Iohexol
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WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF OMNIPAQUE INJECTION 140 mg IODINE/mL and 350 mg IODINE/mL Use only the OMNIPAQUE iodine concentrations and presentations recommended for intrathecal procedure [see Dosage and Administration (2.2 , 2.8) ]. Intrathecal administration of OMNIPAQUE of a wrong iodine concentration, even if inadvertent, may cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions (5.1) ].
WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF OMNIPAQUE INJECTION 140 and 350 mg IODINE/mL Use only the iodine concentrations and presentations recommended for intrathecal procedures. Intrathecal administration of a wrong iodine concentration, even if inadvertent, may cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema. ( 2.2 , 2.8 , 5.1 )
Radiographic Contrast Agent
Dosing in kidney impairment
Renal Impairment The clearance of iohexol decreases with increasing degree of renal impairment and results in delayed opacification of the urinary system. In addition, preexisting renal impairment increases the risk for acute kidney injury [see Warnings and Precautions ] . Iohexol can be removed by dialysis.
| Imaging Procedure | Concentration (mg Iodine/mL) | Volume to Administer per Single Injection for Selective Injection Sites | Maximum Cumulative Total Dose | |
|---|---|---|---|---|
| Cardiac Ventriculography | 350 Use single-dose containers or a 500 mL Pharmacy Bulk Package [see Dosage and Administration (2.11)]. | 40 mL (Range of 30 mL to 60 mL) may be combined with selective coronary arteriography | 250 mL | |
| Aortography and Selective Visceral Arteriography | 300 | Aorta (aortic arch, ascending aorta): 50 mL to 80 mLAbdominal aorta and its branches (celiac, mesenteric, hepatic, and splenic arteries): 30 mL to 60 mLRenal arteries: 5 mL to 15 mL | 290 mL | |
| 350 | 250 mL | |||
| Aortic root and arch study when used alone | 350 | 50 mL (Range of 20 mL to 75 mL) | 250 mL | |
| Selective Coronary Arteriography | 350 | 5 mL (Range of 3 mL to 14 mL) | 250 mL | |
| Cerebral Arteriography | 300 | Common carotid artery: 6 mL to 12 mLInternal carotid artery: 8 mL to 10 mLExternal carotid artery: 6 mL to 9 mLVertebral artery: 6 mL to 10 mL | 290 mL | |
| Peripheral Arteriography | Aortofemoral Runoffs | 300 | 30 mL to 90 mL | 290 mL |
| 350 | 20 mL to 70 mL | 250 mL | ||
| Selective Arteriogram | 300 | 10 mL to 60 mL | 290 mL | |
| 350 | 10 mL to 30 mL | 250 mL | ||
| IA-DSA (head, neck, abdominal, renal, and peripheral vessels) | 140 | Aorta: 20 mL to 45 mL at 8 mL/sec to 20 mL/secCarotid artery: 5 mL to 10 mL at 3 mL/sec to 6 mL/secFemoral artery: 9 mL to 20 mL at 3 mL/sec to 6 mL/secVertebral artery: 4 mL to 10 mL at 2 mL/sec to 8 mL/secRenal arteries: 6 mL to 12 mL at 3 mL/sec to 6 mL/secOther branches of aorta (includes subclavian, axillary, innominate, and iliac): 8 mL to 25 mL at 3 mL/sec to 10 mL/sec | 250 mL | |
| Imaging Procedure | Concentration (mg Iodine/mL) | Volume to Administer | |
|---|---|---|---|
| Excretory Urography | 300 Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)]. | 0.6 mL/kg to 1.2 mL/kg body weight (maximum dose is 102 mL) | |
| 350 | |||
| CT | Head | 240 | 120 mL to 250 mL by infusion |
