Diatrizoate Meglumine and Diatrizoate Sodium 660 mg/mL
Diatrizoate Meglumine and Diatrizoate Sodium · SOLUTION · Camber Pharmaceuticals, Inc.
Diatrizoate Meglumine and Diatrizoate Sodium is a solution containing diatrizoate meglumine and diatrizoate sodium at 660 mg/mL, taken oral. Manufactured by Camber Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Diatrizoate Meglumine and Diatrizoate Sodium
- Generic Name
- Diatrizoate Meglumine and Diatrizoate Sodium
- NDC Code (Product)
31722-019- Manufacturer
- Camber Pharmaceuticals, Inc.
- Strength
- 660 mg/mL
- Dosage Form
- SOLUTION
- Route
- ORAL, RECTAL
- Marketing Status
- Application #
- ANDA215049
- Marketing Start
- 11/17/2023
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Bracco Diagnostics Inc
Presence of foreign substance: One lot of the product may contain black foreign particles
Mallinckrodt, Inc.
Labeling: incorrect or missing lot number and/or expiration date
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND 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 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 administration only. Discard any unused portion after procedure. 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 k…
Warnings
WARNINGS Dehydration: Administration of hypertonic diatrizoate meglumine and diatrizoate sodium solutions 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 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 mus…
Contraindications
CONTRAINDICATIONS Do not administer to patients with a known hypersensitivity to diatrizoate meglumine and diatrizoate sodium solution 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 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.
Frequently Asked Questions
What is Diatrizoate Meglumine and Diatrizoate Sodium used for?
Diatrizoate Meglumine and Diatrizoate Sodium contains Diatrizoate Meglumine and Diatrizoate Sodium. It is a solution taken oral. Consult your doctor for specific uses.
Is Diatrizoate Meglumine and Diatrizoate Sodium a controlled substance?
Diatrizoate Meglumine and Diatrizoate Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Diatrizoate Meglumine and Diatrizoate Sodium?
The generic name for Diatrizoate Meglumine and Diatrizoate Sodium is Diatrizoate Meglumine and Diatrizoate Sodium. There are 2 other brand versions of Diatrizoate Meglumine and Diatrizoate Sodium.
What is the NDC code for Diatrizoate Meglumine and Diatrizoate Sodium 660 mg/mL?
The NDC (National Drug Code) for Diatrizoate Meglumine and Diatrizoate Sodium 660 mg/mL is 31722-019, listed by Camber Pharmaceuticals, Inc..