FDA
Diatrizoate Meglumine and Diatrizoate Sodium
The FDA lists this product in 2 strengths and forms.
Indications
Diatrizoate Meglumine and Diatrizoate Sodium Solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous. Diatrizoate Meglumine and Diatrizoate Sodium Solution may also be used as an adjunct to contrast enhancement is computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology.
Contraindications
Do not administer to patients with a known hypersensitivity to Diatrizoate Meglumine and Diatrizoate Sodium Solution or any of its components.
Warnings and precautions
Dehydration: Administration of hypertonic Diatrizoate Meglumine and Diatrizoate Sodium Solution may lead to hypovolemia and hypotension due to fluid loss from the intestine. A 1 in 4.6 (1:4.6) dilution of Diatrizoate Meglumine and Diatrizoate Sodium Solution yields an approximately isotonic 16.5 percent diatrizoate salts solution; less dilute solutions are hypertonic and may lead to intraluminal movement of fluid with resulting hypovolemia.
In young or debilitated children and in elderly cachectic persons, the loss of plasma fluid may be sufficient to cause a shock-like state. If Diatrizoate Meglumine and Diatrizoate Sodium Solution is used in infants and children (under 10 kg) or in dehydrated or debilitated patients, the solution must be prepared using the specific dilutions described in DOSAGE AND ADMINISTRATION . In debilitated patients and in patients with electrolyte imbalances, postprocedural monitoring of hydration, serum osmolarity, electrolytes and clinical status is essential.
In pediatric or severely debilitated patients, the maintenance of an open intravenous fluid line for rehydration may be advisable should hypotension or shock supervene. Electrolyte disturbances must be corrected prior to the administration of any hypertonic Diatrizoate Meglumine and Diatrizoate Sodium Solution. Aspiration: Aspiration of Diatrizoate Meglumine and Diatrizoate Sodium Solution into the trachea and airways may result in serious pulmonary complications including, pulmonary edema, pneumonitis or death Bronchial entry of any orally administered contrast medium causes a copious osmotic effusion.