| 300 Use single-dose containers, 500 mL Imaging Bulk Packages or Pharmacy Bulk Packages, or 150 mL single-dose bottles with an automated contrast injection system or contrast management system [see Dosage and Administration (2.10, 2.11, 2.12)]. | 70 mL to 150 mL by rapid injection | ||
| 350 | 80 mL by rapid injection | ||
| Body | 300 | 50 mL to 200 mL by rapid injection | |
| 350 | 60 mL to 100 mL by rapid injection | ||
| Peripheral Venography (phlebography) | 240 | 20 mL to 150 mL per leg | |
| 300 | 40 mL to 100 mL per leg | ||
| IV-DSA (head, neck, abdominal, renal, and peripheral vessels) | 350 | 30 mL to 50 mL at 7.5 mL/sec to 30 mL/sec using a pressure injector Frequently three or more doses may be required; the maximum cumulative total dose is 250 mL | |
Dosing in liver impairment
| Imaging Procedure | Concentration (mg Iodine/mL) | Volume to Administer per Single Injection for Selective Injection Sites | Maximum Cumulative Total Dose | |
|---|---|---|---|---|
| Cardiac Ventriculography | 350 Use single-dose containers or a 500 mL Pharmacy Bulk Package [see Dosage and Administration (2.11)]. | 40 mL (Range of 30 mL to 60 mL) may be combined with selective coronary arteriography | 250 mL | |
| Aortography and Selective Visceral Arteriography | 300 | Aorta (aortic arch, ascending aorta): 50 mL to 80 mLAbdominal aorta and its branches (celiac, mesenteric, hepatic, and splenic arteries): 30 mL to 60 mLRenal arteries: 5 mL to 15 mL | 290 mL | |
| 350 | 250 mL | |||
| Aortic root and arch study when used alone | 350 | 50 mL (Range of 20 mL to 75 mL) | 250 mL | |
| Selective Coronary Arteriography | 350 | 5 mL (Range of 3 mL to 14 mL) | 250 mL | |
| Cerebral Arteriography | 300 | Common carotid artery: 6 mL to 12 mLInternal carotid artery: 8 mL to 10 mLExternal carotid artery: 6 mL to 9 mLVertebral artery: 6 mL to 10 mL | 290 mL | |
| Peripheral Arteriography | Aortofemoral Runoffs | 300 | 30 mL to 90 mL | 290 mL |
| 350 | 20 mL to 70 mL | 250 mL | ||
| Selective Arteriogram | 300 | 10 mL to 60 mL | 290 mL | |
| 350 | 10 mL to 30 mL | 250 mL | ||
| IA-DSA (head, neck, abdominal, renal, and peripheral vessels) | 140 | Aorta: 20 mL to 45 mL at 8 mL/sec to 20 mL/secCarotid artery: 5 mL to 10 mL at 3 mL/sec to 6 mL/secFemoral artery: 9 mL to 20 mL at 3 mL/sec to 6 mL/secVertebral artery: 4 mL to 10 mL at 2 mL/sec to 8 mL/secRenal arteries: 6 mL to 12 mL at 3 mL/sec to 6 mL/secOther branches of aorta (includes subclavian, axillary, innominate, and iliac): 8 mL to 25 mL at 3 mL/sec to 10 mL/sec | 250 mL | |
Preparation and administration
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Important Dosage and Administration Instructions Specific dosage forms, concentrations, and presentations of OMNIPAQUE are recommended for each type of imaging procedure [see Dosage and Administration (2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9) and Warnings and Precautions (5.1 , 5.2) ]. Individualize the volume, strength, and rate of administration of OMNIPAQUE injection according to the specific dosing tables [see Dosage and Administration (2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9) ] .
Consider factors such as age, body weight, vessel size, blood flow rate within the vessel, anticipated pathology, degree and extent of opacification required, structures or area to be examined, disease processes affecting the patient, and equipment and technique to be employed. Hydrate patients before and after administration of OMNIPAQUE injection [see Warnings and Precautions ].
