Iodopen (Oral, Injection, Intravenous)

Sodium iodide is used to prevent or treat iodine deficiency.

The body needs iodine for normal growth and health. For patients who cannot get enough iodine in their regular diet or who need more iodine, sodium iodide may be necessary. Iodine is required for your thyroid gland to work properly.

Iodine deficiency is rare in the United States because iodine is added to table salt. Most people get enough salt from the foods they eat without adding salt to their meals. Iodine deficiency is a problem in other parts of the world.

Not getting enough iodine may lead to thyroid issues, mental problems, hearing loss, and goiter.

Injectable sodium iodide is given only by or under the supervision of a health care professional. Some multivitamin/mineral products that contain sodium iodide can be obtained without a prescription from your health care professional.

For good health, it is important to eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of suitable foods. If you think you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Iodine is found in various foods, including seafood, small amounts of iodized salt, and vegetables grown in iodine-rich soils. Iodine-containing mist from the ocean is also an important source of iodine, as iodine can be absorbed through the skin. Iodized salt provides 76 micrograms (mcg) of iodine per gram of salt.

The daily amount of iodine needed is defined in several different ways.

• For U.S.—
• Recommended Dietary Allowances (RDAs) are the amounts of vitamins and minerals needed for adequate nutrition in most healthy persons. RDAs can vary based on a person's age, sex, and physical condition (e.g., pregnancy).
• Daily Values (DVs) are used on food and dietary supplement labels to show the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous term United States Recommended Daily Allowances (USRDAs).

• For Canada—
• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed for adequate nutrition and to reduce the risk of chronic disease.

Normal daily recommended intakes in mcg for iodine are generally defined as follows:

Many other products have iodine in them. For instance, iodine can be absorbed through the skin from certain skin cleansers (like povidone-iodine). It is especially important that infants and small children do not get large amounts of iodine. Talk to your health care professional before using any other products that contain iodine while you are using sodium iodide.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it will provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have been no reported problems in children with the intake of normal daily recommended amounts. However, high doses of sodium iodide may lead to skin rash and thyroid issues in infants.

Geriatric

There have been no reported problems in older adults with the intake of normal daily recommended amounts.

Breast Feeding

Research in women suggests that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should not be taken together at all, while in other cases, two different medicines may be used together even if there could be an interaction. In such situations, your doctor may need to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure to tell your doctor if you have any other medical conditions, especially:

• Kidney disease—Using sodium iodide may increase the amount of iodine in the blood and raise the risk of side effects.

• Thyroid disease—This condition may heighten the risk of side effects from sodium iodide.

• Tuberculosis—Using sodium iodide may worsen this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur, they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Hives
• Joint pain
• Swelling of arms, face, legs, lips, tongue, and/or throat
• Swelling of lymph glands

With long-term use

• Burning of mouth or throat
• Severe headache
• Increased watering of mouth
• Metallic taste
• Skin sores
• Soreness of teeth and gums
• Stomach irritation

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Iodopen

Available Dosage Forms:

• Solution

Therapeutic Class: Parenteral Mineral-Trace Mineral

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (as part of a multivitamin/mineral supplement): To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes: For the U.S. Adults and teenagers—150 micrograms (mcg) per day. Pregnant females—175 mcg per day. Breast-feeding females—200 mcg per day. Children 7 to 10 years of age—120 mcg per day. Children 4 to 6 years of age—90 mcg per day. Children birth to 3 years of age—40 to 70 mcg per day. For Canada Adult and teenage males—125 to 160 mcg per day. Adult and teenage females—110 to 160 mcg per day. Pregnant females—135 to 185 mcg per day. Breast-feeding females—160 to 210 mcg per day. Children 7 to 10 years of age—95 to 125 mcg per day. Children 4 to 6 years of age—85 mcg per day. Children birth to 3 years of age—30 to 65 mcg per day. To treat deficiency: Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on severity of deficiency.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

Store the dietary supplement in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.