Indications
Cysto-Conray II is indicated for use in retrograde cystography and cystourethrography.
Contraindications
See WARNINGS concerning inadvertant intrathecal administration.
Warnings and precautions
SEVERE ADVERSE EVENTS – INADVERTENT INTRATHECAL ADMINISTRATION: Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
Special attention must be given to ensure that this drug product is not administered intrathecally.
Pregnancy and breastfeeding
Use in Pregnancy Category C. Animal reproduction studies have not been conducted with Cysto-Conray II. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cysto-Conray II should be used in pregnant women only if clearly needed.
Adverse reactions
Irritation of the bladder or ureter, common to some degree to all contrast media administered for retrograde urographic procedures, may occasionally occur. As with all contrast media, intravasation may lead to hypersensitivity reactions such as a sense of warmth, flushing, sneezing, sweating, chills, fever, urticaria, laryngeal edema, bronchospasm, hypertension, hypotension, cardiac arrhythmias and cardiac arrest. Adverse reactions associated with procedural technique include injury to the urethra, bladder, ureter, and introduction of infection.
In the event of serious or anaphylactoid reactions, it should be kept in mind that the reactions known to occur with intravenous administration of radiopaque contrast materials are possible.
Composition
At a glance
- Brand name
- Cysto-Conray
- Active substance
- iothalamate meglumine
- Route
- Into the bladder, Ureteral
- Dosage form
- Solution
- Applicant
- Liebel-Flarsheim
- Status
- Prescription
- FDA approval
- 17 Apr 1972
- Application
- NDA017057-001



