OMNIPAQUE 300

Following the intravenous administration of iohexol (between 500 mg iodine/kg to 1,500 mg iodine/kg) to 16 adult subjects, apparent first-order terminal elimination half-life was 12.6 hours and total body clearance was 131 (98 to 165) mL/min. Clearance was not dose dependent.

AbsorptionAs evidenced by the amount recovered in urine, <1% of orally administered iohexol is absorbed from the normal gastrointestinal tract. This amount may increase in the presence of bowel perforation or bowel obstruc...

The safety and effectiveness of OMNIPAQUE for CT of the head were evaluated in three clinical studies. Each study also used an ionic high-osmolar iodinated contrast agent as a comparator. A total of 280 patients were randomized to administration of either OMNIPAQUE (n=142) or the comparator (n=138). OMNIPAQUE patients had a mean age of 52 years (range 16 to 85), 41% were women, and were administered a mean of 692 mg iodine/kg (range 337 to 1,250 mg iodine/kg) by intravenous injection with OMNIPAQUE 240 mg iodine/mL (1 study) or 300 mg iodine/mL (2 studies). Efficacy was determined from investi...

The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Intrathecal Administration of OMNIPAQUE Injection 140 mg Iodine/mL and 350 mg Iodine/mL [see Warnings and Precautions (5.1) ] Risks Associated with Parenteral Administration of OMNIPAQUE Oral Solution [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Acute Kidney Injury [see Warnings and Precautions (5.4) ] Cardiovascular Adver...

OMNIPAQUE for hysterosalpingography is contraindicated during pregnancy or suspected pregnancy, menstruation or when menstruation is imminent, within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract including the external genitalia, and when reproductive tract neoplasia is known or suspect...

Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. ( 5.3 ) Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk. ( 5.4 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. ( 5.5 ) Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Indi...

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, OMNIPAQUE administration in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ;...