Drug information of Iopromide

Iopromide

Drug group:

Available as the FDA-approved product Ultravist, iopromide is used in radiographic studies such as intra-arterial digital subtraction angiography (IA-DSA), cerebral and peripheral arteriography, peripheral venography, excretory urography, brain computer tomography (CT), coronary arteriography, left ventriculography, visceral angiography, and aortography

Mechanism of effect

Iopromide is a low osmolar, non-ionic X-ray contrast agent for intravascular administration. It functions as a contrast agent by opacifying blood vessels in the path of flow of the contrast agent, permitting radiographic visualization of the internal structures until significant hemodilution occurs.

Pharmacodynamic

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

Pharmacokinetics

  • 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%

Dosage

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

Pediatric

< 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

Alerts

  • 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
  • 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

Points of recommendation

  • Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
  • Very bad health problems, paralysis, and death have happened when contrast has been given into blood vessels in the spinal cord. Talk with the doctor.
  • Your blood work may need to be checked. Talk with your doctor.
  • Blood clots have happened with iopromide when used with some heart procedures. Sometimes, blood clots may cause heart attack and stroke, which may be deadly. Talk with the doctor.
  • Thyroid problems have happened after use of this medicine. Some people had to be treated for these thyroid problems. Talk with the doctor.
  • A very bad and sometimes deadly reaction has happened with iopromide. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
  • If you have sickle cell disease, talk with your doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
  • If you are 65 or older, use iopromide with care. You could have more side effects.
  • Use with care in children. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Pregnancy level

B


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