The following Structured Product Label (SPL) was submitted to the FDA by Bracco Diagnostics Inc for the product Cystografin Dilute (NDC 0270-1410). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, indication, contraindications, warnings, precautions, pregnancy–teratogenic effects:, adverse reactions, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
Cystografin Dilute is indicated for retrograde cystourethrography.
This preparation is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid.
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.
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 Category C
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.
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.
Cystografin Dilute (Diatrizoate Meglumine Injection USP 18%) is available in packages of ten 300 mL bottIes (NDC 0270-1410-30).
Store at 20-25°C (68-77°F) [See USP]; protect from light.
Cystografin
Dilute – Carton
NDC 0270-1410-30
Cystografin Dilute Carton (Cystografin Dilute 10x300ml 229125)
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