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warnings
WARNINGS Renacidin Irrigation use should be stopped immediately if the patient develops fever, urinary tract infection, signs and symptoms consistent with urinary tract infection, or persistent flank pain. Irrigation should be stopped if hypermagnesemia or elevated serum creatinine develops. Severe hypermagnesemia has been reported with Renacidin Irrigation. Caution should be employed when irrigating the renal pelvis of patients with impaired renal function. Patients should be observed for early signs and symptoms of hypermagnesemia including nausea, lethargy, confusion and hypotension. Severe hypermagnesemia may result in hyporeflexia, dyspnea, apnea, coma, cardiac arrest and subsequent death. Serum magnesium levels should be monitored and deep tendon reflexes should be evaluated. Treatment of hypermagnesemia should include discontinuation of Renacidin Irrigation followed by medical therapy with intravenous calcium gluconate, fluids and diuresis in severe cases.
ADVERSE REACTIONS The most common adverse reaction in selected case series is transient flank pain which occurs in most patients. Additional common reactions include urothelial ulceration and/or edema (13%) or fever (20% but up to 40% in some case series). Other adverse reactions which occur in 1-10% of cases include: urinary tract infection, back pain, dysuria, transient hematuria, nausea, hypermagnesemia, hyperphosphatemia, elevated serum creatinine, candidiasis, and bladder irritability. Adverse reactions which occur in less than 1 % of patients include: septicemia, ileus, vomiting and thrombophlebitis. Death from sepsis has been reported.