimethoprim given for the treatment of Q fever (Coxiella burnetii) is effective and recommended in the management of this condition in pregnant women up to 32 weeks’ gestation (alternative agent in nonpregnant adults).

  Septic arthritis (methicillin-resistant Staphylococcus aureus)Level of Evidence [G]

Based on the IDSA guidelines for the treatment of MRSA infections in adults and children, sulfamethoxazole and trimethoprim is an effective and recommended treatment option for septic arthritis without prosthetic material caused by MRSA following initial therapy with an appropriate IV antibiotic.

  Skin and soft tissue infectionsLevel of Evidence [C, G]

Data from a limited number of patients studied suggest that trimethoprim and sulfamethoxazole may be beneficial for the treatment of uncomplicated skin infections caused by streptococci Ref.

Clinical experience also suggests the utility of sulfamethoxazole and trimethoprim as an alternative agent in the treatment of mild skin and soft tissue infections (including impetigo and erysipelas) caused by streptococci Ref.

Based on the IDSA guidelines for the diagnosis and management of SSTIs and the treatment of MRSA infections in adults and children, sulfamethoxazole and trimethoprim is an effective and recommended treatment option for mild to moderate SSTIs caused by MRSA.

  Stenotrophomonas maltophilia infectionsLevel of Evidence [C]

Data from a limited number of patients studied suggest that sulfamethoxazole and trimethoprim may be beneficial for the treatment of Stenotrophomonas maltophilia infections Ref. Additional data may be necessary to further define the role of sulfamethoxazole and trimethoprim in this condition.

Clinical experience also suggests the utility of sulfamethoxazole and trimethoprim in the treatment of Stenotrophomonas maltophilia Ref.

  Toxoplasma gondii encephalitis (prophylaxis/treatment/chronic maintenance) in HIV-infected patientsLevel of Evidence [G]

Based on the US Department of Health and Human Services (HHS) guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents, sulfamethoxazole and trimethoprim is an effective and recommended agent for primary prophylaxis of Toxoplasma gondii encephalitis and is an effective and recommended alternative agent for the treatment of or as chronic maintenance therapy of T. gondii encephalitis in HIV-infected patients.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Acne:

American Academy of Dermatology, “Guidelines of care for the management of acne vulgaris,” May 2016

Ascites:

AASLD Practice Guidelines: “Management of Adult Patients with Ascites Due to Cirrhosis: Update 2012,” 2012

Diabetic Foot Infection:

IDSA, “The Diagnosis and Treatment of Diabetic Foot Infections,” 2012

Drug-Induced Liver Injury:

American College of Gastroenterology (ACG), “2014 ACG Guideline for Idiosyncratic Drug-induced Liver Injury,” July 2014

Meningitis and Ventriculitis, Healthcare-associated:

IDSA, “Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis,” February 2017

Methicillin-Resistant Staphylococcus aureus (MRSA) Infections:

Infectious Diseases Society of America, “Practice Guidelines for the Treatment of Methicillin-Resistant Staphylococcus Aureus,” February 2011

Opportunistic Infections:

HHS, Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV-Exposed and HIV-Infected Children, December 2016

HHS, Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, 2017

Osteomyelitis, Native Vertebral:

IDSA, “Clinical Practice Guidelines for the Diagnosis and Treatment of Native Vertebral Osteomyelitis in Adults,” 2015

Peritoneal Dialysis Infections:

ISPD Guidelines, Adults: Peritoneal Dialysis-Related Infections, April 2010

Pneumonia, Community-Acquired:

IDSA/ATS, “Consensus Guideline on Management of Community-Acquired Pneumonia in Adults,” 2007

Prosthetic Joint Infection:

IDSA, “Diagnosis and Management of Prosthetic Joint Infection: Clinical Practice Guideline,” January 2013

Q Fever:

CDC, “Diagnosis and Management of Q Fever”, March 2013

Sexually Transmitted Disease:

CDC, “Sexually Transmitted Diseases Treatment Guidelines,” June 2015.

Public Health Agency of Canada, “Canadian Guidelines on Sexually Transmitted Infections,” January 2010

Shigella Dysentery Type 1:

World Health Organization (WHO), “Guidelines for the Control of Shigellosis, Including Epidemics Due to Shigella dysenteriae Type 1,” 2005

Skin and Soft-tissue Infection:

IDSA, “Practice Guidelines for the Diagnosis and Management of Skin and Soft Tissue Infections,” June 2014.

Urinary Tract Infections:

IDSA, “International Clinical Practice Guidelines for the Treatment of Acute Uncomplicated Cystitis and Pyelonephritis in Women,” March 2011

Urinary Tract Infections, Catheter-Related:

IDSA, “Diagnosis, Prevention, and Treatment of Catheter- Associated Urinary Tract Infection in Adults,” February 2010

Administration: IV

Infuse diluted solution IV over 60-90 minutes; not for IM injection.

Administration: Injectable Detail

pH: 10

Administration: Oral

Administer without regard to meals. Administer with at least 8 ounces of water.

Administration: Pediatric

Oral: Administer without regard to meals. Shake suspension well before use.

Parenteral: IV infusion: Do not administer IM. Must be diluted in D5W prior to administration. Inspect solution for evidence of cloudiness or precipitation prior to administration; infuse diluted solution IV over 60 to 90 minutes.

Dietary Considerations

Should be taken with 8 oz of water. May be taken without regard to meals.

Storage/Stability

Injection: Store at room temperature; do not refrigerate. Less soluble in more alkaline pH. Solution must be diluted prior to administration. Following dilution, store at room temperature; do not refrigerate. Manufacturer recommended dilutions and stability of parenteral admixture at room temperature (25°C):

5 mL/125 mL D5W; stable for 6 hours.

5 mL/100 mL D5W; stable for 4 hours.

5 mL/75 mL D5W; stable for 2 hours.

Studies have also confirmed limited stability in NS; detailed references should be consulted.

Suspension, tablet: Store at controlled room temperature of 15°C to 25°C (59°F to 77°F). Protect from light.

Preparation for Administration: Adult

IV: Must dilute well in D5W prior to administration (ie, 1:15 to 1:25, which equates to 5 mL of drug solution diluted in 75-125 mL base solution)

Preparation for Administration: Pediatric

IV: Dilute in D5W only.

Usual preparation: Dilute to 1:25 dilution (5 mL drug to 125 mL D5W)

Fluid restriction: Dilute to 1:15 dilution (5 mL drug to 75 mL D5W)

Compatibility

See Trissel’s IV Compatibility Database

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, diarrhea, or lack of appetite. Have patient report immediately to prescriber signs of a severe sulfonamide reaction (rash; red, swollen, blistered, or peeling skin; red or irritated eyes; mouth, throat, nose, or eye sores; fever, chills, or pharyngitis; cough that is new or worse; loss of strength and energy; any bruising or bleeding; or signs of liver problems like dark urine, fatigue, lack of appetite, nausea or abdominal pain, light-colored stools, vomiting, or jaundice), signs of high potassium (abnormal heartbeat, confusion, dizziness, passing out, weakness, shortness of breath, or numbness or tingling feeling), signs of aseptic meningitis (headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to lights, fatigue, or confusion), signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of low sodium (headache, difficulty focusing, memory impairment, confusion, weakness, seizures, or change in balance), mood changes, hallucinations, muscle pain, joint pain, purple patches on skin or mouth, shortness of breath, severe injection site pain, burning, edema, or irritation, or signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Contraindications

Hypersensitivity to any sulfa drug, trimethoprim, or any component of the formulation; history of drug induced-immune thrombocytopenia with use of sulfonamides or trimethoprim; megaloblastic anemia due to folate deficiency; infants <2 months (manufacturer’s labeling), infants <4 weeks (CDC 2009); marked hepatic damage or severe renal disease (if patient not monitored); concomitant administration with dofetilide

Note: Although the FDA approved product labeling states this medication is contraindicated with other sulfonamide-containing drug classes, the scientific basis of this statement has been challenged. See “Warnings/Precautions” for more detail.

Canadian labeling: Additional contraindications (not in US labeling): Blood dyscrasias; pregnancy; breastfeeding.

Warnings/Precautions

Concerns related to adverse effects:

• Blood dyscrasias: Fatalities associated with severe reactions including agranulocytosis, aplastic anemia, and other blood dyscrasias have occurred; discontinue use at first sign of rash or signs of serious adverse reactions.

• Dermatologic reactions: Fatalities associated with severe reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have occurred; discontinue use at first sign of rash.

• Hepatic necrosis: Fatalities associated with hepatic necrosis have occurred; discontinue use at first sign of rash or signs of serious adverse reactions.

• Hyperkalemia: May cause hyperkalemia; potential risk factors for trimethoprim-induced hyperkalemia include high dosage (20 mg/kg/day of trimethoprim), renal impairment, older age, hypoaldosteronism, and concomitant use of medications causing or exacerbating hyperkalemia (Perazella 2000).

• Hypoglycemia: May cause hypoglycemia, particularly in malnourished, or patients with renal or hepatic impairment.

