Included as part of the PRECAUTIONS section.
Risks Associated With Inadvertent Parenteral
Oraltag is not a sterile product and is not suitable for
a parenteral route of administration. Serious adverse reactions such as sepsis
can occur if administered parenterally. Do not administer Oraltag parenterally.
Administration of Oraltag can cause life-threatening
hypersensitivity reactions including anaphylaxis [see CONTRAINDICATIONS].
Patients at increased risk include those with a previous reaction to an
iodinated contrast agent and allergic disorders (i.e., bronchial asthma,
allergic rhinitis, and food allergies). Emergency resuscitation equipment and
trained personnel should be available.
Alteration Of Thyroid Function Tests
Iodinated contrast agents may alter the results of
thyroid function tests which depend on iodine estimation, e.g., radioactive
iodine uptake test. Therefore, such testing, if indicated, should be performed
prior to the administration of this preparation.
Impairment Of Fertility
No long-term animal studies
have been performed to evaluate carcinogenic potential or mutagenesis.
In animal reproduction studies,
no evidence of impaired fertility was observed with intravenous administration
of iohexol to rats and rabbits at doses up to 100 times the maximum recommended
human intravenous dose.
Use In Specific Populations
There are no human data on risks associated with the use
of Oraltag during pregnancy. The background risk in the U.S. general population
of major birth defects is 2% to 4% and risk of miscarriage is 15% to 20% of
clinically recognized pregnancies. In animal reproduction studies, no evidence
of fetal harm was observed with intravenous administration of iohexol to rats
and rabbits at doses up to 100 times the maximum recommended human intravenous
Iohexol administered intravenously is present in human
milk at concentrations approximately 0.5% of the maternal dose; however, it is
not known to what extent iohexol administered orally is present in human milk.
Iodinated contrast is poorly excreted into human milk and is poorly absorbed by
the gastrointestinal tract of a breastfed infant. The developmental and health
benefits of breastfeeding should be considered along with the mother's clinical
need for Oraltag and any potential adverse effects on the breastfed infant from
Interruption of breastfeeding after exposure to iodinated
contrast media is not necessary because the potential exposure of the breastfed
infant to iodine is small. However, a lactating woman may consider interrupting
breastfeeding and pumping and discarding breast milk for 10 hours
(approximately 5 half-lives) after Oraltag administration in order to minimize
potential drug exposure to a breastfed infant.
The safety and effectiveness of oral iohexol have been established
in pediatric patients.
In general, dose selection for an elderly patient should
be cautious, usually starting at the low end of the dosing range, reflecting
the greater frequency of decreased hepatic, renal, or cardiac function, and of
concomitant disease or other drug therapy.