WARNINGS AND PRECAUTIONS
Risks Associated with Inadvertent Parenteral Administration: 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.
Hypersensitivity Reactions: Administration of ORALTAG can cause life-threatening hypersensitivity reactions including anaphylaxis. 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.
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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.
ADVERSE REACTIONS
The most common adverse reactions (incidence <2%) are nausea, vomiting, and diarrhea.
USE IN SPECIFIC POPULATIONS
Lactation: 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 ORALTAG.
Geriatric Use: 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.
Please see FULL PRESCRIBING INFORMATION for ORALTAG (iohexol).
About Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.”
Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en.
About Interpharma Praha, a.s.
Interpharma Praha, a.s. develops and commercializes novel contrast media and active ingredients for pharmaceutical and nutraceutical products from its base in the Czech Republic. Established in 1932, it became a wholly owned subsidiary of Otsuka in 2008. For more information, please visit http://www.interpharma-praha.com/en.
