Ioversol (5 brand names, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- OPTIRAY 160
- OPTIRAY 240
- OPTIRAY 300
- OPTIRAY 320
- OPTIRAY 350
Boxed Warning
Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions ( 5.1)].
Indications and Usage
OPTIRAY is indicated for:
Contraindications
Symptomatic hyperthyroidism.
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Inadvertent Intrathecal Administration [see Warnings and Precautions ( 5.1)] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2)] Contrast Induced Acute Kidney Injury [see Warnings and Precautions ( 5.3)] Cardiovascular Adverse Reactions [see Warnings and Precautions ( 5.4)] Thromboembolic Events [see Warnings and Precautions ( 5.5)] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions (5.8)] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.10)
Mechanism of Action
Intravascular injection of ioversol opacifies those vessels in the path of the flow of the contrast medium, permitting radiographic visualization of the internal structures until significant hemodilution occurs. Ioversol may be visualized in the renal parenchyma within 30 to 60 seconds following rapid intravenous injection. Opacification of the calyces and pelves in patients with normal renal function becomes apparent within 1 to 3 minutes, with optimum contrast occurring within 5 to 15 minutes. OPTIRAY enhances computed tomographic imaging through augmentation of radiographic efficiency. The degree of density enhancement is directly related to the iodine content in an administered dose; peak iodine blood levels occur immediately following rapid intravenous injection. Blood levels fall rapidly within 5 to 10 minutes and the vascular compartment half-life is approximately 20 minutes. This can be accounted for by the dilution in the vascular and extravascular fluid compartments which causes an initial sharp fall in plasma concentration. Equilibration with the extracellular compartments is reached in about 10 minutes; thereafter, the fall becomes exponential.
Overdosage
The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular system. Treatment of an overdosage is directed toward the support of all vital functions and prompt institution of symptomatic therapy. Ioversol does not bind to plasma or serum protein and is, therefore, dialyzable.