• Hyponatremia: Severe and symptomatic hyponatremia may occur, particularly in patients treated for Pneumocystis jirovecii pneumonia (PCP).

• Sulfonamide (“sulfa”) allergy: Traditionally, concerns for cross-reactivity have extended to all compounds containing the sulfonamide structure (SO2NH2). An expanded understanding of allergic mechanisms indicates cross-reactivity between antibiotic sulfonamides and nonantibiotic sulfonamides may not occur, or at the very least this potential is extremely low (Brackett 2004; Johnson 2005; Slatore 2004; Tornero 2004). In particular, mechanisms of cross-reaction due to antibody production (anaphylaxis) are unlikely to occur with nonantibiotic sulfonamides and antibiotic sulfonamides. A nonantibiotic sulfonamide compound which contains the arylamine structure and therefore may cross-react with antibiotic sulfonamides is sulfasalazine (Zawodniak 2010). T-cell-mediated (type IV) reactions (eg, maculopapular rash) are less understood and it is not possible to completely exclude this potential based on current insights. In cases where prior reactions were severe (Stevens-Johnson syndrome/TEN), some clinicians choose to avoid exposure to these classes.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

• Thrombocytopenia: Immune mediated thrombocytopenia may occur. Severe cases which may be life-threatening or fatal have been reported. Thrombocytopenia usually resolves within 1 week following discontinuation of therapy.

Disease-related concerns:

• Asthma/allergies: Use with caution in patients with allergies or asthma.

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment recommended. Maintain adequate hydration to prevent crystalluria.

• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• Leucovorin: Avoid concomitant use when treating Pneumocystis jirovecii pneumonia (PCP) in HIV patients; may increase risk of treatment failure and death.

Special populations:

• AIDS patients: Incidence of adverse effects appears to be increased in patients with AIDS.

• Elderly: Use with caution in elderly patients; greater risk for more severe adverse reactions, including hyperkalemia associated with trimethoprim use. Elderly patients are at an increased risk for severe and potentially life-threatening hyperkalemia when trimethoprim is used concomitantly with medications known to cause or exacerbate hyperkalemia, such as spironolactone, ACE inhibitors, or ARBs (Antoniou 2010; Antoniou 2011; Antoniou, 2015).

• G6PD deficiency: Use with caution in patients with G6PD deficiency; hemolysis may occur (dose-related).

• Patients with potential for folate deficiency: Use with caution in patients with potential folate deficiency (malnourished, chronic anticonvulsant therapy, or elderly).

• Porphyria: Use with caution in patients with porphyria.

• Pregnant women: Use during pregnancy may be associated with embryo-fetal toxicity.

• Slow acetylators: May be more prone to adverse reactions.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP [“Inactive” 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP [“Inactive” 1997]; Zar 2007).

• Sulfite sensitivity: Injection may contain sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible persons. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic persons.

Other warnings/precautions:

• Appropriate use: When used for uncomplicated urinary tract infections, this combination should not be used if a single agent is effective. Additionally, sulfonamides should not be used to treat group A beta-hemolytic streptococcal infections.

Geriatric Considerations

Elderly patients appear at greater risk for more severe adverse reactions.

Trimethoprim decreases potassium excretion through competitive inhibition of epithelial sodium channels in the kidney (similar to the action of amiloride), and may cause hyperkalemia in certain susceptible patients, including the elderly (Ben Salem 2014; Perazella 2000). Elderly patients receiving trimethoprim (alone or in combination with sulfamethoxazole) concomitantly with other agents known to cause or exacerbate hyperkalemia (spironolactone, ACE inhibitors, or ARBs) are at an increased risk for severe and potentially life-threatening hyperkalemia (Antoniou 2010; Antoniou 2011; Antoniou 2015).

Warnings: Additional Pediatric Considerations

Sulfa antibiotics have been shown to displace bilirubin from protein binding sites which may potentially lead to hyperbilirubinemia and kernicterus in neonates and young infants; do not use in neonates; avoid use in infants <2 months unless other options are not available (eg, Pneumocystis).

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP, 1997; Shehab, 2009).

Pregnancy Risk Factor

D

Pregnancy Considerations

Sulfamethoxazole and trimethoprim cross the placenta.

An increased risk of congenital malformations (neural tube defects, cardiovascular malformations, urinary tract defects, oral clefts, club foot) following maternal use of sulfamethoxazole and trimethoprim during pregnancy has been observed in some studies. Folic acid supplementation may decrease this risk (Crider 2009; Czeizel 2001; Hernandez-Diaz 2000; Hernandez-Diaz 2001; Matok 2009). Due to theoretical concerns that sulfonamides pass the placenta and may cause kernicterus in the newborn, neonatal health care providers should be informed if maternal sulfonamide therapy is used near the time of delivery (HHS [OI adult 2017]).

The pharmacokinetics of sulfamethoxazole and trimethoprim are similar to nonpregnant values in early pregnancy (Ylikorkala 1973). Sulfamethoxazole and trimethoprim are recommended for the prophylaxis or treatment of Pneumocystis jirovecii pneumonia (PCP), prophylaxis of Toxoplasmic gondii encephalitis (TE), and for the acute and chronic treatment of Q fever in pregnancy (CDC 2013; HHS [OI adult 2017]). Sulfonamides may also be used to treat other infections in pregnant women when clinically appropriate; use during the first trimester should be limited to situations where no alternative therapies are available (ACOG 717 2017).

Breast-Feeding Considerations

Sulfamethoxazole and trimethoprim are present in breast milk.

The manufacturer states that the exposure of sulfamethoxazole and trimethoprim to the breastfeeding infant would be 2% to 5% of the recommended daily dose for infants >2 months of age (maternal dose, milk concentration, and infant dose not specified). The relative infant dose (RID) of trimethoprim is 3% when compared to an infant therapeutic trimethoprim dose of 10 mg/kg/day. In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000).

The RID of trimethoprim was calculated using a mean milk concentration of 2 mcg/mL, providing an estimated daily infant dose via breast milk of <0.3 mg/kg/day. Using an average sulfamethoxazole milk concentration of 5.34 mcg/mL, the estimated daily infant sulfamethoxazole dose via breast milk would be <0.8 mg/kg/day. These milk concentrations were obtained following a maternal dose of trimethoprim 80 mg-sulfamethoxazole 400 mg as either 2 tablets (n=40) or 3 tablets (n=10) twice daily for a minimum of 5 days to women within 5 days of delivery (Miller 1974).

The therapeutic use of sulfamethoxazole and trimethoprim is contraindicated in infants <2 months of age due to the possibility of bilirubin displacement resulting in kernicterus and hemolytic anemia caused by immature erythrocyte enzyme systems; theoretically, the risk of kernicterus and hemolytic anemia is present in breastfed infants exposed to sulfamethoxazole and trimethoprim via breast milk (Mitrano 2009). The manufacturer recommends that caution be used if administered to nursing women, especially if breastfeeding infants that are ill, jaundiced, premature, or stressed due to the potential risk of bilirubin displacement and kernicterus. Avoid use of sulfamethoxazole in women who are breastfeeding an infant with G6PD deficiency (WHO 2002) or hyperbilirubinemia (Della-Giustina 2003). The WHO considers sulfamethoxazole and trimethoprim compatible with breastfeeding in older, healthy, full-term infants with monitoring of the infant for jaundice and hemolysis (WHO 2002). In general, antibiotics that are present in breast milk may cause nondose-related modification of bowel flora. Monitor infants for GI disturbances (WHO 2002).

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Frequency not defined:

Cardiovascular: Allergic myocarditis, periarteritis nodosa (rare)

Central nervous system: Apathy, aseptic meningitis, ataxia, chills, depression, fatigue, hallucination, headache, insomnia, nervousness, peripheral neuritis, seizure, vertigo

Dermatologic: Erythema multiforme (rare), exfoliative dermatitis (rare), pruritus, skin photosensitivity, skin rash, Stevens-Johnson syndrome (rare), toxic epidermal necrolysis (rare), urticaria

Endocrine & metabolic: Hyperkalemia (generally at high dosages), hypoglycemia (rare), hyponatremia

Gastrointestinal: Abdominal pain, anorexia, diarrhea, glottis edema, kernicterus (in neonates), nausea, pancreatitis, pseudomembranous colitis, stomatitis, vomiting

Genitourinary: Crystalluria, diuresis (rare), nephrotoxicity (in association with cyclosporine), toxic nephrosis (with anuria and oliguria)

Hematologic & oncologic: Agranulocytosis, anaphylactoid purpura (IgA vasculitis; rare), aplastic anemia, eosinophilia, hemolysis (with G6PD deficiency), hemolytic anemia, hypoprothrombinemia, leukopenia, megaloblastic anemia, methemoglobinemia, neutropenia, thrombocytopenia

Hepatic: Cholestatic jaundice, hepatotoxicity (including hepatitis, cholestasis, and hepatic necrosis), hyperbilirubinemia, increased transaminases

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction, serum sickness

Neuromuscular & skeletal: Arthralgia, myalgia, rhabdomyolysis (mainly in AIDS patients), systemic lupus erythematosus (rare), weakness

Ophthalmic: Conjunctival injection, injected sclera, uveitis

Otic: Tinnitus

Renal: Increased blood urea nitrogen, increased serum creatinine, interstitial nephritis, renal failure

Respiratory: Cough, dyspnea, pulmonary infiltrates

Miscellaneous: Fever

Postmarketing: Dysgeusia (Syed 2016), immune thrombocytopenia (formerly known as idiopathic thrombocytopenic purpura), metabolic acidosis, prolonged Q-T interval on ECG, thrombotic thrombocytopenic purpura

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Refer to individual components.

