May 3, 2016
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Optiray Injection

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Optiray Injection




Indications
Dosage
How Supplied

INDICATIONS

OPTIRAY 350 is indicated in adults for peripheral and coronary arteriography and left ventriculography. OPTIRAY 350 is also indicated for contrast enhanced computed tomographic imaging of the head and body, intravenous excretory urography, intravenous digital subtraction angiography and venography. OPTIRAY 350 is indicated in children for angiocardiography.

OPTIRAY 320 is indicated in adults for angiography throughout the cardiovascular system. The uses include cerebral, coronary, peripheral, visceral and renal arteriography, venography, aortography, and left ventriculography. OPTIRAY 320 is also indicated for contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

OPTIRAY 320 is indicated in children for angiocardiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

OPTIRAY 300 is indicated for cerebral angiography and peripheral arteriography. OPTIRAY 300 is also indicated for contrast enhanced computed tomographic imaging of the head and body, venography, and intravenous excretory urography.

OPTIRAY 240 is indicated for cerebral angiography and venography. OPTIRAY 240 is also indicated for contrast enhanced computed tomographic imaging of the head and body and intravenous excretory urography.

OPTIRAY 160 is indicated for intra-arterial digital subtraction angiography (IA-DSA).

DOSAGE AND ADMINISTRATION

General

As with all radiopaque contrast agents, only the lowest dose necessary to obtain adequate visualization should be used. A lower dose may reduce the possibility of an adverse reaction. Most procedures do not require use of either the maximum volume or the highest concentration of OPTIRAY. The

combination of volume and concentration of OPTIRAY to be used should be carefully individualized accounting for factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel. Other factors such as anticipated pathology, 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.

It is desirable that intravascularly administered iodinated contrast agents be at or close to body temperature when injected.

If during administration a reaction occurs, the injection should be stopped until the reaction has subsided.

Patients should be well hydrated prior to and following OPTIRAY (ioversol injection) administration.

As with all contrast media, other drugs should not be mixed with ioversol solutions because of the potential for chemical incompatibility.

Sterile technique must be used in all vascular injections involving contrast media.

If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

Withdrawal of contrast agents from their containers should be accomplished under strict aseptic conditions using only sterile syringes and transfer devices. Contrast agents which have been transferred into other delivery systems should be used immediately.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and should not be used if particulates are observed or marked discoloration has occurred.

The OPTIRAY formulations are supplied in single dose containers. Discard unused portion.

INDIVIDUAL INDICATIONS, USAGE AND PROCEDURAL INFORMATION

GENERAL ANGIOGRAPHY

Visualization of the cardiovascular system may be accomplished by any accepted radiological technique. Since intra-arterial digital subtraction angiography (IA-DSA) requires adjustments in the method of administration, this procedure is described separately.

Cerebral Arteriography

Additional Precautions and Adverse Reactions: Extreme caution is advised in patients with advanced arteriosclerosis, severe hypertension, cardiac decompensation, senility, recent cerebral thrombosis or embolism, and migraine. Cardiovascular reactions that may occur with some frequency are bradycardia and either an increase or decrease in systemic blood pressure. Neurological reactions that may occur are: seizures, drowsiness, transient paresis, and mild disturbances in vision.

Central nervous system reactions with OPTIRAY in controlled clinical studies in cerebral arteriography that were considered drug-related and occurred with frequencies greater than 1% were: headache, bradycardia, blood pressure fluctuation, disorientation, nausea and vertigo.

Dosage and Administration: OPTIRAY 240, OPTIRAY 300 or OPTIRAY 320 is recommended for this procedure. The usual individual injection for visualization of the carotid or vertebral arteries is 2 to 12 mL, repeated as necessary. Aortic arch injection for a simultaneous four vessel study requires 20 to 50 mL. Total procedural doses should not usually exceed 200 mL.

Peripheral Arteriography

Additional 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.

Dosage and Administration: OPTIRAY 300, OPTIRAY 320 or OPTIRAY 350 is recommended for this procedure. The usual individual injection volumes for visualization of various peripheral arteries are as follows:

aorta-iliac runoff - 60 mL (range 20 to 90 mL)
common iliac, femoral - 40 mL (range 10 to 50 mL)
subclavian, brachial - 20 mL (range 15 to 30 mL)

These doses may be repeated as necessary. Total procedural doses should not usually exceed 250 mL.

