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Ultravist 370 Generic Name & Formulations
Legal Class
General Description
See Also
How Supplied
300 Soln: single-dose vials (50mL, 100mL, 125mL, 150mL)—10; 370 Soln: single-dose vials (50mL, 100mL, 150mL, 200mL)—10
Manufacturer
Mechanism of Action
Iopromide is a nonionic, water soluble, tri-iodinated x-ray contrast agent for intravascular administration. Intravascular injection of iopromide opacifies those vessels in the path of flow of the contrast agent, permitting radiographic visualization of the internal structures until significant hemodilution occurs.
Ultravist 370 Indications
Indications
Intra-arterial: Coronary arteriography and left ventriculography, visceral angiography and aortography. IV: CT imaging of head and body (intrathoracic, intra-abdominal and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions; Contrast mammography to visualize known or suspected lesions of the breast as an adjunct following mammography and/or ultrasound.
Ultravist 370 Dosage and Administration
Adult
Intra-arterial (Coronary arteriography and left ventriculography): Right/left coronary artery: 3–14mL; Left ventricle: 30–60mL; max 225mL. Intra-arterial (Visceral angiography and aortography): individualize; max 225mL. IV: CT of head: 41–162mL; CT of body (single phase contrast): 41–162mL bolus inj or 81–162mL rapid infusion; max 162mL. IV: CT of body (multiple phase contrast): 41–162mL total volume; Phase 1: 100% contrast; Phase 2: 20–60% contrast using a power injector suitable for simultaneous inj of contrast and saline; max 162mL. IV: Contrast mammography: 1.5mL/kg using a power injector at 2–4mL/sec; max 150mL. Renal impairment: use lowest necessary dose.
Children
<2yrs: not established. ≥2yrs: Intra-arterial: Cardiac chambers and related arteries: 1–2mL/kg; max 4mL/kg. Renal impairment: use lowest necessary dose.
Ultravist 370 Contraindications
Contraindications
Intrathecal use. Preparatory dehydration in children.
Ultravist 370 Boxed Warnings
Boxed Warning
Not for intrathecal use.
Ultravist 370 Warnings/Precautions
Warnings/Precautions
Do not administer intrathecally: severe reactions may occur (eg, death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, brain edema). Have resuscitation equipment and trained personnel available for at least 30–60min after administration. Contrast induced acute kidney injury may occur; risk factors include pre-existing renal insufficiency, diabetes, dehydration, CHF, advanced vascular disease, elderly, multiple myeloma/paraproteinemia). Ensure adequate hydration. Cardiovascular disease (monitor). Monitor ECGs and vital signs. Thromboembolic complications. Homocystinuria: avoid angiocardiography. Hyperthyroidism. Thyroid dysfunction (esp. children 0–3yrs); monitor. Pheochromocytoma. Homozygous sickle cell disease. Avoid extravasation (esp. in arterial or venous disease). History of severe cutaneous reaction: avoid. Children: asthma, cyanotic and acyanotic heart disease, CHF, serum creatinine >1.5mg/dL, immature renal function, dehydration: increased risk of adverse effects. Elderly. Pregnancy. Nursing mothers: may consider interrupting breastfeeding for 12–24hrs after administration.
Ultravist 370 Pharmacokinetics
Distribution
-
Steady-state volume of distribution: 16 L.
-
1% plasma protein bound.
Elimination
-
Renal (97%), fecal (2%)
-
Mean total renal clearance: 107mL/min.
Ultravist 370 Interactions
Interactions
Increased risk for contrast induced acute kidney injury with nephrotoxic or diuretic drugs. May increase risk of metformin-induced lactic acidosis. Caution with concomitant beta-blockers. Recently received cholecystographic agents in patients with hepatic or biliary disorder; increased risk of renal toxicity. Do not mix with other drugs. Radioactive iodine uptake studies may not accurately reflect thyroid function for at least 16 days. May affect coagulation parameters (increased thrombin time, PTT, thrombin coagulase time).
Ultravist 370 Adverse Reactions
Adverse Reactions
Headache, nausea, injection site and infusion site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, abnormal vision; anaphylactoid reactions, acute kidney injury, cardiovascular reactions.
Ultravist 370 Clinical Trials
See Literature
Ultravist 370 Note
Not Applicable
Ultravist 370 Patient Counseling
See Literature
