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. CystografinDilute should be administered to pregnant woman only if clearlyneeded.

WARNINGS SECTION.

WARNINGS. Severe sensitivity reactions aremore likely to occur in patients with personaI 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.

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 functiontests indicative of hypothyroidism or transient thyroid suppressionhave been uncommonly reported following iodinated contrast media administrationto adult and pediatric patients, including infants. Some patientswere treated for hypothyroidism.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. This preparation is contraindicatedin patients with hypersensitivity to salts of diatrizoic acid.

DESCRIPTION SECTION.

DESCRIPTION. Cystografin Dilute (DiatrizoateMeglumine Injection USP 18%) is radiopaque contrast agent suppliedas sterile, aqueous solution. Each mL provides 180 mg diatrizoatemeglumine with 0.4 mg edetate disodium as sequestering agent. EachmL of solution also contains approximately 85 mg organically boundiodine. At the time of manufacture, the air in the container is replacedby nitrogen.

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. . Administration: Aftersterile catheterization, the bladder should be filled to capacitywith Cystografin Dilute using suitable sterile administration set.Care should be taken to avoid using excessive pressure. The presenceof bladder discomfort or reflux and/or spontaneous voiding usuallyindicates that the bladder is full.. Radiography: The commonlyemployed radiographic techniques should be used. scout film is recommendedbefore the contrast agent is administered.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Cystografin Dilute (DiatrizoateMeglumine Injection USP 18%) is available in packages of ten 300 mLbottIes (NDC 0270-1410-30).. Storage. Store at 20-25C (68-77F) [SeeUSP]; protect from light.

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. CystografinDilute should be administered to pregnant woman only if clearlyneeded.