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* 14 130mg tablets per pack (small "baby-aspirin" sized) * Individually foilsealed for single unit storage and dosing * 14 day protection for adult (1 tablet each day of exposure) * 28+ day protection for child (double-scored for exact dosing) * View Iosat Consumer Package Insert * One pack per adult or child recommended by FDA Potassium Iodide Frequently Asked Questions What is radioactive iodine? What is the difference between liquid (ThyroShield) and tablet (Iosat) Potassium Iodide? Will potassium iodide radiation tablets protect me against a "dirty bomb"? How do I know if there is radiation in my area? What about other Potassium Iodide (KI) products? Or Potassium IodATE? Can I give it to my child easily? When should I take it? When should I stop? Is it safe? Who should and shouldn't take it? What do the experts say about potassium iodide? What is radioactive iodine? back to top One of the most feared consequences of a nuclear reactor accident or nuclear bomb is the release of a radioactive iodine plume into the environment. Radioactive Iodine (I-131) is a by-product of nuclear fission which occurs only within a nuclear reactor or during detonation of a nuclear bomb. What makes radioactive iodine so dangerous is that the body cannot distinguish it from ordinary iodine. As a result, if swallowed (in contaminated food or water), or inhaled (it can remain in the atmosphere for days), it will be absorbed into the thyroid gland (only the thyroid absorbs iodine) and may lead to thyroid cancer, especially in children. The value of Potassium Iodide (KI) tablets were demonstrated following the Chernobyl nuclear accident, where authorities began mass distribution of Potassium Iodide just hours after the explosion. In the years following the accident in areas where people received the drug, the incidence of thyroid cancer has not increased. But where Potassium Iodide was not distributed, previously rare forms of juvenile thyroid cancer have begun appearing at epidemic rates, with over 11,000 known cases. This number continues to rise and is not expected to peak until 2010. What is Potassium Iodide? (chemical abbreviation is KI) back to top Potassium Iodide (KI) is used by health officials worldwide to prevent thyroid cancer in people who are exposed to radioactive iodides caused by nuclear reactor accidents and nuclear bombs. It protects against radioactive iodine by preventing its absorption by the thyroid gland located in the neck. Thyroid cells are unique among all cells of the human body as they are the only cells which have the ability to absorb Iodine. The thyroid gland absorbs it from the bloodstream and concentrates it inside the cell to produce hormones. For radiation that is not immediately lethal, the thyroid is your body's most sensitive organ to the effects of radiation. The Radioactive Iodine is absorbed by the thyroid and can cause thyroid disease and cancer later on. Sometimes it only takes a short time if the victim is a child because a child s thyroid is very active in helping the child to grow. FDA Approved IOSAT and ThyroShield saturates the thyroid with stable iodine, shutting off its absorption mechanism, and it will remain off long enough for the radioactive iodine that you inhaled or ingested to to be safely disbursed through the kidneys. IOSAT KI is the only FDA-approved full strength thyroid blocking tablet available to the public. ThyroShield is the only liquid Potassium Iodide approved by the FDA. What is the difference between the liquid (ThyroShield) and the tablet (Iosat) Potassium Iodide? back to top As far as effectiveness and safety for adults or children, there is no difference between the liquid and the tablet. Both are FDA approved, have the same active ingredient (iodine), and can be effectively and safely administered to adults or children. The Iosat has a longer expiration date, is less expensive and is packaged for single-unit dosing. ThyroShield is flavored. An adult could take one Iosat tablet or two droppersful of ThyroShield. A child could take half an Iosat tablet or one dropperful of ThyroShield, etc. If you don't care to quickly crush and dissolve the tablet to administer to a small child then the liquid ThyroShield is your alternative. Will potassium iodide radiation tablets protect me against a "dirty bomb"? back to top A "dirty bomb" is a conventional explosive, such as dynamite, salted with radioactive waste that scatters when the bomb goes off. The bomb can kill or injure through the initial blast of the conventional explosive and possibly through the dispersal of the radioactive materials- hence the term "dirty." Such bombs could be small devices or as big as a truck bomb. There are four categories of radioactive waste ranging from very low-level waste that can be safely disposed of with ordinary refuse, to high-level waste such as spent nuclear fuel. Substantial amounts of radioactive waste are generated through civilian and military applications of radionuclides in medical facilities, food irradiation plants, chemical and manufacturing plants, etc. Some types of radioactive waste would be easier to obtain than others in order to make a "dirty bomb". Radiation detectors are needed to alert officials of their presence. The RADTriage personal radiation detector has the technology to detect Gamma, X-ray and Beta radiation. This includes the ability to detect radioactive iodine, of which Potassium Iodide protects against and would most likely not be present in a dirty bomb due to the fact that it is a byproduct of nuclear fission which takes place only within nuclear reactors and during the detonation of a nuclear bomb. Obviously this type of 'radioactive waste' would be very difficult to obtain and incorporate in the makings of a dirty bomb. If a dirty bomb detonates in your area, follow the instructions of local health officials concerning evacuation, decontamination and the administering of potassium iodide (though unlikely). How do I know if there is radiation in my area? back to top By using a radiation detector, emergency officials, such as FEMA, can monitor the environment for detectable levels of radiation. One would hope that they are in your area with their equipment as quick