Drug Interactions 

Ajmaline: Sulfonamides may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Risk C: Monitor therapy

Amantadine: Trimethoprim may enhance the adverse/toxic effect of Amantadine. Specifically, the risk of myoclonus and/or delirium may be increased. Amantadine may increase the serum concentration of Trimethoprim. Trimethoprim may increase the serum concentration of Amantadine. Risk C: Monitor therapy

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

Amodiaquine: Trimethoprim may enhance the neutropenic effect of Amodiaquine. Trimethoprim may increase the serum concentration of Amodiaquine. Risk X: Avoid combination

Androgens: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Exceptions: Danazol. Risk C: Monitor therapy

Angiotensin II Receptor Blockers: Trimethoprim may enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Angiotensin-Converting Enzyme Inhibitors: Trimethoprim may enhance the hyperkalemic effect of Angiotensin-Converting Enzyme Inhibitors. Risk C: Monitor therapy

Antidiabetic Agents: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

AzaTHIOprine: Sulfamethoxazole may enhance the myelosuppressive effect of AzaTHIOprine. Risk C: Monitor therapy

AzaTHIOprine: Trimethoprim may enhance the myelosuppressive effect of AzaTHIOprine. Risk C: Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Benznidazole: May enhance the adverse/toxic effect of Products Containing Propylene Glycol. Risk X: Avoid combination

Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Chloroprocaine: May diminish the therapeutic effect of Sulfonamide Antibiotics. Management: Avoid concurrent use of chloroprocaine and systemic sulfonamide-based antimicrobials whenever possible. Risk D: Consider therapy modification

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

CycloSPORINE (Systemic): Sulfonamide Antibiotics may enhance the nephrotoxic effect of CycloSPORINE (Systemic). Sulfonamide Antibiotics may decrease the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy

CYP2C9 Inhibitors (Moderate): May decrease the metabolism of CYP2C9 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP2C9 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

Dapsone (Systemic): Trimethoprim may increase the serum concentration of Dapsone (Systemic). Dapsone (Systemic) may increase the serum concentration of Trimethoprim. Risk C: Monitor therapy

Dapsone (Topical): Trimethoprim may enhance the adverse/toxic effect of Dapsone (Topical). More specifically, trimethoprim may increase the risk for hemolysis Risk C: Monitor therapy

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Dexketoprofen: May enhance the adverse/toxic effect of Sulfonamides. Risk C: Monitor therapy

Digoxin: Trimethoprim may increase the serum concentration of Digoxin. Risk C: Monitor therapy

Dofetilide: Trimethoprim may increase the serum concentration of Dofetilide. Risk X: Avoid combination

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

Enzalutamide: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP2C9 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP2C9 substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

Eplerenone: Trimethoprim may enhance the hyperkalemic effect of Eplerenone. Risk C: Monitor therapy

Fosphenytoin: May decrease the serum concentration of Trimethoprim. Trimethoprim may increase the serum concentration of Fosphenytoin. Management: Consider alternatives to this combination when possible, to avoid potential decreased trimethoprim efficacy and increased phenytoin concentrations/effects. Monitor patients receiving this combination closely for both of these possible effects. Risk D: Consider therapy modification

Herbs (Hypoglycemic Properties): May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Hypoglycemia-Associated Agents: May enhance the hypoglycemic effect of other Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

LamiVUDine: Trimethoprim may increase the serum concentration of LamiVUDine. Risk C: Monitor therapy

Leucovorin Calcium-Levoleucovorin: May diminish the therapeutic effect of Trimethoprim. Management: Avoid concurrent use of leucovorin or levoleucovorin with trimethoprim (plus sulfamethoxazole) for Pneumocystis jirovecii pneumonia. If trimethoprim is used for another indication, monitor closely for reduced efficacy. Risk X: Avoid combination

Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased.Risk C: Monitor therapy

Lorlatinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. Risk D: Consider therapy modification

Maitake: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Mecamylamine: Sulfonamides may enhance the adverse/toxic effect of Mecamylamine. Risk X: Avoid combination

Memantine: Trimethoprim may enhance the adverse/toxic effect of Memantine. Specifically, the risk of myoclonus and/or delirium may be increased. Trimethoprim may increase the serum concentration of Memantine. Memantine may increase the serum concentration of Trimethoprim. Risk C: Monitor therapy

Mercaptopurine: Sulfamethoxazole may enhance the myelosuppressive effect of Mercaptopurine. Risk C: Monitor therapy

Mercaptopurine: Trimethoprim may enhance the myelosuppressive effect of Mercaptopurine. Risk C: Monitor therapy

MetFORMIN: Trimethoprim may increase the serum concentration of MetFORMIN. Risk C: Monitor therapy

Methenamine: May enhance the adverse/toxic effect of Sulfonamide Antibiotics. Specifically, the combination may result in the formation of an insoluble precipitate in the urine. Risk X: Avoid combination

Methotrexate: Trimethoprim may enhance the adverse/toxic effect of Methotrexate. Management: Consider avoiding concomitant use of methotrexate and either sulfamethoxazole or trimethoprim. If used concomitantly, monitor for the development of signs and symptoms of methotrexate toxicity (e.g., bone marrow suppression). Risk D: Consider therapy modification

MetroNIDAZOLE (Systemic): May enhance the adverse/toxic effect of Products Containing Propylene Glycol. A disulfiram-like reaction may occur. Risk X: Avoid combination

MiFEPRIStone: May increase the serum concentration of CYP2C9 Substrates (High risk with Inhibitors). Management: Use CYP2C9 substrates at the lowest recommended dose, and monitor closely for adverse effects, during and in the 2 weeks following mifepristone treatment. Risk D: Consider therapy modification

Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Risk D: Consider therapy modification

Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when nitric oxide is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine. Risk C: Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Phenytoin: Trimethoprim may increase the serum concentration of Phenytoin. Phenytoin may decrease the serum concentration of Trimethoprim. Management: Consider alternatives to this combination when possible, to avoid potential decreased trimethoprim efficacy and increased phenytoin concentrations/effects. Monitor patients receiving this combination closely for both of these possible effects. Risk D: Consider therapy modification

Phenytoin: Sulfamethoxazole may increase the serum concentration of Phenytoin. Risk D: Consider therapy modification

Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Risk D: Consider therapy modification

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy

Potassium P-Aminobenzoate: May diminish the therapeutic effect of Sulfonamide Antibiotics. Risk X: Avoid combination

PRALAtrexate: Trimethoprim may increase the serum concentration of PRALAtrexate. More specifically, trimethoprim may decrease excretion of pralatrexate. Management: Closely monitor for increased pralatrexate serum level and/or possible toxicity with concomitant use of trimethoprim. Monitor for decreased pralatrexate levels with discontinuation of trimethoprim. Risk C: Monitor therapy

PRALAtrexate: Sulfamethoxazole may increase the serum concentration of PRALAtrexate. More specifically, sulfamethoxazole may decrease excretion of pralatrexate. Management: Closely monitor for increased pralatrexate serum level and/or possible toxicity with concomitant use of sulfamethoxazole. Monitor for decreased pralatrexate levels with discontinuation of sulfamethoxazole. Risk C: Monitor therapy

Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy

Procainamide: Trimethoprim may increase serum concentrations of the active metabolite(s) of Procainamide. Trimethoprim may increase the serum concentration of Procainamide. Risk D: Consider therapy modification

Procaine: May diminish the therapeutic effect of Sulfonamide Antibiotics. Risk X: Avoid combination

Prothionamide: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Pyrimethamine: May enhance the adverse/toxic effect of Trimethoprim. Risk C: Monitor therapy

Quinolones: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolones may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor therapy

Repaglinide: Trimethoprim may decrease the metabolism of Repaglinide. Risk C: Monitor therapy

Rifapentine: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Risk C: Monitor therapy

Salicylates: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification

Spironolactone: Trimethoprim may enhance the hyperkalemic effect of Spironolactone. Risk C: Monitor therapy

St John’s Wort: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

Sulfonylureas: Sulfonamide Antibiotics may enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

Thiazolidinediones: Trimethoprim may decrease the metabolism of Thiazolidinediones. Risk C: Monitor therapy

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Risk D: Consider therapy modification

Varenicline: Trimethoprim may increase the serum concentration of Varenicline. Management: Monitor for increased varenicline adverse effects with concomitant use of trimethoprim, particularly in patients with severe renal impairment. International product labeling recommendations vary. Consult appropriate labeling. Risk C: Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Sulfonamide Antibiotics may enhance the anticoagulant effect of Vitamin K Antagonists. Risk D: Consider therapy modification

Test Interactions

Increased creatinine (Jaffé alkaline picrate reaction); increased serum methotrexate by dihydrofolate reductase method

Monitoring Parameters

CBC, serum potassium, creatinine, BUN

Advanced Practitioners Physical Assessment/Monitoring

Assess culture and sensitivity report and patient allergy history prior to starting therapy (sulfonamides). For empiric treatment be aware of suspected organisms and institution/region’s sensitivity patterns. Obtain CBC, serum potassium, creatinine, and BUN prior to therapy and periodically during treatment. Test for C. difficile if patient develops diarrhea. Assess for effectiveness of treatment. Assess for signs of rash or serious adverse reactions.

