USA

Cysto-Conray® II (Iothalamate meglumine) Injection

For more information about Cysto-Conray® II, please see the Full Prescribing Information

Cysto-Conray® II contrast agent is injectable, ionic, and high osmolar and intended for instillation into the urinary system.

  • Each mL contains:
    • 172 mg of iothalamate meglumine
    • 0.110 mg of edetate calcium disodium as a stabilizer
    • 0.115 mg of monobasic sodium phosphate as a buffer
  • Solution provides 8.1% (81 mg/mL) organically bound iodine
  • Available in glass bottles and vials in a variety of fill sizes

Important Safety Information1

Not For Intrathecal Use

Not For Intravascular Use


Indication and Usage
Cysto-Conray® II (iothalamate meglumine injection USP 17.2%) is indicated for use in retrograde cystography and cystourethrography.

Contraindications and Warnings

  • 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 Cysto-Conray II is not administered intrathecally.

 

Precautions

  • The possibility of an idiosyncratic reaction in susceptible patients should always be considered. The susceptible population of an idiosyncratic reaction includes patients with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine per se and patients with a known clinical hypersensitivity: bronchial asthma, hay fever and food allergies.

Adverse Reactions

  • Adverse reactions associated with procedural technique include injury to the urethra, bladder, ureter, and introduction of infection.
  • A common adverse event to some degree to all contrast media administered for retrograde urographic procedures is irritation of the bladder or ureter, may occasionally occur.
  • Intravasation as with all contrast media 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.

Use in Specific Populations

  • 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.
  • Nursing Mothers: Iothalamate salts are excreted unchanged in human milk. Although it has not been established that serious adverse reactions occur in nursing infants, because of the potential for adverse reactions, caution should be exercised when Cysto-Conray II is administered to a nursing woman.

You are encouraged to report negative side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Packaging

Cysto-Conray® II (Iothalamate meglumine), 81 mg/mL 

Cysto-Conray II 12x250 mL bottles (0862-50) 12





Cysto-Conray® II is a registered trademark of Guerbet LLC or its affiliates, and is available by prescription only.

Legal Copyright 2018 Guerbet

REFERENCES

  1. Cysto-Conray II [package insert]. Princeton, NJ: Guerbet LLC; Sep 2016.

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