Potassium Iodide (KI) dosages, etc.

["Patricia Milligan" <PXM@NRC.GOV>]

I am posting this with permission of Dr. Orloff, FDA.   I hope this might help address some of the concerns with regards to appropriate dosages, etc for children. 

P. Milligan , RPh, CHP

USNRC

301-415-2223



>> "Orloff, David G" <ORLOFFD@cder.fda.gov> 04/22/02 02:59PM >>>

The revised FDA guidance includes a graded dosing scheme for KI

administration to different age groups (body sizes) that addresses issues of

minimum effective dose.  The guidance also emphasizes that administration

according to the graded dosing scheme may not always be possible, due to the

logistics of a given emergency situation.  As such, it must be understood

that we have provided guidance only and that this is not the only safe and

effective way to administer KI for thyroid protection.  Specifically, higher

doses (e.g., up to 130 mg) will be equally effective and, especially for

children above 1 month of age, and certainly for school aged children,

extremely safe.  On balance, if a risk of significant thyroidal radioiodine

exposure exists, we recommend taking KI as a prophylactic measure to prevent

late development of thyroid nodules and cancer, as this risk supercedes the

minimal risk of overdosage.  In most instances, adverse reactions to iodine

will be GI disturbances only.



The guidance we have issued is not just for the 10-mile EPZ, but for any and

all areas potentially affected.  Close in, there may not be time to deal

with fractional dosage of KI.  That said, FDA is undertaking studies of the

solubility, palatability, and stability of KI in a number of beverages,

including juice and infant formula.  This will enable dosing to small

children and fractional dosing where time permits.  The results of these

studies, as well as a new set of Q&A's will soon be available on the FDA

website.



With regard to lower dosage strengths of KI, FDA is working with

manufacturers to bring 65 mg tablets to market as well as SSKI solution.  We

have no anticipated date of approval at this time, and we do not expect any

denominations below 65 mg.  As above, for those localities where time is

truly of the essence, we do not believe that having multiple strengths would

do other than to make matters more confusing and time consuming.



Finally, we are updating the labels for KI to conform with our new guidance

and to include the message re dose I have repeated above.



I trust this is of help.



David Orloff





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