iopromide (Rx)

Brand and Other Names:Ultravist
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Dosage strength expressed as mg of iodine per mL

injectable solution

  • 150mgI/mL (32%)
  • 240mgI/mL (50%)
  • 300mgI/mL (62%)
  • 370mgI/mL (77%)
more...

Digital Subtraction Angiography

150 mg/mL, intra-arterial single injection dose

Carotid arteries: 6-10 mL

Vertebral arteries: 4-8 mL

Aorta: 20-50 mL

Major branches of the abdominal aorta: 2-20 mL

Not to exceed 250 mL cumulative dose

Cerebral Arteriography

300 mg/mL, intra-arterial single injection dose

Carotid arteries: 3-12 mL

Vertebral arteries: 4-12 mL

Aortic arch injection (4-vessel): 20-50 mL

Not to exceed 150 mL cumulative dose

Peripheral Arteriography

300 mg/mL, intra-arterial single injection dose

Subclavian or femoral artery: 5-40 mL

Aortic bifurcation: 25-50 mL

Not to exceed 250 mL cumulative dose

Coronary Arteriography & Left Ventriculography

370 mg/mL, intra-arterial single injection dose

Right or left coronary artery: 3-14 mL

Left ventricle: 30-60 mL

Not to exceed 225 mL cumulative dose

Visceral Angiography

370 mg/mL, intra-arterial

Use volume and infusion rate proportional to blood flow and related to the vascular and pathological characteristics of the specific vessels being studied

Not to exceed 225 mL cumulative dose

Peripheral Venography

240 mg/mL, IV

Inject minimum volume necessary to visualize structures under examination

Not to exceed 250 mL cumulative dose

Excretory Urography

300 mg/mL, IV

~300 mg/kg, IV (with normal renal function)

Not to exceed 100 mL cumulative dose

Contrast Computed Tomography

300 mg/mL, IV

  • Head: 50-200 mL
  • Body (bolus injection): 50-200 mL
  • Body (rapid infusion): 100-200 mL
  • Not to exceed 200 mL cumulative dose

370 mg/mL, IV

  • Head: 41-162 mL
  • Body (bolus injection): 41-162 mL
  • Body (rapid infusion): 81-162 mL
  • Not to exceed 162 mL cumulative dose

Administration

Hydrate patient adequately before and following administration

Warm contrast solution to body temperature shortly before administration to improve tolerability

Do not exceed cumulative iodine dose of 86 grams

Carefully individualize volume and concentration

Dosage volume and administration rate vary depending on injection site; see prescribing information for specific details

Dosage Forms & Strengths

Dosage strength expressed as mg of iodine per mL

injectable solution

  • 150mgI/mL (32%)
  • 240mgI/mL (50%)
  • 300mgI/mL (62%)
  • 370mgI/mL (77%)
more...

< 2 years

Safety and efficacy not established

> 2 years

Cardiac Chambers and Related Arteries

  • >2 years: 370 mg/mL: Inject 1 to 2 mL/kg intra-arterial; not to exceed cumulative dose of 4 mL/kg

Contrast Computerized Tomography

  • >2 years: 300 mg/mL: Inject 1-2 mL/kg IV; not to exceed cumulative dose of 3 mL/kg

Excretory Urography

  • >2 years (300 mg/mL): 300 mg I/mL: Inject 1-2 mL/kg IV; not to exceed cumulative dose of 3 mL/kg
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Adverse Effects

1-10%

Headache (6%)

Nausea (4%)

Injection Site Reactions (3%)

Vasodilatation (4%)

Vomiting (2%)

Back pain (3%)

Urinary urgency (3%)

Chest pain (3%)

Pain (2%)

Dysgeusia (1%)

Abnormal vision (2%)

<1%

Cardiac disorders: atrioventricular block (complete), bradycardia, ventricular extrasystole

Gastrointestinal disorders: abdominal discomfort, abdominal pain, , constipation, diarrhea, dry mouth, dyspepsia, salivation increased, rectal tenesmus

General disorders and administration site conditions: asthenia, chest discomfort, chills, excessive thirst, extravasation, hyperhidrosis, malaise, edema peripheral, pyrexia

Immune system disorders: asthma, face edema

Investigations: increased blood lactate dehydrogenase, blood urea increased, increased hemoglobin, increased white blood cell count

Musculoskeletal and connective tissue disorders: arthralgia, musculoskeletal pain, myasthenia, neck pain

Nervous system disorders: agitation, confusion, convulsion, dizziness, hypertonia, hypesthesia, incoordination, neuropathy, somnolence, speech disorder, tremor, paresthesia, visual field defect

Psychiatric disorders: anxiety

Renal and urinary disorders: dysuria, urinary retention

Respiratory, thoracic and mediastinal disorders: apnea, dyspnea, hypoxia, pharyngeal edema, pharyngitis, pleural effusion, pulmonary hypertension, respiratory disorder, sore throat

