Indicated for:

Pneumocystis jirovecii Pneumonia:

• The treatment of Pneumocystis jirovecii pneumonia in adults and pediatric patients two months of age and older.

Shigellosis:

• The treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei in adults and pediatric patients two months of age and older.

Urinary Tract Infections:

• The treatment of severe or complicated urinary tract infections in adults and pediatric patients two months of age and older due to susceptible strains of Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii and Proteus species when oral administration of BACTRIM is not feasible and when the organism is not susceptible to single-agent antibacterials effective in the urinary tract.

Administer the solution by intravenous infusion over a period of 60 to 90 minutes. Avoid administration by rapid infusion or bolus injection. Do NOT administer BACTRIM intramuscularly.

BACTRIM is contraindicated in the following:

• Known hypersensitivity to trimethoprim or sulfonamides 
• History of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides
• Patients with documented megaloblastic anemia due to folate deficiency 
• Pediatric patients less than two months of age 
• Marked hepatic damage 
• Severe renal insufficiency when renal function status cannot be monitored 
• Concomitant administration with dofetilide   

Fatalities and serious adverse reactions including severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute febrile neutrophilic dermatosis (AFND), acute generalized erythematous pustulosis (AGEP); fulminant hepatic necrosis; agranulocytosis, aplastic anemia and other blood dyscrasias; acute and delayed lung injury; anaphylaxis and circulatory shock have occurred with the administration of sulfamethoxazole and trimethoprim products, including BACTRIM.

Cough, shortness of breath and pulmonary infiltrates potentially representing hypersensitivity reactions of the respiratory tract have been reported in association with sulfamethoxazole and trimethoprim treatment.

Other severe pulmonary adverse reactions occurring within days to week of BACTRIM initiation and resulting in prolonged respiratory failure requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO), lung transplantation or death have also been reported in patients and otherwise healthy individuals treated with sulfamethoxazole and trimethoprim products.

Circulatory shock with fever, severe hypotension, and confusion requiring intravenous fluid resuscitation and vasopressors has occurred within minutes to hours of re-challenge with sulfamethoxazole and trimethoprim products, including BACTRIM, in patients with history of recent (days to weeks) exposure to sulfamethoxazole and trimethoprim.

BACTRIM-induced thrombocytopenia may be an immune-mediated disorder. Severe cases of thrombocytopenia that are fatal or life threatening have been reported. Monitor patients for hematologic toxicity. Thrombocytopenia usually resolves within a week upon discontinuation of BACTRIM.

Avoid use of BACTRIM in the treatment of streptococcal pharyngitis. Clinical studies have documented that patients with group A β-hemolytic streptococcal tonsillopharyngitis have a greater incidence of bacteriologic failure when treated with BACTRIM than do those patients treated with penicillin, as evidenced by failure to eradicate this organism from the tonsillopharyngeal area. Therefore, BACTRIM will not prevent sequelae such as rheumatic fever.

Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including BACTRIM, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

BACTRIM contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.

Avoid use of BACTRIM in patients with impaired renal or hepatic function, in those with possible folate deficiency (e.g., the elderly, chronic alcoholics, patients receiving anticonvulsant therapy, patients with malabsorption syndrome, and patients in malnutrition states) and in those with severe allergies or bronchial asthma.

Hematologic changes indicative of folic acid deficiency may occur in elderly patients or in patients with preexisting folic acid deficiency or kidney failure. These effects are reversible by folinic acid therapy.

In glucose-6-phosphate dehydrogenase deficient individuals, hemolysis may occur. This reaction is frequently dose-related.

The trimethoprim component of BACTRIM has been noted to impair phenylalanine metabolism, but this is of no significance in phenylketonuric patients on appropriate dietary restriction.

Like other drugs containing sulfonamides, BACTRIM can precipitate porphyria crisis and hypothyroidism. Avoid use of BACTRIM in patients with porphyria or thyroid dysfunction.

Use of BACTRIM at high doses and/or for extended periods of time may cause bone marrow depression manifested as thrombocytopenia, leukopenia and/or megaloblastic anemia.

High dosage of trimethoprim, as used in patients with P. jirovecii pneumonia, induces a progressive but reversible increase of serum potassium concentrations in a substantial number of patients. Even treatment with recommended doses may cause hyperkalemia when trimethoprim is administered to patients with underlying disorders of potassium metabolism, with renal insufficiency, or if drugs known to induce hyperkalemia are given concomitantly. Close monitoring of serum potassium is warranted in these patients.

Severe and symptomatic hyponatremia can occur in patients receiving BACTRIM, particularly for the treatment of P. jirovecii pneumonia. Evaluation for hyponatremia and appropriate correction is necessary in symptomatic patients to prevent life-threatening complications.

During treatment, ensure adequate fluid intake and urinary output to prevent crystalluria. Patients who are “slow acetylators” may be more prone to idiosyncratic reactions to sulfonamides.

Local irritation and inflammation due to extravascular infiltration of the infusion have been observed with BACTRIM. If these occur the infusion should be discontinued and restarted at another site.

