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Thyrosafe





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NOTE: Thyrosafe CANNOT be returned after purchase due to the volume of requests. Do not take Thyrosafe until you receive clear instructions from the Health Authorities.


Thyrosafe

Active Ingredient(s): Potassium Iodide
First Thyrosafe Approval by the FDA: September 10, 2002

Consumer Package Insert
ThyroSafe® - Potassium Iodide Tablets USP, 65 mg -  Abbreviated KI

Take Thyrosafe 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).

DESCRIPTION
Each white, round, cross-scored ThyroSafe® tablet contains 65 mg of potassium iodide.

INDICATIONS for Thyrosafe
ThyroSafe® (Potassium Iodide Tablets, USP) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.

DIRECTIONS FOR Thyrosafe USE

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

Dose:
Adults over 18 years 2 tablets of Thyrosafe (whole or crushed) every day (130 mg)
Children over 12 years to 18 years 2 tablets of Thyrosafe (whole or crushed) every day (130 mg)
who weigh at least 150 pounds
Children over 12 years to 18 years 1 tablet of Thyrosafe (whole or crushed) or 8 teaspoons every day (65 mg)
who weigh less than 150 pounds
Children over 3 years to 12 years 1 tablet of Thyrosafe (whole or crushed) or 8 teaspoons every day (65 mg)
Children over 1 month to 3 years 4 teaspoons every day (32.5 mg)
Babies at birth to 1 month 2 teaspoons every day (16.25 mg)
Thyrosafe tablets can be crushed and mixed in many liquids. To take the Thyrosafe 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:
1. 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 Thyrosafe powder should not have any large pieces.
2. Add 4 teaspoons of water to the crushed KI powder in the bowl and mix until the KI powder is dissolved in the water.
3. Take the KI water mixture solution made in step 2 and mix it with 4 teaspoons of low fat white or chocolate milk, orange juice, flat soda, raspberry syrup, or infant formula.
4. The KI liquid mixture will keep for up to 7 days in the refrigerator. It is recommended that the KI liquid mixtures 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 teaspoon. The number of teaspoons 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 teaspoons
  • Over 12 to 18 years old 8 teaspoons will give you a 65 mg dose who weigh less than 150 pounds
  • Over 3 to 12 years old 8 teaspoons will give you a 65 mg dose
  • Over 1 month to 3 years old 4 teaspoons will give you a 32.5 mg dose
  • Birth to 1 month 2 teaspoons will give you a 16.25 mg dose

Note: This is the amount to give your child for one single dose in teaspoons (not tablespoons). 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 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.

WHO SHOULD NOT TAKE POTASSIUM IODIDE - Thyrosafe
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 - Thyrosafe
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.

THYROSAFE SIDE EFFECTS
Short-term use of KI at the recommended dose is safe. You should not take Thyrosafe 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 reactions 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 THYROSAFE 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


HOW SUPPLIED
ThyroSafe® (potassium iodide, USP) tablets. Packages of 10 and 20 tablets. Each white, round, cross-scored Thyrosafe tablet contains 65 mg potassium iodide. Store at 20-25o C (68-77o F). Keep dry and foil intact. Manufactured by Recipharm Stockholm AB, Sweden, for Recipharm Inc, USA. l-866-849-7672. thyrosafe.com.

1. What is the thyroid gland and what does it do?
The thyroid is a small gland located at the base of the throat. It has the only cells in the body capable of absorbing iodine. A functioning thyroid gland concentrates iodine from a person’s blood, obtained through food, iodized salt, or supplements, and combines that iodine with the amino acid tyrosine. The thyroid then converts the iodine/tyrosine combination into the hormones that control a person’s metabolism and growth rate.

2. What is ThyroSafe™?
ThyroSafe™ is the only FDA approved 65 mg. Potassium Iodide (KI) tablet. It is used to protect your thyroid gland against radioactive iodine released during a nuclear emergency. It does this by flooding the thyroid with stable, safe iodine, which blocks the absorption of dangerous radioactive iodine. ThyroSafe™ is produced by Recipharm AB, Sweden, who has more than 20 years experience in manufacturing Potassium Iodide tablets. Each tablet of ThyroSafe™ has a convenient cross-score, making it easy to break into four pieces for small children.

3. What is the risk to human health during a radiation emergency?
During a nuclear emergency, radioactive iodine is released and is swallowed or inhaled by human beings. It will then be absorbed into the thyroid gland. Even very small amounts of radioactive iodine will eventually deliver a large radiation dose to thyroid cells resulting in various abnormalities later in life including loss of thyroid functions, nodules in the thyroid or thyroid cancer. Children whose thyroids are especially active, are extremely susceptible to it. Four years after the Chernobyl nuclear accident, the observed cases of thyroid cancer among children aged 0-4 years at the time of the accident in Belarus and Ukraine exceeded the expected number of cases by 30-60 fold. During the ensuing years, in the most heavily affected areas, incidence of thyroid cancer is as much as 100-fold compared to pre-Chernobyl rates. However, in Poland, where over 18 million doses of Potassium Iodide (KI) were administered to 97% of the children, there has been no increase in thyroid cancer.

4. Why should we take ThyroSafe™ in a radiological accident?
The effectiveness of KI as a specific blocker of thyroid radioiodine uptake is well established. When administered in the recommended dose, the potassium iodide in ThyroSafe™ is absorbed by the thyroid gland, which will effectively saturate the gland in such a way that inhaled or ingested radioactive iodines will not be accumulated in the thyroid gland. Therefore the risk of thyroid cancer in individuals or populations is reduced.

