Cysto-Conray<sup>® </sup>II (Iothalamate meglumine injection USP 17.2%)

Cysto-Conray® II (Iothalamate meglumine injection USP 17.2%)

Important Safety Information

NOT FOR INTRAVASCULAR ADMINISTRATION
NOT FOR INTRATHECAL USE

Important Safety Information (Continued)

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.

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.

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

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

  • Provides a clear evaluation of the bladder and urinary tract1
  • Solution provides 8.1% (81 mg/mL) organically bound iodine
  • Available in glass bottles
Cystoconrayii (1)

Packaging

Cysto-Conray® II (Iothalamate meglumine), 81 mg/mL 
250 mL glass bottles package of 12 (0862-50)

Important Safety Information

NOT FOR INTRAVASCULAR ADMINISTRATION
NOT FOR INTRATHECAL 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.

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.

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

References 

1. Cysto-Conray II [package insert]. Princeton, NJ: Guerbet LLC; Aug 2017.

GU05201138