as possible and that they report this information to the public immediately. Of course, they cannot follow you and your family around with their detectors and tell you if you specifically have retreated to a safe environment away from the radiation. A back-up to the reliance on emergency officials, such as FEMA, would be the possession of a personal radiation detector to alert you to harmful levels of gamma, beta and x-ray radiation. Do I need a prescription? back to top Because of the inherent safety of Potassium Iodide that is FDA Approved, it is available without a prescription for radiation protection. Its use, however, should be limited to radiation emergencies and only when recommended by emergency response authorities. What about FDA Approval? back to top IOSAT Potassium Iodide is the only full strength brand tested and approved by the FDA for radiation emergencies. ThyroShield is the only liquid Potassium Iodide approved by the FDA. Ask yourself - If you had cancer and could take a drug that would cure it, would you take an FDA regulated and approved drug, or a non-approved drug? Then ask - If you could take a pill to possibly prevent cancer would you take an FDA Approved drug or a non-approved drug? Rad Block , Life-Extension (LEF), I.A.A.A.M. and Potassium IodATE (different spelling, different drug) are not FDA Approved for radiation emergencies. The 1997 Federal Food, Drug and Cosmetic Act states that: "No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval filed pursuant to subsection (b) or (j) of this section is effective with respect to said drug". To verify what brands of Potassium Iodide (or any drug) have FDA approval click on this link for the Orange Book at the FDA Center for Drug Evaluation and Research. Type in Potassium Iodide, click on "OTC" and then "submit". What about other Potassium Iodide (KI) products? Or Potassium IodATE? Are they FDA approved? Rad Block, I.A.A.A.M., No-Rad, Life Extension (LEF), KI4U, NukeProtect, ProKI and KIO3 Potassium IodATE (different spelling, different drug) are not FDA Approved for radiation emergencies. The FDA has sent cease and desist letters to some of these manufacturers who recommend their product for radiation emergencies. Other products (like Rad Block) state they are manufactured in an "FDA licensed and approved over-the-counter (OTC) drug manufacturing facility". Well, the facility might be FDA licensed but their Potassium Iodide is not mandated under strict FDA GMP guidelines, nor do they hold an approved New Drug Application (NDA) for KI (Potassium Iodide). The incoming raw materials and outgoing Potassium Iodide pills are not approved by the FDA. (During a nuclear emergency would you want to give your family a non-FDA-approved drug that cost more?) But they say they were registered with the FDA and have a National Drug Code (NDC) number to prove it! The NDC serves as a universal product identifier for human drugs. An NDC number does not indicate that a drug is FDA approved. FDA s regulation at 21 C.F.R.207.39 specifically states that: "registration of a drug establishment or drug wholesaler, or assignment of a registration number, or assignment of a NDC number does not in any way denote approval of the firm or its products. Any representation that creates an impression of official approval because of registration or possession of registration number or NDC number is misleading and constitutes misbranding". Instead, drug approval involves a completely different process, which includes the submission by a manufacturer of a new drug application (NDA) or an abbreviated new drug application (ANDA), which FDA then may approve - International Academy of Compounding Pharmacists. More info can be found here on our website at Potassium Iodate vs Potassium Iodide We recommended one Iosat pack or one ThyroShield bottle per person for storing at home. Each Iosat pack has 14 130mg tablets. A two week supply for an adult and a 28+ day supply for a child. One ThyroShield bottle has 30ml, a 15 day supply for an adult or month+ supply for a child. However, you should consider stocking Potassium Iodide outside the home as well. You wouldn't want to get caught without Potassium Iodide if something should happen. Can you imagine the traffic jam as everyone leaves town at the same time? Can I give it to my child easily? back to top A whole Iosat pill is the size of a baby aspirin and is scored for easy and exact separation for half and quarter dosages if desired. For children who won't swallow pills, follow this FDA link on administering potassium iodide to children. Black raspberry flavored liquid ThyroShield is easy to administer to children with the use of the enclosed dropper. What is the dosage? back to top On December 10, 2001 the FDA released a guidance on potassium iodide. The guidance issued is not just for the 10-mile Emergency Planning Zone, but for any and all areas potentially affected. Close in, there may not be time to deal with fractional dosage of Potassium Iodide (see below). The guidance acknowledges that strict adherence to the age-related dosing guidelines may be difficult to achieve and, therefore, emphasizes that across populations at risk for radioiodine exposure, the overall benefits of potassium iodide far exceed the risks of overdosing, especially in children, though particular attention should be paid to dose and duration of treatment in infants and in pregnant women. Iosat Consumer Package Insert * One dose every 24 hours. Take one dose as soon as possible and then every 24 hours at the same time each day. Take potassium iodide only when exposed to radioactive iodine as notified by state or local public health officials. Pills are double-scored for easy separation is desired. Follow this FDA Guideline for administering to young children if desired. Age 18+* -130mg daily (One IOSAT tablet) Age 3 - 18 -65mg daily (1/2 IOSAT tablet) - Adolescents approaching adult size should receive the full adult dose (130 mg). 1 month - 3 yrs. - 32mg daily (1/4 IOSAT tablet) Birth - 1 month - 16mg daily (1/8 IOSAT tablet) No prescription required - OTC (Iosat radiation blocking pills fda approved nukepills was posted and is owned by: Carmen Leon) |
carmen.leon@chicagopartsnetwork.com (Carmen Leon) for more information.
