Optiray 350 mg Iod/ml

Optiray 350 mg Iod/ml 350 is indicated in adults for peripheral and coronary arteriography and left ventriculography. Optiray 350 mg Iod/ml 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 mg Iod/ml 350 is indicated in children for angiocardiography.

Optiray 350 mg Iod/ml 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 350 mg Iod/ml 320 is also indicated for contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

Optiray 350 mg Iod/ml 320 is indicated in children for angiocardiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

Optiray 350 mg Iod/ml 300 is indicated for cerebral angiography and peripheral arteriography. Optiray 350 mg Iod/ml 300 is also indicated for contrast enhanced computed tomographic imaging of the head and body, venography, and intravenous excretory urography.

Optiray 350 mg Iod/ml 240 is indicated for cerebral angiography and venography. Optiray 350 mg Iod/ml 240 is also indicated for contrast enhanced computed tomographic imaging of the head and body and intravenous excretory urography.

Optiray 350 mg Iod/ml is in a group of drugs called radiopaque (RAY dee oh payk) contrast agents. Optiray 350 mg Iod/ml contains iodine, a substance that absorbs x-rays. Radiopaque contrast agents are used to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Optiray 350 mg Iod/ml is used to help diagnose certain disorders of the heart, brain, and blood vessels.

Optiray 350 mg Iod/ml may also be used for purposes other than those listed in this medication guide.

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 350 mg Iod/ml. The combination of volume and concentration of Optiray 350 mg Iod/ml 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 350 mg Iod/ml (Optiray 350 mg Iod/ml injection) administration.

As with all contrast media, other drugs should not be mixed with Optiray 350 mg Iod/ml 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 350 mg Iod/ml 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.

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 350 mg Iod/ml 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 350 mg Iod/ml 240, Optiray 350 mg Iod/ml 300 or Optiray 350 mg Iod/ml 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 350 mg Iod/ml 300, Optiray 350 mg Iod/ml 320 or Optiray 350 mg Iod/ml 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 350 mg Iod/ml 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 350 mg Iod/ml 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 350 mg Iod/ml 320 or Optiray 350 mg Iod/ml 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 mg Iod/ml 350 or Optiray 350 mg Iod/ml 320 is recommended for this procedure. The usual single ventricular injection of Optiray 350 mg Iod/ml 350 or Optiray 350 mg Iod/ml 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.

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 350 mg Iod/ml 240, Optiray 350 mg Iod/ml 300, Optiray 350 mg Iod/ml 320 or Optiray 350 mg Iod/ml 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 USP or 5% Dextrose in Water (D5W). Massage and elevation are also helpful for clearing the contrast medium from the extremity.

Computed Tomography

Optiray 350 mg Iod/ml 350, Optiray 350 mg Iod/ml 320, Optiray 350 mg Iod/ml 300 or Optiray 350 mg Iod/ml 240 is recommended for head imaging.

Optiray 350 mg Iod/ml 350, Optiray 350 mg Iod/ml 320, Optiray 350 mg Iod/ml 300 or Optiray 350 mg Iod/ml 240 is recommended for body imaging.

Head Imaging

Tumors

Optiray 350 mg Iod/ml 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.

Non-neoplastic Conditions

Optiray 350 mg Iod/ml may be beneficial in the image enhancement of non-neoplastic 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 mg Iod/ml 350, Optiray 350 mg Iod/ml 320 or Optiray 350 mg Iod/ml 300 or 100 to 250 mL of Optiray 350 mg Iod/ml 240. Scanning may be performed immediately after completion of the intravenous administration. Dosage should not usually exceed 150 mL of Optiray 350 mg Iod/ml 350, Optiray 350 mg Iod/ml 320 or Optiray 350 mg Iod/ml 300 or 250 mL of Optiray 350 mg Iod/ml 240.

Children

The dosage recommended for use in children is 1 mL/kg to 3 mL/kg of Optiray 350 mg Iod/ml 320.

Body Imaging

Optiray 350 mg Iod/ml 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 350 mg Iod/ml 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 mg Iod/ml 350, Optiray 350 mg Iod/ml 320, Optiray 350 mg Iod/ml 300 or Optiray 350 mg Iod/ml 240 may be administered by bolus injection, by rapid infusion, or by a combination of both. The usual doses are summarized below:

Dosage should not usually exceed 150 mL of Optiray 350 mg Iod/ml 350, Optiray 350 mg Iod/ml 320 or Optiray 350 mg Iod/ml 300 or 250 mL of Optiray 350 mg Iod/ml 240.

Children

The dosage recommended for use in children is 1 mL/kg to 3 mL/kg of Optiray 350 mg Iod/ml 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 ensure 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 ensure 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 mg Iod/ml 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 USP or 5% Dextrose in Water (D5W).

Intravenous Urography

Dosage And Administration

Optiray 350 mg Iod/ml 350, Optiray 350 mg Iod/ml 320, Optiray 350 mg Iod/ml 300 or Optiray 350 mg Iod/ml 240 is recommended for routine and high dose excretory urography. Preparatory dehydration is dangerous and may contribute to acute renal failure.

