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diatrizoate meglumine and diatrizoate sodium
Overview
What is MD GASTROVIEW?
MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution) is a palatable lemon-vanilla flavored water-soluble iodinated radiopaque contrast medium for oral or rectal administration only. Each mL contains 660 mg diatrizoate meglumine and 100 mg diatrizoate sodium; pH has been adjusted to 6.0 to 7.6 with sodium hydroxide. Each mL contains approximately 4.8 mg (0.21 mEq) sodium and 367 mg organically bound iodine. MD-Gastroview does not contain the wetting agent polysorbate 80.
The inactive ingredients are: Edetate Disodium Dihydrate, Lemon-Vanilla Flavor, Sodium Citrate, Sodium Hydroxide, Sodium Saccharin, Water for Injection. Air in the container is displaced with nitrogen.
Diatrizoate meglumine is designated chemically as 1-deoxy-1-(methylamino)-D-glucitol 3,5-diacetamido-2,4,6-triiodobenzoate (salt); diatrizoate sodium is monosodium 3,5-diacetamido-2,4,6-triiodobenzoate. The two salts have the following structural formulae:
What does MD GASTROVIEW look like?
What are the available doses of MD GASTROVIEW?
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What should I talk to my health care provider before I take MD GASTROVIEW?
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How should I use MD GASTROVIEW?
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.
This medium is not to be used for the preparation of solutions for parenteral administration. Oral or rectal use only.
The routine preparatory measures employed for barium studies are also appropriate for this agent.
For pediatric and severely cachectic patients, the maintenance of an intravenous fluid line may be advisable.
What interacts with MD GASTROVIEW?
Do not administer to patients with a known hypersensitivity to MD-Gastroview or any of its components.
What are the warnings of MD GASTROVIEW?
8. OATP1B1 substrates – Gemfibrozil is an inhibitor of organic anion-transporter polyprotein (OATP) 1B1 and may increase exposure of drugs that are substrates of OATP1B1 (e.g., atrasentan, atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, SN38 [active metabolite of irinotecan], rosuvastatin, pitavastatin, pravastatin, rifampin, valsartan, olmesartan). Therefore, dosing reductions of drugs that are substrates of OATP1B1 may be required when gemfibrozil is used concomitantly (see ). Combination therapy of gemfibrozil with simvastatin or with repaglinide, which are OATP1B1 substrates, is contraindicated (see ).
Dehydration:
Aspiration:
Anaphylactic Reactions:
What are the precautions of MD GASTROVIEW?
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What are the side effects of MD GASTROVIEW?
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.
What should I look out for while using MD GASTROVIEW?
Do not administer to patients with a known hypersensitivity to MD-Gastroview or any of its components.
Dehydration:
Aspiration:
Anaphylactic Reactions:
What might happen if I take too much MD GASTROVIEW?
See regarding potential hypovolemia, hypotension, or shock. The maintenance of an open intravenous fluid line for rehydration may be advisable. See for appropriate doses and dilutions. Treatment of an overdose should be directed toward the support of all vital functions, and prompt institution of symptomatic therapy.
How should I store and handle MD GASTROVIEW?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. Available as an aqueous lemon-vanilla flavored solution in bottles of 30 mL in packages of 25 (NDC 0019-4816-04).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The most important characteristic of contrast media is the iodine content. The relatively high atomic weight of iodine contributes sufficient radiodensity for radiographic contrast with surrounding tissues.
Diagnostic enteral radiopaque agents have few known pharmacological effects. Diatrizoate meglumine and diatrizoate sodium exert a mild laxative effect attributable to their high osmolarity.
Diatrizoate meglumine and diatrizoate sodium are sparingly absorbed from the intact gastrointestinal tract, and therefore permit gastrointestinal opacification and delineation after oral or rectal administration. Oral administration is used for radiographic evaluation of the esophagus, stomach and proximal small intestine. Rectal administration is used for examination of the colon; however, visualization of the distal small bowel is generally unsatisfactory, since the hypertonicity of the medium causes intraluminal diffusion of water with subsequent dilution of the medium. Enough absorption from the gastrointestinal tract to permit incidental visualization of the urinary tract has been reported; this should also be considered when thyroid testing is being contemplated, since iodine-mediated thyrotropic effects may occur (
).
Non-Clinical Toxicology
Do not administer to patients with a known hypersensitivity to MD-Gastroview or any of its components.Dehydration:
Aspiration:
Anaphylactic Reactions:
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.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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