General

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Iopamidol solutions should be used only if clear and within the normal colorless to pale yellow range. Discard any product which shows signs of crystallization or damage to the container-closure system, which includes the glass container, stopper and/or crimp.

It is desirable that solutions of radiopaque diagnostic agents for intravascular use be at body temperature when injected. Withdrawal of contrast agents from their containers should be accomplished under aseptic conditions with sterile syringes. Sterile techniques must be used with any intravascular injection, and with catheters and guidewires.

The transferring of ISOVUE from ISOVUE Pharmacy Bulk Package should be performed in a suitable work area, such as a laminar flow hood, utilizing aseptic technique. The container closure may be penetrated only one time, utilizing a suitable transfer device.

Patients should be well hydrated prior to and following ISOVUE (Iopamidol Injection) administration.

As with all radiopaque contrast agents, only the lowest dose of ISOVUE necessary to obtain adequate visualization should be used. A lower dose reduces the possibility of an adverse reaction. Most procedures do not require use of either a maximum dose or the highest available concentration of ISOVUE; the combination of dose and ISOVUE concentration to be used should be carefully individualized, and factors such as age, body size, size of the vessel and its blood flow rate, anticipated pathology and degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed should be considered.

Cerebral Arteriography

ISOVUE-300 (Iopamidol Injection, 300 mgI/mL) should be used. The usual individual injection by carotid puncture or transfemoral catheterization is 8 to 12 mL, with total multiple doses ranging to 90 mL.

Peripheral Arteriography

ISOVUE-300 usually provides adequate visualization. For injection into the femoral artery or subclavian artery, 5 to 40 mL may be used; for injection into the aorta for a distal runoff, 25 to 50 mL may be used. Doses up to a total of 250 mL of ISOVUE-300 have been administered during peripheral arteriography.

Selective Visceral Arteriography and Aortography

ISOVUE-370 (Iopamidol Injection, 370 mgI/mL) should be used. Doses up to 50 mL may be required for injection into the larger vessels such as the aorta or celiac artery; doses up to 10 mL may be required for injection into the renal arteries. Often, lower doses will be sufficient. The combined total dose for multiple injections has not exceeded 225 mL.

Pediatric Angiocardiography

ISOVUE-370 should be used. Pediatric angiocardiography may be performed by injection into a large peripheral vein or by direct catheterization of the heart.

The usual dose range for single injections is provided in the following table:

The usual recommended dose for cumulative injections is provided in the following table:

Coronary Arteriography and Ventriculography

ISOVUE-370 should be used. The usual dose for selective coronary artery injections is 2 to 10 mL. The usual dose for ventriculography, or for nonselective opacification of multiple coronary arteries following injection at the aortic root is 25 to 50 mL. The total dose for combined procedures has not exceeded 200 mL. EKG monitoring is essential.

Excretory Urography

ISOVUE-250 ISOVUE-300 or ISOVUE-370 may be used. The usual adult dose for ISOVUE-250 is 50 to 100 mL, for ISOVUE-300 is 50 mL and for ISOVUE-370 is 40 mL administered by rapid intravenous injection.

Pediatric Excretory Urography

ISOVUE-250 or ISOVUE-300 may be used. The dosage recommended for use in children for excretory urography is 1.2 mL/kg to 3.6 mL/kg for ISOVUE-250 and 1.0 mL/kg to 3.0 mL/kg for ISOVUE-300. It should not be necessary to exceed a total dose of 30 grams of iodine.

Drug Incompatibilities

Many radiopaque contrast agents are incompatible in vitro with some antihistamines and many other drugs; therefore, no other pharmaceuticals should be admixed with contrast agents.