Visceral and Renal Arteriography and Aortography

Additional Precautions and Adverse Effects: In aortography, depending on the technique employed, the risks of this procedure also include the following: injury to the aorta and neighboring organs, pleural puncture, renal damage including infarction and acute tubular necrosis with oliguria and anuria, retroperitoneal hemorrhage from the translumbar approach and spinal cord injury and pathology associated with the syndrome of transverse myelitis.

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.

Dosage and Administration: OPTIRAY 320 is recommended for visceral arteriography, renal arteriography, and aortography procedures. The usual individual injection volumes for visualization for the aorta and various visceral arteries are as follows:

aorta - 45 mL (range 10 to 80 mL)
celiac - 45 mL (range 12 to 60 mL)
superior mesenteric - 45 mL (range 15 to 60 mL)
renal or inferior mesenteric - 9 mL (range 6 to 15 mL)

These doses may be repeated as necessary. Total procedural doses should not usually exceed 250 mL.

Coronary Arteriography and Left Ventriculography

Additional Precautions: Mandatory prerequisites to the procedure are specialized personnel, ECG monitoring apparatus and adequate facilities for immediate resuscitation and cardioversion. Electrocardiograms and vital signs should be routinely monitored throughout the procedure.

Adverse Reactions: There were no cardiovascular system reactions with OPTIRAY in controlled clinical studies in coronary arteriography with left ventriculography that were considered drug-related and occurred with a frequency greater than 1%.

Dosage and Administration: OPTIRAY 320 or OPTIRAY 350 is recommended for this procedure. The usual individual injection volumes for visualization of the coronary arteries and left ventricle are:

left coronary - 8 mL (range 2 to 10 mL)
right coronary - 6 mL (range 1 to 10 mL)
left ventricle - 40 mL (range 30 to 50 mL)

These doses may be repeated as necessary. Total procedural dose for the combined procedures should not usually exceed 250 mL. 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.

Pediatric Angiocardiography

Additional Precautions: Mandatory prerequisites to the procedure are specialized personnel, ECG monitoring apparatus and adequate facilities for immediate resuscitation and cardioversion. Electrocardiograms and vital signs should be routinely monitored throughout the procedure. 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.

Dosage and Administration: OPTIRAY 350 or OPTIRAY 320 is recommended for this procedure. The usual single ventricular injection of OPTIRAY350 or OPTIRAY 320 is 1.25 mL/kg of body weight with a range of 1 mL/kg to 1.5 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.

Intra-arterial Digital Subtraction Angiography (IA-DSA)

All of the arteriographic procedures described above can be performed using digital subtraction techniques.

Dosage and Administration: OPTIRAY 160 is recommended for this procedure. As a general rule, the volume and concentration used for IA-DSA is about 50%, or less, of that used for conventional procedures. The actual dosage and flow rate will vary depending on the selectivity of the injection site and the area being examined.

The following suggested volumes per injection are intended only as a guide. Injections may be repeated as necessary. It is advisable to inject at rates approximately equal to the flow of the vessel being injected.

Carotid Arteries..............6 to 10 mL
Vertebral Arteries.............4 to 8 mL
Aorta..........................25 to 50 mL
Subclavian or Brachial Arteries............2 to 10 mL
Major Branches of the Abdominal Aorta.............2 to 20 mL
Dosage should not usually exceed 250 mL.

Venography

Additional Precautions: Special care is required when venography is performed in patients with suspected thrombosis, phlebitis, severe ischemic disease, local infection or a totally obstructed venous system. In order to minimize extravasation during injection, fluoroscopy is recommended.

Dosage and Administration: OPTIRAY 240, OPTIRAY 300, OPTIRAY 320 or OPTIRAY 350 is recommended for this procedure. The usual dose is 50 to 100 mL per extremity with smaller or larger volumes indicated in some cases. Dosage should not usually exceed 250 mL.

