TOKYO--(BUSINESS WIRE)--Otsuka Pharmaceutical Co. Ltd. and its wholly-owned subsidiary Interpharma Praha, a.s. announced today that ORALTAG, a formulation of dry, dissolvable iohexol powder for oral solution, will become commercially available from WMB Enterprises, LLC, (a wholly owned subsidiary of Beekley Corporation) and marketed by Beekley Medical.
ORALTAG was approved in March 2015 by the U.S. Food and Drug Administration for use as a radiographic contrast agent for opacification of the gastrointestinal tract during CT (computed tomography) scanning of the abdomen and pelvis. ORALTAG is not indicated for diagnostic examination of the gastrointestinal tract, and is contraindicated in patients with a known hypersensitivity to iodinated contrast agents, including iohexol.
ORALTAG comes in a graduated bottle, providing clinicians the means to rapidly measure and prepare a unit dose of iohexol. The dried powder can be prepared at a range of desired concentrations, and gives patients an easy-to-handle, hygienic bottle with cap. The iohexol can be prepared in a wide range of beverages, suited to each patient. ORALTAG is not a sterile product and is not suitable for a parenteral route of administration.
In the U.S. barium sulfate or high-osmolar iodine contrast agents have long been the standard practice for patients undergoing CT imaging of the abdomen. However, considerations such as ease of use and taste have led to an increasing trend in iohexol use*1. The liquid formulation of iohexol is commonly poured into a plastic cup and then diluted, but this can lead to complicated dose adjustments and errors in administration. The packaging for ORALTAG allows for preparation of the iohexol in a single-use bottle. There are 5 fill lines pre-molded on the bottle for accurate dilution of the product to a desired concentration. Once dissolved, ORALTAG can then be directly administered to the patient from the bottle.
INDICATIONS and IMPORTANT SAFETY INFORMATION for ORALTAG (iohexol) for Oral Solution
ORALTAG is indicated for use in computed tomography of the abdomen and pelvis to opacify bowel loops and delineate between normal loops and adjacent organs or areas of suspected pathology.
Limitations of Use
ORALTAG is not indicated for diagnostic examination of the gastrointestinal tract.
IMPORTANT SAFETY INFORMATION:
CONTRAINDICATION: ORALTAG is contraindicated in patients with a known hypersensitivity to iodinated contrast agents, including iohexol.
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.
- 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.
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.
About WMB Enterprises, LLC
WMB Enterprises is a wholly owned subsidiary of Beekley Corporation. As the company's joint ventures and acquisitions arm, WMB helps companies looking for a partner to increase sales and market penetration of new products. For more information, please visit http://www.beekleycorporation.com/Our-businesses.
*1 Horton, K.M. et al, The use of iohexol as oral contrast for computed tomography of the abdomen and pelvis. J. Comput. Assist. Tomogr., 32, 207-209, 2008
July 2015 19US16EBC0001