FDA records indicate that there are no current recalls for this drug.
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Iodopen Sodium Iodide Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Iodopen Sodium Iodide Manufacturers
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App Pharmaceuticals, Llc
Iodopen Sodium Iodide | App Pharmaceuticals, Llc
Iodopen provides 100 mcg iodine per mL. For the metabolically stable adults receiving TPN, the suggested dosage level is 1 to 2 mcg iodine/kg/day (normal adults 75-150 mcg daily). For pregnant and lactating mothers and growing children, the suggested additive level is 2 to 3 mcg iodine/kg/day. Aseptic addition of Iodopen to TPN solutions under a laminar flow hood is recommended. Iodine is physically compatible with electrolytes and other trace elements usually present in amino-acid/dextrose solutions used for TPN.
Periodic monitoring of thyroid function is suggested as a guideline for adjusting dosage level.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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