Following the procedure, the venous system should be flushed with Sodium Chloride Injection U.S.P. or 5% Dextrose in Water (D5W). Massage and elevation are also helpful for clearing the contrast medium from the extremity.

Computed Tomography

OPTIRAY 350, OPTIRAY 320, OPTIRAY 300 or OPTIRAY 240 is recommended for head imaging.

OPTIRAY 350, OPTIRAY 320, OPTIRAY 300 or OPTIRAY 240 is recommended for body imaging.

Head Imaging

Tumors: OPTIRAY may be useful to investigate the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas, ependymomas, medulloblastomas, meningiomas, neuromas, pinealomas, pituitary adenomas, craniopharyngiomas, germinomas, and metastatic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and in cases of low grade or infiltrative glioma has not been demonstrated. In calcified lesions, there is less likelihood of enhancement. Following therapy, tumors may show decreased or no enhancement. The opacification of the inferior vermis following contrast media administration has resulted in false-positive diagnosis in a number of otherwise normal studies.

Nonneoplastic Conditions: OPTIRAY may be beneficial in the image enhancement of nonneoplastic lesions. Cerebral infarctions of recent onset may be better visualized with contrast enhancement, while some infarctions are obscured if contrast medium is used. The use of iodinated contrast media results in enhancement in about 60% of cerebral infarctions studied from one to four weeks from the onset of symptoms.

Sites of active infection may also be enhanced following contrast medium administration.

Arteriovenous malformations and aneurysms will show contrast enhancement. For these vascular lesions the enhancement is probably dependent on the iodine content of the circulating blood pool. Hematomas and intraparenchymal bleeders seldom demonstrate contrast enhancement. However, in cases of intraparenchymal clot, for which there is no obvious clinical explanation, contrast media administration may be helpful in ruling out the possibility of associated arteriovenous malformation.

Dosage and Administration: Adults: For adults, the usual dosage is 50 to 150 mL of OPTIRAY 350, OPTIRAY 320 or OPTIRAY 300 or 100 to 250 mL of OPTIRAY 240. Scanning may be performed immediately after completion of the intravenous administration. Dosage should not usually exceed 150 mL of OPTIRAY 350, OPTIRAY 320 or OPTIRAY 300 or 250 mL of OPTIRAY 240.

Children: The dosage recommended for use in children is 1 mL/kg to 3 mL/kg of OPTIRAY 320.

Body Imaging

OPTIRAY may be useful for enhancement of computed tomographic images for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, pelvis, abdominal cavity, and retroperitoneal space.

Enhancement of computed tomography with OPTIRAY may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone (i.e., tumor extension) or may help to define suspicious lesions seen with unenhanced CT (i.e., pancreatic cyst).

Dosage and Administration: Adults: OPTIRAY 350, OPTIRAY 320, OPTIRAY 300 or OPTIRAY 240 may be administered by bolus injection, by rapid infusion, or by a combination of both. The usual doses are summarized below:

  bolus injection infusion
OPTIRAY 350 25 to 75 mL 50 to 150 mL
OPTIRAY 320 25 to 75 mL 50 to 150 mL
OPTIRAY 300 25 to 75 mL 50 to 150 mL
OPTIRAY 240 35 to 100 mL 70 to 200 mL

Dosage should not usually exceed 150 mL of OPTIRAY 350, OPTIRAY 320 or OPTIRAY 300 or 250 mL of OPTIRAY 240.

Children: The dosage recommended for use in children is 1 mL/kg to 3 mL/kg of OPTIRAY 320, with a usual dose of 2 mL/kg.

Intravenous Digital Subtraction Angiography

Intravenous digital subtraction angiography (IV DSA) is a radiographic modality which allows dynamic imaging of the arterial system following intravenous injection of iodinated x-ray contrast media through the use of image intensification, enhancement of the iodine signal and digital processing of the image data. Temporal subtraction of the images obtained prior to and during the "first arterial pass" of the injected contrast medium yields images which are devoid of bone and soft tissue.

IV DSA is most frequently used to examine the heart, including coronary by-pass grafts; the pulmonary arteries; arteries of the brachiocephalic circulation; the aortic arch; the abdominal aorta and its major branches; the iliac arteries; and the arteries of the extremities.