Nursing Physical Assessment/Monitoring

Check ordered labs and report abnormalities. Monitor for severe or bloody diarrhea and send a specimen to the lab for C. difficile. Monitor for and instruct patient to report signs of hepatic impairment (dark urine, jaundice, nausea, vomiting, lack of appetite) or rash or other skin changes.

Dosage Forms Considerations

The 5:1 ratio (SMX:TMP) remains constant in all dosage forms.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous:

Generic: Sulfamethoxazole 80 mg and trimethoprim 16 mg per mL (5 mL, 10 mL, 30 mL)

Suspension, Oral:

Sulfatrim Pediatric: Sulfamethoxazole 200 mg and trimethoprim 40 mg per 5 mL (473 mL) [contains alcohol, usp, fd&c red #40, fd&c yellow #6 (sunset yellow), methylparaben, polysorbate 80, propylene glycol, propylparaben, saccharin sodium]

Sulfatrim Pediatric: Sulfamethoxazole 200 mg and trimethoprim 40 mg per 5 mL (473 mL [DSC]) [contains alcohol, usp, fd&c red #40, fd&c yellow #6 (sunset yellow), methylparaben, polysorbate 80, propylene glycol, propylparaben, saccharin sodium; cherry flavor]

Generic: Sulfamethoxazole 200 mg and trimethoprim 40 mg per 5 mL (20 mL, 473 mL)

Tablet, Oral:

Bactrim: Sulfamethoxazole 400 mg and trimethoprim 80 mg [scored; contains sodium benzoate]

Bactrim DS: Sulfamethoxazole 800 mg and trimethoprim 160 mg [scored; contains sodium benzoate]

Generic: Sulfamethoxazole 400 mg and trimethoprim 80 mg, Sulfamethoxazole 800 mg and trimethoprim 160 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous:

Septra: Sulfamethoxazole 80 mg and trimethoprim 16 mg per mL (5ml) [contains ALCOHOL, USP, PROPYLENE GLYCOL, SODIUM METABISULFITE]

Suspension, Oral:

Generic: Sulfamethoxazole 200 mg and trimethoprim 40 mg per 5 mL (100ml, 400ml, 800ml)

Tablet, Oral:

Protrin DF: Sulfamethoxazole 800 mg and trimethoprim 160 mg [DSC]

Sulfatrim Pediatric: Sulfamethoxazole 100 mg and trimethoprim 20 mg

Generic: Sulfamethoxazole 400 mg and trimethoprim 80 mg, Sulfamethoxazole 800 mg and trimethoprim 160 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • J01EE01
Generic Available (US)

Yes

Pricing: US

Solution (Sulfamethoxazole-Trimethoprim Intravenous)

400-80 mg/5 mL (per mL): $1.51

Suspension (Sulfamethoxazole-Trimethoprim Oral)

200-40 mg/5 mL (per mL): $0.25 – $0.42

Suspension (Sulfatrim Pediatric Oral)

200-40 mg/5 mL (per mL): $0.24

Tablets (Bactrim DS Oral)

800-160 mg (per each): $3.12

Tablets (Bactrim Oral)

400-80 mg (per each): $1.73

Tablets (Sulfamethoxazole-Trimethoprim Oral)

400-80 mg (per each): $0.66 – $0.78

800-160 mg (per each): $0.37 – $1.40

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Sulfamethoxazole interferes with bacterial folic acid synthesis and growth via inhibition of dihydrofolic acid formation from para-aminobenzoic acid; trimethoprim inhibits dihydrofolic acid reduction to tetrahydrofolate resulting in sequential inhibition of enzymes of the folic acid pathway

Pharmacodynamics/Kinetics

Absorption: Oral: Rapid; almost completely (90% to 100%)

Distribution: Both SMX and TMP distribute to middle ear fluid, sputum, vaginal fluid; TMP also distributes into bronchial secretions

Vd: TMP:

Newborns: ~2.7 L/kg (range: 1.3 to 4.1 hours) (Springer 1982)

Infants: 1.5 L/kg (Hoppu 1989)

Children 1 to 10 years: 0.86 to 1 L/kg (Hoppu 1987)

Adults: ~1.3 L/kg (Hoppu 1987)

Protein binding: SMX: ~70%, TMP: ~44%

Metabolism: Hepatic, both to multiple metabolites; SMX to hydroxy (via CYP2C9) and acetyl derivatives, and also conjugated with glucuronide; TMP to oxide and hydroxy derivatives; the free forms of both SMX and TMP are therapeutically active

Half-life elimination:

TMP: Prolonged in renal failure

Newborns: ~19 hours; range: 11 to 27 hours (Springer 1982)

Infants 2 months to 1 year: ~4.6 hours; range: 3 to 6 hours (Hoppu 1989)

Children 1 to 10 years: 3.7 to 5.5 hours (Hoppu 1987)

Children and Adolescents >10 years: 8.19 hours

Adults: 6 to 11 hours

SMX: 9 to 12 hours, prolonged in renal failure

Time to peak, serum: Oral: 1 to 4 hours

Excretion: Both are excreted in urine as metabolites and unchanged drug

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: Patients with severely impaired renal function exhibit an increase in the half-lives of both components, requiring dosage adjustments.

Geriatric: Total body clearance of trimethoprim was 19% lower in elderly patients.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Stomatitis.

Effects on Bleeding

No information available to require special precautions

Index Terms

Cotrimoxazole; Co-Trimoxazole; Septra; SMX-TMP; SMZ-TMP; Sulfamethoxazole-Trimethoprim; Sulfamethoxazole/Trimethoprim; Sulfatrim; TMP-SMX; TMP-SMZ; Trimethoprim and Sulfamethoxazole; Trimethoprim-Sulfamethoxazole

FDA Approval Date
July 30, 1973
References

Agha R, Goldberg MB. Shigella infection: treatment and prevention in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 10, 2017.

Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]

Alexander BD, Fishman JA. Prophylaxis of infections in solid organ transplantation. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 10, 2017.

American Academy of Pediatrics Subcommittee on Urinary Tract Infection, Steering Committee on Quality improvement and Management. Urinary tract infection: clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months. Pediatrics. 2011;128(3):595-610.[PubMed 21873693]

American College of Obstetricians and Gynecologists (ACOG) Committee on Obstetric Practice, “ACOG Committee Opinion No. 494: Sulfonamides, Nitrofurantoin, and Risk of Birth Defects,” Obstet Gynecol, 2011, 117(6):1484-5.[PubMed 21606771]

American College of Obstetricians and Gynecologists (ACOG). Committee on Obstetric Practice. Committee opinion no. 717: sulfonamides, nitrofurantoin, and risk of birth defects. Obstet Gynecol. 2017;130(3):e150-e152.

Anderson A, Bijlmer H, Fournier PE, et al. Diagnosis and management of Q fever–United States, 2013: recommendations from CDC and the Q Fever Working Group [published correction appears in MMWR Recomm Rep. 2013;62(35):730]. MMWR Recomm Rep. 2013;62(RR-03):1-30.[PubMed 23535757]

Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52.[PubMed 27060684]

Antoniou T, Gomes T, Juurlink DN, Loutfy MR, Glazier RH, Mamdani MM. Trimethoprim-sulfamethoxazole-induced hyperkalemia in patients receiving inhibitors of the renin-angiotensin system: a population-based study. Arch Intern Med. 2010;170(12):1045-1049.[PubMed 20585070]

Antoniou T, Gomes T, Mamdani MM, et al. Trimethoprim-sulfamethoxazole induced hyperkalaemia in elderly patients receiving spironolactone: nested case-control study. BMJ. 2011;343.[PubMed 21911446]

Antoniou T, Hollands S, Macdonald EM, et al. Trimethoprim-sulfamethoxazole and risk of sudden death among patients taking spironolactone. CMAJ. 2015;187(4):E138-143.[PubMed 25646289]

Bactrim (sulfamethoxazole and trimethoprim) injection [prescribing information]. Cranbury, NJ: Sun Pharmaceuticals; March 2017.

Baddour LM. Impetigo. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed June 7, 2018.

Bartlett JG, Sethi S. Management of infection in exacerbations of chronic obstructive pulmonary disease. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 10, 2017.

Ben Salem C, Badreddine A, Fathallah N, Slim R, Hmouda H. Drug-induced hyperkalemia. Drug Saf. 2014;37(9):677-692.[PubMed 25047526]

Berbari E, Baddour LM. Prosthetic joint infection. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed March 12, 2018.

