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Diatrizoate meglumine and diatrizoate sodium (Gastrografin): Drug information

Diatrizoate meglumine and diatrizoate sodium (Gastrografin): Drug information
(For additional information see "Diatrizoate meglumine and diatrizoate sodium (Gastrografin): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Gastrografin;
  • MD-Gastroview [DSC]
Brand Names: Canada
  • Gastrografin
Pharmacologic Category
  • Iodinated Contrast Media;
  • Radiological/Contrast Media (Ionic, High Osmolality)
Dosing: Adult
Radiographic exam of GI tract segments

Radiographic exam of GI tract segments:

Oral: 30 to 90 mL; decrease dose in debilitated or dehydrated patients.

Rectal enema/enterostomy instillation: Dilute 240 mL in 1,000 mL tap water.

Tomography

Tomography: Oral: Dilute 25 to 77 mL in 1000 mL tap water, then administer 240 mL of this solution 15 to 30 minutes prior to imaging.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Pediatric
Angiocardiography

Angiocardiography: IV (injected into larger peripheral vein or by direct catheterization of the heart):

Infants and Children <5 years: 10 to 20 mL. Note: The risk of using this dose in children weighing <7 kg is increased especially if infants have pre-existing right heart strain, right heart failure, or decreased or obliterated pulmonary vascular beds.

Children 5 to 10 years: 20 to 30 mL; up to 100 mL have been administered.

Aortography

Aortography: IV or intra-arterial: Adolescents >16 years: Refer to adult dosing.

Excretory urography

Excretory urography: IV: Infants, Children, and Adolescents:

<6 months: 4 mL

6 to 12 months: 6 mL

1 to 2 years: 8 mL

2 to 5 years: 10 mL

5 to 7 years: 12 mL

8 to 10 years: 14 mL

11 to 15 years: 16 mL

≥16 years: Refer to adult dosing

Note: Ensure low residue diet the day prior to procedure with a laxative given the evening prior to the procedure unless contraindicated. Do not fluid restrict infants and young children prior to procedure.

Peripheral arteriography

Peripheral arteriography: Intra-arterial (femoral or subclavian artery): Children and Adolescents: Adjust adult dose proportionally based on body weight. Consult product labeling for additional procedure specific warnings/precautions.

Radiographic exam of GI tract segments

Radiographic exam of GI tract segments:

Oral:

Infants and Children <5 years: 30 mL; may dilute 1:1 in a recommended liquid (if patient <10 kg or debilitated, should dilute 1:3 in water).

Children 5 to 10 years: 60 mL; may dilute 1:1 in a recommended liquid (if patient <10 kg or debilitated, should dilute 1:3 in water).

Children >10 years and Adolescents: Dosage varies.

Rectal enema/enterostomy instillation:

Children <5 years: Dosage varies. Dilute 1:5 in tap water.

Children >5 years: Dilute 90 mL in 500 mL tap water.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling. Use caution in severe impairment and in setting of combined renal and hepatic disease.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling. Use caution in patients with combined hepatic and renal disease.

Dosing: Older Adult

Radiographic exam of GI tract segments: Oral: 30 to 90 mL; If patient has cachexia, a 1:1 dilution of the oral solution using a recommended liquid is recommended. Decrease dose in debilitated or dehydrated patients.

Other indications: Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Oral:

Gastrografin: Diatrizoate meglumine 660 mg and diatrizoate sodium 100 mg per 1 mL (30 mL, 120 mL) [contains disodium edta, polysorbate 80, saccharin sodium]

MD-Gastroview: Diatrizoate meglumine 660 mg and diatrizoate sodium 100 mg per 1 mL (30 mL [DSC]) [contains disodium edta, saccharin sodium; lemon-vanilla flavor]

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Combination:

Gastrografin: 66-10 % (30 mL, 120 mL) [contains edetate (edta) sodium (tetrasodium), polysorbate 80, saccharin sodium]

Administration: Adult

Oral: May be administered diluted. May be diluted 1:1 with water, carbonated beverage, milk, or mineral oil for older adults with cachexia. Maintain an open IV fluid line in pediatric or severely debilitated patients in case hypotension or shock occurs and rehydration is required.

Rectal: Administer diluted prior to enema or enterostomy instillation.

