Official product label reference
Cystografin Dilute — BRACCO DIAGNOSTICS INC
This page contains 11 source sections for DIATRIZOATE MEGLUMINE, intravesical route. Label set e56882fa-4a30-43b1-bb6b-f7d4a4101c4e, version 7.
Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label
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Uses described in the label
INDICATION Cystografin Dilute is indicated for retrograde cystourethrography.
Dosage and administration — label text
DOSAGE AND ADMINISTRATION 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. Administration: After sterile catheterization, the bladder should be filled to capacity with Cystografin Dilute 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.
Contraindications
CONTRAINDICATIONS This preparation is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid.
Warnings
WARNINGS Severe sensitivity reactions are more likely to occur in patients with a personaI 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
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.
Unclassified section
For retrograde cystourethrography Not intended for intravascular injection
Revised June 2024 Rx only Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08540 by Patheon Italia S.p.A. 03013 Ferentino (Italy)
Table text from source:
| Revised June 2024 |
| Rx onlyManufactured for Bracco Diagnostics Inc. Princeton, NJ 08540by Patheon Italia S.p.A. 03013 Ferentino (Italy)
Product description
DESCRIPTION Cystografin Dilute (Diatrizoate Meglumine Injection USP 18%) is a radiopaque contrast agent supplied as a sterile, aqueous solution. Each mL provides 180 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. Each mL of solution also contains approximately 85 mg organically bound iodine. At the time of manufacture, the air in the container is replaced by nitrogen.
Precautions
PRECAUTIONS Safe and effective use of this preparation depends upon proper dosage, correct technique, adequate precautions, and readiness for emergencies. Retrograde cystourethrography should be performed with caution in patients with a known active infectious process of the urinary tract. Sterile technique should be employed in administration. During administration, care should be taken to avoid excessive pressure, rapid or acute distention of the bladder, and trauma. Contrast agents may interfere with some chemical determinations made on urine specimens; therefore, urine should be collected before administration of the contrast medium or two or more days afterwards. Pregnancy–Teratogenic Effects: Animal reproduction studies have not been conducted with diatrizoate meglumine injection. It is also not known whether diatrizoate meglumine injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cystografin Dilute should be administered to a pregnant woman only if clearly needed.
Teratogenic effects
Pregnancy–Teratogenic Effects: Animal reproduction studies have not been conducted with diatrizoate meglumine injection. It is also not known whether diatrizoate meglumine injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cystografin Dilute should be administered to a pregnant woman only if clearly needed.
Supply and packaging
HOW SUPPLIED Cystografin Dilute (Diatrizoate Meglumine Injection USP 18%) is available in packages of ten 300 mL bottIes (NDC 0270-1410-30). Storage Store at 20-25°C (68-77°F) [See USP]; protect from light.
Storage and handling
Storage Store at 20-25°C (68-77°F) [See USP]; protect from light.
Official sources and product identifiers
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- Drugs@FDA application NDA010040Application history where available; verify the specific product and indication.
Substances listed: DIATRIZOATE MEGLUMINE
Package NDC codes
0270-1410-30
Further research and background
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Coverage and corrections
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.
Source retrieved 2026-10-02. Read the source policy.