Cystografin
(Diatrizoate Meglumine)Cystografin Prescribing Information
Cystografin is indicated for retrograde
cystourethrography.
the night before the examination and a low residue diet the day before
the procedure are recommended.
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.
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 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.
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.