Iopamidol - Iopamidol injection, Solution prescribing information
- Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency resuscitation equipment and trained personnel available.
- Acute Kidney Injury: Acute injury including renal failure can occur. Use the lowest dose and maintain adequate hydration to minimize risk.
- Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after iopamidol injection administration.
- Thyroid Dysfunction in Pediatric Patients 0 Years to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity.
Intrathecal administration, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Iopamidol injection is for intra-arterial or intravenous use only and must not be administered intrathecally
Iopamidol injection can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock
Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions does not prevent serious life-threatening reactions but may reduce both their incidence and severity. Obtain a history of allergy, hypersensitivity, or hypersensitivity reactions to iodinated contrast agents and always have emergency resuscitation equipment and trained personnel available prior to iopamidol injection administration. Monitor all patients for hypersensitivity reactions.
Acute kidney injury, including renal failure, may occur after iopamidol injection administration. Risk factors include: pre-existing renal insufficiency, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma or other paraproteinemias, and repetitive or large doses of iopamidol injection.
Use the lowest necessary dose of iopamidol injection in patients with renal impairment. Adequately hydrate patients prior to and following iopamidol injection administration. Do not use laxatives, diuretics, or preparatory dehydration prior to iopamidol injection administration.
Iopamidol injection increases the circulatory osmotic load and may induce acute or delayed hemodynamic disturbances in patients with congestive heart failure, severely impaired renal function, combined renal and hepatic disease, and combined renal and cardiac disease, particularly when repetitive or large doses are administered. Fatal cardiovascular reactions have occurred mostly within 10 minutes of iopamidol injection; the main feature was cardiac arrest with cardiovascular disease as the main underlying factor. Hypotensive collapse and shock have occurred. Cardiac decompensation, serious arrhythmias, and myocardial ischemia or infarction can occur during coronary arteriography and ventriculography.
The administration of iopamidol injection may cause pulmonary edema in patients with heart failure. Based upon published reports, deaths associated with the administration of iodinated contrast agents range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent). Use the lowest necessary dose of iopamidol injection in patients with congestive heart failure and always have emergency resuscitation equipment and trained personnel available. Monitor all patients for severe cardiovascular reactions.
Serious, in some cases fatal, thromboembolic events, including myocardial infarction and stroke, can occur during angiographic procedures. During these procedures, increased thrombosis and activation of the complement system occurs. Risk factors for developing thromboembolic events include: length of procedure, catheter and syringe material, underlying disease state, and concomitant medications.
To minimize thromboembolic events, use meticulous angiographic techniques and minimize the length of the procedure. Avoid blood remaining in contact with syringes containing iodinated contrast agents, which increases risk of clotting. Avoid angiocardiography in patients with homocystinuria because of the risk of inducing thrombosis and embolism.
Extravasation can occur with iopamidol injection administration, particularly in patients with severe arterial or venous disease. Inflammation, blistering, skin necrosis, and compartment syndrome have been reported following extravasation. In addition, injection site reactions such as pain and swelling at the injection site can also occur
Thyroid storm has occurred after the intravascular use of iodinated agents in patients with hyperthyroidism or with an autonomously functioning thyroid nodule. Evaluate the risk in such patients before use of iopamidol injection
Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast agents in pediatric patients 0 years to 3 years of age.
Younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with an increased risk of hypothyroidism after iodinated contrast agent exposure. Pediatric patients with congenital cardiac conditions may be at greatest risk given that they often require high doses of contrast during invasive cardiac procedures.
An underactive thyroid during early life may be harmful for cognitive and neurological development and may require thyroid hormone replacement therapy. After exposure to iodinated contrast agents, individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates.
Hypertensive crisis in patients with pheochromocytoma has occurred with iodinated contrast agents. Closely monitor patients when administering iopamidol injection if pheochromocytoma or catecholamine-secreting paragangliomas are suspected. Inject the minimum amount of iopamidol injection necessary and have measures for treatment of hypertensive crisis readily available.
Iodinated contrast agents can promote sickling in individuals who are homozygous for sickle cell disease. Hydrate patients prior to and following iopamidol injection administration and use only if the necessary imaging information cannot be obtained with alternative imaging modalities.
Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration. These 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 a contrast agent; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions. Avoid administering iopamidol injection to patients with a history of a severe cutaneous adverse reaction to iopamidol injection.
Iopamidol injection can interfere with protein-bound iodine test
- Individualize the volume and concentration according to the specific dosing tables accounting for factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel.
