INDIVIDUAL INDICATIONS AND USAGE
ANGIOCARDIOGRAPHY
PharmacologyHemodynamic Changes
OMNIPAQUE 350 at a concentration of 350 mg Iodine/mL is indicated in adults for angiocardiography (ventriculography, aortic root injections, and selective coronary arteriography). OMNIPAQUE 350 at a concentration of 350 mg Iodine/mL is indicated in pediatric patients for angiocardiography (ventriculography, pulmonary arteriography, and venography, and studies of the collateral arteries).
OMNIPAQUE 300 at a concentration of 300 mg Iodine/mL is indicated in pediatric patients pediatric patients for angiocardiography (ventriculography).
After both ventricular and coronary injection, decreases in systolic pressure were less pronounced and returned to baseline values earlier with OMNIPAQUE 350 than with diatrizoate meglumine and diatrizoate sodium injection.
OMNIPAQUE 350 produced less Q-T interval prolongation than seen with diatrizoate meglumine and diatrizoate sodium injection.
In pediatric patients, after injection of all sites, but particularly following ventricular and pulmonary artery injections, decreases in both systolic and diastolic intravascular pressure were significantly less pronounced with OMNIPAQUE 350 than with diatrizoate meglumine and diatrizoate sodium injection. In pediatric patients OMNIPAQUE 350 produced significantly less shortening of the R-R interval than seen with diatrizoate meglumine and diatrizoate sodium injection.
If repeat injections are made in rapid succession, all these changes are likely to be more pronounced. (See
DOSAGE AND ADMINISTRATION.)
Precautions
During administration of large doses of OMNIPAQUE 350, continuous monitoring of vital signs is desirable. Caution is advised in the administration of large volumes to patients with incipient heart failure because of the possibility of aggravating the preexisting condition. Hypotension should be corrected promptly since it may induce serious arrhythmias. Special care regarding dosage should be observed in patients with right ventricular failure, pulmonary hypertension, or stenotic pulmonary vascular beds because of the hemodynamic changes which may occur after injection into the right heart outflow tract. (See
PRECAUTIONSGeneral.)
Pediatric patients at higher risk of experiencing adverse events during contrast medium administration may include those having asthma, a sensitivity to medication and/or allergens, congestive heart failure, a serum creatinine greater than 1.5 mg/dL or those less than 12 months of age.
Adverse Reactions
Cardiovascular system reactions in angiocardiography included angina (8%), hypotension (2.5%), bradycardia (1%), and tachycardia (1%). (See
ADVERSE REACTIONS: IntravascularGeneral.)
Dosage and Administration
The individual dose or volume is determined by the size of the structure to be visualized, the anticipated degree of hemodilution, and valvular competence. Weight is a minor consideration in adults, but must be considered in infants and young pediatric patients. The volume of each individual injection is a more important consideration than the total dosage used. When large individual volumes are administered, as in ventriculography and aortography, it has been suggested that several minutes be permitted to elapse between each injection to allow for subsidence of possible hemodynamic disturbances.
The recommended single injection volume of OMNIPAQUE 350 for angiocardiographic procedures in adults and the recommended single injection volumes of OMNIPAQUE 350 and OMNIPAQUE 300 for angiographic procedures in pediatric patients are as follows:
Ventriculography
Adults
The usual adult volume for a single injection is 40 mL with a range of 30 mL to 60 mL. This may be repeated as necessary. When combined with selective coronary arteriography, the total administered volume should not exceed 250 mL (87.5 g Iodine).
Pediatrics
The usual single injection dose of OMNIPAQUE 350 is 1.25 mL/kg of body weight with a range of 1 mL/kg to 1.5 mL/kg. For OMNIPAQUE 300 the usual single injection dose is 1.75 mL/kg with a range of 1.5 mL/kg to 2.0 mL/kg. When multiple injections are given, the total administered dose should not exceed 5 mL/kg up to a total volume of 250 mL of OMNIPAQUE 350 or up to a total volume of 291 mL of OMNIPAQUE 300.
Selective Coronary Arteriography
The usual adult volume for right or left coronary arteriography is 5 mL (range 3 mL to 14 mL) per injection.
Aortic Root and Arch Study When Used Alone
The usual adult single injection volume is 50 mL, with a range of 20 mL to 75 mL.
Pulmonary Angiography
Pediatrics
The usual single injection dose is 1 mL/kg of OMNIPAQUE 350.
Combined Angiocardiographic Procedures
Multiple Procedures
Adults
The visualization of multiple vascular systems and target organs is possible during a single radiographic examination of the patient.
Large doses of OMNIPAQUE 350 were well tolerated in angiographic procedures requiring multiple injections.
The maximum total volume for multiple procedures should not exceed 250 mL of 350 mg Iodine/mL (87.5 g Iodine).
Pediatrics
Visualization of multiple vascular systems and target organs is possible during a single radiographic examination of the patient.
