July 5, 2016
Otsuka Pharmaceutical Co., Ltd.
ORALTAG™(iohexol), a New Oral Contrast Agent for Abdominal CT Scans, Launched in U.S. Developed by Otsuka Subsidiary Interpharma Praha
- ORALTAG™ from Interpharma Praha is a dissolvable powder form of the widely-used contrast agent iohexol
- Iohexol has been available in liquid form but its preparation is complicated and prone to errors, leaving room for improved packaging that better complies with guidelines for drug dispensing.
- In the U.S. iohexol is increasingly used as an oral agent for abdominal CT scans due to better patient acceptance compared to barium or high-osmolar iodinated agents
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.
- 1Horton, 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
Information in this news release was current as of the original release date.