Diatrizoate Meglumine and Diatrizoate Sodium
Generic: DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM
Basic Information
Manufacturer
Guardian Drug Company
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
e9da4d3d-d0ca-44f7-aaeb-ae49c3839775
Indications & Usage
INDICATIONS & USAGE 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.
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.
Warnings
WARNINGS 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.
Therefore, avoid use of Diatrizoate Meglumine and Diatrizoate Sodium Solution in patients with esophagotracheal fistula and minimize risks for pulmonary aspiration in all patients.
If Diatrizoate Meglumine and Diatrizoate Sodium Solution 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 Diatrizoate Meglumine and Diatrizoate Sodium Solution.
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 Diatrizoate Meglumine and Diatrizoate Sodium Solution is used.
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.
Therefore, avoid use of Diatrizoate Meglumine and Diatrizoate Sodium Solution in patients with esophagotracheal fistula and minimize risks for pulmonary aspiration in all patients.
If Diatrizoate Meglumine and Diatrizoate Sodium Solution 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 Diatrizoate Meglumine and Diatrizoate Sodium Solution.
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 Diatrizoate Meglumine and Diatrizoate Sodium Solution is used.
Adverse Reactions
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.
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.