The maximum total dose for multiple injection procedures should not exceed 5 mL/kg up to a total volume of 250 mL of OMNIPAQUE 350 or 6 mL/kg up to a total volume of 291 mL of OMNIPAQUE 300.
AORTOGRAPHY AND SELECTIVE VISCERAL ARTERIOGRAPHY
OMNIPAQUE 300 at a concentration of 300 mg Iodine/mL and OMNIPAQUE 350 at a concentration of 350 mg Iodine/mL are indicated in adults for use in aortography and selective visceral arteriography including studies of the aortic arch, ascending aorta, and abdominal aorta and its branches (celiac, mesenteric, renal, hepatic and splenic arteries).
OMNIPAQUE 350 at a concentration of 350 mg Iodine/mL is indicated in pediatric patients for use in aortography including studies of the aortic root, aortic arch, ascending and descending aorta.
Precautions
Under conditions of slowed aortic circulation there is an increased likelihood for aortography to cause muscle spasm. Occasional serious neurologic complications, including paraplegia, have also been reported in patients with aortoiliac obstruction, femoral artery obstruction, abdominal compression, hypotension, hypertension, spinal anesthesia, and injection of vasopressors to increase contrast. In these patients the concentration, volume and number of repeat injections of the medium should be maintained at a minimum with appropriate intervals between injections. The position of the patient and catheter tip should be carefully monitored.
Entry of a large aortic dose into the renal artery may cause, even in the absence of symptoms, albuminuria, hematuria, and an elevated creatinine and urea nitrogen. Rapid and complete return of function usually follows. (See
PRECAUTIONSGeneral.)
Adverse Reactions
See
ADVERSE REACTIONS: IntravascularGeneral, and
ADVERSE REACTIONS ANGIOCARDIOGRAPHY.
Dosage and Administration
Adults
The usual adult volume as a single injection is 50 mL to 80 mL for the aorta, 30 mL to 60 mL for major branches including celiac and mesenteric arteries, and 5 mL to 15 mL for renal arteries. Repeated injections may be performed if indicated, but the total volume should not exceed 291 mL of OMNIPAQUE 300 or 250 mL of OMNIPAQUE 350 (87.5 g Iodine).
Pediatrics
The usual single injection dose is 1.0 mL/kg of OMNIPAQUE 350 and should not exceed 5.0 mL/kg up to a total volume of 250 mL of OMNIPAQUE 350.
CEREBRAL ARTERIOGRAPHY
OMNIPAQUE 300 at a concentration of 300 mg Iodine/mL is indicated in adults for use in cerebral arteriography.
The degree of pain and flushing as the result of the use of OMNIPAQUE 300 in cerebral arteriography is less than that seen with comparable injections of many contrast media.
In cerebral arteriography, patients should be appropriately prepared consistent with existing or suspected disease states.
Precautions
Cerebral arteriography should be undertaken with extreme care with special caution in elderly patients, patients in poor clinical condition, advanced arteriosclerosis, severe arterial hypertension, recent cerebral embolism or thrombosis, and cardiac decompensation.
Since the contrast medium is given by rapid injection, the patient should be monitored for possible untoward reactions. (See
PRECAUTIONSGeneral.)
Adverse Reactions
Cerebral arteriography with water-soluble contrast media has been associated with temporary neurologic complications including seizures, drowsiness, transient paresis, and mild disturbances in vision such as photomas of 1-second or less duration.
Central nervous system reactions in cerebral arteriography included photomas (15%), headache (5.5%), and pain (4.5%). (See
ADVERSE REACTIONS: IntravascularGeneral.)
Dosage and Administration
OMNIPAQUE 300 is recommended for cerebral arteriography at the following volumes: common carotid artery (6 mL to 12 mL), internal carotid artery (8 mL to 10 mL), external carotid artery (6 mL to 9 mL), and vertebral artery (6 mL to 10 mL).
DIGITAL SUBTRACTION ANGIOGRAPHY
Intravenous Administration
OMNIPAQUE 350 at a concentration of 350 mg Iodine/mL is indicated in adults for use in intravenous digital subtraction angiography (I.V.DSA) of the vessels of the head, neck, and abdominal, renal and peripheral vessels.
Arteriograms of diagnostic quality can be obtained following the intravenous administration of contrast media employing digital subtraction and computer imaging enhancement techniques. The intravenous route of administration using these techniques has the advantage of being less invasive than the corresponding selective catheter placement of medium. The dose is administered into a peripheral vein, the superior vena cava or right atrium, usually by mechanical injection although sometimes by rapid manual injection. The technique has been used to visualize the ventricles, aorta and most of its larger branches, including the carotids, cerebrals, vertebrals, renal, celiac, mesenterics, and the major peripheral vessels of the limbs. Radiographic visualization of these structures is possible until significant hemodilution occurs.
