Get your patient on Cystografin - Diatrizoate Meglumine injection, Solution (Diatrizoate Meglumine)
Cystografin - Diatrizoate Meglumine injection, Solution prescribing information
INDICATION
Cystografin is indicated for retrograde cystourethrography.
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.
| 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 |
CONTRAINDICATIONS
This preparation is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid.
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.
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.
DESCRIPTION
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.
HOW 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.