- See full prescribing information for important dosage and administration information.
- Iopamidol Injection, USP is for intra-arterial or intravenous use only and must not be administered intrathecally[see Warnings and Precautions ].
- Specific concentrations of Iopamidol Injection, USP are recommended for each type of imaging procedure[see Dosage and Administration ].
- Individualize the volume, concentration, and injection rate of iopamidol injection according to the specific dosing tables[see Dosage and Administration ]. Consider factors such as: age, body weight, blood vessel size and blood flow rate, anticipated pathology and degree and extent of opacification required, structures or area to be examined, concomitant medical conditions, imaging equipment, and technique to be employed.
- Hydrate patients before and after Iopamidol Injection, USP administration[see Warnings and Precautions ].
- Use aseptic technique for all handling and administration of Iopamidol Injection, USP.
- Iopamidol Injection, USP may be administered at either body temperature (37°C, 98.6°F) or room temperature (20°C to 25°C, 68°F to 77°F).
- Visually inspect Iopamidol Injection, USP for particulate matter or discoloration before administration. Do not administer Iopamidol Injection, USP if particulate matter or discolorations are observed.
- Do not mix Iopamidol Injection, USP with other drugs or inject in intravenous lines containing other drugs or total nutritional admixtures.
- Iopamidol Injection, USP single-dose containers are intended for one procedure only. Discard any unused portion.
The recommended doses for intra-arterial procedures in adults are shown in Table 1.
Imaging Procedure | Concentration (mg Iodine/mL) | Volume to Administer per Single Injection for Selected Injection Sites | Maximum Cumulative Total Dose |
Cerebral Arteriography | 300 | 8 mL to 12 mL by carotid puncture or transfemoral catheterization | 90 mL |
Peripheral Arteriography | 300 | • 5 mL to 40 mL into the femoral artery or subclavian artery • 25 mL to 50 mL into the aorta for a distal runoff | 250 mL |
Selective Visceral Arteriography and Aortography | 370 | • Up to 10 mL for the renal arteries • Up to 50 mL into the larger vessels such as the aorta or celiac artery | 225 mL |
Coronary Arteriography and Cardiac Ventriculography | 370 | • 2 mL to 10 mL for selective coronary artery injection • 25 mL to 50 mL for cardiac ventriculography or for nonselective opacification of multiple coronary arteries following injection at the aortic root | 200 mL |
The recommended doses for intra-arterial procedures in adults are shown in Table 2.
Imaging Procedure | Concentration (mg Iodine/mL) | Volume to Administer |
Excretory Urography | 250 300 370 | 50 mL to 100 mL by rapid injection 50 mL by rapid injection 40 mL by rapid injection |
CT of the Head | 250 300 | 130 mL to 240 mL 100 mL to 200 mL |
CT of Body | 250 300 370 | 130 mL to 240 mL by rapid infusion or bolus injection 100 mL to 200 mL by rapid infusion or bolus injection 80 mL to 160 mL by rapid infusion or bolus injection |
Peripheral Venography | 200 | 25 mL to 150 mL per lower extremity; the maximum total dose is 350 mL |
The recommended doses in pediatric patients are shown in Table 3.
Imaging Procedure | Concentration (mg Iodine/mL) | Volume per Body Weight to Administer | Maximum Dose |
Intra-arterial Procedures | |||
Angiocardiography | 370 | 0.5 mL/kg to 2 mL/kg per single injection | Maximum Cumulative Dose by Weight • Neonates: 5 mL/kg • Aged 4 weeks and older: 8 mL/kg • Do not exceed maximum cumulative doses by age below. Maximum Cumulative Dose by Age • <2 years 40 mL • 2 years to 4 years 50 mL • 5 years to 9 years 100 mL • 10 years to 18 years 125 mL |
Intravenous Procedures | |||
Excretory Urography | 250 | 1.2 mL/kg to 3.6 mL/kg | 120 mL |
300 | 1 mL/kg to 3 mL/kg | 100 mL | |
CT of the Head and Body | 250 | 1.2 mL/kg to 3.6 mL/kg | 120 mL |
300 | 1 mL/kg to 3 mL/kg | 100 mL | |
Iopamidol Injection, USP is a radiographic contrast agent indicated for:
- Cerebral arteriography in adults
- Peripheral arteriography in adults
- Selective visceral arteriography and aortography in adults
- Coronary arteriography and cardiac ventriculography in adults
- Angiocardiography in pediatric patients
- Cerebral arteriography in adults
- Peripheral arteriography in adults
- Selective visceral arteriography and aortography in adults
- Coronary arteriography and cardiac ventriculography in adults
- Angiocardiography in pediatric patients
- Excretory urography in adults and pediatric patients
- Computed tomography (CT) of head and body in adults and pediatric patients
- Peripheral venography in adults
- Excretory urography in adults and pediatric patients
- Computed tomography (CT) of head and body in adults and pediatric patients
- Peripheral venography in adults
The recommended doses for intra-arterial procedures in adults are shown in Table 1.
