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warnings
WARNINGS WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Sensitization to iodides and deaths due to anaphylactic shock following iodide administration have been reported. The physician must evaluate the patient for hypersensitivity before initiating TPN supplementation with Iodopen. Iodopen is a hypotonic solution and should be administered in admixtures only.
ADVERSE REACTIONS The amount of iodine present in Iodopen is small. In normal patients (see WARNINGS ), symptoms of toxicity from iodine are unlikely to occur at the recommended dosage levels. Hypersensitivity to iodides may result in angioneurotic edema, cutaneous and mucosal hemorrhages, fever, arthralgia, lymph-node enlargement and eosinophilia. If patient develops a reaction, TPN supplementation with Iodopen should be immediately withdrawn and appropriate measures taken.