Cysto-Conray II

Cysto-Conray II is an FDA-registered drug product whose active ingredient is IOTHALAMATE MEGLUMINE. It is labelled by Liebel-Flarsheim Company LLC taken by ureteral and marketed as a human prescription drug product. Identifiers on file: NDC 0019-0862, application NDA017057, label effective 20201231. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing IOTHALAMATE MEGLUMINE are most often described in connection with: usage cysto-conray, retrograde cystography. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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. Children require a volume in proportion to their body size. The usual dose ranges from 30 to 300 mL.

CONTRAINDICATIONS See WARNINGS concerning inadvertant intrathecal administration.

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.

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.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

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

Who makes Cysto-Conray II?
Liebel-Flarsheim Company LLC is the labeler of record for Cysto-Conray II.

What form does Cysto-Conray II come in?
administered by ureteral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Cysto-Conray II prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Cysto-Conray II been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.