Iodopen Sodium Iodide

APP Pharmaceuticals, LLC

Iodopen Sodium Iodide Injection

FULL PRESCRIBING INFORMATION: CONTENTS*

• IODOPEN SODIUM IODIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• IODOPEN SODIUM IODIDE INDICATIONS AND USAGE
• IODOPEN SODIUM IODIDE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• IODOPEN SODIUM IODIDE ADVERSE REACTIONS
• OVERDOSAGE
• IODOPEN SODIUM IODIDE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED

FULL PRESCRIBING INFORMATION

Trace Element Additive

FOR IV USE ONLY AFTER DILUTION

IODOPEN SODIUM IODIDE DESCRIPTION

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.

CLINICAL PHARMACOLOGY

Iodine is an integral part of thyroid hormones, triiodothyronine (T₃) and thyroxine (T₄).  The hormones regulate basal metabolism.  The thyroid function is modulated by hypothalmicpituitary axis through thyroid-releasing hormone and thyroid-stimulating hormone by negative feed back of thyroxine levels in plasma.  The essentiality of iodine in humans and animals is well established.  Persistent iodine deficiency results in histological changes in thyroid gland and impaired thyroid function, which may culminate in goiter.  Iodine deficiency in early stage in life has been reported to produce cretinism.  Published reports on pharmacokinetics of iodine in humans and animals show that absorption of iodine from the gastrointestinal tract is rapid and complete.

Skin and lungs can also absorb iodine.  Iodine is utilized as iodide or iodated organic complexes.  On administration iodide equilibrates in extracellular fluids and although all body cells contain iodide, it is specifically concentrated by thyroid gland, which, in humans, is estimated to contain 7 to 8 mg total iodine.

Other important organs to take up iodide are salivary glands and gastric mucosa, and to a lesser extent, choroid plexus, skin, hair, mammary glands and placenta. Iodine in saliva and gastric mucosal secretions is reabsorbed and recycled.  The circulating iodine is hormonal thyroxine of which 30 to 70 mcg is protein bound and 0.5 mcg is free thyroxine.  The normal plasma inorganic iodide levels are estimated between 0.5 and 1.5 mcg/100 mL.  The major route of excretion is via kidneys.  Some excretion of conjugated thyroid hormones takes place via bile.

IODOPEN SODIUM IODIDE INDICATIONS AND USAGE

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 CONTRAINDICATIONS

Iodopen is contraindicated for patients with known hypersensitivity to iodine.  Iodopen should not be given undiluted by direct injection into a peripheral vein because of potential for infusion phlebitis.

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.

PRECAUTIONS

As iodine is eliminated in urine, iodine supplements in TPN solutions may be adjusted, reduced or omitted in patients with renal dysfunction.

Iodine is constituent of several medications and diagnostic compounds, and is reported to be bioavailable from them.  If the patients are using such compounds, consideration to their contribution should be given.

Iodine is readily absorbed through skin, lungs and mucous membrane.  Consideration should be given to environmental, topical skin disinfection and wound treatment practices with surgical swabs and solutions containing iodine and povidone iodine.  Air in the coastal areas is known to contain more iodine than inland areas.

IODOPEN SODIUM IODIDE 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.

OVERDOSAGE

The symptoms of chronic iodide poisoning in humans include metallic taste, soreness of the mouth, increased salivation, coryza, sneezing, swelling of the eyelids, severe headache, pulmonary edema, tenderness of salivary glands, acneform skin lesions and skin eruptions.

Abundant fluids and salt intake helps in elimination of iodides.

IODOPEN SODIUM IODIDE DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

45861E

Revised: January 2008

PACKAGE LABEL - PRINCIPAL DISPLAY - Iodopen^® 10 mL Single Dose Vial Label

NDC 63323-019-10

1910

Iodopen^® Sodium Iodide Injection

Trace Element Additive equivalent to

100 mcg/mL

Iodide

For IV Use Only After Dilution

10 mL Single Dose Vial

Rx only