Skin and subcutaneous tissue disorders: erythema, pruritus, rash, urticaria

Vascular disorders: coronary artery thrombosis, flushing, hypertension, hypotension, peripheral vascular disorder, syncope

Frequency Not Defined

Additional adverse effects observed in children include

  • Epistaxis
  • Angioedema
  • Migraine
  • Joint disorder (effusion)
  • Muscle cramps
  • Mucous membrane disorder (mucosal swelling)
  • Conjunctivitis
  • Hypoxia
  • Fixed eruptions
  • Vertigo
  • Diabetes insipidus
  • Cerebral edema

Postmarketing Reports

Cardiac disorders: cardiac arrest, ventricular fibrillation, atrial fibrillation, tachycardia, palpitations, congestive heart failure, myocardial infarction, angina pectoris Ear and labyrinth disorders: vertigo, tinnitus Endocrine disorders: hyperthyroidism, thyrotoxic crisis, hypothyroidism Eye disorders: mydriasis, lacrimation disorder

Gastrointestinal disorders: dysphagia, swelling of salivary glands Immune system disorders: anaphylactoid reaction (including fatal cases), respiratory arrest, anaphylactoid shock, angioedema, laryngeal edema, laryngospasm, bronchospasm, hypersensitivity

Musculoskeletal and connective tissue disorders: compartment syndrome in case of extravasation

Nervous system disorders: cerebral ischemia/infarction, paralysis, paresis, transient cortical blindness, aphasia, coma, unconsciousness, amnesia, hypotonia, aggravation of myasthenia gravis symptoms

Renal and urinary disorders: renal failure, hematuria

Respiratory, thoracic and mediastinal disorders: pulmonary edema, acute respiratory distress syndrome, asthma

Skin and subcutaneous tissue disorders: Stevens-Johnson Syndrome, skin , toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS) discoloration

Vascular disorders: vasospasm

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Warnings

Black Box Warning

May be fatal if given intrathecally

Serious adverse events reported from inadvertent intrathecal administration including paralysis, coma, acute renal failure, seizures, cardiac arrest, rhabdomyolysis, convulsions, cerebral hemorrhage, hyperthermia, and brain edema

Contraindications

Intrathecal administration

Preparatory dehydration (prolonged fasting, bowel prep) before injection in pediatric patients is contraindicated due to risk of acute renal failure

Cautions

Severe cutaneous adverse reactions (SCAR) may develop from 1 hr to several weeks after intravascular contrast agent administration; reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS); reaction severity may increase and time to onset may decrease with repeat administration of contrast agent; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions; avoid administering therapy to patients with history of a severe cutaneous adverse reaction to therapy

Contrast induced acute kidney injury; adequately hydrate before and after procedure

Monitor closely postprocedure with if patient has preexisting cardiovascular disease

Monitor electrocardiogram and vital signs throughout procedure

If possible, avoid angiography with homocystinuria (increased risk for thrombosis/embolism)

Delayed adverse reactions may occur; monitor patient for 30-60 min after injection

Consider monitoring for thyroid storm in patients with hyperthyroidism,

Caution in patients with seizures, thromboembolic diseases including IM and stroke, chronic alcoholism, heart failure, diabetes mellitus, hepatorenal insufficiency, multiple myeloma, pheochromocytoma, renal disease, sickle cell disease

Sickle cell disease: Contrast agents may promote sickling following administration in homozygous genotypes

Drug-laboratory Test Interactions

Thyroid Function Tests: Protein bound iodine and radioactive iodine uptake studies, may not accurately reflect thyroid function for at least 16 days following administration

Laboratory Assay of Coagulation Parameters, Fibrinolysis and Complement System: The effect of iopromide on coagulation factors in in vitro assays increased with the administered dose.

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Pregnancy & Lactation

Pregnancy Category: B

Lactation: Excretion in breast milk unknown; use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Nonionic, water soluble, tri-iodinated x-ray contrast agent for intravascular administration; opacifies vessels, permitting radiographic visualization of the internal structures until significant hemodilution occurs

Absorption

  • Bioavailability Onset 15-120 seconds post bolus injection

Distribution

  • Protein Bound: 1%
  • Vd: 16 L suggesting distribution into extracellular space

Elimination

  • Half-life: 0.24 hr (initial distribution); 2.4 hr (main elimination); 6.2 hr (terminal elimination)
  • Dialyzable
  • Renal clearance: 104 mL/min
  • Total body clearance: 107 mL/min
  • Excretion: Feces 2%, urine 97%
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Administration

IV Incompatibilities

Due to potential for chemical incompatibility, do not mix or inject in intravenous administration lines containing other drugs, solutions, or total nutritional admixtures

IV Preparation

Withdraw from container under strict aseptic conditions using only sterile syringes and transfer devices. Use immediately contrast agents which have been transferred into other delivery systems

IV Administration

Administer at or close to body temperature

Storage

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) and protected from light

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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