Indications
Cystografin is indicated for retrograde cystourethrography.
Contraindications
This preparation is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid.
Warnings and precautions
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
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.
Composition
- Active ingredients
- DIATRIZOATE MEGLUMINE 30%
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA010040.
At a glance
- Brand name
- Cystografin
- Active substance
- diatrizoate meglumine
- Route
- Urethral
- Dosage form
- Solution
- Applicant
- Bracco
- Status
- Prescription
- FDA approval
- 2 Aug 1955
- Application
- NDA010040-018
- RxCUI
- 3320



