ferric-oxide--saccharated and Vomiting

It is now recognized that the majority of patients on epoetin therapy require intravenous (IV) iron supplementation to maximize the response to treatment. Of the IV iron preparations available, iron sucrose has proved its efficacy and safety; however, there are no guidelines or systematic studies examining the optimum safe dosage regimen for this compound. The aim of the present study was to investigate prospectively a variety of dosing regimens for IV iron sucrose in patients with renal failure to develop treatment strategies for this preparation. A total of 335 iron infusions was administered to 249 patients in this study, which was conducted in four phases. In phase I, 89 patients were administered a dose of 200 mg as an IV infusion over 2 hours. No adverse events were seen. A 500-mg dose by 2-hour infusion was then assessed, but was abandoned after 8 of 22 patients developed reactions characterized by dizziness, hypotension, and nausea. The dose was then reduced to 300 mg by 2-hour infusion for the next 189 patients, and again, no adverse reactions were witnessed. Finally, a 400-mg dose by 2-hour infusion was examined in 35 patients, but 2 patients experienced such symptoms as hypotension, nausea, and lower back pain. Both the 200- and 300-mg doses of IV iron sucrose administered over 2 hours appear to be safe. The incidence of adverse events with the 400- and 500-mg doses administered as a 2-hour infusion seems too high to recommend their routine use, although it may be possible to administer these doses over a longer period.

Topics: Abdominal Pain; Adult; Aged; Aged, 80 and over; Back Pain; Dose-Response Relationship, Drug; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Humans; Hypotension; Infusions, Intravenous; Kidney Transplantation; Male; Middle Aged; Nausea; Peritoneal Dialysis; Prospective Studies; Renal Dialysis; Renal Insufficiency; Vomiting

This report summarizes the data gathered in four prospective studies of intravenous iron sucrose therapy administered to iron-deficient hemodialysis patients with a history of intolerance to other parenteral iron preparations.. A total of 130 iron dextran- and/or sodium ferric gluconate-sensitive patients received intravenous iron sucrose therapy to correct iron deficiency, and/or maintain body iron stores. A history of intolerance to iron dextran alone was reported in 109 patients, to ferric sodium gluconate alone in 6 patients, and to both iron dextran and ferric sodium gluconate in 15 patients. Therapy with iron sucrose consisted of 100- or 200-mg doses administered undiluted intravenously over 2-5 min, or diluted in normal saline and infused over 15-30 min. Test doses of iron sucrose were not administered. The median cumulative dose was 1,000 mg, with a range of 100-5,000 mg.. There were no serious adverse events related to iron sucrose therapy in the 130 patients intolerant to other iron preparations. There were 14 nonserious drug-related adverse events in 8 patients attributed to iron sucrose, none of which resulted in discontinuation of therapy. These events were classified as either of severe (diarrhea), moderate (hypotension, nausea, vomiting), or mild severity (constipation, dry mouth, skin irritation).. Iron sucrose therapy is safe and well tolerated in hemodialysis patients intolerant to iron dextran and/or sodium ferric gluconate.

Topics: Anemia, Iron-Deficiency; Diarrhea; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Hypotension; Infusions, Intravenous; Male; Nausea; Prospective Studies; Renal Dialysis; Vomiting