IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

POTASSIUM IODIDE - ORAL

(poh-TASS-ee-um EYE-oh-dyed)

COMMON BRAND NAME(S): SSKI

USES: Potassium iodide is used to loosen and break up mucus in the airways. This helps you cough up the mucus so you can breathe more easily if you have long-term lung problems (e.g., asthma, chronic bronchitis, emphysema). This medication is known as an expectorant.

Potassium iodide is also used along with antithyroid medicines to prepare the thyroid gland for surgical removal, to treat certain overactive thyroid conditions (hyperthyroidism), and to protect the thyroid in a radiation exposure emergency. It works by shrinking the size of the thyroid gland and decreasing the amount of thyroid hormones produced.

In a radiation emergency, potassium iodide blocks only the thyroid from absorbing radioactive iodine, protecting it from damage and reducing the risk of thyroid cancer. Use this medication along with other emergency measures that will be recommended to you by public health and safety officials (e.g., finding safe shelter, evacuation, controlling food supply).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat a certain type of fungal skin infection (sporotrichosis).

HOW TO USE: Take this medication by mouth with a full glass of water (8 ounces or 240 milliliters) as directed by your doctor or public health and safety officials. To avoid stomach upset, take after meals or with food. Drink plenty of liquids with this medication unless otherwise directed. If you are taking the tablets, do not lie down for 10 minutes after taking this medication. If you are using the drops or liquid medication, use the dropper that comes with the bottle or a medication spoon/device to measure the correct dose. Liquid forms of this product may be mixed in water, milk, formula, or juice before taking. Do not use this medication if the solution turns brownish-yellow.

Dosage is based on your medical condition and response to therapy. In children, dosage is also based on age. Do not increase your dose, take it more often, or take it for longer than prescribed or recommended because of the increased risk of side effects.

In a radiation emergency, take this drug only when public health and safety officials tell you to do so. Read the Patient Information Leaflet that comes with the medication. Start treatment as soon as possible for the best protection. Take this medication usually once every 24 hours. The length of treatment will be determined by public health and safety officials and depends on several factors (e.g., whether you continue to be exposed to the radiation, and whether you are pregnant, breast-feeding, or have a newborn baby). See also Precautions.

If so directed, use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Nausea, vomiting, stomach ache, diarrhea, metallic taste in the mouth, fever, headache, or acne may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: burning mouth/throat, sore teeth/gums, swelling inside the mouth, increased saliva, eye irritation/swollen eyelids, severe headache, swelling of the front of the neck/throat (goiter), signs of decreased thyroid gland function (e.g., weight gain, cold intolerance, slow/irregular heartbeat, constipation, unusual tiredness), confusion, numbness/tingling/pain/weakness of the hands/feet.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, black stools, vomit that looks like coffee grounds, bloody diarrhea.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, fever with joint pain.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking potassium iodide, tell your doctor or pharmacist if you are allergic to it; or to iodine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: current attack/worsening of bronchitis (if taking potassium iodide to thin mucus in the lungs), a certain type of skin condition (dermatitis herpetiformis), a certain type of blood vessel disease (hypocomplementemic vasculitis), nodular thyroid disease with heart disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain thyroid disorders (e.g., multinodular goiter, Graves' disease, autoimmune thyroiditis), overactive thyroid disease (unless you are specifically prescribed potassium iodide to treat hyperthyroidism), tuberculosis, high potassium blood level, kidney disease, Addison's disease, a certain muscle disorder (myotonia congenita).

Caution is advised when this drug is given to newborn babies younger than 1 month old. Treatment for more than 1 day should be avoided because repeated dosing increases the risk of blocking thyroid function, possibly affecting the newborn's brain development. If treatment is needed for longer than 1 day, discuss the risks and benefits with the doctor. Treated babies should be given thyroid function tests.

During pregnancy, this medication should be used only when clearly needed. Treatment for more than 1 day should be avoided because repeated dosing increases the risk of blocking thyroid function in the unborn baby, possibly causing harm. If treatment is needed for longer than 1 day, discuss the risks and benefits with your doctor.

Caution is advised when this drug is used by women who are breast-feeding. This drug passes into breast milk. Treatment for more than 1 day should be avoided if you are breast-feeding because repeated dosing increases the risk of blocking thyroid function in the nursing infant. This effect may cause harm, especially in newborns younger than 1 month old. If treatment is needed for longer than 1 day, discuss with your doctor the risks and benefits, as well as whether you should stop breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: ACE inhibitors (e.g., captopril, lisinopril), angiotensin receptor blockers (ARBs such as losartan, valsartan), certain "water pills" (potassium-sparing diuretics such as amiloride, spironolactone, triamterene), drospirenone, eplerenone, lithium, potassium-containing drugs (e.g., supplements such as potassium chloride).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., thyroid function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not freeze. If crystals form in the solution, dissolve them by placing the closed bottle in a container of warm water, then gently shake the bottle. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.