Class: Radiopaque agent
- Injection, solution 311.7 mg/mL
- Injection, solution 498.72 mg/mL
- Injection, solution 623.4 mg/mL
- Injection, solution 768.86 mg/mL
Provides contrast enhancement of the internal structures.
Vd is approximately 16 L. Protein binding is 1%. May cross the blood-brain barrier.
Excreted unchanged in the urine (97%) and feces (2%). Terminal half-life is 6.2 h.
Special PopulationsRenal Function Impairment
Plasma AUC is increased approximately 2-fold in moderate and 6-fold in severe renal impairment.Elderly
Vd is 30 to 40 L; terminal elimination half-life is 40 h.Children
Pharmacokinetic parameters have not been established.
Indications and UsageIntra-arterial
For intra-arterial digital subtraction angiography (IADSA); cerebral arteriography; peripheral arteriography; coronary arteriography; left ventriculography; visceral angiography; aortography.IV
Peripheral venography; contrast-enhanced computed tomographic (CECT) imaging of the head and body; excretory urography.
Intrathecal administration; preparatory dehydration (prolonged fasting and the administration of a laxative) before administration in children.
Dosage and AdministrationAortography and Visceral Angiography
Intra-arterial ( Ultravist 370 ) The volume and rate of contrast injection should be proportional to the blood flow through the vessels of interest, and related to the vascular and pathological characteristics of the specific vessels being studied. Total dose for the procedure should not usually exceed 225 mL.Cardiac Chamber and Related Arteries
Children 2 yr of age and older
Intra-arterial ( Ultravist 370 ) 1 to 2 mL/kg. Do not exceed 4 mL/kg as total dose.CECT of the Body
IV ( Ultravist 300 ) May administer IV by bolus injection, rapid infusion, or a combination of both. The usual dose for bolus injection is 50 to 200 mL. The usual dose for infusion is 100 to 200 mL. Total dose for the procedure should not usually exceed 200 mL. ( Ultravist 370 ) May administer IV by bolus injection, by rapid infusion, or by a combination of both. The usual dose for bolus injection is 41 to 162 mL. The usual dose for infusion is 81 to 162 mL. Total dose for the procedure should not usually exceed 162 mL.CECT of the Head
IV ( Ultravist 300 ) 50 to 200 mL. Total dose for the procedure should not usually exceed 200 mL. ( Ultravist 370 ) 41 to 162 mL. Total dose for the procedure should not usually exceed 162 mL.CECT or Excretory Urography
Children 2 yr of age and older
IV ( Ultravist 300 ) 1 to 2 mL/kg. Do not exceed 3 mL/kg as total dose.Cerebral Arteriography
Intra-arterial ( Ultravist 300 ) The usual volume ranges are: carotid arteries 3 to 12 mL; vertebral arteries 4 to 12 mL; aortic arch injection for a simultaneous 4-vessel study 20 to 50 mL. Total dose for the procedure should not usually exceed 150 mL.Coronary Arteriography and Left Ventriculography
Intra-arterial ( Ultravist 370 ) The usual volume ranges are: left coronary artery 3 to 14 mL; right coronary artery 3 to 14 mL; left ventricle 30 to 60 mL. Total dose for the procedure should not usually exceed 225 mL.Excretory Urography
IV ( Ultravist 300 ) Iodine 300 mg/kg body weight. Total dose for the procedure should not usually exceed 100 mL.IADSA
Intra-arterial ( Ultravist 150 ) The usual volumes ranges are: carotid arteries 6 to 10 mL; vertebral arteries 4 to 8 mL; aorta 20 to 50 mL; major branches of the abdominal aorta 2 to 20 mL. Total dose for the procedure should not usually exceed 250 mL.Peripheral Arteriography
Intra-arterial ( Ultravist 300 ) The usual volume ranges are: subclavian or femoral artery 5 to 40 mL; aortic bifurcation for distal runoff 25 to 50 mL. Total dose for the procedure should not usually exceed 250 mL.Peripheral Venography
IV ( Ultravist 240 ) The minimum volume necessary to visualize satisfactorily the structures under examination should be used. Total dose for the procedure should not usually exceed 250 mL.
- The volume and rate of injection of the contrast agent will vary depending on the injection site and the area being examined.
- Injection rates should be approximately equal to the flow rate in the vessel being injected.
- Patients should be adequately hydrated prior to and following the intravascular administration of iodinated contrast agents.
- Inspect visually for particulate matter and discoloration and do not use if particulates are observed or marked discoloration has occurred.
- Do not mix with or inject in IV-administration lines containing other drugs, solutions, or total nutritional admixtures.
- When large individual volumes are administered, it is recommended that sufficient time be permitted to elapse between each injection to allow for subsidence of possible hemodynamic disturbances.
- Inject intravascularly administered iodinated contrast agents at or close to body temperature.
- Mandatory prerequisites to the procedure are specialized personnel, ECG monitoring apparatus, and adequate facilities for immediate resuscitation and cardioversion.
- The maximum recommended total dose of iodine in adults is 86 g.
Store between 59° and 86°F and protect from light.