Use aseptic technique for all handling and administration of OMNIPAQUE injection. Administer OMNIPAQUE injection at either body (37°C, 98.6°F) or room temperature (20°C to 25°C, 68°F to 77°F). Do not mix OMNIPAQUE injection with, or inject in intravenous lines containing, other drugs or total nutritional admixtures except when OMNIPAQUE injection is administered in an automated contrast injection system or contrast management system suitable for simultaneous injection of OMNIPAQUE injection and 0.9% Sodium Chloride Injection [see Dosage and Administration (2.10 , 2.11) ].
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Each container of OMNIPAQUE injection and OMNIPAQUE oral solution in single-dose containers are intended for one procedure only. Discard any unused portion.
| Imaging Procedure | Injection Type | Concentration (mg Iodine/mL) | Volume to Administer |
|---|---|---|---|
| Lumbar Myelography | Lumbar | 180 Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)]. | 10 mL to 17 mL |
| 240 | 7 mL to 12.5 mL | ||
| Thoracic Myelography | Lumbar Cervical | 240 | 6 mL to 12.5 mL |
| 300 | 6 mL to 10 mL | ||
| Cervical Myelography | Lumbar | 240 | 6 mL to 12.5 mL |
| 300 | 6 mL to 10 mL | ||
| C1-2 | 180 | 7 mL to 10 mL | |
| 240 | 6 mL to 12.5 mL | ||
| 300 | 4 mL to 10 mL | ||
| Total Columnar Myelography | Lumbar | 240 | 6 mL to 12.5 mL |
| 300 | 6 mL to 10 mL | ||
| CT Cisternography | Lumbar | 180 | 10 mL to 17 mL |
| 240 | 7 mL to 12.5 mL |
| Imaging Procedure | Concentration (mg Iodine/mL) | Volume to Administer per Single Injection for Selective Injection Sites | Maximum Cumulative Total Dose | |
|---|---|---|---|---|
| Cardiac Ventriculography | 350 Use single-dose containers or a 500 mL Pharmacy Bulk Package [see Dosage and Administration (2.11)]. | 40 mL (Range of 30 mL to 60 mL) may be combined with selective coronary arteriography | 250 mL | |
| Aortography and Selective Visceral Arteriography | 300 | Aorta (aortic arch, ascending aorta): 50 mL to 80 mLAbdominal aorta and its branches (celiac, mesenteric, hepatic, and splenic arteries): 30 mL to 60 mLRenal arteries: 5 mL to 15 mL | 290 mL | |
| 350 | 250 mL | |||
| Aortic root and arch study when used alone | 350 | 50 mL (Range of 20 mL to 75 mL) | 250 mL | |
| Selective Coronary Arteriography | 350 | 5 mL (Range of 3 mL to 14 mL) | 250 mL | |
| Cerebral Arteriography | 300 | Common carotid artery: 6 mL to 12 mLInternal carotid artery: 8 mL to 10 mLExternal carotid artery: 6 mL to 9 mLVertebral artery: 6 mL to 10 mL | 290 mL | |
| Peripheral Arteriography | Aortofemoral Runoffs | 300 | 30 mL to 90 mL | 290 mL |
| 350 | 20 mL to 70 mL | 250 mL | ||
| Selective Arteriogram | 300 | 10 mL to 60 mL | 290 mL | |
| 350 | 10 mL to 30 mL | 250 mL | ||
| IA-DSA (head, neck, abdominal, renal, and peripheral vessels) | 140 | Aorta: 20 mL to 45 mL at 8 mL/sec to 20 mL/secCarotid artery: 5 mL to 10 mL at 3 mL/sec to 6 mL/secFemoral artery: 9 mL to 20 mL at 3 mL/sec to 6 mL/secVertebral artery: 4 mL to 10 mL at 2 mL/sec to 8 mL/secRenal arteries: 6 mL to 12 mL at 3 mL/sec to 6 mL/secOther branches of aorta (includes subclavian, axillary, innominate, and iliac): 8 mL to 25 mL at 3 mL/sec to 10 mL/sec | 250 mL | |
| Imaging Procedure | Concentration (mg Iodine/mL) | Volume to Administer | |
|---|---|---|---|
| Excretory Urography | 300 Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)]. | 0.6 mL/kg to 1.2 mL/kg body weight (maximum dose is 102 mL) | |
| 350 | |||
| CT | Head | 240 | 120 mL to 250 mL by infusion |
