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| Product NDC Code | 51803-002 | ||||||
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| Drug Name | Iosat |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET | ||||||
| RxCUI drug identifier | 430174, 1423814 |
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| Application Number | NDA018664 | ||||||
| Labeler Name | Anbex Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (in each tablet ) Potassium iodide 65 mg
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Each white, round, cross-scored—the name IOSAT stamped on one side—tablet contains 65 mg of potassium iodide.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 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. Age Dose Adults over 18 years 2 tablets (whole or crushed) daily (130 mg) Children over 12 years to 18 years who weigh at least 150 pounds 2 tablets (whole or crushed) daily (130 mg) Children over 12 years to 18 years who weigh less than 150 pounds 1 tablet (whole or crushed) daily (65 mg) Children over 3 years to 12 years 1 tablet (whole or crushed) daily (65 mg) Children over 1 month to 3 years 1/2 tablet (crushed) 32.5 mg daily as directed in the consumer package insert Birth to 1 month 16.25 mg daily as directed in the consumer package insert 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.
| 2 tablets (whole or crushed) daily (130 mg) | |
| 2 tablets (whole or crushed) daily (130 mg) | |
| 1 tablet (whole or crushed) daily (65 mg) | |
| 1 tablet (whole or crushed) daily (65 mg) | |
| 1/2 tablet (crushed) 32.5 mg daily as directed in the consumer package insert | |
| 16.25 mg daily as directed in the consumer package insert |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients magnesium stearate, microcrystalline cellulose, silica gel, sodium thiosulfate
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses 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 IOSAT™ (Potassium Iodide tablets, USP) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.
Purpose
Information about the drug product’s indications for use.Purpose Thyroid blocking
Spl product data elements
Usually a list of ingredients in a drug product.IOSAT Potassium Iodide CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE SILICON DIOXIDE SODIUM THIOSULFATE ANHYDROUS POTASSIUM IODIDE IODIDE ION IOSAT
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL IOSAT™ (Potassium Iodide Tablets, USP 65 mg) iosat 65 package label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other Information store at 20-25°C (68-77°F) keep dry and foil intact protect from light do not throw away consumer package insert
Distributed by: ANBEX INC. 1812 West Sunset Blvd, Suite 1A-618 St George, UT 84770 (833) 467-2854 www.anbex.com • www.iosat.com
DIRECTIONS FOR USE Use only as directed by public officials if a nuclear radiation emergency happens. Age Dose Adults over 18 years 2 tablets (whole or crushed) every day (130 mg) Children over 12 years to 18 years who weigh at least 150 pounds 2 tablets (whole or crushed) every day (130 mg) Children over 12 years to 18 years who weigh less than 150 pounds 1 tablet (whole or crushed) or 8 teaspoonfuls every day (65 mg) Children over 3 years to 12 years 1 tablet (whole or crushed) or 8 teaspoonfuls every day (65 mg) Children over 1 month to 3 years 4 teaspoonfuls every day (32.5 mg) Birth to 1 month 2 teaspoonfuls every day (16.25 mg) 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: Child's Age Give your child this amount in teaspoonfuls Over 12 years to 18 years who weigh less than 150 pounds 8 teaspoonfuls will give you a 65 mg dose Over 3 years to 12 years old 8 teaspoonfuls will give you a 65 mg dose Over 1 month to 3 years old 4 teaspoonfuls will give you a 32.5 mg dose Birth to 1 month 2 teaspoonful will give you a 16.25 mg dose 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.
Distributed by: ANBEX INC. 1812 West Sunset Blvd, Suite 1A-618 St George, UT 84770 (833) 467-2854 www.anbex.com www.iosat.com SH905-2 8/23
| 2 tablets (whole or crushed) every day (130 mg) | |
| 2 tablets (whole or crushed) every day (130 mg) | |
| 1 tablet (whole or crushed) or 8 teaspoonfuls every day (65 mg) | |
| 1 tablet (whole or crushed) or 8 teaspoonfuls every day (65 mg) | |
| 4 teaspoonfuls every day (32.5 mg) | |
| 2 teaspoonfuls every day (16.25 mg) |
| 8 teaspoonfuls will give you a 65 mg dose | |
| 8 teaspoonfuls will give you a 65 mg dose | |
| 4 teaspoonfuls will give you a 32.5 mg dose | |
| 2 teaspoonful will give you a 16.25 mg dose |
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you have ever had an allergic reaction to iodine nodular thyroid disease with heart disease hypocomplementemic vasculitis dermatitis herpetiformis
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? call toll free 1-833-467-2854
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.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).
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if 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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.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). IOSAT™ (Potassium Iodide Tablets, USP 65 mg) Packages of 14 tablets. Each white, round tablet, cross-scored on one side and the IOSAT name on the other, contains 65 mg potassium iodide. NDC 51803-002-02: 14 Unit dose, Foil Sealed, 65 mg Tablets (14 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
Information about safe storage and handling of the drug product.STORAGE AND HANDLING Store at 20-25°C (68-77°F). Keep dry and foil intact.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings 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 Do not use if you have ever had an allergic reaction to iodine nodular thyroid disease with heart disease hypocomplementemic vasculitis dermatitis herpetiformis Stop use and ask a doctor if 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API