Drug InteractionsBiguanides (eg, metformin)
There is increased risk of lactic acidosis. In patients taking biguanides, acute alterations in renal function after iodinated contrast agents may precipitate lactic acidosis. Stop biguanides 48 h before the contrast medium examination and withhold 48 h after the procedure.Cholecystographic agents (eg, Hypaque)
Renal toxicity has been reported in a few patients with liver dysfunction who were given an oral cholecystographic agent followed by intravascular contrast agents. Therefore, postpone administration of any intravascular contrast agent in patients who have recently received a cholecystographic contrast agent.Interleukins
Interleukins are associated with an increased prevalence of delayed hypersensitivity reactions after receiving iodinated contrast agents. These reactions include chills, diarrhea, edema, fever, hypotension, nausea, oliguria, pruritus, rash, and vomiting.
Laboratory Test Interactions
The results of protein-bound iodine and radioactive iodine uptake studies, which depend on iodine estimation, will not accurately reflect thyroid function for at least 16 days following administration of iodinated contrast agents. However, thyroid function tests that do not depend on iodine estimations, such as T3 resin uptake and total or free thyroxine (T4) assays, are not affected.
The effect of iopromide on coagulation factors in in vitro assays increased with the administered dose. The thrombin time increased from approximately 20 sec at an iopromide concentration of 10 mg/mL up to 100 sec at a concentration of 70 mg/mL. Data on reversibility are not available.
The PTT increased from approximately 50 sec at an iopromide concentration of 10 mg/mL up to approximately 100 sec at a concentration of 70 mg/mL. A similar increase was noted in the thrombin coagulase time. Lesser effects were noted in the calcium thromboplastin time. Coagulation time increased from 13.5 to 23 sec at the highest iopromide concentration of 70 mg/mL. The Hageman factor split products decreased by approximately 20% over the range of iodine 10 to 70 mg/mL of iopromide. Plasminogen was relatively stable. There was no evidence of activation of fibrinolysis. The complement alternate pathway was activated. Factor B conversion increased in a dose-dependent manner. The duration of these effects was not studied.
In vitro studies with human blood showed that iopromide had a slight effect on coagulation and fibrinolysis. No factor XIIa formation could be demonstrated. The complement alternate pathway also can be activated.
Vasodilation (3%); angina pectoris, atrial fibrillation, cardiac arrest, CHF, MI, palpitations, tachycardia, vasospasm, ventricular fibrillation (postmarketing).
Headache (4%); dysgeusia (1%); brain edema, migraine, vertigo; amnesia, aphasia, cerebral ischemia/infarction, coma, hypotonia, paralysis, paresis, unconsciousness (postmarketing).
Skin discoloration, Stevens-Johnson syndrome (postmarketing).
Abnormal vision (1%); conjunctivitis, epistaxis, lacrimation disorder, mydriasis, tinnitus, transient cortical blindness, vertigo (postmarketing).
Hyperthyroidism, hypothyroidism, thyrotoxic crisis (postmarketing).
Nausea (4%); vomiting (2%); dysphagia, swelling of the salivary glands (postmarketing).
Urinary urgency (2%); hematuria, renal failure (postmarketing).
Anaphylactoid reaction (including fatal cases), anaphylactoid shock, angioedema, bronchospasm, hypersensitivity, laryngeal edema, laryngospasm, respiratory arrest (postmarketing).
Back pain (2%); joint disorder (effusion), muscle cramps.
Hypoxia; acute respiratory distress syndrome, asthma, pulmonary edema (postmarketing).
Injection-site and infusion reactions (4%); chest pain (2%); pain (1%); diabetes insipidus, mucus membrane disorder (mucosal swelling), sensation of warmth.
Monitor ECG and vital signs throughout the procedure. Observe patients with preexisting CV disease for several hours after administration. Observe patients with CHF receiving concurrent diuretic therapy for several hours following the procedure to detect delayed hemodynamic renal function disturbances.
Safety and efficacy not established in children younger than 2 yr of age.
Life-threatening or fatal anaphylactoid reactions may occur. Emergency personnel should be available for at least 30 to 60 min after administration.
Exercise caution and use lowest dose necessary.
Special Risk Patients
Exercise care in performing venography in patients with suspected thrombosis, phlebitis, severe ischemic disease, local infection, venous thrombosis, or a totally obstructed venous system.
May occur. The increase in circulatory osmotic load may induce acute or delayed hemodynamic disturbances in patients with CHF, severely impaired renal function, renal/hepatic disease, or renal/cardiac disease.
May occur, particularly in patients with severe arterial or venous disease.
Avoid angiography in these patients because of the risk of inducing thrombosis and embolism.
Thyroid storm may occur.
Hypertensive crisis may occur; use extreme caution.
Acute renal insufficiency or failure may occur, particularly in patients with advanced vascular disease, CHF, diabetes, multiple myeloma or other paraproteinemias disease, patients on medications that alter renal function, and elderly patients with age-related renal impairment.
May promote sickling in patients who are homozygous for sickle cell disease when administered intravascularly.
Angiography may be associated with local and distal organ damage, ischemia, thromboembolism and organ failure, including stroke, brachial plexus palsy, chest pain, MI, sinus arrest, and/or hepatorenal function abnormalities. Increased thrombosis and activation of the complement system has also occurred. Test injections to ensure proper placement are recommended.
Pulmonary and CV system effects.
- Advise patients to inform health care provider if they may be pregnant or are breast-feeding an infant.
- Instruct patients to inform health care provider if they are diabetic of if they have multiple myeloma, pheochromocytoma, homozygous sickle cell disease, or thyroid disorder.
- Advise patients to inform health care provider if they are allergic to drugs or food, or if they have immune, autoimmune, or immune deficiency disorders, or if they have had any reaction to previous injections of dyes used for x-ray procedures.
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