Oraltag

The following adverse reactions are described in greater detail in other sections:

• Hypersensitivity reactions [see Warnings and Precautions (5.2)]

  Clinical Trials Experience

In studies involving 44 adult and 69 pediatric patients who received oral and intravenous iohexol for CT examinations of the abdomen, two reports of vomiting (2%) were noted.

  Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been reported following oral administration of the dilute, hypotonic solutions of iohexol (9 mgI/mL to 21 mgI/mL):

• Gastrointestinal: nausea, diarrhea

Oraltag (iohexol) is a radiographic contrast agent for oral solution. Oraltag is provided as a nonsterile white to off-white powder with 9.7 g iohexol (equivalent to 4.5 g of carbon bound iodine) in a 20-ounce beverage bottle. Each bottle is individually sealed in a foil laminated pouch. Oraltag consists of 100 percent iohexol and contains no excipients.

Iohexol is designated chemically as N,N´-bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodoisophthalamide. It is a nonionic, water-soluble iodinated contrast medium with a molecular weight of 821.14 (carbon bound iodine content 46.36%). In aqueous solution each triiodinated molecule remains undissociated.

The chemical structure is:

Oraltag, when prepared at a concentration of 9 mgI/mL in water, has an osmolality of 30 mOsmol/kg water. The calculated osmolality of 21 mgI/mL in water is 55 mOsmol/kg water. The prepared solutions are hypotonic.