Patient Medication Information: uses, side effects, how to take - Optiray 320
Serious warnings and precautions box
What OPTIRAY® is used for:
- OPTIRAY is an imaging agent used to visualize the blood vessels, the compartment of the heart, the brain, parts of the body, the kidney and the bladder.
How OPTIRAY® works:
OPTIRAY is an iodine-based contrast agent that opacify the vessels and create a contrast difference between tissues permitting the radiographic visualization. Once OPTIRAY is injected, your doctor will take an image of the area to be examined. The contrast difference between tissues will appear in the image and help your doctor make the diagnosis.
- FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY
There are risks with the accidental injection of products like OPTIRAY into the space around the spinal chord (subarachnoidal administration). This can cause:
- death,
- uncontrollable movements of your body (convulsions or seizures),
- bleeding in the brain (cerebral hemorrhage),
- prolonged state of unconsciousness (coma),
- the inability to move (paralysis),
- swelling of the area around your spinal chord (arachnoiditis),
- kidney failure (acute renal failure),
- your heart to stop beating (cardiac arrest),
- your muscle to start breaking down (rhabdomyolysis),
- increased body temperature (hyperthermia), and
- Brain swelling (brain edema).
The ingredients in OPTIRAY® are:
Medicinal ingredient(s): Ioversol
Non-medicinal ingredients: Edetate Calcium Disodium USP, Hydrochloric Acid NF, Sodium Hydroxide NF, Tromethamine HCl, Tromethamine USP.
OPTIRAY® comes in the following dosage form(s):
Vials: 300 mgI/mL, 320 mgI/mL, and 350 mgI/mL
Prefilled Syringes: 300 mgI/mL, 320 mgI/mL, and 350 mgI/mL
Do not use OPTIRAY® if:
- You are allergic to iodine-containing contrast media (like OPTIRAY) or any of the ingredients in the formulation or component of the container.
- You have symptomatic hyperthyroidism
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OPTIRAY®. Talk about any health conditions or problems you may have, including if you:
- have previous reaction to a contrast agent or have a history of iodine sensitivity.
- have heart or cardiovascular problems, including high blood pressure, atherosclerosis or blockages
- have pheochromocytoma (tumor in the adrenal gland), multiple myeloma (cancer) or the sickle cell disease.
- have kidney problems or have a condition that stops urine production (anuria or oliguria)
- have liver problems
- have diabetes mellitus
- have homocystinuria, a hereditary disorder where your body cannot process certain amino acids
- have diminished mental ability (dementia)
- have recent issues with the blood brain barrier, such as embolisms, bleeding in your brain, migraine.
could be pregnant. If there is a need to consider OPTIRAY during your pregnancy, your doctor will discuss the benefits and risks of giving it to you.
- are breastfeeding. Contrast media are secreted in human milk; therefore, breastfeeding should be discontinued for at least 48 hours following the procedure.
Other warnings you should know about:
Thyroid function
Contrast media containing iodine, such as OPTIRAY, may change thyroid activity in some patients, both in adults and infants. This may cause:
- Hypothyroidism (i.e. too little thyroid hormones in the blood)
- Or hyperthyroidism (i.e. too much thyroid hormones in the blood)
Thyroid function in infants
Contrast media containing iodine may cause hypothyroidism in infants, especially infants born too soon or whose mothers have received a contrast media containing iodine during pregnancy that:
- Can continue for several weeks to a month after treatment
- Can harm growth and development
- Can harm mental growth
- May require treatment
Can cause symptoms such as:
- Fatigue, shortness of breath, low heart rate
- Reduced appetite, feeling cold, weight gain
- Muscle stiffness
Contact your doctor if these symptoms happen to you or your infant.
Your doctor may order blood tests for your infant after treatment to follow thyroid hormone levels in the blood.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious drug interactions:
- Some drugs used to treat nausea or allergies (such as phenothiazine derivatives) should not be used with OPTIRAY.
The following may also interact with OPTIRAY®:
- Phenothiazine contrast agents
- Cholecystographic contrast agents
- Metformin
- Interleukin
- Diuretics
- Vasopressors
- Thyroid function tests. The accuracy of some thyroid function tests may be affected for up to 16 days after receiving OPTIRAY
How to take OPTIRAY®:
- OPTIRAY will always be used in a hospital or similar setting. It will only be administered to you under the supervision of a health professional skilled and experienced in the particular procedure to be performed.
Usual dose:
Your doctor will determine the amount of OPTIRAY to be used. The dose administered will depend on the procedure.
Overdose:
Overdose affect mainly the pulmonary, cardiovascular, and central nervous systems.
If you think you, or a person you are caring for, have taken too much OPTIRAY, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Possible side effects from using OPTIRAY®:
These are not all the possible side effects you may have when taking OPTIRAY. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Perception of noise or ringing in the ears.
- Inflammation of infection of the eyes, abnormal tear production
- Dry mouth, difficulty or discomfort swallowing, diarrhea.
- Abnormal physical weakness, abdominal pain back pain, fatigue, injection site pain, fever, nausea.
- Coughing, nasal congestion, sneezing, irritation and inflammation of the nose.
- Sleepiness, involuntary muscle contraction and relaxation, anxiety.
- Distortion of the sense of the taste.
- Stiffness, difficulty coordinating muscle movements, involuntary eye movement.
- Urge to urinate, urinating more than usual. .
- Itching, increased redness of the skin, , excessive sweat, rash.
Serious side effects and what to do about them
| Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | |
|---|---|---|---|
| Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Allergic Reaction: difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat. | X | ||
| Cardiac disorders (Issues with your heart): chest discomfort, shortness of breath, weakness, change in | X | ||
| heart rate, sudden collapse, no pulse, no breathing, loss of consciousness | |||
| Hypothyroidism (underactive/low thyroid): Weight gain, tiredness, hair loss, muscle weakness, feeling cold, dry skin, constipation, puffy face, heavier than normal or irregular menstrual periods, enlarged thyroid gland. | X | ||
| Kidney failure (severe kidney problems): confusion; itchiness or rashes; puffiness in your face and hands; swelling in your feet or ankles; urinating less or not at all; weight gain. | X | ||
| Neurological disorders (Issues with your brain and nerves): headache, visual disturbances, loss of vision, confusion, seizures, loss of coordination, weakness on one side of your body, loss of ability to move (paralysis), difficulty speaking or understanding others, unconsciousness. | X | ||
| Pulmonary embolism (blood clot in the lung): chest pain that may increase with deep breathing, cough, coughing up bloody sputum, shortness of breath | X | ||
| Severe skin reactions: fever, severe rash, swollen lymph glands, flu-like feeling, blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often, less urine | X | ||
| Stroke: Sudden numbness or weakness of your arm, leg or face, especially if only on one side of the body; sudden confusion, difficulty speaking or understanding others; sudden difficulty in walking or loss of balance or coordination; suddenly feeling dizzy or sudden severe headache with no known cause. | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store at controlled room temperature (between 15° and 30° C). Protect from light and freezing. Keep out of reach and sight of children.
If you want more information about OPTIRAY®:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the importer’s website (www.methapharm.com) or by calling 1-800-287-7686.
Date of Authorization: AUG 21, 2025