pharmacopeia

Diatrizoate

Imaging Contrast ActivityUS-FDASourced from openFDA
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Mechanism of action

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Mechanism-of-action class: Imaging Contrast Activity.

Indications

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  • INDICATION Cystografin is indicated for retrograde cystourethrography.

Contraindications

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  • This preparation is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid.contraindicated

Dosage & administration

Sourced from openFDA

Preparation of the patient: Appropriate preparation is desirable for optimal results. A laxative the night before the examination and a low residue diet the day before the procedure are recommended. Dosage: The dose for retrograde use in cystography and voiding cystourethrography ranges from 25 to 300 mL depending on the age of the patient and the degree of bladder irritability; amounts greater than 300 mL may be used if the bladder capacity allows. Best results are obtained when the bladder is filled with the contrast agent. If desired, the preparation may be diluted with sterile water or sterile saline as indicated in the table below. Administration: After sterile catheterization, the bladder should be filled to capacity with Cystografin using a suitable sterile administration set. Care should be taken to avoid using excessive pressure. The presence of bladder discomfort or reflux and/or spontaneous voiding usually indicates that the bladder is full. Radiography: The commonly employed radiographic techniques should be used. A scout film is recommended before the contrast agent is administered. Dilution Table USE DILUTED SOLUTIONS IMMEDIATELY 100 mL Bottle Sterile Water or Sterile Saline Added % Diatrizoate Meglumine w/v % Organically Bound Iodine w/v Total Volume 0 mL 30.0 14.1 100 mL 25 mL 24.0 11.3 125 mL 50 mL 20.0 9.4 150 mL 67 mL 18.0 8.5 167 mL 300 mL Bottle Sterile Water or Sterile Saline Added 0 mL 30.0 14.1 300 mL 50 mL 25.7 12.1 350 mL

Warnings & precautions

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Severe sensitivity reactions are more likely to occur in patients with a personal or family history of bronchial asthma, significant allergies, or previous reactions to contrast agents. A history of sensitivity to iodine per se or to other contrast agents is not an absolute contraindication to the use of diatrizoate meglumine, but calls for extreme caution in administration.

Adverse reactions

Sourced from openFDA

Retrograde genitourinary procedures may cause such complications as hematuria, perforation of the urethra or bladder, introduction of infection into the genitourinary tract, and oliguria or anuria. If intravasation of this drug occurs, the reactions which may be associated with intravenous administration may possibly be encountered. Hypersensitivity or anaphylactoid reactions may occur. Severe reactions may be manifested by edema of the face and glottis, respiratory distress, convulsions or shock; such reactions may prove fatal unless promptly controlled by such emergency measures as maintenance of a clear airway and immediate use of oxygen and resuscitative drugs. Endocrine: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and pediatric patients, including infants. Some patients were treated for hypothyroidism.

Approval history

Sourced from openFDA
  • Aug 2, 1955NDANDA010040Bracco
  • Jan 17, 1958NDANDA011245Bracco
  • Sep 2, 1981ANDAANDA087388Liebel-flarsheim
  • Jun 27, 2022ANDAANDA214201Anda Repository
  • Nov 17, 2023ANDAANDA215049Annora Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
511 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea8817%
  2. 2Off Label Use8817%
  3. 3Drug Ineffective8016%
  4. 4Dyspnoea7815%
  5. 5Rash7314%
  6. 6Pain7214%
  7. 7Confusional State6312%
  8. 8Drug Hypersensitivity6312%
  9. 9Product Use Issue6112%
  10. 10Type 2 Diabetes Mellitus6112%
  11. 11Pericarditis6012%
  12. 12Psoriatic Arthropathy6012%
  13. 13C-reactive Protein Increased5912%
  14. 14Pemphigus5912%
  15. 15Rheumatic Fever5912%

Literature

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Recent PubMed references pinned to Diatrizoate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 43 ClinicalTrials.gov registrations naming Diatrizoate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Diatrizoate work?
Mechanism-of-action class: Imaging Contrast Activity.
What is Diatrizoate used for?
According to FDA labeling, Diatrizoate carries indications including: INDICATION Cystografin is indicated for retrograde cystourethrography.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Diatrizoate?
Diatrizoate is classified as Imaging Contrast Activity.
What are the contraindications for Diatrizoate?
Diatrizoate labeling lists contraindications including: This preparation is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid.. Always consult the full prescribing information and a clinician.
Note. Data for diatrizoate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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