Fatalities, although rare, have occurred due to severe reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, thrombocytopenia, and other blood dyscrasias; d/c at the 1st appearance of skin rash or any sign of adverse reaction. Cough, SOB, and pulmonary infiltrates reported. Do not use for treatment of group A β-hemolytic streptococcal infections. Clostridium difficile-associated diarrhea (CDAD) reported; d/c if CDAD is suspected or confirmed. May result in bacterial resistance if used in the absence of proven or suspected bacterial infection or a prophylactic indication. Caution with hepatic/renal impairment, possible folate deficiency (eg, in the elderly, chronic alcoholics, those receiving anticonvulsant therapy, with malabsorption syndrome, and in malnutrition states), severe allergies or bronchial asthma, porphyria, and thyroid dysfunction. Hematological changes indicative of folic acid deficiency may occur in the elderly, or with preexisting folic acid deficiency or kidney failure; effects are reversible by folinic acid therapy. Hemolysis may occur in patients with G6PD deficiency. Cases of hypoglycemia in nondiabetic patients reported rarely. TMP may impair phenylalanine metabolism. AIDS patients may not tolerate or respond to therapy in the same manner as non-AIDS patients; increased incidence of side effects, particularly rash, fever, leukopenia, elevated transaminase values, and hyperkalemia, in AIDS patients being treated for P. jiroveci pneumonia; reevaluate therapy if skin rash or any sign of adverse reaction develops. May cause hyperkalemia in patients receiving high dosage of TMP, with underlying disorders of K+ metabolism, with renal insufficiency, or when used concomitantly with drugs known to induce hyperkalemia; closely monitor serum K+. Ensure adequate fluid intake and urinary output during treatment to prevent crystalluria. Slow acetylators may be more prone to idiosyncratic reactions to sulfonamides. D/C if a significant reduction in the count of any formed blood element is noted. Lab test interactions may occur. (Inj) Contains sodium metabisulfite, which may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. Contains benzyl alcohol, which has been associated with an increased incidence of neurological and other complications (sometimes fatal) in newborns. Local irritation and inflammation due to extravascular infiltration of the infusion reported; d/c infusion and restart at another site if these occur. (Tab) Severe and symptomatic hyponatremia may occur, particularly in patients treated for P. jiroveci pneumonia; evaluation for hyponatremia and appropriate correction is necessary in symptomatic patients to prevent life-threatening complications. Use during pregnancy may be associated with an increased risk of congenital malformations.
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