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Diatrizoate Meglumine

Pronunciation

(dye a tri ZOE ate MEG loo meen)

Dosage Forms

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

Solution, Urethral:

Cystografin: 30% (100 mL, 300 mL)

Cystografin-Dilute: 18% (300 mL)

Brand Names: U.S.

  • Cystografin
  • Cystografin-Dilute

Pharmacologic Category

  • Iodinated Contrast Media
  • Radiological/Contrast Media, Ionic (High Osmolality)

Pharmacology

Radiopaque contrast agent.

Use: Labeled Indications

Retrograde cystourethrography: Diagnostic agent for retrograde cystourethrography

Contraindications

Hypersensitivity to diatrizoate meglumine, salts of diatrizoic acid, or any component of the formulation

Dosing: Adult

Note: A low residue diet the day prior to procedure and a laxative the night before are recommended. A scout film is recommended prior to contrast administration.

Retrograde cystourethrography: Bladder instillation: 25 to 300 mL; dose depends on the patient’s age and the degree of bladder irritability; may use >300 mL if bladder capacity allows. Results are best when bladder is filled with contrast agent.

Dosing: Pediatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Reconstitution

Diatrizoate meglumine 18% (Cystografin-Dilute): This is a ready-to-use product.

Diatrizoate meglumine 30%: Use undiluted or may dilute by adding sterile water or sterile saline to the bottle prior to instillation as follows:

100 mL bottle: Add 25 mL, 50 mL, or 67 mL (sterile water or sterile saline) for a total volume of 125 mL, 150 mL, or 167 mL, respectively.

300 mL bottle: Add 50 mL (sterile water or sterile saline) for a total volume of 350 mL.

Administration

For bladder instillation only. Not for intravascular or IV use. After sterile catheterization, fill bladder to capacity using a sterile bladder administration set. Avoid using excessive pressure, rapid or acute bladder distention, and trauma. Bladder discomfort or reflux/spontaneous voiding generally indicate a full bladder.

Dietary Considerations

Some products contain sodium.

Storage

Store at 20°C to 25°C (68°F to 77°F). Protect from light. If diluting diatrizoate meglumine 30% with sterile water or sterile saline prior to administration, use immediately after dilution.

Drug Interactions

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

Test Interactions

Urine specimen assay: Contrast agent instillation into the bladder may interfere with urine specimen assay; collect urine prior to or at least 2 days after contrast administration.

Adverse Reactions

Frequency not defined.

Endocrine & metabolic: Altered thyroid hormone levels (transient suppression), hypothyroidism

Hypersensitivity: Anaphylactoid reactions (risk if intravasation of drug occurs), hypersensitivity reaction (risk if intravasation of drug occurs; reactions reported include facial edema, glottis edema, respiratory distress, convulsions, shock)

<1% (Limited to important or life-threatening): Thyroid dysfunction (underactive; premature infants and infants with underlying medical conditions are more vulnerable; FDA Safety Alert, 2015)

Warnings/Precautions

Concerns related to adverse effects:

• Allergic reactions: Severe sensitivity reactions may occur; reactions are more likely to occur in patients with a history (personal or family) of bronchial asthma, significant allergies, or prior reaction to contrast agents. A history of sensitivity to iodine or to other contrast agents is not an absolute contraindication, although extreme caution should be exercised.

• Hypothyroidism: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been reported (uncommon) in adult and pediatric patients (including infants); some patients were treated for hypothyroidism.

Disease-related concerns:

• Urinary infection: Use with caution in patients with known active urinary tract infection.

Other warnings/precautions:

• Appropriate use: Intended for bladder instillation only; not for intravascular or IV administration. Safe and effective use depends on proper dosage, correct technique, adequate precautions, and preparation for potential emergencies. Use sterile technique for administration. Avoid excessive pressure, rapid or acute bladder distention, and trauma.

Monitoring Parameters

Monitor for signs/symptoms of hypersensitivity.

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted. In general, iodinated contrast media agents may cross the placenta; use should be avoided unless absolutely required to obtain diagnostic information that will influence the care of the mother or fetus during pregnancy (ACOG 2016; ACR 2015).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber seizures, hematuria, bladder irritation, change in amount of urine passed, or urinary retention (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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