Conray (Iothalamate Meglumine Intravascular) - Indications and Dosage

INDICATIONS AND USAGE

CONRAY is indicated for use in excretory urography, cerebral angiography, peripheral arteriography, venography, arthrography, direct cholangiography, endoscopic retrograde cholangiopancreatography, contrast enhancement of computed tomographic brain images, cranial computerized angiotomography, intravenous digital subtraction angiography and arterial digital subtraction angiography.

CONRAY may also be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, abdominal aorta, mediastinum, abdominal cavity and retroperitoneal space. Continuous or multiple scans separated by intervals of 1-3 seconds during the first 30-90 seconds post-injection of the contrast medium (dynamic CT scanning) may provide enhancement of diagnostic significance, and may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone, and in supplying additional features of the lesions. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone, or may help to define suspicious lesions seen with unenhanced CT. (See CLINICAL PHARMACOLOGY). Subsets of patients in whom delayed body CT scans might be helpful have not been identified. Inconsistent results have been reported and abnormal and normal tissues may be isodense during the time frame used for delayed CT scanning. The risks of such indiscriminate use of contrast media are well known and such use is not recommended. At present, consistent results have been documented using dynamic CT techniques only.

DOSAGE AND ADMINISTRATION

It is advisable that CONRAY be at or close to body temperature when injected.

The patient should be instructed to omit the meal that precedes the examination. Appropriate premedication, which may include a barbiturate, tranquilizer or analgesic drug, may be administered prior to the examination.

A preliminary film is recommended to check the position of the patient and the x-ray exposure factors.

If a minor reaction occurs during administration, the injection should be slowed or stopped until the reaction has subsided. If a major reaction occurs, the injection should be discontinued immediately.

Under no circumstances should either corticosteroids or antihistamines be mixed in the same syringe with the contrast medium because of a potential for chemical incompatibility.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

EXCRETORY UROGRAPHY

Following intravenous injection, CONRAY is rapidly excreted by the kidneys. CONRAY may be visualized in the renal parenchyma 30 seconds following bolus injection. Maximum radiographic density in the calyces and pelves occurs in most instances within 3-8 minutes after injection. In patients with severe renal impairment contrast visualization may be substantially delayed.

Patient Preparation

Appropriate preparation of the patient is important for optimal visualization. A low residue diet is recommended for the day preceding the examination and a laxative is given the evening before the examination, unless contraindicated.

Precautions

Infants and small children should not have any fluid restrictions prior to excretory urography. Injections of CONRAY represent an osmotic load which, if superimposed on increased serum osmolality due to partial dehydration, may magnify hypertonic dehydration. (See WARNINGS and PRECAUTIONS, General concerning preparatory dehydration).

Adverse Reactions

See section on general Adverse Reactions.

Usual Dosage

Adults — The usual dose is 30-60 mL. Children 14 years of age and over, of average weight, may receive the adult dose. The total dose is normally injected within 30-90 seconds. Higher dosage may be indicated to achieve optimum results in instances where poor visualization may be anticipated (e.g., elderly patients or patients with impaired renal function). When nephrograms and/or sequential urograms are desired, the total dose should be rapidly injected, normally within 15-30 seconds.

The dosage for children is reduced in proportion to age and body weight. The following approximate schedule is recommended for infants and children, based on a dosage of about 0.5 mL/kg of body weight:

Under 6 months of age	5 mL
6-12 months	8 mL
1-2 years	10 mL
2-5 years	12 mL
5-8 years	15 mL
8-12 years	18 mL
12-14 years	20-30 mL

ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY

Arterial digital subtraction angiography provides images similar in quality to conventional film-screen systems. The advantages of arterial DSA when compared to standard film angiography include: the use of less contrast medium; the use of lower concentrations for some procedures; a decreased need for selective arterial catheterization reducing the possibility of dislodging atheromatous plaques or significantly reducing the blood flow in the artery; and a shortened examination time. The limitations of arterial DSA include: reduced spatial resolution; limited field size; and the inability to conduct simultaneous biplane examinations.

Patient Preparation

No special patient preparation is required for arterial DSA. However, it is advisable to insure that patients are well hydrated prior to examination.

Precautions

In addition to the general precautions described, the risks associated with arterial DSA are those usually attendant with catheter procedures. Following the procedure, gentle pressure hemostasis is required, followed by observation and immobilization of the limb for several hours to prevent hemorrhage from the site of arterial puncture.

Usual Dosage

The following dosage schedule for adults should serve only as a guide since the volume administered, the concentration selected and the flow rate will be determined by the resolution of the equipment being used. As a general rule, the volume used and the flow rates for arterial DSA are 50% or less than that used for conventional film arteriography. Diagnostic studies have been obtained using CONRAY undiluted (28.2% iodine), diluted 1:1 (14.1% iodine), and diluted 1:2 (9.4% iodine). Sodium Chloride Injection U.S.P. or Water for Injection U.S.P. may be used for dilution.

The following doses, equivalent in iodine content to undiluted CONRAY, have been used.

Carotid or vertebral arteries:	3-8 mL
Aortic Arch:	15-25 mL
Subclavian and brachial arteries:	5-15 mL
Major branches of the aorta:	5-20 mL
Lumbar aorta (bifurcation):	10-25 mL

HOW SUPPLIED

CONRAY ® Glass Vials/Bottles	NDC Number
50x30 mL vials	0019-0953-13
50x50 mL vials	0019-0953-15
12x100 mL vials	0019-0953-03
12x100 mL bottles	0019-0953-09
12x150 mL bottles	0019-0953-11

Storage – Store below 30°C (86°F). Exposing this product to very cold temperatures may result in crystallization of the salt. If this occurs, the container should be brought to room temperature. Shake vigorously to assure complete dissolution of any crystals. The speed of dissolution may be increased by heating with circulating warm air. Before use, examine the product to assure that all solids are redissolved, and that the container and closure have not been damaged.

This preparation is sensitive to light and must be protected from strong daylight or direct exposure to the sun.

As with all contrast media, glass containers should be inspected prior to use to ensure that breakage or other damage has not occurred during shipping and handling. All containers should be inspected for closure integrity. Damaged containers should not be used.