Imaging Procedure | Concentration (mg Iodine/mL) | Volume to Administer per Single Injection for Selected Injection Sites | Maximum Cumulative Total Dose |
Cerebral Arteriography | 300 | 8 mL to 12 mL by carotid puncture or transfemoral catheterization | 90 mL |
Peripheral Arteriography | 300 | • 5 mL to 40 mL into the femoral artery or subclavian artery • 25 mL to 50 mL into the aorta for a distal runoff | 250 mL |
Selective Visceral Arteriography and Aortography | 370 | • Up to 10 mL for the renal arteries • Up to 50 mL into the larger vessels such as the aorta or celiac artery | 225 mL |
Coronary Arteriography and Cardiac Ventriculography | 370 | • 2 mL to 10 mL for selective coronary artery injection • 25 mL to 50 mL for cardiac ventriculography or for nonselective opacification of multiple coronary arteries following injection at the aortic root | 200 mL |
The recommended doses for intra-arterial procedures in adults are shown in Table 2.
Imaging Procedure | Concentration (mg Iodine/mL) | Volume to Administer |
Excretory Urography | 250 300 370 | 50 mL to 100 mL by rapid injection 50 mL by rapid injection 40 mL by rapid injection |
CT of the Head | 250 300 | 130 mL to 240 mL 100 mL to 200 mL |
CT of Body | 250 300 370 | 130 mL to 240 mL by rapid infusion or bolus injection 100 mL to 200 mL by rapid infusion or bolus injection 80 mL to 160 mL by rapid infusion or bolus injection |
Peripheral Venography | 200 | 25 mL to 150 mL per lower extremity; the maximum total dose is 350 mL |
The recommended doses in pediatric patients are shown in Table 3.
Imaging Procedure | Concentration (mg Iodine/mL) | Volume per Body Weight to Administer | Maximum Dose |
Intra-arterial Procedures | |||
Angiocardiography | 370 | 0.5 mL/kg to 2 mL/kg per single injection | Maximum Cumulative Dose by Weight • Neonates: 5 mL/kg • Aged 4 weeks and older: 8 mL/kg • Do not exceed maximum cumulative doses by age below. Maximum Cumulative Dose by Age • <2 years 40 mL • 2 years to 4 years 50 mL • 5 years to 9 years 100 mL • 10 years to 18 years 125 mL |
Intravenous Procedures | |||
Excretory Urography | 250 | 1.2 mL/kg to 3.6 mL/kg | 120 mL |
300 | 1 mL/kg to 3 mL/kg | 100 mL | |
CT of the Head and Body | 250 | 1.2 mL/kg to 3.6 mL/kg | 120 mL |
300 | 1 mL/kg to 3 mL/kg | 100 mL | |
- Individualize the volume and concentration according to the specific dosing tables accounting for factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel. (,
2.2 Recommended Dosage for Intra-arterial Procedures in AdultsThe recommended doses for intra-arterial procedures in adults are shown in Table 1.
Table 1: Recommended Concentrations and Volumes of Iopamidol Injection, USP for Intra-arterial Procedures in AdultsImaging ProcedureConcentration(mg Iodine/mL)Volume to Administer per Single Injection for Selected Injection SitesMaximum CumulativeTotal DoseCerebral Arteriography
300
8 mL to 12 mL by carotid puncture or transfemoral catheterization
90 mL
Peripheral Arteriography
300
• 5 mL to 40 mL into the femoral artery or subclavian artery
• 25 mL to 50 mL into the aorta for a distal runoff
250 mL
Selective Visceral Arteriography and
Aortography
370
• Up to 10 mL for the renal arteries
• Up to 50 mL into the larger vessels such as the aorta or celiac artery
225 mL
Coronary Arteriography
and Cardiac Ventriculography
370
• 2 mL to 10 mL for selective coronary artery injection
• 25 mL to 50 mL for cardiac ventriculography or for nonselective opacification of multiple coronary arteries following injection at the aortic root
200 mL
,2.3 Recommended Dosage for Intravenous Procedures in AdultsThe recommended doses for intra-arterial procedures in adults are shown in Table 2.
