Iopromide

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

This is not a complete list of Iopromidedrug interactions. Ask your doctor or pharmacist for more information.

Take iopromide exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Iopromide dose your doctor recommends will be based on the following (use any or all that apply):

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Iopromide is available in the following doses:

• Iopromide 150 Mg/ml Injectable Solution
• Iopromide 240 Mg/ml Injectable Solution
• Iopromide 300 Mg/ml Injectable Solution
• Iopromide 370 Mg/ml Injectable Solution

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flushing.
• Feeling of warmth.
• Headache.
• Upset stomach.
• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If you need to store iopromide at home, talk with your doctor, nurse, or pharmacist about how to store it.

• Iodinated Contrast Media
• Radiological/Contrast Media, Nonionic (Low Osmolality)

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer's labeling.

Concerns related to adverse effects:

• Contrast media reactions: Serious and life-threatening reactions have occurred. Use extreme caution in patients with a history of previous reaction to contrast dye or iodine and patients with a known allergic disorder (eg, bronchial asthma, hay fever, food allergies) or other hypersensitivities. Monitor closely during and for 30 to 60 minutes after administration (delayed reactions have occurred).

• Contrast-induced acute kidney injury: Acute kidney injury, including renal failure, may occur following intravascular administration of iodinated contrast media. Risk factors include patients with preexisting renal disease, advanced age, advanced vascular disease, heart failure, dehydration, diabetes mellitus, concomitant use of nephrotoxic agents or diuretics, multiple myeloma/paraproteinemia, or large doses or multiple doses of iodinated contrast media. Adequately hydrate patients prior to and following administration to minimize the risk.

• Dermatological effects: Severe cutaneous adverse reactions (including Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], acute generalized exanthematous pustulosis [AGEP], drug reaction with eosinophilia and systemic symptoms [DRESS]) have occurred 1 hour to several weeks after administration; reaction severity may increase and time to onset may decrease with repeat administration. Avoid use in patients with a history of a severe cutaneous adverse reaction to iothalamate.

• Extravasation: Vesicant; ensure proper needle/catheter/line placement prior to and during administration. Avoid infiltration. Extravasation may result in tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease.

• Thromboembolic events: Serious thromboembolic events have been reported during angiographic procedures with both ionic and nonionic contrast agents. Clotting may occur when blood remains in contact with syringes containing iodinated contrast media. Therefore, meticulous intravascular administration technique is necessary.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease or heart failure. Iodinated contrast media may result in an increased circulatory osmotic load and subsequent acute or delayed hemodynamic changes, especially following the use of large doses or repeated doses. Observe patients with cardiovascular disease for several hours after procedure for the development of delayed hemodynamic changes. Preparatory dehydration may contribute to acute renal failure in patients with heart failure or advanced vascular disease; avoid fluid restriction and maintain normal hydration in these patients.

• Diabetes: Use with caution in patients with diabetes mellitus; these patients may have altered renal blood flow, increasing risk of nephrotoxicity. Preparatory dehydration may contribute to acute renal failure in patients with diabetes; avoid fluid restriction and maintain normal hydration in these patients.

• Hepatic impairment: Use with caution in patients with hepatic impairment, especially those with concomitant renal impairment or when using both oral and IV contrast agents in close proximity.

• Homocystinuria: Avoid angiography in patients with homocystinuria; may be at risk for thrombosis and embolism.

• Hyperthyroidism: Use with caution in patients with thyroid disease; thyroid storm has been reported in patients with history of hyperthyroidism or with an autonomously functioning thyroid nodule.

• Hypothyroidism: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been reported (uncommon) in adult and pediatric patients (including infants); some patients were treated for hypothyroidism.

• Multiple myeloma: Use with caution in patients with multiple myeloma; use of intravascular contrast agents may lead to renal impairment, especially with concurrent dehydration.

• Pheochromocytoma: Use with extreme caution in patients with pheochromocytoma (known or suspected). Minimize the amount of contrast agent used (for intravascular administration) and monitor blood pressure closely throughout procedure. Therapy for treatment of hypertensive crisis should be readily available.

• Renal impairment: Use with caution in patients with renal impairment. May be associated with deterioration of renal function and/or increases in serum creatinine, particularly in elderly patients and patients with diabetes, advanced vascular disease, and those who are dehydrated. Use lowest dose possible in patients with renal impairment.

• Sickle cell disease: Use with caution in patients with sickle cell disease; may promote sickling.

Other warnings/precautions:

• Appropriate use: For IV or intra-arterial use only. [US Boxed Warning]: Not for intrathecal use. Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. In contrast-enhanced computerized tomography, contrast may obscure some lesions previously seen on unenhanced CT scans.

• Trained personnel: Clinicians using radiopaque contrast agents should be well trained in diagnosis and management of emergencies that may arise from the use of these agents. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use during and for 30 to 60 minutes after administration (delayed reactions have occurred).