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warnings
WARNINGS Experience with trimethoprim alone is limited, but it has been reported rarely to interfere with hematopoiesis, especially when administered in large doses and/or for prolonged periods. The presence of clinical signs such as sore throat, fever, pallor or purpura may be early indications of serious blood disorders.
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Allegis Holdings, LLC at 1-866-633-9033, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Adverse Events Reported During Pediatric Clinical Trials With PRIMSOL The following table lists those drug-related adverse events reported most frequently during the clinical trials in pediatric patients aged 6 months to 12 years. Most of these events were determined to be mild. The incidence of drug related adverse events was significantly lower for PRIMSOL, which was most apparent for those events related to skin/appendages as a body system. Drug-related Adverse Event Percent of Pediatric Patients PRIMSOL (N=310) SMX + TMP sulfamethoxazole + trimethoprim oral suspension (N=197) Body as a whole abdominal pain <1 2.5 Digestive system diarrhea 4.2 4.6 vomiting 1.6 1.5 Skin/Appendages rash 1.3 6.1 An increase in lymphocytes and eosinophils was noted in some pediatric patients following treatment with PRIMSOL or sulfamethoxazole + trimethoprim oral suspension. Adverse Reactions Reported For Trimethoprim In addition to the adverse events listed above which have been observed in pediatric patients receiving PRIMSOL, the following adverse reactions and altered laboratory tests have been previously reported for trimethoprim and therefore, may occur with PRIMSOL therapy: Dermatologic reactions: pruritus and exfoliative dermatitis. At the recommended adult dosage regimens of 100 mg b.i.d ., or 200 mg q.d., each for 10 days, the incidence of rash is 2.9% to 6.7%. In clinical studies which employed high doses of trimethoprim in adults, an elevated incidence of rash was noted. These rashes were maculopapular, morbilliform, pruritic and generally mild to moderate, appearing 7 to 14 days after the initiation of therapy. Gastrointestinal reactions: Epigastric distress, nausea, and glossitis. Hematologic reactions: Thrombocytopenia, leukopenia, neutropenia, megaloblastic anemia and methemoglobinemia. Metabolic reactions: Hyperkalemia, hyponatremia. Miscellaneous reactions: Fever, elevation of serum transaminase and bilirubin, and increases in BUN and serum creatinine levels.