
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.
There is currently no manufacturer warning information available for this drug.
Iodopen® (Sodium Iodide Injection) is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of Iodopen in TPN solutions helps to prevent depletion of endogenous stores and subsequent deficiency symptoms.
Iodopen (Sodium Iodide Injection) is a sterile, nonpyrogenic solution for use as an additive to solutions for total parenteral nutrition (TPN).
Each mL contains:
Sodium Iodide
(equivalent to 100 mcg iodide) …….118 mcg
Water for Injection, USP ……………………….q.s.
pH adjusted with sodium hydroxide or hydrochloric acid.