Bissuel F, Cotte L, Crapanne JB, et al, “Trimethoprim-Sulphamethoxazole Rechallenge in 20 Previously Allergic HIV-Infected Patients After Homeopathic,” AIDS, 1995, 9(4):407-8.[PubMed 7794554]

Bowen AC, Carapetis JR, Currie BJ, Fowler V Jr, Chambers HF, Tong SYC. Sulfamethoxazole-Trimethoprim (Cotrimoxazole) for Skin and Soft Tissue Infections Including Impetigo, Cellulitis, and Abscess. Open Forum Infect Dis. 2017;4(4):ofx232. doi: 10.1093/ofid/ofx232.[PubMed 29255730]

Brackett CC, Singh H, Block JH. Likelihood and mechanisms of cross-allergenicity between sulfonamide antibiotics and other drugs containing a sulfonamide functional group. Pharmacotherapy. 2004;24(7):856-870.[PubMed 15303450]

Bradley JS, Nelson JD, Barnett E, et al. Nelson’s Pediatric Antimicrobial Therapy. 23rd ed. American Academy of Pediatrics; 2017.

Centers for Disease Control and Prevention (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm[PubMed 6810084]

Centers for Disease Control and Prevention (CDC), “Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV-Exposed and HIV-Infected Children,” MMWR Recomm Rep, 2009, 58(RR-11):1-166. Available at http://www.antimicrobe.org/h04c.files/history/CDC-HIV%20ExposeInfectChildren-2009.pdf

Centers for Disease Control and Prevention (CDC). National Antimicrobial Resistance Monitoring System for Enteric Bacteria (NARMS): Human Isolates Final Report, 2010. Atlanta, Georgia: US Department of Health and Human Services, CDC, 2012. https://www.cdc.gov/narms/pdf/2010-annual-report-narms.pdf.

Centers for Disease Control and Prevention (CDC). DPDx – Laboratory identification of parasitic diseases of public health concern. Cystoisosporiasis. https://www.cdc.gov/dpdx/cystoisosporiasis/tx.html. Updated November 29, 2013. Accessed October 13, 2017.

Centers for Disease Control and Prevention (CDC). Treatment for cyclosporiasis. https://www.cdc.gov/parasites/cyclosporiasis/health_professionals/tx.html. Updated January 10, 2013. Accessed October 10, 2017.

Centers for Disease Control and Prevention (CDC). Nocardiosis: laboratory diagnostics and treatment. https://www.cdc.gov/nocardiosis/health-care-workers/laboratory-diagnostics.html. Updated March 30, 2016. Accessed October 13, 2017.[PubMed 23535757]

Cheng AC, McBryde ES, Wuthiekanun V, et al. Dosing regimens of cotrimoxazole (trimethoprim-sulfamethoxazole) for melioidosis. Antimicrob Agents Chemother. 2009;53(10):4193-4199. doi: 10.1128/AAC.01301-08.[PubMed 19620336]

Choo V, “UK Revises Indications for Co-Trimoxazole,” Lancet, 1995, 346(8968):175.

Cockerill FR and Edson RS, “Trimethoprim-Sulfamethoxazole,” Mayo Clin Proc, 1991, 66(12):1260-9.[PubMed 1749295]

Cordero-Ampuero J, Esteban J, Garcia-Cimbrelo E, Munuera L, Escobar R. Low relapse with oral antibiotics and two-stage exchange for late arthroplasty infections in 40 patients after 2-9 years. Acta Orthopaedica. 2007;78(4):511-519.[PubMed 17966006]

Crider KS, Cleves MA, Reefhuis J, et al, “Antibacterial Medication Use During Pregnancy and Risk of Birth Defects: National Birth Defects Prevention Study,” Arch Pediatr Adolesc Med, 2009, 163(11):978-85.[PubMed 19884587]

Czeizel AE, Rockenbauer M, Sørensen HT, et al, “The Teratogenic Risk of Trimethoprim-Sulfonamides: A Population Based Case-Control Study,” Reprod Toxicol, 2001, 15(6):637-46.[PubMed 11738517]

Della-Giustina K and Chow G, “Medications in Pregnancy and Lactation,” Emerg Med Clin North Am, 2003, 21(3):585-613.[PubMed 12962348]

Fishman JA. Prevention of infection caused by Pneumocystis carinii in transplant recipients. Clin Infect Dis. 2001;33(8):1397-1405.[PubMed 11565082]

Gentry CA, Nguyen AT. An evaluation of hyperkalemia and serum creatinine elevation associated with different dosage levels of outpatient trimethoprim-sulfamethoxazole with and without concomitant medications. Ann Pharmacother. 2013;47(12):1618-1626. doi: 10.1177/1060028013509973.[PubMed 24259630]

Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: 2017 report. http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-prevention-copd/. Accessed August 10, 2017.

Goldenberg DL, Sexton DJ. Septic arthritis in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 10, 2017.

Golightly LK, Teitelbaum I, Kiser TH, et al, eds. Renal Pharmacotherapy. New York, NY: Springer Science; 2013.

Guerrant RL, Van Gilder T, Steiner TS, et al; Infectious Diseases Society of America. Practice guidelines for the management of infectious diarrhea. Clin Infect Dis. 2001;32(3):331-351.[PubMed 11170940]

Gupta K, Hooton TM, Naber KG, et al; Infectious Diseases Society of America; European Society for Microbiology and Infectious Diseases. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011;52(5):e103-e120. doi: 10.1093/cid/ciq257.[PubMed 21292654]

Harper M. Clinical manifestations and initial management of animal and human bites. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 10, 2017.

Heintz BH, Matzke GR, Dager WE. Antimicrobial dosing concepts and recommendations for critically ill adult patients receiving continuous renal replacement therapy or intermittent hemodialysis. Pharmacotherapy. 2009;29(5):562-577.[PubMed 19397464]

Hernández-Díaz S and Mitchell AA, Author reply, NEJM, 2001, 344(12): 934-5.

Hernández-Díaz S, Werler MM, Walker AM, et al, “Folic Acid Antagonists During Pregnancy and the Risk of Birth Defects,” N Engl J Med, 2000, 343(22):1608-14.[PubMed 11096168]

HHS Panel on Opportunistic Infections in HIV-Infected Adults and Adolescents. Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. 2017. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/adult_oi.pdf. Accessed August 28, 2017.

Hoge CW, Shlim DR, Ghimire M, et al. Placebo-controlled trial of co-trimoxazole for cyclospora infections among travellers and foreign residents in Nepal Nepal [published correction appears in Lancet. 1995;345(8956):1060]. Lancet. 1995;345(8951):691-693.[PubMed 7885125]

Hooton TM, Gupta K. Acute complicated cystitis and pyelonephritis in women. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 10, 2017.

Hoppu K, “Age Differences in Trimethoprim Pharmacokinetics: Need for Revised Dosing in Children?” Clin Pharmacol Ther, 1987, 41(3):336-43.[PubMed 3816021]

Hughes W, Leoung G, Kramer F, et al, “Comparison of Atovaquone (566C80) With Trimethoprim-Sulfamethoxazole to Treat Pneumocystis carinii Pneumonia in Patients With AIDS,” N Engl J Med, 1993, 328(21):1521-7.[PubMed 8479489]

“Inactive” ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343(2):118-126.[PubMed 10891521]

Jick H and Derby LE, “A Large Population-Based Follow-Up Study of Trimethoprim-Sulfamethoxazole, Trimethoprim, and Cephalexin for Uncommon Serious Drug Toxicity,” Pharmacotherapy, 1995, 15(4):428-32.[PubMed 7479194]

Jick H and Derby LE, “Is Co-Trimoxazole Safe?” Lancet, 1995, 345(8957):1118-9.[PubMed 7715367]

Johnson KK, Green DL, Rife JP, Limon L. Sulfonamide cross-reactivity: fact or fiction? [published correction appears in Ann Pharmacother. 2005;39(7-8):1373]. Ann Pharmacother. 2005;39(2):290-301.[PubMed 15644481]

Kimberlin DW, Brady MT, Jackson MA, Long SS, eds. Red Book: 2012 Report of the Committee on Infectious Diseases. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2012.

Kimberlin DW, Brady MT, Jackson MA, Long SS, eds. Red Book: 2015 Report of the Committee on Infectious Diseases. 30th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2015.

Lalani T. Overview of osteomyelitis in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 10, 2017.

Leder K. Management of cystoisospora (isospora) infections. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 10, 2017.

Lee M, Bozzo P, Einarson A, et al, “Urinary Tract Infections in Pregnancy,” Can Fam Physician, 2008, 54(6):853-4.[PubMed 18556490]

Lerner PI. Nocardiosis. Clin Infect Dis. 1996;22(6):891-903.[PubMed 8783685]

Lewis SS, Zaas A. Stenotrophomonas maltophilia. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 10, 2017.

