MD GASTROVIEW 600 mg/mL
diatrizoate meglumine and diatrizoate sodium · SOLUTION · Liebel-Flarsheim Company LLC
MD GASTROVIEW is a solution containing diatrizoate meglumine and diatrizoate sodium at 600 mg/mL, taken oral. Manufactured by Liebel-Flarsheim Company LLC.
Key Facts
- Brand Name
- MD GASTROVIEW
- Generic Name
- diatrizoate meglumine and diatrizoate sodium
- NDC Code (Product)
0019-4816- Manufacturer
- Liebel-Flarsheim Company LLC
- Strength
- 600 mg/mL
- Dosage Form
- SOLUTION
- Route
- ORAL, RECTAL
- Marketing Status
- Application #
- ANDA087388
- Marketing Start
- 08/31/2009
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION General 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. Radiographic Examination of Segments of the Gastrointestinal Tract Oral Administration: Adult oral dosage may range from 30 to 90 mL (11 to 33 g iodine), depending on the nature of the examination and the size of the patient. For infants and children less than 5 years of age, 30 mL (11 g iodine) are usually adequate; for children 5 to 10 years of age, the suggested dose is 60 mL (22 g iodine). These pediatric doses may be diluted 1:1, if desired, with water, carbonated beverage, milk, or mineral oil. When used in infants, the solution may be given in a nursing bottle. Pediatric doses may also be used in dehydrated and/or debilitated adult patients. A 1:1 dilution is also recommended when the contrast medium is used in elderly cachectic individuals. For very young (under 10 kg) and debilitated children the dose should be diluted…
Warnings
WARNINGS Dehydration: Administration of hypertonic MD-Gastroview solutions may lead to hypovolemia and hypotension due to fluid loss from the intestine. A 1 in 4.6 (1:4.6) dilution of MD-Gastroview 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 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 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 MD-Gastroview solutions. Aspiration: Asp…
Contraindications
CONTRAINDICATIONS Do not administer to patients with a known hypersensitivity to MD-Gastroview or any of its components.
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 or 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.
Frequently Asked Questions
What is MD GASTROVIEW used for?
MD GASTROVIEW contains diatrizoate meglumine and diatrizoate sodium. It is a solution taken oral. Consult your doctor for specific uses.
Is MD GASTROVIEW a controlled substance?
MD GASTROVIEW is not classified as a controlled substance by the DEA.
What is the generic name for MD GASTROVIEW?
The generic name for MD GASTROVIEW is diatrizoate meglumine and diatrizoate sodium. There are 4 other brand versions of diatrizoate meglumine and diatrizoate sodium.
What is the NDC code for MD GASTROVIEW 600 mg/mL?
The NDC (National Drug Code) for MD GASTROVIEW 600 mg/mL is 0019-4816, listed by Liebel-Flarsheim Company LLC.