Iopromide

Iopromide is a prescription medication used as a contrast agent in intravenous procedures such as angiography, arteriography, ventriculography, aortography, venography, urography, and Computed Tomography (CT). 

• Iopromide is available under the following different brand names: Ultravist 

Common side effects of Iopromide include:

• Change in taste,
• Vision changes,
• Abdominal pain,
• Indigestion,
• Agitation,
• Burping,
• Gas,
• Body aches,
• Pain,
• Numbness and tingling,
• Difficulty moving,
• Dry mouth,
• Excessive muscle tone,
• Feeling unwell,
• Lack of coordination,
• Weakness,
• Muscle tension or tightness,
• Drowsiness,
• Tender or swollen glands in the neck,
• Hoarseness,
• Dilated pupils,
• Burning, dry, or itching eyes,
• Ringing in the ears,
• Excessive tearing of the eyes,
• Spinning sensation,
• Headache,
• Hearing loss,
• Increased sensitivity to light, and
• Redness, pain, or swelling of the eye

Serious side effects of Iopromide include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• discoloration of the skin,
• irritation at the injection site (redness, irritation, tenderness, burning, coldness, inflammation, itching, or a lump),
• chest pain or pressure,
• dizziness,
• lightheadedness,
• fainting,
• flushing (redness or warmth of the skin),
• headache,
• sweating,
• increased urge to urinate,
• bloating,
• bluish lips or skin,
• convulsions,
• cough,
• little or no urination,
• increased thirst,
• fever,
• chills,
• nausea,
• vomiting,
• noisy breathing,
• pain or discomfort in the arms, jaw, back, or neck,
• pale skin at the injection site,
• irregular heartbeat,
• tingling of the hands or feet,
• unusual tiredness,
• weakness,
• weight gain or loss,
• blistering, peeling, or loosening of the skin,
• bloody urine,
• cough with frothy pink sputum,
• diarrhea,
• wheezing,
• difficulty swallowing,
• sore throat,
• dilated neck veins,
• extreme fatigue,
• irregular breathing,
• joint or muscle pain,
• loss of appetite,
• back or side pain,
• nervousness,
• red or irritated eyes,
• red skin rash with a purple center,
• sensitivity to heat,
• itching,
• white spots in the mouth or on the lips,
• swelling the feet or lower legs, and
• trouble sleeping  

Rare side effects of iopromide include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 150 mg/mL (32%)
• 240 mg/mL (50%)
• 300 mg/mL (62%)
• 370 mg/mL (77%)

Digital Subtraction Angiography

Adult dosage

• 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

Adult dosage

• 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

Adult dosage

• 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

Adult dosage

• 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

Adult dosage

• 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

Adult dosage

• 240 mg/mL, Intravenous
• Inject the minimum volume necessary to visualize structures under examination
• Not to exceed 250 mL cumulative dose

Excretory Urography

Adult dosage

• 300 mg/mL, Intravenous
• Approximately 300 mg/kg, Intravenous (with normal renal function)
• Not to exceed 100 mL cumulative dose

Pediatric dosage

• Above 2 years (300 mg/mL): 300 mg I/mL: Inject 1-2 mL/kg Intravenous; not to exceed the cumulative dose of 3 mL/kg

Contrast Computed Tomography

Adult dosage

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

Pediatric dosage

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

Cardiac Chambers and Related Arteries

Pediatric dosage

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

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Iopromide has no noted severe interactions with any other drugs.
• Iopromide has no noted serious interactions with any other drugs.
• Iopromide has no noted moderate interactions with any other drugs.
• Iopromide has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

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

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Iopromide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Iopromide?”

Cautions

• Severe cutaneous adverse reactions (SCAR) may develop from 1 hour 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 a history of a severe cutaneous adverse reaction to therapy
• Contrast-induced acute kidney injury; adequately hydrate before and after the procedure
• Monitor closely post-procedure if the patient has preexisting cardiovascular disease
• Monitor electrocardiogram and vital signs throughout the 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 below 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 is 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 (. g, requiring care in neonatal or pediatric ICUs)
  • Patients with cardiac conditions may be at the 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 and Lactation

• 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 the placenta and reaches fetal tissues in small amounts
• Lactation
  • There are no data on the presence of the drug in human milk, its 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 the breastfed infant from treatment or underlying maternal condition