Lieberthal AS, Carroll AE, Chonmaitree T, et al. The diagnosis and management of acute otitis media [published correction appears in Pediatrics. 2014;133(2):346]. Pediatrics.2013;131(3):e964-999.[PubMed 23439909]

Limper AH, Knox KS, Sarosi GA, et al; American Thoracic Society Fungal Working Group. An official American Thoracic Society statement: Treatment of fungal infections in adult pulmonary and critical care patients. Am J Respir Crit Care Med. 2011;183(1):96-128. doi: 10.1164/rccm.2008-740ST.[PubMed 21193785]

Lipsitz R, Garges S, Aurigemma R, et al. Workshop on treatment of and postexposure prophylaxis for Burkholderia pseudomallei and B. mallei Infection, 2010. Emerg Infect Dis. 2012;18(12):e2. doi: 10.3201/eid1812.120638.[PubMed 23171644]

Lipsky BA. Medical treatment of diabetic foot infections. Clin Infect Dis. 2004;39(suppl 2):S104-S114.[PubMed 15306988]

Lipsky BA, Berendt AR, Cornia PB, et al; Infectious Diseases Society of America. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012;54(12):e132-e173. doi: 10.1093/cid/cis346.[PubMed 22619242]

Lipsky BA, Peters EJ, Senneville E, et al Expert opinion on the management of infections in the diabetic foot. Diabetes Metab Res Rev. 2012;28(suppl 1):163-178. doi: 10.1002/dmrr.2248.[PubMed 22271739]

Liu C, Bayer A, Cosgrove SE, et al; Infectious Diseases Society of America. Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children [published correction appears in Clin Infect Dis. 2011;53(3):319]. Clin Infect Dis. 2011;52(3):e18-e55. doi: 10.1093/cid/ciq146.[PubMed 21208910]

Long S, Pickering L, eds. Principles and Practice of Pediatric Infectious Diseases. 4th ed. Philadelphia, PA: Saunders Elsevier; 2012.

Lontos S, Shelton E, Angus PW, et al. A randomized controlled study of trimethoprim-sulfamethoxazole versus norfloxacin for the prevention of infection in cirrhotic patients. J Dig Dis. 2014;15(5):260-267.[PubMed 24612987]

Looney WJ, Narita M, Mühlemann K. Stenotrophomonas maltophilia: an emerging opportunist human pathogen. Lancet Infect Dis. 2009;9(5):312-323. doi: 10.1016/S1473-3099(09)70083-0.[PubMed 19393961]

Lundstrom TS and Sobel JD, “Vancomycin, Trimethoprim-Sulfamethoxazole, and Rifampin,” Infect Dis Clin North Am, 1995, 9(3):747-67.[PubMed 7490442]

Martin SI, Fishman JA; AST Infectious Diseases Community of Practice. Pneumocystis pneumonia in solid organ transplantation. Am J Transplant. 2013;13(suppl 4):272-279. doi: 10.1111/ajt.12119.[PubMed 23465020]

Masur H, Kaplan JE, Holmes KK; US Public Health Service; Infectious Diseases Society of America. Guidelines for preventing opportunistic infections among HIV-Infected persons – 2002. Recommendations of the US Public Health Service and the Infectious Diseases Society of America. Ann Intern Med. 2002;137(5)(pt 2):435-478.[PubMed 12617574]

Matok I, Gorodischer R, Koren G, et al, “Exposure to Folic Acid Antagonists During the First Trimester of Pregnancy and the Risk of Major Malformations,” Br J Clin Pharmacol, 2009, 68(6):956-62.[PubMed 20002091]

Mattoo TK. Medical management of vesicoureteral reflux – quiz within the article. Don’t overlook placebos. Pediatr Nephrol. 2007;22(8):1113-1120.[PubMed 17483966]

Miller LG, Daum RS, Creech CB, et al; DMID 07-0051 Team. Clindamycin versus trimethoprim-sulfamethoxazole for uncomplicated skin infections. N Engl J Med. 2015;372(12):1093-1103. doi: 10.1056/NEJMoa1403789.[PubMed 25785967]

Miller RD, Salter AJ. The passage of trimethoprim/sulfamethoxazole into breast milk and its significance. Proceedings of the 8th international congress of chemotherapy, Athens. Hellenic Soc Chemother. 1974;1:687-691.

Mitrano JA, Spooner LM, Belliveau P. Excretion of antimicrobials used to treat methicillin-resistant Staphylococcus aureus infections during lactation: safety in breastfeeding infants. Pharmacotherapy. 2009;29(9):1103-1109.[PubMed 19698015]

Montoya JG, Giraldo LF, Efron B, et al. Infectious complications among 620 consecutive heart transplant patients at Stanford University Medical Center. Clin Infect Dis. 2001;33(5):629-640.[PubMed 11486285]

Naber K, Vergin H, and Weigand W, “Pharmacokinetics of Co-trimoxazole and Co-tetroxazine in Geriatric Patients,” Infection, 1981, 9(5):239-43.[PubMed 6975241]

Neumann S, Krause SW, Maschmeyer G, von Lilienfeld-Toal M; Infectious Diseases Working Party (AGIHO); German Society of Hematology and Oncology (DGHO). Primary prophylaxis of bacterial infections and Pneumocystis jirovecii pneumonia in patients with hematological malignancies and solid tumors: guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO). Ann Hematol. 2013;92(4):433-442. doi: 10.1007/s00277-013-1698-0.[PubMed 23412562]

Noto H, Kaneko Y, Takano T, et al, “Severe Hyponatremia and Hyperkalemia Induced by Trimethoprim-Sulfamethoxazole in Patients With Pneumocystis carinii Pneumonia,” Intern Med, 1995, 34(2):96-9.[PubMed 7727887]

Opportunistic Infections Project Team of the Collaboration of Observational HIV Epidemiological Research in Europe (COHERE), Mocroft A, Reiss P, Kirk O, et al. Is it safe to discontinue primary Pneumocystis jiroveci pneumonia prophylaxis in patients with virologically suppressed HIV infection and a CD4 cell count <200 cells/microL? [published correction appears in Clin Infect Dis. 2010;51(9):1114]. Clin Infect Dis. 2010;51(5):611-619. doi: 10.1086/655761.[PubMed 20645862]

Osmon DR, Berbari EF, Berendt AR, et al; Infectious Diseases Society of America. Diagnosis and management of prosthetic joint infection: clinical practice guideline by the Infectious Diseases Society of America. Clin Infect Dis. 2013,56(1):e1-e25.[PubMed 23223583]

Palmer SM, Zaas A, Wolfe C. Fungal infections following lung transplantation. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 10, 2017.

Pape JW, Verdier RI, Boncy M, Johnson WD Jr. Cyclospora infection in adults infected with HIV. Clinical manifestations, treatment, and prophylaxis. Ann Intern Med. 1994;121(9):654-657.[PubMed 7944073]

Perazella MA. Trimethoprim-induced hyperkalaemia: clinical data, mechanism, prevention and management. Drug Saf. 2000;22(3):227-236.[PubMed 10738846]

Runyon BA. Management of adult patients with ascites due to cirrhosis: update 2012. Alexandria, VA: American Association for the Study of Liver Diseases; 2012. http://aasld.org/sites/default/files/guideline_documents/adultascitesenhanced.pdf. Accessed May 12, 2015.

Runyon BA. Spontaneous bacterial peritonitis in adults: treatment and prophylaxis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 10, 2017.

Septra (sulfamethoxazole/trimethoprim) [product monograph]. Toronto, Ontario, Canada: Aspen Pharmacare Canada; January 2018.

Slatore CG, Tilles SA. Sulfonamide hypersensitivity. Immunol Allergy Clin North Am. 2004;24(3):477-490.[PubMed 15242722]

Snow V, Lascher S, Mottur-Pilson C; Joint Expert Panel on Chronic Obstructive Pulmonary Disease of the American College of Chest Physicians and the American College of Physicians-American Society of Internal Medicine. Evidence base for management of acute exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 2001;134(7):595-599.[PubMed 11281744]

Spelman D, Baddour LM. Cellulitis and skin abscess in adults: Treatment. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed June 7, 2018.

Spelman D. Treatment of nocardiosis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 10, 2017.

Springer C, Eyal F, and Michel J, “Pharmacology of Trimethoprim-Sulfamethoxazole in Newborn Infants,” J Pediatr, 1982, 100(4):647-50.[PubMed 7062219]

Stevens DL, Bisno AL, Chambers HF, et al; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America [published correction appears in Clin Infect Dis. 2015;60(9):1448]. Clin Infect Dis. 2014;59(2):e10-e52. doi: 10.1093/cid/ciu444.[PubMed 24973422]

Sulfatrim tablets (sulfamethoxazole/trimethoprim) [product monograph]. Vaughan, Ontario, Canada: AA Pharma Inc; January 2019.

Sulfatrim DS tablets (sulfamethoxazole/trimethoprim) [product monograph]. Vaughan, Ontario, Canada: AA Pharma Inc; January 2019.

Sulfatrim Pediatric tablets (sulfamethoxazole/trimethoprim) [product monograph]. Vaughan, Ontario, Canada: AA Pharma Inc; January 2019.