Patient Preparation

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

Precautions

In addition to the general precautions previously described, the risks associated with IV DSA include those usually attendant with catheter procedures and include intramural injections, vessel dissection and tissue extravasation. The potential risk is reduced when small test injections of contrast medium are made under fluoroscopic observation to insure that the catheter tip is properly positioned and, in the case of peripheral placement, that the vein is of adequate size.

Patient motion, including respiration and swallowing, can result in misregistration leading to image degradation and non-diagnostic studies.

Usual Dosage

OPTIRAY 350 may be injected centrally, in either the superior or inferior vena cava or right atrium; or peripherally into an appropriate arm vein. For central injections, catheters may be introduced at the antecubital fossa into either the basilic or cephalic vein or at the leg into the femoral vein and advanced to the distal segment of the corresponding vena cava. For peripheral injections, the catheter is introduced at the antecubital fossa into an appropriate size arm vein. In order to reduce the potential for extravasation during peripheral injection, a catheter of approximately 20 cm in length should be employed.

Depending on the area to be imaged, the usual dose range per injection is 30 to 50 mL. Injections may be repeated as necessary. The total procedural dose should not exceed 250 mL.

Injection rates will vary depending on the site of catheter placement and vessel size. Central catheter injections are usually made at a rate of between 10 and 30 mL/second. Peripheral injections are usually made at a rate of between 12 and 20 mL/second. Since the injected medium can sometimes remain in the arm vein for an extended period, it is advisable to flush the vein immediately following injection with an appropriate volume (20 to 25 mL) of Sodium Chloride Injection U.S.P. or 5% Dextrose in Water (D5W).

Intravenous Urography

Dosage and Administration: OPTIRAY 350, OPTIRAY 320, OPTIRAY 300 or OPTIRAY 240 is recommended for routine and high dose excretory urography. Preparatory dehydration is dangerous and may contribute to acute renal failure (see PRECAUTIONS, General).

Adults: The usual dose for routine excretory urography in adults is 50 to 75 mL of OPTIRAY 350, OPTIRAY 320 or OPTIRAY 300 or 75 to 100 mL of OPTIRAY 240. Higher dosages may be indicated to achieve optimum results where poor visualization is anticipated (e.g., elderly patients or patients with impaired renal function). In these patients, high dose urography may be preferred, using OPTIRAY 350 at a dose of 1.4 mL/kg (maximum 140 mL), OPTIRAY 320 at a dose of 1.5 to 2 mL/kg (maximum 150 mL), OPTIRAY 300 at a dose of 1.6 mL/kg (maximum 150 mL) or OPTIRAY 240 at a dose of 2 mL/kg (maximum 200 mL).

Children: OPTIRAY 320 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 children is 1 mL/kg to 1.5 mL/kg. Dosage for infants and children should be administered in proportion to age and body weight. The total administered dose should not exceed 3 mL/kg.

