Imaging agents:

Indications for: OMNIPAQUE 300

Intrathecal administration: in adults, for myelography (lumbar, thoracic, cervical, total columnar) and computerized tomography [CT] (myelography, cisternography, ventriculography). IV: in adults, for aortography including studies of the aortic arch, abdominal aorta and its branches, CT head and body imaging, cerebral arteriography, peripheral venography (phlebography), and excretory urography. In children, for angiocardiography (ventriculography), excretory urography, and CT head and body imaging. Oral or rectal: in children, for oral and rectal radiographic examination of the GI tract. Oral in conjunction with IV: in adults and children, for CT of the abdomen. Intraarticular: in adults, for arthrography. Body cavity: in adults, for hysterosalpingography. In children, for voiding cystourethrography (VCU).

Adults and Children:

See full labeling for dosing based on procedure.

OMNIPAQUE 300 Contraindications:

Omnipaque 140 and 350: for intrathecal use. Omnipaque body cavity 240 and 300: for hysterosalpingography 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 suspected.

Boxed Warning:

Risks with inadvertent intrathecal administration of Omnipaque 140 and 350 injection.

OMNIPAQUE 300 Warnings/Precautions:

Do not administer Omnipaque 140 and 350 intrathecally: severe reactions may occur (eg, death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, brain edema). Have emergency treatment and trained personnel readily available. Monitor for hypersensitivity reactions. Cardiovascular disease (monitor). Pheochromocytoma. Homozygous sickle cell disease. Homocystinuria: avoid angiocardiography. Thyroid disorder. Renal impairment or risk of (eg, diabetes, dehydration, multiple myeloma, CHF, advanced vascular disease). History of severe cutaneous reaction: avoid. Ensure adequate hydration. Avoid extravasation (esp. in arterial or venous disease). Elderly. Pregnancy. Nursing mothers: consider interrupting; pump/discard breast milk for 10hrs after administration.

OMNIPAQUE 300 Classification:

Radiographic contrast medium.

OMNIPAQUE 300 Interactions:

Concomitant drugs that lower seizure threshold (eg, phenothiazines): not recommended with intrathecal use. Discontinue metformin at time of, or prior to Omnipaque in patients with eGFR 30–60mL/min/1.73m2, history of hepatic impairment, alcoholism, heart failure, or will be given intra-arterial contrast; reevaluate eGFR 48hrs after procedure and restart metformin if renally stable. Increased risk of kidney injury with concomitant nephrotoxic drugs or diuretics. Discontinue CNS active drugs (eg, MAOIs, tricyclics, CNS stimulants, analeptics, tranquilizers, antipsychotics) ≥48hrs before myelography and for ≥24hrs post-procedure. Caution with beta-blockers. May interfere with thyroid uptake of radioactive iodine and decrease efficacy in thyroid carcinoma for up to 6–8 weeks. May reduce iodine-binding capacity of thyroid tissue for up to 2 weeks.

Adverse Reactions:

Intrathecal: headache, backache, neckache, stiffness, neuralgia, nausea, vomiting, dizziness. IV: inj site reactions, pain, arrhythmias, angina/chest pain, hypotension, vertigo, vision abnormalities, headache, taste perversion, nausea; severe skin reactions (eg, SJS, TEN, AGEP, DRESS). Oral: diarrhea, nausea, vomiting, abdominal pain, flatulence, headache; children: also, fever, hypotension, urticaria. Body cavities: pain, swelling, heat sensation. Angiocardiography: thromboembolism. Hypersensitivity reactions, acute kidney injury, cardiovascular reactions.

Generic Drug Availability:

NO

How Supplied:

Omnipaque 140 (50mL)—10; Omnipaque 180 (10mL, 20mL)—10; Omnipaque 240 (10mL, 20mL, 50mL, 100mL, 150mL, 200mL)—10; Omnipaque 300 (10mL, 30mL, 50mL, 75mL, 100mL, 125mL, 150mL, 200mL)—10; Omnipaque 350 (50mL, 75mL, 100mL, 125mL, 150mL, 200mL, 250mL)—10