Hypaque

This medium is indicated for radiographic examination of the gastrointestinal tract following oral or rectal administration.

SEVERE ADVERSE EVENTS-INADVERTENT INTRATHECAL ADMINISTRATION

Severe adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that this drug product is not administered intrathecally.

Serious or fatal reactions have been associated with the parenteral administration of radiopaque media. It is important that a course of action be carefully planned in advance for the treatment of possible serious reactions with oral use of Hypaque solutions. (See Precautions.)

Usage in Pregnancy

The safety of orally administered Hypaque solutions during pregnancy has not been established. Therefore, before administration of the drug to women of childbearing potential, the benefit to the patient should be carefully weighed against the possible risk to the fetus. In addition, most authorities consider elective contrast radiography of the abdomen contraindicated during pregnancy.

There have been few reported cases of adverse reactions with orally administered solutions of water-soluble contrast agents. Because of their osmotic effect, such solutions tend to exert cathartic action, but this is generally considered an advantage. Nausea, vomiting, or slight diarrhea may occasionally occur, particularly when the medium is used in a high concentration or large volume. Urticaria has been observed in a few patients; presumably the condition was caused by allergy to the contrast medium and it was readily alleviated by antihistamine therapy.

Because small amounts of the medium may be absorbed, the possibility of systemic reactions should be considered, particularly in cases of perforation.