Table 2: Recommended Concentrations and Volumes of Iopamidol Injection, USP for Intravenous Procedures in AdultsImagingProcedureConcentration(mg Iodine/mL)Volume to AdministerExcretory
Urography
250
300
370
50 mL to 100 mL by rapid injection
50 mL by rapid injection
40 mL by rapid injection
CT of the Head
250
300
130 mL to 240 mL
100 mL to 200 mL
CT of Body
250
300
370
130 mL to 240 mL by rapid infusion or bolus injection
100 mL to 200 mL by rapid infusion or bolus injection
80 mL to 160 mL by rapid infusion or bolus injection
Peripheral
Venography
200
25 mL to 150 mL per lower extremity; the maximum total dose is 350 mL
)2.4 Recommended Dosage in Pediatric PatientsThe recommended doses in pediatric patients are shown in Table 3.
Table 3: Recommended Concentrations and Volumes per Body Weight of Iopamidol Injection, USP for Intra-arterial and Intravenous Procedures in Pediatric PatientsImagingProcedureConcentration(mg Iodine/mL)Volume per Body Weight to AdministerMaximum DoseIntra-arterial ProceduresAngiocardiography
370
0.5 mL/kg to 2 mL/kg per single injection
Maximum Cumulative Dose by Weight• Neonates: 5 mL/kg
• Aged 4 weeks and older: 8 mL/kg
• Do not exceed maximum
cumulative doses by age below.
Maximum Cumulative Dose by Age• <2 years 40 mL
• 2 years to 4 years 50 mL
• 5 years to 9 years 100 mL
• 10 years to 18 years 125 mL
Intravenous ProceduresExcretory Urography
250
1.2 mL/kg to
3.6 mL/kg
120 mL
300
1 mL/kg to
3 mL/kg
100 mL
CT of the Head and Body
250
1.2 mL/kg to
3.6 mL/kg
120 mL
300
1 mL/kg to
3 mL/kg
100 mL
- See full prescribing information for important dosage and administration information. ()
2.1 Important Dosing and Administration Information- Iopamidol Injection, USP is for intra-arterial or intravenous use only and must not be administered intrathecally[see Warnings and Precautions ].
- Specific concentrations of Iopamidol Injection, USP are recommended for each type of imaging procedure[see Dosage and Administration ].
- Individualize the volume, concentration, and injection rate of iopamidol injection according to the specific dosing tables[see Dosage and Administration ]. Consider factors such as: age, body weight, blood vessel size and blood flow rate, anticipated pathology and degree and extent of opacification required, structures or area to be examined, concomitant medical conditions, imaging equipment, and technique to be employed.
- Hydrate patients before and after Iopamidol Injection, USP administration[see Warnings and Precautions ].
- Use aseptic technique for all handling and administration of Iopamidol Injection, USP.
- Iopamidol Injection, USP may be administered at either body temperature (37°C, 98.6°F) or room temperature (20°C to 25°C, 68°F to 77°F).
- Visually inspect Iopamidol Injection, USP for particulate matter or discoloration before administration. Do not administer Iopamidol Injection, USP if particulate matter or discolorations are observed.
- Do not mix Iopamidol Injection, USP with other drugs or inject in intravenous lines containing other drugs or total nutritional admixtures.
- Iopamidol Injection, USP single-dose containers are intended for one procedure only. Discard any unused portion.
- Iopamidol Injection, USP is for intra-arterial or intravenous use only and must not be administered intrathecally
Injection: Clear, colorless to pale yellow solution available in the following concentrations of iodine:
Concentration (mg Iodine/mL) | Package Size | Package Type |
200 | 50 mL | Single-Dose Vial |
250 | 50 mL | Single-Dose Vial |
300 | 30 mL, 50 mL, 100 mL | Single-Dose Vial |
370 | 50 mL, 75 mL, and 100 mL | Single-Dose Vial |
Lactation: A lactating woman may pump and discard breast milk for 10 hours after iopamidol injection administration. (
There are no data on the presence of iopamidol in human milk, the effects on the breastfed infant, or the effects on milk production. Iodinated contrast agents are present unchanged in human milk in very low amounts, with poor absorption from 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 iopamidol injection and any potential adverse effects on the breastfed infant from iopamidol injection or from the underlying maternal condition.
Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small. However, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 half-lives) after iopamidol injection administration in order to minimize drug exposure to a breastfed infant.
None.