Iodoral 50 mg tablet Information/90 tablets


                                                            Iodoral


    Information about Iodoral from Optimox Corporation



- High Potency Iodine/Potassium Iodide Supplement

One tablet of Iodoral supplies an amount of total elemental iodine, comparable to the average
daily intake of this essential element by mainland Japanese, a population with a very low
prevalence of fibrocystic disease of the breast and breast cancer.

I. GENERAL INFORMATION

Iodine is an essential element. Although its main function is in the production of thyroid
hormones by the thyroid gland, other organs in the body have a need for iodine in order to
function normally(*4).

Several studies have demonstrated a relationship between low iodine intake and fibrocystic
disease of the breast (FDB), both in women and laboratory animals (*1,2). The minimum amount
of iodine required for control and prevention of FDB is equivalent to 0.1mg/kg body
weight/day. For example, for a 50 kg woman, the daily amount of iodine would be 5 mg. The
thyroid gland needs iodide to function properly. The original study done 80 years ago to
control goiter in adolescent girls used 9 mg iodide daily (*3).

During the early 1900's, the iodine/iodide solution called Lugol solution was used extensively,
effectively and safely in medical practice, for both low activity and above normal activity of the
thyroid gland (*4). The recommended daily intake for iodine supplementation was 2 to 6 drops
of Lugol solution containing 12.5 to 37.5 mg total iodide. That amount was mentioned as lately
as 1995 in a book on Pharmaceutical Sciences (*5). Several investigators have shown
convincing evidence connecting inadequate iodine intake and breast cancer (*6). Japanese
women living in Japan consumed a daily average of 13.8 mg total elemental iodine and they
experience one of the lowest prevalence (risk) for breast, ovarian and uterine cancer (*6). In
the 1960's, one slice of bread in the USA contained the full RDA of 0.15 mg iodine. The risk for
breast cancer was then 1 in 20 (*7). Over the last 2 decades, iodine was replaced by bromine in
the bread making process. Bromine blocks thyroid function and may interfere with the
anticancer effect of iodine on the breast (*4). Now, the risk for breast cancer is 1 in 8 and
increasing 1% per year (*7).

The RDA limits for vitamins and minerals were established after World War II. One of the last
essential elements included in the RDA system was iodine, established in 1980 and confirmed
in 1989 (*8). The RDA for iodine was based on the amount of iodine/iodide needed to prevent
goiter, extreme stupidity and hypothyroidism (*9). The optimal requirement of the whole human
body for iodine has never been studied. Therefore, the optimal amount of this element for
physical and mental wellbeing is unknown. Based on demographic studies, the mainland
Japanese consumed an average of 13.8 mg daily and they are one of the healthiest people on
planet earth (*6). Lugol solution is a time-tested preparation with a proven track record for
over 150 years. Two drops contain 12.5 mg iodine/iodide, an amount very close to the 13.8 mg
average intake of mainland Japanese.

II. RATIONALE FOR THIS

FORMULATION

Administration of iodine/iodide in liquid solution is not very accurate, may stain clothing, has
an unpleasant taste and causes gastric irritation. Iodoral® is a precisely quantified tablet form
containing 5 mg iodine and 7.5 mg iodide as the potassium salt. To prevent gastric irritation,
the iodine/iodide preparation was absorbed unto a colloidal silica excipient; and to eliminate
the unpleasant taste of iodine, the tablets were coated with a thin film of pharmaceutical glaze
(*10).

III. SUGGESTED USE

The suggested daily amount is 1-4 tablets/day as recommended by your physician. Work closely
with your physician while on the Iodoral® program. Report to your physician any history of
thyroid surgery and/or radiation, chronic lymphocytic thyroiditis (Hashimoto), and any previous
problem with your thyroid. Before starting Iodoral®, your physician (He/She = He) will order
blood tests for hematology, blood chemistry and thyroid functions. He will also perform an
ultrasound of your thyroid to measure the size and appearance of your thyroid. Depending on
the results of the thyroid function tests and ultrasound, he may order some blood tests for
thyroid antibodies. If you are taking thyroid hormones, let your physician know about it. Be
aware that Iodoral® enhances the response of your body to thyroid hormones (*4,6). Subjects
on Iodoral® feel warmer in cold environments and that is expected. However, you will need to
cut down the amount of thyroid hormones if you experience palpitation, anxiety, increased
sweating and intolerance to heat. That is because Iodoral® decreases your need for thyroid
hormones. Your physician will guide you in titrating downward the amount of thyroid
hormones. Your physician will reevaluate you one month afterward if you are on thyroid
hormones, and 3 months if not. Keep a record of what you observe while on Iodoral® and show
it to your physician.

To test whole body sufficiency for iodine, 4 tablets of Iodoral® are ingested, followed by 24 hr.
urine collection. The more deficient a subject is in iodine, the more iodine is retained by the
body and the least excreted in the urine. Sufficiency is achieved when 90% or more of the
ingested amount is excreted in the urine. In most subjects tested, 3-4 tablets of Iodoral®/day
were required to achieve whole body sufficiency within 3 months and the body retained
approximately 1.5 gm iodine at sufficiency (*4,8). The best response in patients with FDB was
observed with ingestion of 2 tablets twice a day (*8). Check with your physician for more
information about the loading test.

IV. REFERENCES

1) Ghent, W., et al, Can. J. Surg., 36:453-460,1993.

2) Eskin, B., et al, Biological Trace Element Research, 49:9-19, 1995.

3) Marine, D., Atl. Med. J., 26:437-442, 1923.

4) Abraham,G.E., The Original Internist, 11:17-36, 2004.

5) Gennaro A.R., Remington: 19th Edition, 1995, Mack Publishing Co, 1267.

6) Abraham, G.E., Flechas, J.D., Hakala, J.C., The Original Internist, 9:30-41, 2002.

7) Epstein, S.S., et al, Breast Cancer Prevention Program Macmillan, NY, 1998, pg5.

8) Abraham, G.E., The Original Internist, 11:(2) 29-38, 2004.

9) Abraham, G.E. Townsend Letter, 245:100-101, 2003.

10) Abraham, G.E., Flechas, J.D., Hakala, J.C., The Original Internist, 9:5-20, 2002.

V. POTENTIAL SIDE EFFECTS

Ingestion of iodine and/or iodide has been associated with certain complaints. If you experience any of the
following, stop ingesting Iodoral® and contact your physician:

• acne-like skin lesions in certain areas of your body

• headache in the frontal sinus

• unpleasant brassy taste

• increased salivation and sneezing

If you experience any unusual symptom since starting on Iodoral®, contact your physician.