Cases of hypoglycemia in non-diabetic patients treated with BACTRIM have been seen, usually occurring after a few days of therapy. Patients with renal dysfunction, liver disease, malnutrition or those receiving high doses of BACTRIM are particularly at risk.

AIDS patients may not tolerate or respond to BACTRIM in the same manner as non AIDS patients. The incidence of adverse reactions, particularly rash, fever, leukopenia, and elevated aminotransferase (transaminase) values, with BACTRIM therapy in AIDS patients who are being treated for Pneumocystis jirovecii pneumonia has been reported to be greatly increased compared with the incidence normally associated with the use of BACTRIM in non-AIDS patients. If a patient develops skin rash, fever, leukopenia or any sign of an adverse reaction, reevaluate benefit-risk of continuing therapy or re challenge with BACTRIM.

BACTRIM contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.

BACTRIM contains propylene glycol as a solvent (40% v/v). When administered at high doses as for the treatment of P. jirovecii pneumonia and concomitantly with other products that contain propylene glycol, hyperosmolarity with anion gap metabolic acidosis, including lactic acidosis can occur. Propylene glycol toxicity can lead to acute kidney injury, CNS toxicity, and multi-organ failure. Monitor for the total daily intake of propylene glycol from all sources and for acid-base disturbances.

Complete blood counts and clinical chemistry testing should be done frequently in patients receiving BACTRIM. Discontinue BACTRIM if a significant electrolyte abnormality, renal insufficiency or reduction in the count of any formed blood element is noted. Perform urinalysis with careful microscopic examination and renal function tests during therapy, particularly for those patients with impaired renal function.

Treatment failure and excess mortality were observed when BACTRIM was used concomitantly with leucovorin for the treatment of HIV positive patients with P. jirovecii pneumonia in a randomized placebo-controlled trial. Avoid co-administration of BACTRIM and leucovorin during treatment of P. jirovecii pneumonia.

Trimethoprim is an inhibitor of CYP2C8 as well as OCT2 transporter. Sulfamethoxazole is an inhibitor of CYP2C9. Avoid co-administration of BACTRIM with drugs that are substrates of CYP2C8 and 2C9 or OCT2.

Avoid use with diuretics, methotrexate, cyclosporine, indomethacin, pyrimethamine, amantadine, angiotensin converting enzyme inhibitors and dofetilide.

BACTRIM, specifically the trimethoprim component, can interfere with a serum methotrexate assay as determined by the competitive binding protein technique (CBPA) when a bacterial dihydrofolate reductase is used as the binding protein. No interference occurs, however, if methotrexate is measured by a radioimmunoassay (RIA).

The presence of BACTRIM may also interfere with the Jaffé alkaline picrate reaction assay for creatinine, resulting in overestimations of about 10% in the range of normal values.

BACTRIM contains benzyl alcohol as a preservative. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol preserved formulations in infusion solutions, including BACTRIM. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. BACTRIM is contraindicated in pediatric patients less than two months of age.

BACTRIM may cause fetal harm if administered to a pregnant woman. Some epidemiologic studies suggest that exposure to BACTRIM during pregnancy may be associated with an increased risk of congenital malformations, particularly neural tube defects, cardiovascular abnormalities, urinary tract defects, oral clefts, and club foot. If BACTRIM is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential hazards to the fetus.

Because of the potential risk of bilirubin displacement and kernicterus on the breastfed child, advise women to avoid breastfeeding during treatment with BACTRIM.

GoToSource

• Use in patients under the age of 2 months. GoToSource

• Acne. GoToSource

• Toxoplasma encephalitis. GoToSource

• Prophylactic therapy for pediatric urinary tract infections. GoToSource

• Chronic prostatitis/chronic pelvic pain syndrome. GoToSource

• Preventing implant infections in the irradiated chest wall. GoToSource

• Prevention of HIV-related opportunistic infections. GoToSource

• Ocular toxoplasmosis. GoToSource

⚠️  Risk of hemolytic anemia in patients with G6PD deficiency.

Hyponatremia (low sodium level). GoToSource

Neural tube defects after use during first trimester of pregnancy. GoToSource

QT prolongation. GoToSource

Antiphospholipid antibody syndrome (disorder causing blood clot formation). GoToSource

Stevens-johnson syndrome and exfoliative dermatitis (severe skin reaction). GoToSource

Toxic epidermal necrolysis (life-threatening skin condition). GoToSource

Acute psychosis. GoToSource

Thrombocytopenia (low blood platelet count). GoToSource

Cholestatic hepatitis (impairment of bile formation or bile flow). GoToSource

Acute kidney injury. GoToSource

Acute bilateral parotitis (inflammation of salivary glands). GoToSource

Interstitial lung disease. GoToSource

Hypoglycemia when used with repaglinide. GoToSource

Higher-level gait disorder and nocturnal delirium. GoToSource

Myoclonus and delirium when used with memantine. GoToSource

Pancreatitis (inflammation of pancreas). GoToSource

Aseptic meningitis. GoToSource

Renal tubular acidosis (accumulation of acid in the body). GoToSource

Lawsuits filed for stevens-johnson syndrome and toxic epidermal necrolysis.