5. How safe is ThyroSafe™?
As reported in the American Journal of Medicine (Volume 94, P.524-532, May, 1993) the incidence of side effects in Poland among the roughly 18 million who took KI after the Chernobyl accident is very small. Approximately 3% suffered some form of stomach upset (due, in part, to the fact that a liquid KI was used instead of a tablet), 1% had a mild skin rash, and 1% suffered other mild symptoms. Only 2 cases of more serious side effects were noted, and both of these occurred among people with known allergies to iodide who had been warned not to take KI—but did so anyway (preferring to suffer an allergic respiratory problem to the possibility of thyroid cancer.)

6. Has there been an FDA extension of the expiration dates of ThyroSafe™?
The FDA has approved an extension of the expiration dating period to 72 months according to ANDA 76-350/S-007.

7. Should pregnant women take ThyroSafe™?
According to the FDA, pregnant women should be given KI for their own protection and for that of the fetus, as iodine (whether stable or radioactive) readily crosses the placenta. However, because of the risk of blocking fetal thyroid function with excess stable iodine, repeat dosing with KI of pregnant women should be avoided.

8. Who should not take ThyroSafe™ or have restricted use?
According to the FDA, persons with known iodine sensitivity should avoid ThyroSafe™, as should individuals with dermatitis herpetiformis and hypocomplementemic vasculitis, extremely rare conditions associated with an increased risk of iodine hypersensitivity. Individuals with multinodular goiter, Graves’ disease, and autoimmune thyroiditis should be treated with caution—especially if dosing extends beyond a few days.

9. Why are there 65 mgs. of Potassium Iodide in each tablet of ThyroSafe™?
ThyroSafe™ is the only FDA approved Potassium Iodide (KI) tablet with 65 mg. strength. The FDA Guideline suggests: “For the sake of logistical simplicity in the dispensing and administration of KI to children, FDA recommends a 65-mg. dose as standard for all school-age children while allowing for the adult dose (130 mg., 2 X 65 mg. tablets) in adolescents approaching adult size.”

10. When should one take ThyroSafe™?
ThyroSafe™ should be taken as soon as possible after an alert from public health officials tell you. If health officials instruct you to repeat the dose, you should take one dose every 24 hours. Do not take any KI product unless instructed to do so by local health authorities.

11. How is ThyroSafe™ prepared for small children?
One of the major advantages of ThyroSafe™ over other Potassium Iodide products is that the ThyroSafe™ 65 mg. tablet has a cross-score, making it be easily broken into ½ or ¼ tablet to satisfy the graded dose requirement, as recommended by the FDA Guideline (see below).

Age Group KI Dose ThyroSafe™ 65 mg. tablets
 Children ages 3 through 18 yrs.  65 mg 1
 Children over 1 month through 3 years  32 mg ½
 Children under 1 month  16 mg ¼


For those small children who cannot swallow the tablet with water, the required fraction of tablet should be ground into powder first and then dissolved in water or other preferable drink. If you have difficulty breaking ThyroSafe™ into ¼ tablet for a neonate, take ½ tablet and follow the above procedure. Then give half the drink volume to the neonate. For more information on treating infants, visit the U.S. FDA’s discussion of the topic.

12. Will delayed administration of ThyroSafe™ flush radioactive iodine out of the thyroid gland?
Radioactive iodine, once bound in the thyroid, cannot be flushed out by subsequent administration of nonradioactive iodine. Therefore, any delay in saturating your thyroid with ThyroSafe™ is a serious risk to be aggressively avoided, especially for your children. It is highly recommended that you should have a supply of ThyroSafe™ on hand now.

A population of about 2.3 million children living in southern Belarus, northern Ukraine and the most easterly regions of the Russian federation was exposed to significant amounts of radioactive iodine during the Chernobyl accident. The result, less than fifteen years after the accident, is more than 1,000 cases of thyroid cancer, most probably solely attributable to this single release of radioactivity to the environment.

The sensitivity of the child’s thyroid to the carcinogenic effects of radiation represents a significant public health risk in the event of exposure to radioactive iodine. This has been well established. In the most affected area in Belarus, the yearly incidence has risen close to 100 cases per million children, which is more than 100 times the incidence in the general population. It is now generally accepted that this excess has resulted from exposure to the radioactive iodine released in the accident. The Chernobyl accident has demonstrated that significant levels of radioactive iodine can drift hundreds of miles from the site. Another important insight gained from the Chernobyl accident concerns the side effects of stable iodine. In Poland, potassium iodide, as single doses, was given to 10 million children. No serious side effects were seen. The incidence of severe side effects from a single dose of iodine was less than 1 in 10 million in children and less than 1 in a million in adults.


The American Thyroid Association released a study of potassium iodide on September 28, 2002. In that statement the Association endorsed potassium iodide for radiation emergencies.To support this conclusion, the Association reviewed the disaster at Chernobyl. “After the 1986 Chornobyl (formerly called Chernobyl) nuclear accident, strong winds blew a radioactive cloud over much of eastern Europe. As many as 3,000 people exposed to that radiation have already developed thyroid cancer. Most were babies or young children living in Ukraine, Belarus, or Russia at the time of the accident. According to a UN report released in February 2002, another 8,000 to 10,000 exposed people may develop thyroid cancer within the next 10 years. Poland, immediately adjacent to Belarus and Ukraine, distributed KI (potassium iodide) to its population and does not appear to have had an increase in thyroid cancer.” 

Chernobyl not only proved that potassium iodide was effective in preventing thyroid cancer, it also showed that its distribution should not be limited to 10 or 20 miles. No one can predict how a radioactive cloud may spread. After the disaster at Chernobyl, higher than expected rates of thyroid cancer were found more than 200 miles away from the nuclear plant.



References




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