Cysto-Conray (Iothalamate Meglumine)

CYSTO-CONRAY® CYSTO-CONRAY® II

Mallinckrodt

Iothalamate Meglumine

Radiopaque Medium

Description: Retrograde instillation opacifies selected segments of the urinary tract, permitting fluoroscopic and radiographic visualization of structures such as the urethra, bladder, ureters and pelvico-calyceal system.

Indications And Clinical Uses: Use in retrograde cystography and cystourethrography. Cysto-Conray is also indicated for use in retrograde pyelography.

Contra-Indications: In patients with a known hypersensitivity to salts of iothalamic acid, the use of this preparation is contraindicated as intravasation may lead to hypersensitivity reactions and anaphylactic shock. However, a history of sensitivity to iodine per se or to other contrast media is not an absolute contraindication to the use of Cysto-Conray or Cysto-Conray II, but calls for extreme caution in administration.

Obstruction and acute or severe infection of the urinary tract are generally regarded as contraindications to instrumentation and to the retrograde instillation of contrast material; do not inject by intravascular, s.c. or i.m. routes.

Manufacturers’ Warnings In Clinical States: A history of allergy, bronchial asthma, sensitivity to other iodine-containing compounds or a previous reaction to a contrast agent warrant special attention and may predict the likelihood of an allergic reaction.

Anuria may develop following retrograde pyelography, especially in patients with impaired renal function. Retrograde pyelography should not be repeated within 48 hours in patients with impaired renal functions.

Severe irritation of the urinary tract and hemorrhagic cystitis may occur following prolonged exposure to contrast media. It is imperative that the urinary bladder be emptied at the completion of the diagnostic procedures.

Pregnancy: The safe use of these preparations during pregnancy has not been established. Exposures of the abdomen and pelvis to radiation during pregnancy, especially in the first trimester, should be avoided, unless in the judgment of the physician the expected benefits to the mother outweigh the risk to the developing fetus.

Precautions: Diagnostic procedures which involve the use of radiopaque contrast media should be carried out under the direction of appropriately trained personnel. Appropriate facilities should be available for coping with emergencies which may arise.

For sensitivity testing 0.1 mL of the contrast medium may be injected intradermally. The patient should be observed for local and general hypersensitivity reaction for 15 to 30 minutes.

Sensitivity testing cannot be relied upon to predict severe reactions.

An impending reaction is often indicated by apprehension, respiratory difficulty, faintness, sneezing, itching, vomiting or urticaria. In some instances, reactions to the test dose may be delayed.

Since iodine-containing contrast agents may alter the results of thyroid function tests, such tests, if indicated, should be performed prior to the administration of this preparation.

Adverse Reactions: Irritation of the bladder or ureter, common to some degree to all contrast media administered for retrograde urographic procedures, may occasionally occur. Hemorrhagic cystitis may result. 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, cardiac arrest and anaphylactic shock. Oliguria or anuria may occur following retrograde pyelography, especially in patients with severe preexisting renal disease. Adverse reactions associated with procedural technique include injury to the urethra, bladder, ureter and introduction of infection.

Treatment of Adverse Effects: Contrast media should be administered only by physicians thoroughly familiar with the emergency treatment of all adverse reactions to contrast media. The assistance of other trained personnel such as cardiologists, internists and anesthetists is required in the management of severe reactions.

Dosage And Administration: Cysto-Conray is more concentrated than other currently used retrograde urographic contrast media. The lowest possible concentration giving satisfactory contrast should be employed. The use of undiluted Cysto-Conray should be necessary only in selected adult patients.

Patient Preparation: Unless contraindicated, an appropriate laxative is given the night before the examination. The bladder should be emptied before the contrast agent is instilled.

Radiographic Technique: The radiographic procedure normally employed for cystography, cystourethrography and retrograde pyelography should be employed. A preliminary radiograph is recommended before the contrast agent is administered.

Administration: Sterile catheterization is essential. Cysto-Conray and 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.

Adults: Retrograde Pyelography: Ordinarily about 25 mL of Cysto-Conray are required for bilateral and 15 mL for unilateral pyelograms. About 5 to 6 mL are usually administered for each exposure.

Retrograde Cystography and Cystourethrography: The desired concentration will vary depending on the patient’s size and age and also with the technique and equipment used. 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: Retrograde Cystography and Cystourethrography: Concentrations of iothalamate meglumine used in children should not exceed 21.5 %. Cysto-Conray II is preferred in this patient population.

Children require a volume in proportion to their body size. The usual dose ranges from 30 to 300 mL. Until further experience has been gained, the use of Cysto-Conray and Cysto-Conray II for retrograde pyelography in children is not recommended.

Availability And Storage: Cysto-Conray: Each mL of sterile aqueous solution contains: iothalamate meglumine 430 mg (iodine 20.2%), edetate calcium disodium 0.110 mg as a stabilizer and sodium biphosphate 0.115 mg as a buffer. Vials of 50, boxes of 50. Bottles of 200 mL fill/250 mL, boxes of 12.

Cysto-Conray II: Each mL of sterile aqueous solution contains: iothalamate meglumine 172 mg (iodine 8.1%), edetate calcium disodium 0.110 mg as a stabilizer and sodium biphosphate 0.115 mg as a buffer. Bottles of 200 mL fill/250 mL, boxes of 12; bottles of 500 mL, boxes of 12.

Cysto-Conray and Cysto-Conray II are hypertonic under conditions of use and are supplied in containers from which the air has been displaced by nitrogen.

Store between 15 to 30°C. Protect from light. Protect from freezing. Discard unused portion.

CYSTO-CONRAY® CYSTO-CONRAY® II Mallinckrodt Iothalamate Meglumine Radiopaque Medium

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