HOW SUPPLIED

OPTIRAY 350 NDC Number
Glass
25x50 mL bottles 0019-1333-06
12x75 mL fill/100 mL bottles 0019-1333-41
12x100 mL bottles 0019-1333-11
12x150 mL bottles 0019-1333-16
12x200 mL fill/250 mL bottles 0019-1333-21
Plastic
20x30 mL hand held syringes 0019-1333-73
20x50 mL hand held syringes 0019-1333-75
20x50 mL fill/125 mL power injector syringes 0019-1333-77
20x75 mL fill/125 mL power injector syringes 0019-1333-91
20x100 mL fill/125 mL power injector syringes 0019-1333-83
20x125 mL power injector syringes 0019-1333-81
RFID-Tagged Syringes*
20x50 mL fill/125 mL power injector syringes 0019-1333-55
20x75 mL fill/125 mL power injector syringes 0019-1333-85
20x100 mL fill/125 mL power injector syringes 0019-1333-00
20x125 mL power injector syringes 0019-1333-27
OPTIRAY 320
Glass
25x20 mL vials 0019-1323-02
25x30 mL vials 0019-1323-04
25x50 mL bottles 0019-1323-06
12x75 mL fill/100 mL bottles 0019-1323-41
12x100 mL bottles 0019-1323-11
12x150 mL bottles 0019-1323-16
12x200 mL fill/250 mL bottles 0019-1323-21
Plastic
20x30 mL hand held syringes 0019-1323-73
20x50 mL hand held syringes 0019-1323-75
20x50 mL fill/125 mL power injector syringes 0019-1323-77
20x75 mL fill/125 mL power injector syringes 0019-1323-91
20x100 mL fill/125 mL power injector syringes 0019-1323-83
20x125 mL power injector syringes 0019-1323-81
RFID-Tagged Syringes*
20x50 mL fill/125 mL power injector syringes 0019-1323-55
20x75 mL fill/125 mL power injector syringes 0019-1323-85
20x100 mL fill/125 mL power injector syringes 0019-1323-00
20x125 mL power injector syringes 0019-1323-27
OPTIRAY 300
Glass
25x50 mL bottles 0019-1332-06
12x100 mL bottles 0019-1332-11
12x150 mL bottles 0019-1332-16
12x200 mL fill/250 mL bottles 0019-1332-21
Plastic
20x50 mL hand held syringes 0019-1332-75
20x100 mL fill/125 mL power injector syringes 0019-1332-83
20x125 mL power injector syringes 0019-1332-81
RFID-Tagged Syringes*
20x100 mL fill/125 mL power injector syringes 0019-1332-00
20x125 mL power injector syringes 0019-1332-27
OPTIRAY 240
Glass
25x50 mL bottles 0019-1324-06
12x100 mL bottles 0019-1324-11
12x150 mL bottles 0019-1324-16
12x200 mL fill/250 mL bottles 0019-1324-21
Plastic
20x50 mL hand held syringes 0019-1324-75
20x125 mL power injector syringes 0019-1324-81
RFID-Tagged Syringes*
20x125 mL power injector syringes 0019-1324-27
*Radio Frequency Identification (RFID) Technology

This information is for Ultraject™ syringes containing OPTIRAY that have been labeled with a Radio Frequency Identification (RFID) tag. When used with an RFIDenabled Optivantage™ injector, this tag allows for the exchange of product information such as lot number, expiration, concentration, and identification of the syringe as being "unused" prior to use and "used" after product administrations. Patient information is not utilized in any form with this RFID technology. OPTIRAY product quality is not impacted with the use of this RFID tag. OPTIRAY RFIDtagged syringes require no special handling and should be stored at the conditions listed for the drug product.

RFID-Tagged Syringe Directions for Use

For the RFID Technology to function, the syringe must be used with an Optivantage Injector with RFID technology. Function of the RFID technology is not dependent on syringe orientation as it is placed in the injector. Instructions for use of injector are provided on the injector interface screen and operator's manual.

If the RFID tag is damaged or otherwise non-functional, the injector will notify the user. Should this occur the OPTIRAY syringe with the non-functional RFID tag may still be used but no data will be transferred to the injector.

Regarding interference with medical devices, the RFID tag and injector system meet the IEC 60601-1-2 requirements for emission and immunity standards for medical devices.

Follow all manufacturers' guidelines and do not operate any part of the Optivantage Injector System and RFID-tagged syringes within 6 inches (15 cm) of a pacemaker and/or defibrillator.

Storage: Store OPTIRAY and OPTIRAY RFID-tagged syringes at 25C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. OPTIRAY is sensitive to light and must be protected from strong daylight or direct exposure to the sun. If OPTIRAY syringes are frozen or if crystallization occurs, the syringe and contents should be discarded. If OPTIRAY in glass bottles is frozen or if crystallization occurs, the bottle and contents should be discarded. OPTIRAY may be stored at 40°C for up to one month in a contrast media warmer utilizing circulating warm air. When storing OPTIRAY for periods longer than one month, store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Do not reautoclave plastic container because of possible damage to syringe.

As with all contrast media, glass and plastic 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.

Optiray, Ultraject and Optivantage are trademarks of Mallinckrodt Inc.
Tyco Healthcare. Mallinckrodt Inc. Hazelwood, MO 63042 USA. Revised 03/08. FDA Rev date: 4/25/2008

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/18/2008

Indications
Dosage
How Supplied

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