openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS Dehydration: Administration of hypertonic Gastrografin solutions may lead to hypovolemia and hypotension due to fluid loss from the intestine. A 1 in 4.6 (1:4.6) dilution of Gastrografin 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 Gastrografin 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 Gastrografin solutions. Aspiration: Aspiration of Gastrografin 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 Gastrografin in patients with esophagotracheal fistula and minimize risks for pulmonary aspiration in all patients. If Gastrografin is given by nasogastric tube, the position of the tube in the stomach must be verified before administration. Anaphylactic reactions: Anaphylactic reactions, including fatalities, have been reported with the use of Gastrografin. 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). Medical personnel trained in the treatment of anaphylactic reactions and the necessary drugs and medical equipment should always be readily available when Gastrografin is used.
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 of large volumes of solution are administered. Severe changes in serum osmolarity and electrolyte concentrations may produce shock-like states (see WARNINGS ). 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.