Administration: Pediatric

Parenteral: MD-76 R: IV, Intra-arterial: Administer at body temperature; may need to be warmed before use. Slow or stop the injection if a minor reaction occurs during administration; discontinue if a major reaction occurs. Patient should omit the meal that precedes the examination. Appropriate premedication (eg, barbiturate, tranquilizer, or an analgesic) may be administered prior to the examination. Patients with a strong allergic history may receive an antihistamine within 30 minutes of administration of the contrast agent and corticosteroids prior to and for 24 hours after the contrast agent. Procedure specific administration considerations should also be reviewed; see product labeling for details.

Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation. If extravasation occurs, stop infusion immediately and disconnect; remove needle/cannula; elevate extremity. Aspiration of extravasated contrast media is not recommended (ACR 2018). Information conflicts regarding the use of hyaluronidase; the American College of Radiology (ACR) Manual on Contrast Media does not recommend hyaluronidase in the management of contrast media extravasation (ACR 2018); other sources suggest its utility in extravasation management (Bellin 2002; Reynolds 2014) (see Management of Drug Extravasations for more details).

Oral: May be diluted prior to administration. May administer in a bottle to infants. Maintain an open IV fluid line in case hypotension or shock occurs and rehydration is required.

Nasogastric tube: If ng administration is necessary, tube position must be verified prior to administration

Rectal: Dilute prior to enema or enterostomy instillation.

Use: Labeled Indications

Imaging: Oral/rectal: Radiographic examination of GI tract; adjunct to contrast enhancement in computed tomography of the torso (in conjunction with an IV radiopaque contrast agent).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reactions listed are based on reports for other agents in this same pharmacologic class and may not be specifically reported for diatrizoate meglumine and diatrizoate sodium. Also see diatrizoate meglumine.

Postmarketing:

Cardiovascular: Tachyarrhythmia

Dermatologic: Erythema of skin, urticaria

Endocrine & metabolic: Hyperthyroidism

Gastrointestinal: Diarrhea, nausea, vomiting

Hypersensitivity: Anaphylaxis

Respiratory: Dyspnea (acute), hypoxia

Contraindications

Hypersensitivity to diatrizoate or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Aspiration: Aspiration may occur following oral administration; serious complications may result due to the formation of a copious osmotic effusion. Avoid use in patients with esophagotracheal fistula; ensure proper positioning of the tube in the stomach prior to administration via nasogastric tube.

• Contrast media reactions: Adverse reactions (including delayed reactions) to iodine-containing contrast media have occurred. Most cases are minor; however, serious and life-threatening reactions may occur without warning and often resemble allergic-type reactions. Patients with a history of bronchial asthma, allergy (including food allergy), family history of allergy, or prior allergy or hypersensitivity to contrast agents are at a higher risk for allergic reaction. Obtain allergy and hypersensitivity history prior to administration.

• Dehydration: Use of hypertonic oral/rectal contrast solutions may cause hypovolemia and hypotension due to fluid loss from the intestines. Specific dilution guidelines are provided for administering solutions to young children, children <10 kg, older adults, or dehydrated and/or debilitated persons. Correct electrolyte imbalances prior to administration of hypertonic contrast solutions.

Disease-related concerns:

• Hyperacidity: Conditions that promote GI hyperacidity (eg, fasting, emotional upset, stress) may lead to the precipitation of orally administered water-soluble contrast agents; potential for false interpretation of precipitate as a GI anatomical abnormality or injury should be kept in mind.

• Hyperthyroidism: Cases of hyperthyroidism have been reported with the use of oral contrast media. Use with caution in patients who are hyperthyroid or euthyroid with a goiter.

• Myasthenia gravis: Use may worsen myasthenia gravis (MG); use with caution and monitor for worsening MG (AAN [Narayanaswami 2021]).

Special populations:

• Debilitated patients: Use oral/rectal hypertonic contrast agents with caution in debilitated patients due to the potential for fluid loss from the intestine.

• Older adults: Use with caution in older adult patients. Hypovolemia, hypotension, and shock may occur in older adult patients with cachexia following oral/rectal administration of the hypertonic contrast agent solution if dilution instructions are not followed.

• Pediatric: Use with caution in children. Injury to the colonic mucosa may occur if oral/rectal dilution instructions are not followed; risk may be increased with underlying diseases that affect intestinal viability. Hypovolemia, hypotension, and shock may occur in young, debilitated children following oral/rectal administration of the hypertonic contrast agent solution if dilution instructions are not followed.

