Diatrizoate Meglumine and Diatrizoate Sodium

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 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 kg) and debilitated children the dose should be diluted: 1 part diatrizoate meglumine and diatrizoate sodium solution in 3 parts water is recommended. For Enemas or Enterostomy Instillations: Diatrizoate meglumine and diatrizoate sodium solution should be diluted when it is used for enemas and enterostomy instillations. When used as an enema, the suggested dilution for adults is 240 mL (88 g iodine) in 1,000 mL of tap water. For children under 5 years of age, a 1:5 dilution in tap water is suggested; for children over 5 years of age, 90 mL (33 g iodine) in 500 mL of tap water is a suitable dilution. Tomography (Body Imaging) A usual adult dose is 240 mL of a dilute diatrizoate meglumine and diatrizoate sodium solution prepared by diluting 25 mL (9.17 g iodine) to one liter with tap water. Less dilute solutions [up to 77 mL (28.26 g iodine) diluted to one liter with tap water] may be used when indicated. The dose is administered orally about 15 to 30 minutes prior to imaging in order to permit the contrast medium to reach the pelvic loops.

CONTRAINDICATIONS Do not administer to patients with a known hypersensitivity to diatrizoate meglumine and diatrizoate sodium solution or any of its components.

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.

DESCRIPTION Diatrizoate Meglumine and Diatrizoate Sodium Solution, USP is a palatable strawberry-flavored water-soluble iodinated radiopaque contrast medium for oral or rectal administration only. Each mL contains 660 mg diatrizoate meglumine USP and 100 mg diatrizoate sodium USP; 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. Inactive ingredients: edetate disodium dihydrate, polysorbate 80, saccharin sodium, simethicone, sodium hydroxide, strawberry flavor and tri-sodium citrate dihydrate. 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. Structural formulas: Diatrizoate meglumine C 11 H 9 I 3 N 2 O 4 .C 7 H 17 NO 5 Molecular Weight: 809.13 Organically bound Iodine: 47.1% Diatrizoate sodium C 11 H 8 I 3 N 2 NaO 4 Molecular Weight: 635.90 Organically bound Iodine: 59.9% dmdschemicalstructure dmdschemicalstructure2

OVERDOSAGE See WARNINGS regarding potential hypovolemia, hypotension, or shock. The maintenance of an open intravenous fluid line for rehydration may be advisable. See DOSAGE AND ADMINISTRATION 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 SUPPLIED Diatrizoate Meglumine and Diatrizoate Sodium Solution USP is available as clear, aqueous, pale yellow color solution, with strawberry flavor in packages of: Twenty-four 30 mL single dose bottles (NDC 31722-019-31). Twelve 120 mL single dose bottles (NDC 31722-019-32). Storage Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; avoid excessive heat. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Annora Pharma Pvt. Ltd. Sangareddy - 502313, Telangana, India. Revised: 04/2024 dmdscamberlogo