Cystografin®

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

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 (Diatrizoate Meglumine Injection USP 30%) is available in 200 mL and 400 mL bottles containing 100 mL and 300 mL of Cystografin respectively with sufficient capacity for dilution up to 167 mL and 350 mL respectively.

Cystografin is a radiopaque contrast agent supplied as a sterile, clear, colorless to pale yellow, mobile or slightly viscous solution. Each mL provides 300 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. Each mL of solution also contains approximately 141 mg organically bound iodine. At the time of manufacture, the air in the container is replaced by nitrogen. The preparation should be protected from strong light.

For retrograde cystourethrography

Not intended for intravascular injection

Cystografin 100 mL Label

NDC 0270-0149-60

Cystografin 1 Box 10 Bottles — 300 mL each

NDC 0270-0149-57

Store at 20-25°C (68-77°F) [See USP]. Protect from light.

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.

Cystografin is indicated for retrograde cystourethrography.

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.

Cystografin Dilute (Diatrizoate Meglumine Injection USP 18%) is also available, as a 300 mL fill in a 400 mL bottle.

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 should be administered to a pregnant woman only if clearly needed.

For retrograde cystourethrography

Not intended for intravascular injection

Cystografin 100 mL Label

NDC 0270-0149-60

Cystografin 1 Box 10 Bottles — 300 mL each

NDC 0270-0149-57

Store at 20-25°C (68-77°F) [See USP]. Protect from light.

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.

Cystografin is indicated for retrograde cystourethrography.

Cystografin is a radiopaque contrast agent supplied as a sterile, clear, colorless to pale yellow, mobile or slightly viscous solution. Each mL provides 300 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. Each mL of solution also contains approximately 141 mg organically bound iodine. At the time of manufacture, the air in the container is replaced by nitrogen. The preparation should be protected from strong light.

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.

Cystografin (Diatrizoate Meglumine Injection USP 30%) is available in 200 mL and 400 mL bottles containing 100 mL and 300 mL of Cystografin respectively with sufficient capacity for dilution up to 167 mL and 350 mL respectively.

Cystografin Dilute (Diatrizoate Meglumine Injection USP 18%) is also available, as a 300 mL fill in a 400 mL bottle.

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.

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

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 should be administered to a pregnant woman only if clearly needed.