Dosing & Uses
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%)
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%)
< 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
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: Reactions range from mild (e.g. rash, erythema, pruritus, urticaria and skin discoloration) to severe [e.g. Stevens-Johnson Syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS)]
Vascular disorders: vasospasm
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
FDA MedWatch
- March 30, 2022: FDA recommended newborns and children aged ≤3 years have follow-up thyroid monitoring within 3 weeks after receiving iodinated contrast media (ICM) for X-rays and other medical imaging procedures
- Published studies found underactive thyroid and temporary decreases in thyroid hormone levels were uncommon; however, if identified and treated early, future complications may be prevented
- Appropriately monitor for signs and symptoms of hypothyroidism and decreased thyroid hormone levels following ICM exposure; consider evaluating thyroid function within 3 weeks, especially in term and preterm neonates and children with some underlying conditions
- If thyroid dysfunction detected, treat and monitor thyroid function as needed to avoid future complications
- Certain pediatric patients are at increased risk, including newborns or have very low birth weight, prematurity, or presence of cardiac or other conditions (eg, requiring care in neonatal or pediatric ICUs)
- Patients with cardiac conditions may be at greatest risk since they often require high doses of contrast during invasive cardiac procedures
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.
Pregnancy & Lactation
Pregnancy
There are no data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Drug crosses placenta and reaches fetal tissues in small amounts
Animal data
- In animal reproduction studies, intravenous administration of iopromide to pregnant rats and rabbits during organogenesis at doses up to 0.35 and 0.7 times, respectively, maximum recommended human dose based on body surface area resulted in no relevant adverse developmental effects
Lactation
There are no data on the presence of drug in human milk, effects on the breastfed infant, or the effects on milk production. Iodinated contrast agents are poorly excreted into human milk and are poorly absorbed by the gastrointestinal tract of a breastfed infant
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition
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.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%
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
Images
Formulary
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.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.