This product is Shipped by Express Post/AirMail.
NOTE: This product CANNOT be returned after purchase due to the volume of requests.
Do not take it until you receive clear instructions from Health Authorities.
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
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
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
8. Who should not take ThyroSafe™ or have
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
Iodide (KI) tablet with 65 mg. strength. The
FDA Guideline suggests: “For the sake of logistical simplicity in the
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
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).
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 at: www.fda.gov/cder/drugprepare/kiprep65mg.htm.
||ThyroSafe™ 65 mg. tablets
| Children ages 3 through 18
|| 65 mg
| Children over 1 month through
|| 32 mg
| Children under 1 month
|| 16 mg
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.
Consumer Package Insert
(Potassium Iodide Tablets USP, 65 mg)
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).
Each white, round, cross-scored ThyroSafe® tablet contains 65 mg of potassium iodide.
ThyroSafe® (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.
Adults over 18 years 2 tablets (whole or crushed) every day (130 mg)
Children over 12 years to 18 years 2 tablets (whole or crushed) every day (130 mg)
who weigh at least 150 pounds
Children over 12 years to 18 years 1 tablet (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 (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)
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:
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 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
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.
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
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.
Short-term use of KI at the recommended dose is safe. You should not take this drug for longer than you
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 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
ThyroSafe® (potassium iodide, USP) tablets. Packages of 10 and 20 tablets. Each white, round, cross-scored
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.