Other warnings/precautions:

• Rectal administration: Undiluted solutions may cause mucosal irritation.

• Trained personnel: Clinicians using radiopaque contrast agents should be well trained in diagnosis and management of emergencies that may arise from the use of these agents. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use during and after administration (delayed reactions have occurred).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Aldesleukin: May enhance the potential for allergic or hypersensitivity reactions to Iodinated Contrast Agents. Risk C: Monitor therapy

Loop Diuretics: May enhance the nephrotoxic effect of Iodinated Contrast Agents. Risk C: Monitor therapy

Sodium Iodide I131: Iodinated Contrast Agents may diminish the therapeutic effect of Sodium Iodide I131. Management: Discontinue iodinated contrast agents before sodium iodide I-131 administration, and avoid concurrent use. Stop water soluble agents 2 months before, and stop lipophilic agents 6 months before, sodium iodide I-131 administration. Risk X: Avoid combination

Pregnancy Considerations

Following IV administration, diatrizoate salts cross the placenta and may enter fetal circulation.

Due to theoretical concerns that exposure to free iodide may adversely affect the fetus, use should be avoided unless absolutely required to obtain diagnostic information that will influence the care of the mother or fetus during pregnancy (ACOG 723 2017; ACR 2021).

Breastfeeding Considerations

Iodine can be detected in breast milk following diatrizoate meglumine injection (Weyrauch 1977).

Because of the low expected excretion of iodinated contrast agents into breast milk and the low absorption from an infant's GI tract, breastfeeding may be continued without interruption (ACOG 723 2017; ACR 2021). Theoretically, the taste of milk could be altered if it contains contrast media. Patients who prefer to temporarily withhold breastfeeding may express and discard milk from both breasts during a period of 12 to 24 hours after the administration of contrast media. They can pump and store milk prior to the procedure then bottle feed using the stored milk during this time (ACR 2021).

Monitoring Parameters

Hydration, serum osmolarity, and electrolyte status in debilitated patients and in patients with electrolyte imbalances. Procedure specific monitoring considerations should also be reviewed; see product labeling for details.

Mechanism of Action

Radiopaque contrast agent; opacifies vessels or tissues in the path of the flow of the contrast medium, permitting radiographic visualization of the internal structures of the body.

Pharmacokinetics

Absorption: Sparingly absorbed following oral administration.

Pricing: US

Solution (Gastrografin Oral)

66-10% (per mL): $0.97

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Gastrografin (AU, CL, CY, ES, FI, GR, HR, HU, KR, MT, NO, NZ, QA, SA);
  • Gastrografine (FR);
  • MD 76 (AU);
  • MD Gastroview (AU);
  • MD-76R (AR);
  • MD-Gastroview (LK);
  • Pielograf (CO)


For country code abbreviations (show table)
  1. American College of Obstetricians and Gynecologists (ACOG) Committee on Obstetric Practice. Committee opinion no. 723: guidelines for diagnostic imaging during pregnancy and lactation. Obstet Gynecol. 2017;130(4):e210-e216. [PubMed 28937575]
  2. American College of Radiology (ACR) Committee on Drugs and Contrast Media. ACR manual on contrast media. https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf. Published 2021. Accessed March 23, 2022.
  3. Gastrografin (diatrizoate meglumine and diatrizoate sodium) [prescribing information]. Monroe Township, NJ: Bracco Diagnostics Inc; August 2019.
  4. Gastrografin (diatrizoate meglumine and diatrizoate sodium) [product monograph]. Montreal, Quebec, Canada: Bracco Imagining Canada; April 2022.
  5. MD-Gastroview (diatrizoate meglumine and diatrizoate sodium) [prescribing information]. Raleigh, NC: Liebel-Flarsheim Company; August 2017.
  6. Narayanaswami P, Sanders DB, Wolfe G, et al. International consensus guidance for management of myasthenia gravis: 2020 update. Neurology. 2021;96(3):114-122. doi:10.1212/WNL.0000000000011124 [PubMed 33144515]
  7. Weyrauch U, Volkhardt V, Speck U. Transfer of amidotrizoate in maternal milk following phlebography in a patient 10 days post partum. Rofo. 1977;127(3):275-276. [PubMed 143435]
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