MD-Gastroview^® (diatrizoate meglumine and diatrizoate sodium solution USP)

Indication and Usage
MD-Gastroview^® (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.

MD-Gastroview may also be used as an adjunct to contrast enhancement in 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 MD-Gastroview or any of its components.

Precautions
Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for coping with any complication of administration, as well as for treatment of reaction to the contrast medium.

Rectal administration of undiluted MD-Gastroview in any patient, particularly with large doses and/or in those with overdistention, has been reported to be associated with mucosal irritation. Cases of hyperthyroidism have been reported with the use of oral contrast media. Some of these patients reportedly had multinodular goiters which may have been responsible for the increased hormone synthesis in response to excess iodine. Administration of an intravascular iodinated radiopaque diagnostic agent to a hyperthyroid patient precipitated thyroid storm; a similar situation could follow administration of oral preparations of iodides. Therefore, caution should be exercised when administering enteral gastrointestinal radiopaque agents to hyperthyroid and euthyroid goiterous patients.

Consideration should be given to the potential for precipitation of water-soluble contrast agents under conditions that may promote hyperacidity (i.e., fasting, emotional upset, or stress). Harmful effects directly attributable to precipitate formation have not been reported. However, the possibility of interpreting the precipitate radiologically as an anatomical abnormality (i.e., ulceration of the stomach or small intestine) or injury, should be kept in mind.

Adverse Reactions
Most adverse reactions to enteral diagnostic radiopaque agents are mild and transitory. Nausea, vomiting and/or diarrhea, urticaria with erythema, hypoxia, acute dyspnea, tachyarrhythmia, and anaphylaxis have occurred following ingestion of the contrast medium, particularly when high concentrations or large volumes of solution are administered. Severe changes in serum osmolarity and electrolyte concentrations may produce shock-like states. It should be kept in mind that serious or anaphylactoid reactions that may occur with intravascular administration of radiopaque contrast agents are theoretically possible following administration by other routes.

Warnings

• Dehydration: Administration of hypertonic MD-Gastroview solutions may lead to hypovolemia and hypotension due to fluid loss from the intestine. Hypertonic solutions 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. In debilitated patients and in patients with electrolyte imbalances, postprocedural monitoring of hydration, serum osmolarity, electrolytes and clinical status is essential.
• Aspiration: Aspiration of MD-Gastroview 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. Therefore, avoid use of MD-Gastroview in patients with esophagotracheal fistula and minimize risks for pulmonary aspiration in all patients.
• Anaphylactic reactions: Anaphylactic reactions,including fatalities, have been reported with the use of MD-Gastroview. Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine, and patients with a known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies).

Use in Specific Populations

• Pregnancy Category B: Intravenous administration causes diatrizoate salts to cross the placenta and evenly distribute in fetal tissues. Teratogenic effects attributable to diatrizoate meglumine or diatrizoate sodium have not been observed in teratology studies performed in animals. There are, however, no adequate and well-controlled studies in pregnant women. Because small amounts of these agents may be absorbed, and animal teratology studies are not always predictive of human response, these agents should be used during pregnancy only when clearly needed. Procedures including radiation involve a certain risk related to the exposure of the fetus.
• Nursing Mothers: Diatrizoate meglumine is excreted in breast milk following intravascular administration. Because small amounts of enteral gastrointestinal radiopaque agents may be absorbed following oral or rectal administration, caution should be exercised when they are administered to a nursing woman.
• Pediatric Use: If MD-Gastroview^® 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 the prescribing information. 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 MD-Gastroview solutions.

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