| 300 Use single-dose containers, 500 mL Imaging Bulk Packages or Pharmacy Bulk Packages, or 150 mL single-dose bottles with an automated contrast injection system or contrast management system [see Dosage and Administration (2.10, 2.11, 2.12)]. | 70 mL to 150 mL by rapid injection | ||
| 350 | 80 mL by rapid injection | ||
| Body | 300 | 50 mL to 200 mL by rapid injection | |
| 350 | 60 mL to 100 mL by rapid injection | ||
| Peripheral Venography (phlebography) | 240 | 20 mL to 150 mL per leg | |
| 300 | 40 mL to 100 mL per leg | ||
| IV-DSA (head, neck, abdominal, renal, and peripheral vessels) | 350 | 30 mL to 50 mL at 7.5 mL/sec to 30 mL/sec using a pressure injector Frequently three or more doses may be required; the maximum cumulative total dose is 250 mL | |
Drug interactions
Check iohexol against a medication listLabel text (4 paragraphs)
7 DRUG INTERACTIONS
7.1 Drug-Drug Interactions Metformin In patients with renal impairment, metformin can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function. Stop metformin at the time of, or prior to, OMNIPAQUE administration in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of hepatic impairment, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure, and reinstitute metformin only after renal function is stable.
Radioactive Iodine OMNIPAQUE may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post OMNIPAQUE.
7.2 Drug-Laboratory Test Interactions Protein-Bound Iodine Test Iodinated contrast agents, including OMNIPAQUE, will temporarily increase protein-bound iodine in blood. Do not perform protein-bound iodine test for at least 16 days following administration of OMNIPAQUE. However, thyroid function tests that do not depend on iodine estimation, e.g., T 3 resin uptake or direct thyroxine assays, are not affected.
Contraindications
4 CONTRAINDICATIONS OMNIPAQUE for hysterosalpingography is contraindicated during pregnancy or suspected pregnancy, menstruation or when menstruation is imminent, within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract including the external genitalia, and when reproductive tract neoplasia is known or suspected because of the risk of peritoneal spread of neoplasm.
Hysterosalpingography during pregnancy (or suspected pregnancy), menstruation (or when menstruation is imminent), within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract, including the external genitalia, and when reproductive tract neoplasia is known or suspected. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Hysterosalpingography is contraindicated in pregnant women due to the potential risk to the fetus from an intrauterine procedure [see Contraindications (4) ]. There are no data with iohexol use in pregnant women to inform any drug-associated risks. Iohexol crosses the placenta and reaches fetal tissues in small amounts ( see Data ) . In animal reproduction studies, no developmental toxicity occurred with intravenous iohexol administration to rats and rabbits at doses up to 0.4 (rat) and 0.5 (rabbit) times the maximum recommended human intravenous dose ( see Data ).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Literature reports show that intravenously administered iohexol crosses the placenta and is visualized in the digestive tract of exposed infants after birth.
Animal Data Iohexol was neither embryotoxic nor teratogenic in either rats or rabbits at the following dose levels tested: 1.0, 2.0, 4.0 g iodine/kg in rats, administered intravenously to 3 groups of 25 dams once daily during days 6 through 15 of pregnancy; 0.3, 1.0, 2.5 g iodine/kg in rabbits, administered intravenously to 3 groups of 18 rabbits dosed once a day during days 6 through 18 of pregnancy.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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