Syed Q, Hendler KT, Koncilja K. The impact of aging and medical status on dysgeusia. Am J Med. 2016;129(7):753.[PubMed 26899755]

Teva-Trimel and Teva-Trimel DS (sulfamethoxazole and trimethoprim) tablets and oral suspension [product monograph]. Toronto, Ontario, Canada: Teva Canada Limited; February 2018.

Thomas CF, Limper AH. Treatment and prevention of pneumocystis pneumonia in HIV-uninfected patients. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 10, 2017.

Tomblyn M, Chiller T, Einsele H, et al; Center for International Blood and Marrow Research; National Marrow Donor program; European Blood and Marrow Transplant Group; American Society of Blood and Marrow Transplantation; Canadian Blood and Marrow Transplant Group; Infectious Diseases Society of America; Society for Healthcare Epidemiology of America; Association of Medical Microbiology and Infectious Disease Canada; Centers for Disease Control and Prevention. Guidelines for preventing infectious complications among hematopoietic cell transplantation recipients: a global perspective [published correction appears in Biol Blood Marrow Transplant. 2010;16(2):294]. Biol Blood Marrow Transplant.2009;15(10):1143-1238. doi: 10.1016/j.bbmt.2009.06.019.[PubMed 19747629]

Tornero P, De Barrio M, Baeza ML, Herrero T. Cross-reactivity among p-amino group compounds in sulfonamide fixed drug eruption: diagnostic value of patch testing. Contact Dermatitis. 2004;51(2):57-62.[PubMed 15373844]

Torre D, Casari S, Speranza F, et al, “Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Pyrimethamine-Sulfadiazine for Therapy of Toxoplasmic Encephalitis in Patients With AIDS. Italian Collaborative Study Group,” Antimicrob Agents Chemother, 1998, 42(6):1346-9.[PubMed 9624473]

Trotman RL, Williamson JC, Shoemaker DM. Antibiotic dosing in critically ill adult patients receiving continuous renal replacement therapy. Clin Infect Dis. 2005;41(8):1159-1166.[PubMed 16163635]

Tunkel AR, Hartman BJ, Kaplan SL, et al. Practice guidelines for the management of bacterial meningitis. Clin Infect Dis. 2004;39(9):1267-1284.[PubMed 15494903]

Tunkel AR, Hasbun R, Bhimraj A, et al. 2017 Infectious Diseases Society of America’s clinical practice guidelines for healthcare-associated ventriculitis and meningitis [published online ahead of print February 14, 2017]. Clin Infect Dis. doi: 10.1093/cid/ciw861.[PubMed 28203777]

US Department of Health and Human Services Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Guidelines for the prevention and treatment of opportunistic infections in HIV-exposed and HIV-infected children. https://aidsinfo.nih.gov/contentfiles/lvguidelines/oi_guidelines_pediatrics.pdf. Accessed December 2016.

US Department of Health and Human Services Panel on Opportunistic Infections in HIV-Infected Adults and Adolescents. Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/adult_oi.pdf. Accessed August 28, 2017.

Veltri MA, Neu AM, Fivush BA, Parekh RS, Furth SL. Drug dosing during intermittent hemodialysis and continuous renal replacement therapy: special considerations in pediatric patients. Paediatr Drugs. 2004;6(1):45-65.[PubMed 14969569]

Wang YL, Scipione MR, Dubrovskaya Y, et al. Monotherapy with fluoroquinolone or trimethoprim-sulfamethoxazole for treatment of stenotrophomonas maltophilia infections. Antimicrob Agents Chemother. 2014;58(1):176-182. doi: 10.1128/AAC.01324-13.[PubMed 24145530]

Wang HK, Sheng WH, Hung CC, et al. Clinical characteristics, microbiology, and outcomes for patients with lung and disseminated nocardiosis in a tertiary hospital. J Formos Med Assoc. 2015;114(8):742-749. doi: 10.1016/j.jfma.2013.07.017.[PubMed 24008153]

Weller PF, Leder K. Cyclospora infection. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 10, 2017.

Wood GC, Underwood EL, Croce MA, et al, “Treatment of Recurrent Stenotrophomonas maltophilia Ventilator-Associated Pneumonia With Doxycycline and Aerosolized Colistin,” Ann Pharmacother, 2010, 44(10):1665-8.[PubMed 20736426]

Workowski KA, Bolan GA; Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015 [published correction appears in MMWR Recomm Rep. 2015;64(33):924]. MMWR Recomm Rep. 2015;64(RR-03):1-137.[PubMed 26042815]

World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the eleventh WHO model list of essential drugs. 2002. Available at http://www.who.int/maternal_child_adolescent/documents/55732/en/

World Health Organization (WHO). Guidelines for the control of shigellosis, including epidemics due to Shigella dysenteriae type 1. Available at http://whqlibdoc.who.int/publications/2005/9241592330.pdf. Published 2005. Accessed September 20, 2017.

Ylikorkala O, Sjöstedt E, Järvinen PA, et al, “Trimethoprim-Sulfonamide Combination Administered Orally and Intravaginally in the First Trimester of Pregnancy: Its Absorption Into Serum and Transfer to Amniotic Fluid,” Acta Obstet Gynecol Scand, 1973, 52(3):229-34.[PubMed 4743777]

Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-973.e33. http://www.jaad.org/article/S0190-9622(15)02614-6/pdf. Accessed May 17, 2016.[PubMed 26897386]

Zar T, Graeber C, Perazella MA. Recognition, treatment, and prevention of propylene glycol toxicity. Semin Dial. 2007;20(3):217-219.[PubMed 17555487]

Zawodniak A, Lochmatter P, Beeler A, Pichler WJ. Cross-reactivity in drug hypersensitivity reactions to sulfasalazine and sulfamethoxazole. Int Arch Allergy Immunol. 2010;153(2):152-156.[PubMed 20413982]

Brand Names: International

Abacin (IT); Acuco (ZA); Alcorim-F (IN); Anitrim (MX); Avlotrin (BD); Bacdan (TW); Bacin (MY, SG, TH); Bactelan (MX); Bacteric (MX); Bacterol (CL); Bacterol Forte (CL); Bacticel (AR); Bactiver (MX); Bactoprim (TH); Bactramin (JP); Bactrim (AE, AR, AT, AU, BB, BH, BR, CH, CY, CZ, DE, DK, EC, EE, FR, IN, IQ, IR, IT, JO, KW, LB, LV, LY, MT, MX, NO, OM, PK, PL, PT, SA, SE, SK, SY, TH, TR, UA, VN, YE); Bactrim DS (AU, BB); Bactrim F (CO); Bactrim Forte (AT, BE, BH, FI, FR, LB, LU, PH, PT, SE); Bactrimel (GR, VE); Bactropin (MX); Biseptol (BG, LV); Brogamax (MX); Chemotrim (EG, QA); Co-Try (BD); Colizole (IN); Colizole DS (IN); Comazole (MY); Comex (EG); Cotriinol (ZW); Cotrim (BF, BJ, CI, ET, GH, GM, GN, KE, KR, LR, MA, ML, MR, MU, MW, MY, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM); Cotrim DS (MY); Cotrimel (HK); Cotrix (AE, CY, IQ, IR, JO, KW, LY, OM, SA, SY, YE); Cotrizol (TW); Cotrizole (ZW); Deprim (MT); Dhatrim (MY); Dibaprim (MX); Diseptyl (IL); Duocide (TW); Duratrimet (DE); Ectaprim (MX); Epitrim (AE, CY, IQ, IR, JO, KW, LY, OM, RO, SA, SY, YE); Escoprim (CH); Espectrin (BR); Eusaprim (AT, FI, IS, IT, NO, SE); Eusaprim Forte (BE); Farcotrim (QA); Fectrim (GB); Gantaprim (IT); Gantrim (IT); Ikaprim (ID); Infectrim (PE); Introcin (CL); Isotrim (IT); Kepinol (DE); Lagatrim (AE, BF, BJ, CI, CY, ET, GH, GM, GN, IQ, IR, JO, KE, KW, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZM); Lagatrim Forte (BF, BJ, BM, BS, BZ, CI, ET, GH, GM, GN, GY, JM, KE, LR, MA, ML, MR, MU, MW, NE, NG, NL, PR, SC, SD, SL, SN, SR, TN, TT, TZ, UG, ZM); Lidaprim (AE, SA); Lidaprim Forte (AE, AT, SA); Mano-Trim (TH); Mano-Trim Forte (TH); Medixin (IT); Metoxiprim (MX); Metrim (TH); Mezenol (ZW); Mezenol DS (ZW); Microtrim (DE); Morbifurb (CN); Mortin (VN, ZW); Nopil (AE, CY, IQ, IR, JO, KW, LY, OM, QA, SA, SY, YE); Novabact (ZW); Octex (MX); Omsat (BF, BJ, CI, DE, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM); Oriprim (RU); Oriprim DS (KE, TZ, UG); Oxaprim (IT); Politrim (BD); Primzole (SG); Purbal (ZA); Resprim (AU); Resprim Forte (AU); Sanprima (ID); Sanprima Forte (ID); Septran (IN, PK, PY); Septran Forte (CR, DO, GT, HN, NI, PA, SV); Septrin (AE, AU, BF, BH, BJ, CI, CY, ES, ET, GB, GH, GM, GN, ID, IE, IQ, IR, JO, KE, KR, KW, LR, LY, MA, ML, MR, MT, MU, MW, MX, NE, NG, OM, PE, PH, SA, SC, SD, SG, SL, SN, SY, TN, TZ, UG, VN, YE, ZM, ZW); Septrin D.S. (EG); Septrin DS (BH, HK); Septrin Forte (AU); Servitrim (MX); Sevatrim (KR); Sigaprim (DE); Sinersul (HR); Soltrim (MX); Suftrex (EC); Sulfacet (DE); Sulfoid Trimetho (MX); Sulfotrimin (DE); Sulotrim (HR); Suntrim (TH); Suntrim Forte (TH); Suprim (PE); Suprin (IT); Tagremin (RO); Timexole (MX); TMS (DE); Trim (IT, ZA); Trimaxazole (SG); Trimetoger (MX); Trimexan (CR, DO, GT, HN, NI, PA, SV); Trimexazol (MX); Trimexazole (TH); Trimezol (BG); Trimol (BH, QA); Trimol D.S. (QA); Trimoprim (HK); Trimox (TW); Trimoxis (PH); Triomax (JO); Trisolvat (CO); Trisul (BD, NZ); Trizole (PH); Tryseptol (UA); Umoxazole (ZW); Xepaprim (ID); Xepaprim Forte (ID); Zoltrim (EC); Zultrop (ID); Zultrop Forte (ID)

