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warnings
WARNINGS Strongly hypertonic solution. Must be properly diluted and thoroughly mixed before injection. 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. Contains no phosphate. Patients receiving TPN solutions containing concentrated dextrose may also require phosphate in addition to Hyperlyte® CR. Each 20 mL dose contains 20 mEq of potassium. Patient requirements should be carefully evaluated prior to the addition of any potassium salt to a solution containing Hyperlyte® CR. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema. Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease, and in such instances, cardiac monitoring is recommended. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Solutions containing calcium ions should not be administered through the same administration set as blood because of the likelihood of coagulation. Solutions containing acetate should be used with great care in patients with metabolic or respiratory alkalosis. The administration of acetate should be done with great care in those conditions in which there is an increased level or an impaired utilization of acetate, such as severe hepatic insufficiency.
ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. Symptoms may result from an excess or deficit of one or more of the ions present in the final infusate. Therefore, frequent monitoring of blood electrolyte levels is essential. Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume. Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular functions, and intestinal ileus and dilatation. If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect. Abnormally high plasma levels of calcium can result in depression, amnesia, headaches, drowsiness, disorientation, syncope, hallucinations, hypotonia of both skeletal and smooth muscles, dysphagia, arrhythmias and coma. Calcium deficits can result in neuromuscular hyperexcitability, including cramps and convulsions. Abnormally high plasma levels of magnesium can result in flushing, sweating, hypotension, circulatory collapse, and depression of cardiac and central nervous system function. Respiratory depression is the most immediate threat to life. Magnesium deficits can result in tachycardia, hypertension, hyperirritability and psychotic behavior. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.