POTASSIUM IODIDE

Use Helps prevent radioactive iodine from getting into the thyroid gland during a nuclear radiation emergency. Use along with other emergency measures recommended by public officials.

INDICATIONS: Potassium Iodide Oral Solution is a thyroid blocking medicine that is used in a nuclear radiation emergency only.

Purpose Thyroid blocking

HOW POTASSIUM IODIDE WORKS: Certain forms of iodine help your thyroid gland work right. Most people get the iodine they need from foods like iodized salt or fish. The thyroid can “store” or hold only a certain amount of iodine. In a nuclear radiation emergency, radioactive iodine may be released in the air. This material may be breathed or swallowed. It may enter the thyroid gland and damage it. The damage would probably not show itself for years. Children are most likely to have thyroid damage. If you take KI, it will block or reduce the chances that radioactive iodine will enter your thyroid gland.

Directions use as directed by public officials in the event of a nuclear radiation emergency. do not take more than 1 dose in 24 hours. Dosing Chart (dropper inside) Adults over 18 years 2 mL every day (130 mg) and Children over 12 years to 18 years who weigh at least 150 pounds 2 mL every day (130 mg) Children over 12 years to 18 years who weigh less than 150 pounds 1 mL every day (65 mg) and Children over 3 years to 12 years 1 mL every day (65 mg) Children over 1 month to 3 years 0.5 mL every day (32.5 mg) Babies at birth to 1 month 0.25 mL every day (16.25 mg) Dropper 2mL Dropper 1mL Dropper 0.5mL Dropper 0.25 mL

DIRECTIONS FOR USE: Use only as directed by public officials if a nuclear radiation emergency happens. Dose: Adults over 18 years 2 mL every day (130 mg) Children over 12 years to 18 years 2 mL every day (130 mg) who weigh at least 150 pounds Children over 12 years to 18 years 1 mL every day (65 mg) who weigh less than 150 pounds Children over 3 years to 12 years 1 mL every day (65 mg) Children over 1 month to 3 years 0.5 mL every day (32.5 mg) Babies at birth to 1 month 0.25 mL every day (16.25 mg) Take KI every day (every 24 hours) as directed by public officials. Do not take more than 1 dose in 24 hours. More will not help you. Too much medicine may increase the chances of side effects. Dropper 2mL Dropper 1mL Dropper 0.5mL Dropper 0.25mL

CONTRAINDICATIONS Contraindicated in patients with a known sensitivity to iodides.

SIDE EFFECTS: Short-term use of KI at the recommended dose is safe. You should not take this drug for longer than you are told. Possible side effects include: swelling of the salivary glands, nausea, vomiting, diarrhea, stomach ache, fever, headache, metallic taste, and allergic reactions. Allergic reaction can include skin rashes such as hives swelling of various parts of the body such as the face, lips, tongue, throat, hands or feet fever with joint pain trouble breathing, speaking or swallowing wheezing or shortness of breath Get medical attention right away if you have trouble breathing, speaking or swallowing; wheezing; shortness of breath; or swelling of the mouth, tongue or throat. Taking iodide, in rare cases, may cause overactivity of the thyroid gland, underactivity of the thyroid gland, or enlargement of the thyroid gland (goiter). Symptoms of an overactive thyroid gland may include an irregular heart beat and chest pain. Patients with thyroid disease are more likely to get these side effects. Babies under 1 month of age are more likely to get an underactive thyroid gland (hypothyroidism).

WHAT TO DO IF SIDE EFFECTS OCCUR: Stop taking KI and call a doctor if you have one or more of the following symptoms: swelling of the face, hands or feet fever and joint pain skin rash Stop taking KI and get medical help right away if you have one or more of the following symptoms: trouble breathing, speaking or swallowing shortness of breath or wheezing swelling of the lips, tongue or throat irregular heart beat or chest pain

WHO SHOULD NOT TAKE POTASSIUM IODIDE: People should avoid KI if they are allergic to iodine, have dermatitis herpetiformis or hypocomplementemic vasculitis, or have nodular thyroid disease with heart disease, because these conditions may increase the chances of side effects to iodine.

ADVERSE REACTIONS The most frequent adverse reactions to potassium iodide are stomach upset, diarrhea, nausea, vomiting, stomach pain, skin rash, and salivary gland swelling or tenderness. Less frequent adverse reactions include gastrointestinal bleeding, confusion, irregular heartbeat, numbness, tingling, pain or weakness in hands or feet, unusual tiredness, weakness or heaviness of legs, fever, and swelling of neck or throat. Thyroid adenoma, goiter, and myxedema are possible side effects. Iodism or chronic iodine poisoning may occur during prolonged treatment or with the use of high doses. The symptoms of iodism include burning of mouth or throat, severe headache, metallic taste, soreness of teeth and gums, symptoms of head cold, irritation of the eyes with swelling of the eyelids, unusual increase in salivation, acneform skin lesions in the seborrheic areas, and rarely, severe skin eruptions. If symptoms of iodism appear, the drug should be withdrawn and the patient given appropriate supportive therapy. Hypersensitivity to iodides may occur and may be manifested by angioedema, cutaneous and mucosal hemorrhage, and signs and symptoms resembling serum sickness, such as fever, arthralgia, lymph node enlargement, and eosinophilia.

DRUG INTERACTIONS Concurrent use with lithium or antithyroid drugs may potentiate the hypothyroid and goitrogenic effects of these medications. Concurrent use with potassium-containing medications, potassium-sparing diuretics and angiotensin-converting enzyme inhibitors (ACE inhibitors) may result in hyperkalemia and cardiac arrhythmias or cardiac arrest.

DESCRIPTION: Each milliliter (1 mL) of Potassium Iodide Oral Solution contains 65 mg of potassium iodide (USP) in a black raspberry-flavored solution. Inactive ingredients are: FD&C Red #40 and Blue #1, methylparaben, natural and artificial black raspberry flavor, propylene glycol, propylparaben, purified water (USP), sodium saccharin, sucrose.

Active Ingredient Potassium iodide (USP) 65 mg

OVERDOSAGE Acute toxicity from potassium iodide is relatively rare. An occasional individual may show marked sensitivity and the onset of acute poisoning can occur immediately or hours after administration. Angioedema, laryngeal edema and cutaneous hemorrhages may occur. Iodism or chronic iodine poisoning may occur during prolonged treatment or with the use of high doses. Symptoms of iodism typically disappear soon after discontinuation of the drug. Abundant fluid and salt intake aids in iodide elimination.

HOW SUPPLIED Potassium iodide oral solution, USP is supplied in 1 fluid ounce (30 ml) bottles (NDC 72162-2423-03) with a calibrated dropper marked to deliver 0.3 ml (300 mg) and 0.6 ml (600 mg); and 8 fluid ounce (237 ml) bottles (NDC 72162-2423-02). Inactive ingredient: Sodium thiosulfate as a preservative. NDC: 72162-2423-2: 237 mL in a BOTTLE. NDC: 72162-2423-3: 30 mL in a BOTTLE, WITH APPLICATOR. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed and protected from light. For the 237mL bottle, dispense in tight, light-resistant containers with child-resistant closures. For the 30mL bottle, place the child-resistant cap back on the amber glass bottle after using the clear plastic dropper for dispensing. Notice: When exposed to cold temperatures, crystallization may occur, but on warming and shaking, the crystals will redissolve. If the solution turns brownish-yellow in color, it should be discarded. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504