iopromide (Rx)

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

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

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.

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%

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