Optiray 300 (Ultraject): Uses, Side Effects and Dosage

What is Optiray 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. Optiray can also be used to visualize the spinal canal.

How does Optiray work?

Optiray is an iodine-based contrast agent that opacifie 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.

What are the ingredients in Optiray?

Medicinal ingredients: Ioversol

Non-medicinal ingredients: Edetate Calcium Disodium USP, Hydrochloric Acid NF, Sodium Hydroxide NF, Tromethamine HCl, Tromethamine USP.

Optiray comes in the following dosage forms:

Vials: 240 mgI/mL, 300 mgI/mL, 320 mgI/mL, and 350 mgI/mL

Prefilled Syringes: 240 mgI/mL, 300 mgI/mL, 320 mgI/mL, and 350 mgI/mL

Do not use Optiray if:

• You are hypersensitive to Optiray or any of the ingredients in the formulation or component of the container.
• You have clinically significant impairment of both hepatic and renal function.

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.
• You have bronchial asthma, homocystinuria, endotoxemia, elevated body temperature, severe hypertension, cardiovascular disease or hyperthyroidism.

• You have a serum creatinine level above 3 mg/d, a renal disease or have a recent renal

  • transplant.
• You have pheochromocytoma (tumor), multiple myeloma (cancer) or the sickle cell disease.
• You receive administration of vasopressors, cholecystographic agent or adrenergic beta-blockers.
• You have local or systemic infection.
• You have a history of seizure or you are epileptics.
• You are a patient with obstructed vascular system issues (thrombosis, ischemic disease or Buerger's disease).

• You 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.

• You are breastfeeding. Contrast media are secreted in human milk, therefore breastfeeding should be discontinued for at least 48 hours following the procedure.

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 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.

The following may interact with Optiray:

• Phenothiazine derivatives
• Cholocystographic contrast agents

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.

What are possible side effects from using Optiray?

These are not all the possible side effects you may feel when taking Optiray. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions. Side effects may include:

• Hypotension, hypertension, cardiac arrest, cardiovascular disorder, palpitation.
• Perception of noise or ringing in the ears.
• Inflammation of infection of the eyes, transient blindness, vision loss, lacrimation.
• Lack of thyroid hormone (hypothyroidism).
• Dry mouth, difficulty or discomfort swallowing, diarrhea.
• Abnormal physical weakness, abdominal pain back pain, chest pain, fatigue, injection site pain, fever, nausea.
• Coughing, nasal congestion, sneezing, irritation and inflammation of the nose.
• Headache, disorientation, brain mass, somnolence, involuntary muscle contraction and relaxation, anxiety, hallucination, coma, convulsion, confusional state, psychotic disorders.
• Distorsion of the sense of the taste.
• Musculoskeletal stiffness, motor dysfunction, involuntary eye movement, paralysis.
• Urge to urinate, production of abnormal large volumes of urine, renal pain, urinary retention, renal failure.
• Hyperventilation, pulmonary embolism, edema, coagulation, abnormal level of white cells, heart block, apnea.
• Itching, erythema, excessive sweat, rash.
• Vasodilation, vasospasm.
• Hypersensivity or allergic reaction.

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

Storage:

Store at controlled room temperature. 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 this Patient Medication Information by visiting the Health Canada website or by calling 1-844-208-7620.

Liebel-Flarsheim Company LLC, 8800 Durant Road, Raleigh, North Carolina, 27616 USA