openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
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. Sodium Phosphates Injection must be diluted and thoroughly mixed before use. To avoid phosphate intoxication, infuse solutions containing sodium phosphate slowly. Infusing high concentrations of phosphate may result in a reduction of serum calcium and symptoms of hypocalcemic tetany. Calcium levels should be monitored. Solutions containing sodium ion 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 exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
ADVERSE REACTIONS Adverse reactions involve the possibility of phosphate intoxication. Phosphate intoxication results in a reduction of serum calcium and the symptoms are those of hypocalcemic tetany (see WARNINGS ).