Cystografin

Generic Name: diatrizoate meglumine
Dosage Form: Injection

For retrograde cystourethrography
Not intended for intravascular injection

Cystografin Description

Cystografin is a radiopaque contrast agent supplied as a sterile, aqueous 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.

INDICATION

Cystografin 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 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.

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

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.

Cystografin 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. If desired, the preparation may be diluted with sterile water or sterile saline as indicated in the table below.

Administration: After sterile catheterization, the bladder should be filled to capacity with Cystografin 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.

Dilution Table

USE DILUTED SOLUTIONS IMMEDIATELY
100 mL Bottle
Sterile Water or Sterile Saline Added	% Diatrizoate Meglumine w/v	% Organically Bound Iodine w/v	Total Volume
0 mL	30.0	14.1	100 mL
25 mL	24.0	11.3	125 mL
50 mL	20.0	9.4	150 mL
67 mL	18.0	8.5	167 mL
300 mL Bottle
Sterile Water or Sterile Saline Added
0 mL	30.0	14.1	300 mL
50 mL	25.7	12.1	350 mL

How is Cystografin Supplied

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.

Storage

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

Also Available

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

Manufactured for
Bracco Diagnostics Inc.
Princeton, NJ 08543

by SICOR Pharmaceuticals, Inc.
Irvine, CA 92618

Rev September 2003
Printed in USA

Cystografin (diatrizoate meglumine)

PRODUCT INFO Product Code 0270-0149 Dosage Form INJECTION, SOLUTION Route Of Administration INTRAVESICAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength diatrizoate meglumine (diatrizoic acid) Active 300 MILLIGRAM  In 1 MILLILITER edetate disodium Inactive 0.4 MILLIGRAM  In 1 MILLILITER

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color Score Shape Symbol Imprint Code Coating Size

PACKAGING # NDC Package Description Multilevel Packaging 1 0270-0149-60 10 BOTTLE In 1 PACKAGE contains a BOTTLE 1 100 MILLILITER In 1 BOTTLE This package is contained within the PACKAGE (0270-0149-60) 2 0270-0149-57 10 BOTTLE In 1 PACKAGE contains a BOTTLE 2 300 MILLILITER In 1 BOTTLE This package is contained within the PACKAGE (0270-0149-57)

Revised: 01/2007