Cysto-Conray II 172 mg/mL

Iothalamate meglumine · INJECTION · Liebel-Flarsheim Company LLC

No Recall History

Plain English

Cysto-Conray II is a contrast dye injected into the ureters to help doctors visualize your urinary system during imaging procedures. It contains iothalamate meglumine and is used to improve the visibility of the kidneys and urinary tract on X-rays.

Key Facts

Brand Name: Cysto-Conray II
Generic Name: Iothalamate meglumine
NDC Code (Product): 0019-0862
Manufacturer: Liebel-Flarsheim Company LLC
Strength: 172 mg/mL
Dosage Form: INJECTION
Route: URETERAL
Marketing Status: HUMAN PRESCRIPTION DRUG
Application #: NDA017057
Drug Class: Radiographic Contrast Agent [EPC]; X-Ray Contrast Activity [MoA]
Marketing Start: 10/08/2010

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

incorrect route of drug administration8 reports

wrong drug administered4 reports

anaphylactoid reaction2 reports

no adverse event2 reports

agranulocytosis1 reports

anaphylactic reaction1 reports

angioedema1 reports

cough1 reports

drug ineffective1 reports

expired product administered1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Cysto-Conray II is indicated for use in retrograde cystography and cystourethrography.

Dosage & Administration

DOSAGE AND ADMINISTRATION Patient Preparation Unless contraindicated, an appropriate laxative is given the night before the examination. Radiographic Technique The radiographic procedure normally employed for cystography and cystourethrography should be employed. A preliminary radiograph is recommended before the contrast agent is administered. Administration Sterile catherization is essential. Cysto-Conray II may be introduced by gravity flow using an appropriate venoclysis set or by syringe. Excessive pressure should be avoided with any method of administration. Usual Dosage Cystography and Cystourethrography – Either Conray 43 supplied at 43% w/v or Cysto-Conray II supplied at a 17.2% w/v concentration may be used for these procedures. The desired concentration will vary depending upon the patient’s size and age and also with the technique and equipment used. (SEE CONRAY 43 PACKAGE INSERT FOR SPECIFIC INFORMATION ABOUT THE USE OF THIS PRODUCT.) Sufficient volume of contrast medium is administered to adequately fill the urinary bladder. The volume of solution required will vary depending upon the individual patient. Adults usually require a volume in the range of 200 to 400 mL. C…

Warnings

WARNINGS 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.

Contraindications

CONTRAINDICATIONS See WARNINGS concerning inadvertant intrathecal administration.

Adverse Reactions

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.