diatrizoate meglumine/diatrizoate sodium (Rx)

Brand and Other Names:Gastrografin, Renocal 76, more...Renografin, MD-Gastroview

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection solution

  • (660mg diatrizoate meglumine/100mg diatrizoate sodium)/1mL

oral/rectal solution

  • (660mg diatrizoate meglumine/100mg diatrizoate sodium)/1mL

Aortography

15-40 mL IV or intra-arterially once; may repeat if necessary; not to exceed 160 mL

Contrast Enhancement of CT Brain Imaging

Tumors or non-neoplastic conditions: 1.3 mL/kg IV; not to exceed 125 mL; adequately hydrate patient prior to procedure

Excretory Urography

20 mL IV; may administer 40 mL dose if inadequate visualization occurs

Digital Subraction Angiography

20-60 mL IV; may repeat PRN; hydrate patient adequately prior to procedure

Peripheral Arteriography

Visualization of entire extremity: 20-40 mL

Visualization of lower or uper half of extremity: 10-20 mL

Radiographic Exam of GI Tract Segments

Oral: 30-90 mL

Rectal enema: Dilute 240 mL in 1000 mL tap water

Selective Renal Arteriography

5-10 mL; may repeat PRN; not to exceed 60 mL

Tomography

Dilute 25-77 mL in 1000 mL tap water; administer 240 mL of this solution PO 15-30 min prior to imaging

Dosage Forms & Strengths

injection solution

  • (660mg diatrizoate meglumine/100mg diatrizoate sodium)/1mL

oral/rectal solution

  • (660mg diatrizoate meglumine/100mg diatrizoate sodium)/1mL

Angiocardiography

Infants and children (<5 years): 10-20 mL

5-10 years: 20-30 mL; not to exceed 100 mL

Aortography

<16 years: Safety & efficacy not established

>16 years: 15-40 mL IV or intra-arterially once; may repeat if necessary; not to exceed 160 mL

Excretory Urography

<6 months: 4 mL

6-12 months: 6 mL

1-2 years: 8 mL

2-5 years: 10 mL

5-7 years: 12 mL

8-10 years: 14 mL

11-15 years: 16 mL

Radiographic Exam of GI Tract Segments

<5 years: 30 mL PO; may dilute 1:1 in a recommended liquid; alternatively may administer enema by diluting in tab water at 1:5 ration

5-10 years: 60 mL PO; may dilute 1:1 in a recommended liquid; alternatively may administer enema by diluting 90 mL in 500 mL tap water

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Adverse Effects

Frequency Not Defined

Oral/Rectal

  • Diarrhea
  • Urticaria
  • Dyspnea
  • Anaphylaxis
  • Hypoxia
  • Erythema
  • Tachyarrhythmia
  • Nausea
  • Vomiting

Injection

  • Arterial thrombosis, cardiac arrhythmia, brachial plexopathy, chest pain, choking sensation, ECG changes, edema, flushing, hypertension, hypotension, myocardial infarction, venous pain, ventricular fibrillation, chills, headache, pallor, nausea, hypothyroidism, pruritus, skin rash, urticaria, neutropenia, anaphylactoid reaction, burning sensation at injection site, muscle cramps, sneezing, wheezing, conjunctival petechiae, lacrimation
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Warnings

Black Box Warnings

Indicated for retrograde pyelography, CT, and angiography

Not for intrathecal use

Contraindications

Hypersensitivity to diatrizoate

Intrathecal use

Myelography

Cautions

Personal or family history of bronchial asthma, significant allergies, or previous reactions to contrast agents

Iodine sensitivity

Aspiration may occur following oral administration that may result in serious complications

May cause hypovolemia and hypotension due to fluid loss from hypertonic oral/rectal contrast solutions

Serious thromboembolic events including myocardial infarction and stroke reported with intravascular administration

Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration; these reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS); reaction severity may increase and time to onset may decrease with repeat administration of contrast agent; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions; avoid administering MD-76R to patients with a history of a severe cutaneous adverse reaction to MD-76R

FDA MedWatch

  • March 30, 2022: FDA recommended newborns and children aged ≤3 years have follow-up thyroid monitoring within 3 weeks after receiving iodinated contrast media (ICM) for X-rays and other medical imaging procedures
  • Published studies found underactive thyroid and temporary decreases in thyroid hormone levels were uncommon; however, if identified and treated early, future complications may be prevented
  • Appropriately monitor for signs and symptoms of hypothyroidism and decreased thyroid hormone levels following ICM exposure; consider evaluating thyroid function within 3 weeks, especially in term and preterm neonates and children with some underlying conditions
  • If thyroid dysfunction detected, treat and monitor thyroid function as needed to avoid future complications
  • Certain pediatric patients are at increased risk, including newborns or have very low birth weight, prematurity, or presence of cardiac or other conditions (eg, requiring care in neonatal or pediatric ICUs)
  • Patients with cardiac conditions may be at greatest risk since they often require high doses of contrast during invasive cardiac procedures
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Pregnancy & Lactation

Pregnancy Category: B (oral); C (parenteral)

Lactation: Distributed in milk, use caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Contrast enhancement

Pharmacokinetics

Protein binding: Poor binding to albumin

Half-life: 100 min

Excretion: Urine; feces

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Gastrografin oral
-
66-10 % solution
Gastrografin oral
-
66-10 % solution
MD-Gastroview oral
-
66-10 % solution

Copyright © 2010 First DataBank, Inc.

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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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Code Definition
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.