Diatrizoate Meglumine-Diatrizoate Sodium

Diatrizoate Meglumine-Diatrizoate Sodium is an iodinated contrast media used for aortography, contrast enhancement of CT brain imaging, excretory urography, peripheral arteriography, digital subtraction angiography, radiographic examination of gastrointestinal (GI) tract segments, and selective renal arteriography and tomography.

• Diatrizoate Meglumine-Diatrizoate Sodium is available under the following different brand names: Gastrografin, Renocal 76, Renografin, MD-Gastroview.

Common side effects of Diatrizoate Meglumine-Diatrizoate Sodium include:

• nausea
• vomiting
• diarrhea
• hives and redness
• low blood oxygen
• shortness of breath
• fast heart rate
• severe allergic reaction (anaphylaxis)

Serious side effects of Diatrizoate Meglumine-Diatrizoate Sodium include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• blood in the urine
• convulsions
• cough
• little or no urination
• difficulty swallowing
• dizziness
• fast heartbeat
• itching
• rash
• pain or burning while urination
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• tightness in the chest
• tiredness or weakness

Rare side effects of Diatrizoate Meglumine-Diatrizoate Sodium include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection solution

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

Oral/rectal solution

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

Aortography

Adult dosage

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

Pediatric dosage

• Children younger than 16 years: Safety & efficacy not established
• Children older than 16 years: 15-40 mL IV or intra-arterially once; may repeat if necessary; not to exceed 160 mL

Contrast enhancement of CT brain imaging

Adult dosage

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

Excretory urography

Adult dosage

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

Pediatric dosage

• Children aged less than 6 months: 4 mL
• Children aged between 6-12 months: 6 mL
• Children aged between 1-2 years: 8 mL
• Children aged between 2-5 years: 10 mL
• Children aged between 5-7 years: 12 mL
• Children aged between 8-10 years: 14 mL
• Children aged between 11-15 years: 16 mL

Digital subraction angiography

Adult dosage

• 20-60 mL IV; may repeat as needed; hydrate patient adequately prior to the procedure

Peripheral arteriography

Adult dosage

• Visualization of the entire extremity: 20-40 mL
• Visualization of lower or upper half of extremity: 10-20 mL

Radiographic exam of GI tract segments

Adult dosage

• Oral: 30-90 mL
• Rectal enema: Dilute 240 mL in 1000 mL tap water

Pediatric dosage

• Children younger than 5 years: 30 mL orally; may dilute 1:1 in a recommended liquid; alternatively, may administer enema by diluting in tab water at 1:5 ration
• Children between 5-10 years: 60 mL orally; may dilute 1:1 in a recommended liquid; alternatively, may administer enema by diluting 90 mL in 500 mL tap water

Selective renal arteriography

Adult dosage

• 5-10 mL; may repeat as needed; not to exceed 60 mL

Tomography

Adult dosage

• Dilute 25-77 mL in 1000 mL tap water; administer 240 mL of this solution orally 15-30 min before imaging

Angiocardiography

Pediatric dosage

• Infants and children (less than 5 years): 10-20 mL
• Children aged between 5-10 years: 20-30 mL; not to exceed 100 mL

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Diatrizoate Meglumine-Diatrizoate Sodium has no noted severe interactions with any other drugs
• Diatrizoate Meglumine-Diatrizoate Sodium has no noted serious interactions with any other drugs
• Diatrizoate Meglumine-Diatrizoate Sodium has no noted moderate interactions with any other drugs
• Diatrizoate Meglumine-Diatrizoate Sodium has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to diatrizoate
• Intrathecal use
• Myelography

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Diatrizoate Meglumine-Diatrizoate Sodium?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Diatrizoate Meglumine-Diatrizoate Sodium?”

Cautions

• Personal or family history of bronchial asthma, significant allergies, or previous reactions to contrast agents
• Iodine sensitivity
• Aspiration may occur following oral administration and 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 may develop from 1 hour to several weeks after intravascular contrast agent administration; these reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis, acute generalized exanthematous pustulosis and drug reaction with eosinophilia and systemic symptoms; 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 less than 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 is 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

Pregnancy and Lactation

• May be acceptable during pregnancy when used orally, Use with caution if the benefits outweigh the risks during pregnancy when used parenterally
• Lactation
  • Distributed in milk, use caution