OMNIPAQUE 350 can be injected intravenously as a rapid bolus to provide arterial visualization using digital subtraction radiography. Preprocedural medications are not considered necessary. OMNIPAQUE 350 has provided diagnostic arterial radiographs in about 95% of patients. In some cases, poor arterial visualization has been attributed to patient movement. OMNIPAQUE 350 is very well tolerated in the vascular system. Patient discomfort (general sensation of heat and/or pain) following injection is less than with various other contrast media.
Precautions
Since the contrast medium is usually administered mechanically under high pressure, rupture of smaller peripheral veins can occur. It has been suggested that this can be avoided by using an intravenous catheter threaded proximally beyond larger tributaries or, in the case of the antecubital vein, into the superior vena cava. Sometimes the femoral vein is used. (See
PRECAUTIONSGeneral.)
Adverse Reactions
Cardiovascular system reactions in digital arteriography included transient PVCs (16%) and PACs (6.5%). (See
ADVERSE REACTIONS: IntravascularGeneral.)
Dosage and Administration
The usual injection volume of OMNIPAQUE 350 for the intravenous digital technique is 30 mL to 50 mL of a 350 mg Iodine/mL solution. This is administered as a bolus at 7.5 to 30 mL/second using a pressure injector. The volume and rate of injection will depend primarily on the type of equipment and technique used.
Frequently three or more injections may be required, up to a total volume not to exceed 250 mL (87.5 g Iodine).
PERIPHERAL ANGIOGRAPHY
OMNIPAQUE 300 at a concentration of 300 mg Iodine/mL or OMNIPAQUE 350 at a concentration of 350 mg Iodine/mL is indicated in adults for use in peripheral arteriography. OMNIPAQUE 300 at a concentration of 300 mg Iodine/mL is indicated in adults for use in peripheral venography.
Sedative medication may be employed prior to use. Anesthesia is not considered necessary. Patient discomfort during and immediately following injection is substantially less than that following injection of various other contrast media. Moderate to severe discomfort is very unusual.
Precautions
Pulsation should be present in the artery to be injected. In thromboangiitis obliterans, or ascending infection associated with severe ischemia, angiography should be performed with extreme caution, if at all. (See
PRECAUTIONSGeneral.)
Adverse Reactions
A transient sensation of mild warmth is usual, immediately following injection. This has not interfered with the procedure.
In phlebography the incidence of leg pain was 21%. This usually was mild and lasted a short time after injection. (See
ADVERSE REACTIONS: IntravascularGeneral.)
Dosage and Administration
The volume required will depend on the size, flow rate, and disease state of the injected vessel and on the size and condition of the patient, as well as the imaging technique used. The dosage recommended for use in peripheral angiography is as follows:
Aortofemoral runoffs:
20 mL to 70 mL of OMNIPAQUE 350 (350 mg Iodine/mL)
30 mL to 90 mL of OMNIPAQUE 300 (300 mg Iodine/mL)
Selective arteriograms:
(femoral/iliac)
10 mL to 30 mL of OMNIPAQUE 350 (350 mg Iodine/mL)
10 mL to 60 mL of OMNIPAQUE 300 (300 mg Iodine/mL)
Venography (per leg):
40 mL to 100 mL of OMNIPAQUE 300 (300 mg Iodine/mL)
EXCRETORY UROGRAPHY
OMNIPAQUE 300 at a concentration of 300 mg Iodine/mL or OMNIPAQUE 350 at a concentration of 350 mg Iodine/mL is indicated for use in adults in excretory urography to provide diagnostic contrast of the urinary tract.
OMNIPAQUE 300 at a concentration of 300 mg Iodine/mL is indicated in pediatric patients for excretory urography. (See
Section III for information on voiding cystourethrography.)
For pharmacokinetics of excretion in adults, see
CLINICAL PHARMACOLOGYIntravascular.
Precautions
Preparatory dehydration is not recommended in the elderly, pediatric patients, diabetic or azotemic patients, or in patients with suspected myelomatosis.
Pediatric patients at higher risk of experiencing adverse events during contrast medium administration may include those having asthma, a sensitivity to medication and/or allergens, congestive heart failure, a serum creatinine greater than 1.5 mg/dL or those less than 12 months of age.
Since there is a possibility of temporary suppression of urine formation, it is recommended that a suitable interval elapse before excretory urography is repeated, especially in patients with unilateral or bilateral reduction in renal function. (See
PRECAUTIONSGeneral.)
Adverse Reactions
See
ADVERSE REACTIONS: IntravascularGeneral.
Dosage and Administration
Adults
OMNIPAQUE 300 and OMNIPAQUE 350 at dosages from 200 mg Iodine/kg body weight to 350 mg Iodine/kg body weight have produced diagnostic opacification of the excretory system in patients with normal renal function.
Pediatrics
Excretory Urography
OMNIPAQUE 300 at doses of 0.5 mL/kg to 3 mL/kg of body weight has produced diagnostic opacification of the excretory tract. The usual dose for pediatric patients is 1 mL/kg to 1.5 mL/kg. Dosage for pediatric patients should be administered in proportion to age and body weight. The total administered dose should not exceed 3 mL/kg.