Sulfamethoxazole and Trimethoprim (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(sul fa meth OKS a zole & trye METH oh prim)

Brand Names: US

Bactrim; Bactrim DS; Sulfatrim Pediatric

Brand Names: Canada

Protrin DF; Septra Injection; Sulfatrim; Trisulfa; Trisulfa DS; Trisulfa S

What is this drug used for?
  • It is used to treat or prevent bacterial infections.
What do I need to tell my doctor BEFORE I take this drug?
  • For all patients taking this drug:
  • If you have an allergy to sulfamethoxazole, trimethoprim, or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have anemia caused by a lack of folic acid.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you have any of these health problems: Asthma, porphyria, thyroid disease, not enough folate in the body, poor absorption, or poor nutrition.
  • If you have been drinking alcohol for a long time or are taking a drug for seizures.
  • If you have ever had a low platelet count when using trimethoprim or a sulfa (sulfonamide) drug.
  • If you are taking any of these drugs: Amantadine, cyclosporine, dofetilide, indomethacin, leucovorin, methotrexate, or pyrimethamine.
  • If you are taking or have recently taken any of these drugs: Benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.
  • If you are taking a water pill.
  • If you are breast-feeding or plan to breast-feed.
  • Children:
  • If your child is younger than 2 months of age. Do not give this drug to an infant younger than 2 months of age.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have your urine checked as you have been told by your doctor.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • Do not use longer than you have been told. A second infection may happen.
  • Be careful if you have G6PD deficiency. Anemia may happen.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • Talk with your doctor before you drink alcohol.
  • This drug may make you sunburn more easily. Use care if you will be in the sun. Tell your doctor if you sunburn easily while taking this drug.
  • This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs.
  • Rarely, very bad effects have happened with sulfa drugs. Sometimes, these have been deadly. These effects have included liver problems, blood problems, and very bad skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis). Call your doctor right away if you have a rash; red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, or eyes; fever, chills, or sore throat; cough that is new or worse; feeling very tired or weak; any bruising or bleeding; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • This drug may raise the chance of a very bad brain problem called aseptic meningitis. Call your doctor right away if you have a headache, fever, chills, very upset stomach or throwing up, stiff neck, rash, bright lights bother your eyes, feeling sleepy, or feeling confused.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.
  • Injection:
  • If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
  • This drug has propylene glycol in it. Too much propylene glycol may lead to very bad health problems like nervous system problems, kidney problems, or other organ problems. If you have questions, talk with the doctor.
  • Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn or infant. Talk with the doctor to see if this product has benzyl alcohol in it.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
  • Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
  • Muscle or joint pain.
  • Purple patches on the skin or mouth.
  • Shortness of breath.
  • Hallucinations (seeing or hearing things that are not there).
  • Mood changes.
  • It is common to have diarrhea when taking antibiotics. Rarely, a severe form of diarrhea called C diff–associated diarrhea (CDAD) may happen. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking an antibiotic or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat diarrhea without first checking with your doctor.
  • Injection:
  • This drug may irritate the vein. If the drug leaks from the vein, it may also cause irritation around that area. Tell your nurse if you have any redness, burning, pain, swelling, or leaking of fluid where the drug is going into your body.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Upset stomach or throwing up.
  • Diarrhea.
  • Not hungry.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
  • All oral products:
  • Take with or without food. Take with food if it causes an upset stomach.
  • Take with a full glass of water.
  • Take this drug at the same time of day.
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Liquid (suspension):
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Injection:
  • It is given as an infusion into a vein over a period of time.
What do I do if I miss a dose?
  • All oral products:
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Injection:
  • Call your doctor to find out what to do.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Protect from light.
  • Injection:
  • If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Sulfamethoxazole and Trimethoprim (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(sul fa meth OKS a zole & trye METH oh prim)

Brand Names: US

Bactrim; Bactrim DS; Sulfatrim Pediatric

Brand Names: Canada

Protrin DF; Septra Injection; Sulfatrim; Trisulfa; Trisulfa DS; Trisulfa S

What is this drug used for?
  • It is used to treat or prevent bacterial infections.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has anemia caused by a lack of folic acid.
  • If your child has any of these health problems: Kidney disease or liver disease.
  • If your child has any of these health problems: Asthma, porphyria, thyroid disease, not enough folate in the body, poor absorption, or poor nutrition.
  • If your child has been drinking alcohol for a long time or is taking a drug for seizures.
  • If your child has ever had a low platelet count when using trimethoprim or a sulfa (sulfonamide) drug.
  • If your child is taking any of these drugs: Amantadine, cyclosporine, dofetilide, indomethacin, leucovorin, methotrexate, pyrimethamine, or a water pill.
  • If your child is taking or has recently taken any of these drugs: Benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.
  • If your child is younger than 2 months of age. Do not give this drug to an infant younger than 2 months of age.
  • If your child is breast-feeding a baby:
  • Talk with the doctor if your child is breast-feeding a baby or plans to breast-feed a baby.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child’s blood work checked often. Talk with your child’s doctor.
  • Have your child’s urine checked as you have been told by the doctor.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • Do not give to your child longer than you have been told. A second infection may happen.
  • Be careful if your child has G6PD deficiency. Anemia may happen.
  • If your child has high blood sugar (diabetes), you will need to watch his/her blood sugar closely.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • This drug may make your child sunburn more easily. Use care if your child will be in the sun. Tell your child’s doctor if your child sunburns easily while taking this drug.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • If your child is pregnant:
  • This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
  • Injection:
  • If your child is allergic to sulfites, talk with your child’s doctor. Some products have sulfites in them.
  • This drug has propylene glycol in it. Too much propylene glycol may lead to very bad health problems like nervous system problems, kidney problems, or other organ problems. If you have questions, talk with the doctor.
  • Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn or infant. Talk with the doctor to see if this product has benzyl alcohol in it.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
  • Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
  • Muscle or joint pain.
  • Purple patches on the skin or mouth.
  • Shortness of breath.
  • Hallucinations (seeing or hearing things that are not there).
  • Mood changes.
  • It is common to have diarrhea when taking antibiotics. Rarely, a severe form of diarrhea called C diff-associated diarrhea (CDAD) may happen. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while your child is taking an antibiotic or within a few months after he/she stops taking it. Call your child’s doctor right away if your child has stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat diarrhea without first checking with the doctor.
  • Rarely, very bad effects have happened with sulfa drugs. Sometimes, these have been deadly. These effects have included liver problems, blood problems, and very bad skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis). Call the doctor right away if your child has a rash; red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, or eyes; fever, chills, or sore throat; cough that is new or worse; feeling very tired or weak; any bruising or bleeding; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • This drug may raise the chance of a very bad brain problem called aseptic meningitis. Call the doctor right away if your child has a headache, fever, chills, very upset stomach or throwing up, stiff neck, rash, bright lights bother the eyes, feeling sleepy, or feeling confused.
  • Injection:
  • This drug may irritate the vein. If the drug leaks from the vein, it may also cause irritation around that area. Tell your child’s nurse if your child has any redness, burning, pain, swelling, or leaking of fluid where the drug is going into your child’s body.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Upset stomach or throwing up.
  • Diarrhea.
  • Not hungry.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Have your child drink lots of noncaffeine liquids every day unless told to drink less liquid by your child’s doctor.
  • All oral products:
  • Give this drug with or without food. Give with food if it causes an upset stomach.
  • Give this drug with a full glass of water.
  • Give this drug at the same time of day.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Liquid (suspension):
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Injection:
  • It is given as an infusion into a vein over a period of time.
What do I do if my child misses a dose?
  • All oral products:
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • Injection:
  • Call your child’s doctor to find out what to do.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Protect from light.
  • Injection:
  • If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.