IODIXANOL

DistributionIn an in vitro human plasma study, iodixanol did not bind to protein. The volume of distribution in adults was 0.26 L/kg body weight, consistent with distribution to extracellular space.

EliminationIn 40 healthy, young male volunteers receiving a single intravenous administration of iodixanol in doses of 0.3 gram Iodine/kg to 1.2 gram Iodine/kg body weight, the elimination half-life was 2.1 hr. (± 0.1). Renal clearance was 110 ± 14 mL/min, equivalent to glomerular filtration (108 m...

Iodixanol was studied in 1,244 adult patients. Approximately one-half (590) of the iodixanol patients were 60 years of age or older; the mean age was 56 years (range 18 to 90). A total of patients, 806 (65%) were male. The racial distribution was: Caucasian-85%, Black-12%, Oriental <1%, and other or unknown-3%. A total of 1,235 patients were evaluable for efficacy. Efficacy assessment was based on quality of the radiographic diagnostic visualization (i.e., either: excellent, good, poor, or none) and on the ability to make a diagnosis (i.e., either: confirmed a previous diagnosis, found normal,...

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 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 Patient...

Iodixanol is contraindicated for intrathecal use [see Warnings and Precautions (5.1) ] : Not indicated for intrathecal use. ( 4 )

Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. ( 5.2 ) Contrast-Induced Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk. ( 5.3 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. ( 5.4 ) Thyroid Dysfunction in Pediatric Patients 0 to 3 Y...

7 DRUG INTERACTIONS 7.1 Drug-Drug Interactions Metformin In patients with renal impairment, metformin can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function. Stop metformin at the time of, or prior to, iodixanol administration in patients with an eGFR between 30 mL/min/1.73 m 2 and 60 m...