Classes
DEA Class; Rx
Common Brand Names; Bactrim, Bactrim DS, Septra, Septra DS, Cotrim, cotrimoxazole, Sulfatrim
- Sulfonamides;
- Antibiotics, Combos
Description
Combination product of trimethoprim and sulfamethoxazole in a fixed 1:5 ratio; both are synthetic folate antagonists.
Indications
Indicated for acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae
Documented Pneumocystis jiroveci pneumonia (PCP); also, prophylaxis against PCP in individuals who are immunosuppressed
Enteritis caused by susceptible strains of Shigella flexneri and S sonnei
Traveler’s diarrhea due to susceptible strains of enterotoxigenic Escherichia coli
UTIs caused by susceptible strains of Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis, and Proteus vulgaris
Also indicated for
- Acne Vulgaris (Off-label)
- Community Acquired Pneumonia (Off-label)
- Sepsis
- Meningitis, Bacterial
Contraindications
Known hypersensitivity
Age <2 months
CrCl <15 mL/min when renal function status cannot be monitored
Documented megaloblastic or folate deficiency anemia
Significan hepatic impairment
Contraindicated in pregnant patients at term and in nursing mothers, because sulfonamides, which pass the placenta and are excreted in the milk, may cause kernicterus
History of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides
Concomitant administration with dofetilide
Adverse Effects
- Anorexia
- Nausea
- Vomiting
- Vertigo
- Seizure
- Peripheral neuritis
- Erythema multiforme
- Hyperkalemia
- Rash
- Urticaria
- Immune hypersensitivity reaction
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Agranulocytosis
- Aplastic anemia
- Hyponatremia
- Disorder of hematopoietic structure
- Fulminant hepatic necrosis
Warnings
Not for use in areas with resistance rates >10%
Severe and symptomatic hyponatremia can occur in patients receiving sulfamethoxazole/ trimethoprim, particularly for treatment of P. jirovecii pneumonia; evaluation for hyponatremia and appropriate correction is necessary in symptomatic patients to prevent life-threatening complications
If patient treated for Pneumocystis jirovecii develops skin rash, fever, leukopenia, or any other sign of adverse reaction, therapy or re-challenge should be re-evaluated
Circulatory shock with fever, severe hypotension, and confusion requiring intravenous fluid resuscitation and vasopressors has occurred within minutes to hours of re-challenge with trimethoprim-sulfamethoxazole in patients with history of recent (days to weeks) exposure to sulfamethoxazole-trimethoprim
Fatalities associated with the administration of sulfonamides, although rare, have occurred due to severe reactions, including severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) and acute febrile neutrophilic dermatosis (AFND), fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias; clinical signs, such as rash, sore throat, fever, arthralgia, pallor, purpura or jaundice may be early indications of serious reactions; discontinue therapy at first appearance of skin rash or any sign of serious adverse reaction
Acute and delayed lung injury; anaphylaxis and circulatory shock have occurred with administration of sulfamethoxazole and trimethoprim products
Cough, shortness of breath and pulmonary infiltrates potentially representing hypersensitivity reactions of the respiratory tract reported in association with sulfamethoxazole and trimethoprim treatment
Severe pulmonary adverse reactions occurring within days to week of initiation of treatment and resulting in prolonged respiratory failure requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO), lung transplantation or death also reported in patients and otherwise healthy individuals treated with sulfamethoxazole and trimethoprim products
Caution when used in elderly individuals; risk of bone marrow suppression
Pregnancy and Lactation
Therapy may cause fetal harm if administered to pregnant woman; some epidemiologic studies suggest that exposure to drug during pregnancy may be associated with increased risk of congenital malformations, particularly neural tube defects, cardiovascular abnormalities, urinary tract defects, oral clefts, and club foot
Levels of drug in breast milk are approximately 2 to 5% of recommended daily dose for pediatric patients over two months of age
Maximum Dosage
All doses are based on trimethoprim component.
20 mg/kg/day PO (Max: 1,600 mg/day); 20 mg/kg/day IV (Max: 960 mg/day).
20 mg/kg/day PO (Max: 1,600 mg/day); 20 mg/kg/day IV (Max: 960 mg/day).
20 mg/kg/day PO (Max: 1,600 mg/day); 20 mg/kg/day IV (Max: 960 mg/day).
20 mg/kg/day PO (Max: 1,600 mg/day); 20 mg/kg/day IV (Max: 960 mg/day).
2 to 11 months: 20 mg/kg/day PO/IV.
younger than 2 months: Contraindicated in infants younger than 2 months of age; however, doses up to 10 mg/kg/day PO are used off-label for PCP prophylaxis in HIV-infected/exposed infants as young as 4 weeks of age.
Contraindicated in infants younger than 2 months of age; however, doses up to 10 mg/kg/day PO are used off-label for PCP prophylaxis in HIV-infected/exposed infants as young as 4 weeks of age.
How supplied
Trimethoprim/sulfamethoxazole
injected solution
- (16mg/80mg)/mL
oral suspension
- (40mg/200mg)/5mL
tablet
- 80mg/400mg
- 160mg/800mg
