Country: United States
Language: English
Source: NLM (National Library of Medicine)
diatrizoate meglumine (UNII: 3X9MR4N98U) (diatrizoic acid - UNII:5UVC90J1LK)
BRACCO DIAGNOSTICS INC
INTRAVESICAL
PRESCRIPTION DRUG
This preparation is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid.
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.
New Drug Application
CYSTOGRAFIN DILUTE- DIATRIZOATE MEGLUMINE INJECTION, SOLUTION BRACCO DIAGNOSTICS INC ---------- CYSTOGRAFIN DILUTE DIATRIZOATE MEGLUMINE INJECTION USP 18% FOR RETROGRADE CYSTOURETHROGRAPHY NOT INTENDED FOR INTRAVASCULAR INJECTION 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. INDICATION Cystografin Dilute is indicated for retrograde cystourethrography. CONTRAINDICATIONS This preparation is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid. 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. 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 Read the complete document