IOSAT

Anbex Inc.

IOSAT™ - (Potassium Iodide Tablets, USP, 65 mg)

FULL PRESCRIBING INFORMATION: CONTENTS*

• Distributed by:
• Consumer Package Insert
• IOSAT DESCRIPTION
• INDICATIONS
• DIRECTIONS FOR USE
• WARNING
  • HOW POTASSIUM IODIDE WORKS
  • WHO SHOULD NOT TAKE POTASSIUM IODIDE
  • HOW AND WHEN TO TAKE POTASSIUM IODIDE
  • SIDE EFFECTS
  • WHAT TO DO IF SIDE EFFECTS OCCUR
• HOW SUPPLIED
• STORAGE AND HANDLING
• Distributed by:
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Potassium iodide 65 mg

Thyroid blocking

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.

Allergy alert: Iodine may cause an allergic reaction with 1 or more of the following symptoms:

• shortness of breath or wheezing
• swelling
• skin rash
• trouble breathing, speaking or swallowing
• fever and joint pain

if you have

• ever had an allergic reaction to iodine
• nodular thyroid disease with heart disease
• hypocomplementemic vasculitis
• dermatitis herpetiformis

you have

• an allergic reaction. Get medical help right away if you have trouble breathing, speaking or swallowing; shortness of breath; wheezing; swelling of the mouth, tongue or throat; or rash.
• irregular heartbeat or chest pain. Get medical help right away.
• swelling of the hands or feet, fever, or joint pain.

In case of overdose, get medical help or contact a Poison Control Center right away.

• use as directed by public officials in the event of a nuclear radiation emergency
• do not take more than 1 dose in 24 hours
• tablets can be whole or crushed and mixed in milk, baby formula, water, orange juice, flat soda like cola, or raspberry syrup

The liquid mixture should be given to infants, young children, and others who cannot swallow tablets; see consumer package insert on how to make a liquid mixture.

• If pregnant, breastfeeding, have a baby up to 1 month of age or have thyroid disease (except nodular thyroid disease with heart disease), take as directed above and contact a doctor as soon as possible.

• store at 20-25°C (68-77°F)
• keep dry and foil intact
• protect from light
• do not throw away consumer package insert

magnesium stearate, microcrystalline cellulose, silica gel, sodium thiosulfate

call toll free 1-866-463-6754

Distributed by:

ANBEX INC.
290 W. Mt Pleasant Ave., Suite 3310
Livingston, NJ 07039
www.anbex.com

Consumer Package Insert

IOSAT™

(Potassium Iodide Tablets USP, 65 mg)
(Abbreviated KI)

Take potassium iodide (KI) only when public officials tell you. In a nuclear radiation emergency, radioactive iodine could be released into the air. KI protects only the thyroid gland from uptake of radioactive iodine. Therefore, KI should be used along with other emergency measures that will be recommended to you by public officials. If you are told to take this medicine, take it 1 time every 24 hours. Do not take it more often. More KI will not help you. Too much KI may increase the chances of side effects. Do not take this medicine if you know you are allergic to iodine (see SIDE EFFECTS below).

IOSAT DESCRIPTION

Each white, round, cross-scored—the name IOSAT stamped on one side—tablet contains 65 mg of potassium iodide.

INDICATIONS

IOSAT™ (Potassium Iodide tablets, USP) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.

DIRECTIONS FOR USE

Use only as directed by public officials if a nuclear radiation emergency happens.

Tablets can be crushed and mixed in many liquids. To take the tablet in liquid solution, use dosing directions under Making a Potassium Iodide Liquid Mixture.

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.

Making a Potassium Iodide Liquid Mixture:

• Put one 65 mg KI tablet into a small bowl and grind it into a fine powder using the back of a metal teaspoon against the inside of the bowl. The powder should not have any large pieces.
• Add 4 teaspoonfuls of water to the crushed KI powder in the bowl and mix until the KI powder is dissolved in the water.
• Take the KI water mixture solution made in step 2 and mix it with 4 teaspoonfuls of low fat white or chocolate milk, orange juice, flat soda, raspberry syrup, or infant formula.
• The KI liquid mixture will keep for up to 7 days in the refrigerator. It is recommended that the KI liquid mixture be prepared weekly. Throw away unused portions.

The amount of KI (65 mg tablet) in the drink when mixed as described above is 8.125 mg per teaspoonful. The number of teaspoonfuls of the drink to give your child depends on your child’s age as described in the following table:

Note: This is the amount to give your child for one single dose in teaspoonfuls (not tablespoonfuls). You should give your child one dose each day as recommended by the public officials.

Pregnant or breastfeeding women, or babies under 1 month of age: Take as directed above and call a doctor as soon as possible. Repeat dosing should be avoided. It is recommended that thyroid function be checked in babies less than 1 month of age that take KI. Women who are pregnant or breastfeeding should also be checked by a doctor if repeat dosing is necessary. Although these precautions should be taken, the benefits of short-term use of KI to block uptake of radioactive iodine by the thyroid gland far exceed its chances of side effects.

Patients with thyroid disease: If you have both a nodular thyroid condition such as multinodular goiter with heart disease, you should not take KI. Patients with other thyroid conditions may take KI as directed above, but call a doctor if you need to take KI for more than a few days.

WARNING

People who are allergic to iodine, have dermatitis herpetiformis or hypocomplementemic vasculitis, or have nodular thyroid disease with heart disease should not take KI. Keep out of the reach of children. In case of an allergic reaction (difficulty breathing, speaking or swallowing; wheezing; shortness of breath or swelling of the mouth or throat), call 911 or get medical care right away. In case of overdose, get medical help or call a Poison Control Center right away.

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 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.

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.

HOW AND WHEN TO TAKE POTASSIUM IODIDE

KI should be taken as soon as possible after public officials tell you. If you are told to repeat the dose, you should take the second dose 24 hours after the first dose. Do not take it sooner. More KI will not help you because the thyroid can “hold” only certain amounts of iodine. Taking more than 1 dose per day will increase the chances of side effects. The public officials will tell you how many days to take KI. You should take KI until the chances of major exposure to radioactive iodine by breathing or swallowing stops.

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 heartbeat 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 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

HOW SUPPLIED

IOSAT™ (Potassium Iodide Tablets, USP 65 mg) Packages of 20 tablets. Each white, round tablet, cross-scored on one side and the IOSAT name on the other, contains 65 mg potassium iodide.
NDC 51803-002-01: 2 X 10 Unit dose, Foil Sealed, 65 mg Tablets (20 Tablets).

Also available: IOSAT™ (Potassium Iodide Tablets, USP 130 mg) Each white, round tablet, cross-scored on one side and the IOSAT name on the other, contains 130 mg potassium iodide.
NDC 51803-001-01: 14 Unit dose, Foil Sealed, 130 mg Tablets.

STORAGE AND HANDLING

Store at 20-25°C (68-77°F). Keep dry and foil intact.

Distributed by:

ANBEX INC.
290 W. Mt Pleasant Ave., Suite 3310
Livingston, NJ 07039
(866) 463-6754
www.anbex.com

SH905-2

PRINCIPAL DISPLAY PANEL

IOSAT™ (Potassium Iodide Tablets, USP 65 mg)