ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Retrograde genitourinary proceduresmay cause such complications as hematuria, perforation of the urethraor bladder, introduction of infection into the genitourinary tract,and oliguria or anuria.If intravasation of this drug occurs, the reactions which may beassociated with intravenous administration may possibly be encountered.Hypersensitivity or anaphylactoid reactions may occur. Severe reactionsmay be manifested by edema of the face and glottis, respiratory distress,convulsions or shock; such reactions may prove fatal unless promptlycontrolled by such emergency measures as maintenance of clear airwayand immediate use of oxygen and resuscitative drugs.Endocrine: Thyroid function tests indicative of hypothyroidism or transientthyroid suppression have been uncommonly reported following iodinatedcontrast media administration to adult and pediatric patients, includinginfants. Some patients were treated for hypothyroidism.

DESCRIPTION SECTION.

DESCRIPTION. Cystografin is radiopaque contrastagent supplied as sterile, clear, colorless to pale yellow, mobileor slightly viscous solution. Each mL provides 300 mg diatrizoatemeglumine with 0.4 mg edetate disodium as sequestering agent. EachmL of solution also contains approximately 141 mg organically boundiodine. At the time of manufacture, the air in the container is replacedby nitrogen. The preparation should be protected from strong light.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Preparation of the patient: Appropriate preparation is desirable for optimal results. laxativethe night before the examination and low residue diet the day beforethe procedure are recommended.. Dosage: The dose forretrograde use in cystography and voiding cystourethrography rangesfrom 25 to 300 mL depending on the age of the patient and the degreeof bladder irritability; amounts greater than 300 mL may be used ifthe bladder capacity allows. Best results are obtained when the bladderis filled with the contrast agent. If desired, the preparation maybe diluted with sterile water or sterile saline as indicated in thetable below.. Administration: Aftersterile catheterization, the bladder should be filled to capacitywith Cystografin using suitable sterile administration set. Careshould be taken to avoid using excessive pressure. The presence ofbladder discomfort or reflux and/or spontaneous voiding usually indicatesthat the bladder is full.. Radiography: The commonlyemployed radiographic techniques should be used. scout film is recommendedbefore the contrast agent is administered.Dilution TableUSE DILUTEDSOLUTIONS IMMEDIATELY100 mL Bottle Sterile Water or Sterile SalineAdded Diatrizoate Meglumine w/v% Organically Bound Iodine w/v Total Volume0 mL 30.0 14.1 100 mL 25 mL 24.0 11.3 125 mL50 mL 20.09.4 150 mL67 mL 18.0 8.5 167 mL300 mL Bottle Sterile Water or Sterile SalineAdded mL 30.0 14.1 300 mL50 mL 25.7 12.1 350 mL.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Cystografin (Diatrizoate MeglumineInjection USP 30%) is available in 200 mL and 400 mL bottles containing100 mL and 300 mL of Cystografin respectively with sufficient capacityfor dilution up to 167 mL and 350 mL respectively.. Storage. Store at 20-25C (68-77F) [SeeUSP]. Protect from light.. Also Available. Cystografin Dilute (DiatrizoateMeglumine Injection USP 18%) is also available, as 300 mL fill ina 400 mL bottle.

PRECAUTIONS SECTION.

PRECAUTIONS. Safe and effective use of thispreparation depends upon proper dosage, correct technique, adequateprecautions, and readiness for emergencies.Retrograde cystourethrography should be performedwith caution in patients with known active infectious process ofthe urinary tract.Steriletechnique should be employed in administration. During administration,care should be taken to avoid excessive pressure, rapid or acute distentionof the bladder, and trauma.Contrast agents may interfere with some chemical determinations madeon urine specimens; therefore, urine should be collected before administrationof the contrast medium or two or more days afterwards.. Pregnancy--Teratogenic Effects:. Animal reproduction studies have not been conductedwith diatrizoate meglumine injection. It is also not known whetherdiatrizoate meglumine injection can cause fetal harm when administeredto pregnant woman or can affect reproduction capacity. Cystografinshould be administered to pregnant woman only if clearly needed.

TERATOGENIC EFFECTS SECTION.

Pregnancy--Teratogenic Effects:. Animal reproduction studies have not been conductedwith diatrizoate meglumine injection. It is also not known whetherdiatrizoate meglumine injection can cause fetal harm when administeredto pregnant woman or can affect reproduction capacity. Cystografinshould be administered to pregnant woman only if clearly needed.

WARNINGS SECTION.

WARNINGS. Severe sensitivity reactions aremore likely to occur in patients with personal or family historyof bronchial asthma, significant allergies, or previous reactionsto contrast agents.Ahistory of sensitivity to iodine per se or to othercontrast agents is not an absolute contraindication to the use ofdiatrizoate meglumine, but calls for extreme caution in administration.