ULTRAVIST 300 Dosage & Rx Info | Uses, Side Effects

Ultravist 300 Generic Name & Formulations

Legal Class

General Description

Iopromide 623.4mg (equivalent to 300mg of iodine) per mL; soln; preservative-free; contains tromethamine and edetate calcium disodium.

How Supplied

300 Soln: single-dose vials (50mL, 100mL, 125mL, 150mL)—10; 370 Soln: single-dose vials (50mL, 100mL, 150mL, 200mL)—10

Manufacturer

Bayer Corporation

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 300 Indications

Indications

Intra-arterial: Cerebral and peripheral arteriography. IV: Excretory urography; 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 300 Dosage and Administration

Adult

Intra-arterial (Cerebral arteriography): Carotid arteries: 3–12mL; Vertebral arteries: 4–12mL; Aortic arch injection [4 vessel study]: 20–50mL; max 150mL. Intra-arterial (Peripheral arteriography): Subclavian or femoral artery: 5–40mL; Aortic bifurcation [distal runoff]: 25–50mL; max 250mL. IV: Excretory Urography (normal renal function): 1mL/kg; max 100mL. IV: CT of head: 50–200mL; CT of body (single phase contrast): 50–200mL bolus inj or 100–200mL rapid infusion; max 200mL. IV: CT of body (multiple phase contrast): 50–200mL total volume; Phase 1: 100% contrast; Phase 2: 20–60% contrast using a power injector suitable for simultaneous inj of contrast and saline; max 200mL. 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: IV: Contrast CT or Excretory Urography: 1–2mL/kg; max 3mL/kg. Renal impairment: use lowest necessary dose.

Ultravist 300 Contraindications

Contraindications

Intrathecal use. Preparatory dehydration in children.

Ultravist 300 Boxed Warnings

Boxed Warning

Not for intrathecal use.

Ultravist 300 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 300 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 300 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 300 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 300 Clinical Trials

See Literature

Ultravist 300 Note

Not Applicable

Ultravist 300 Patient Counseling