Adults

The usual dose for routine excretory urography in adults is 50 to 75 mL of Optiray 350 mg Iod/ml 350, Optiray 350 mg Iod/ml 320 or Optiray 350 mg Iod/ml 300 or 75 to 100 mL of Optiray 350 mg Iod/ml 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 mg Iod/ml 350 at a dose of 1.4 mL/kg (maximum 140 mL), Optiray 350 mg Iod/ml 320 at a dose of 1.5 to 2 mL/kg (maximum 150 mL), Optiray 350 mg Iod/ml 300 at a dose of 1.6 mL/kg (maximum 150 mL) or Optiray 350 mg Iod/ml 240 at a dose of 2 mL/kg (maximum 200 mL).

Children

Optiray 350 mg Iod/ml 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

This information is for Ultraject™ syringes containing Optiray 350 mg Iod/ml that have been labeled with a Radio Frequency Identification (RFID) tag. When used with an RFID-enabled 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 350 mg Iod/ml product quality is not impacted with the use of this RFID tag. Optiray 350 mg Iod/ml RFID-tagged 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 350 mg Iod/ml 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 350 mg Iod/ml and Optiray 350 mg Iod/ml RFID-tagged syringes at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Optiray 350 mg Iod/ml is sensitive to light and must be protected from strong daylight or direct exposure to the sun. If Optiray 350 mg Iod/ml syringes are frozen or if crystallization occurs, the syringe and contents should be discarded. If Optiray 350 mg Iod/ml in glass bottles is frozen or if crystallization occurs, the bottle and contents should be discarded. Optiray 350 mg Iod/ml may be stored up to 40°C for up to one month in a contrast media warmer utilizing circulating warm air. When storing Optiray 350 mg Iod/ml for periods longer than one month, store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). 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.

Manufactured by: Liebel-Flarsheim Company LLC Raleigh, NC 27616. Revised: Aug 2016

See also:
What is the most important information I should know about Optiray 350 mg Iod/ml?

You should not receive Optiray 350 mg Iod/ml if you have any type of active infection.

Tell your doctor if you have asthma, hay fever, or history of food or drug allergies, especially if you have had any type of reaction to another contrast agent.

Drink extra fluids before and after you receive Optiray 350 mg Iod/ml. This medication can cause you to get dehydrated, which can lead to dangerous effects on your kidneys. Follow your doctor's instructions about the types and amount of fluids you should drink before and after your test.

See also:
What other drugs will affect Optiray 350 mg Iod/ml?

Renal toxicity has been reported in a few patients with liver dysfunction who were given oral cholecystographic agents followed by intravascular contrast agents. Administration of any intravascular contrast agent should therefore be postponed in patients who have recently received a cholecystographic contrast agent.

Other drugs should not be mixed with Optiray 350 mg Iod/ml injection.

Drug/Laboratory Test Interactions

The results of PBI and radioactive iodine uptake studies, which depend on iodine estimation, will not accurately reflect thyroid function for up to 16 days following administration of iodinated contrast media. However, thyroid function tests not depending on iodine estimations, e.g., T3 resin uptake and total or free thyroxine (T4) assays are not affected.

See also:
What are the possible side effects of Optiray 350 mg Iod/ml?

Applies to Optiray 350 mg Iod/ml: injection solution

As well as its needed effects, Optiray 350 mg Iod/ml (the active ingredient contained in Optiray 350 mg Iod/ml) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking Optiray 350 mg Iod/ml, check with your doctor or nurse immediately:

Less common or rare:

• Arm, back, or jaw pain
• blue lips and fingernails
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• chest tightness or heaviness
• confusion
• coughing
• coughing that sometimes produces a pink frothy sputum
• decrease in the frequency of urination
• decrease in urine volume
• difficult, fast, noisy breathing, sometimes with wheezing
• difficulty in passing urine (dribbling)
• difficulty with swallowing
• dizziness or lightheadedness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• feeling of constant movement of self or surroundings
• headache
• hives or welts, itching, or skin rash
• hoarseness
• increased sweating
• nausea
• nervousness
• painful urination
• pale skin
• pounding in the ears
• redness of the skin
• sensation of spinning
• severe numbness, especially on one side of the face or body
• severe, unusual tiredness or weakness
• slow, fast, or irregular heartbeat
• slow or irregular breathing
• sweating
• swelling around the eyes
• swelling in the legs and ankles
• unusual tiredness or weakness

• Blood in the stools or urine
• bruising
• changes in skin color
• coughing or vomiting blood
• pains in the chest, groin, or legs, especially calves of the legs
• pain, tenderness, or swelling of the foot or leg
• persistent bleeding or oozing from puncture sites, mouth, or nose
• severe headaches of sudden onset
• sudden loss of coordination
• sudden onset of shortness of breath for no apparent reason
• sudden onset of slurred speech
• sudden vision changes

• Extremely high fever or body temperature
• fast, shallow breathing
• fast, weak heartbeat
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• muscle cramps
• no sensation in the legs
• not able to pass urine
• pale, clammy skin
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• thirst
• unable to move the legs

Minor Side Effects

Some Optiray 350 mg Iod/ml side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common or rare:

• Bad taste
• collection of blood under the skin
• deep, dark purple bruise
• dry mouth
• pain, redness, or pale skin at the injection site
• vomiting

Optiray 350 mg Iod/ml is an organoiodine compound used as a diagnostic contrast medium. It features both a high iodine content, as well as several hydrophilic groups.