Omnipaque

OMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. (

• For each imaging procedure, specific dosage forms, concentrations, and presentations are recommended.
• Individualize the concentration and volume according to the specific dosing tables and accounting for factors such as age, body weight, and condition of the patient, and the equipment and imaging technique used. (
  2.2 Recommended Dosage for Intrathecal Procedures in Adults

  • The recommended doses for intrathecal procedures in adults are shown in Table 1.
  • Administer over 1 minute to 2 minutes.
  • If sequential or repeat examinations are required, allow at least 48 hours for clearance of the drug from the body before repeat administration; however, whenever possible, 5 days to 7 days is recommended.
  • If CT myelography is performed, delay imaging by several hours to reduce the degree of contrast.

  Table 1. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intrathecal Procedures in Adults

  Imaging Procedure	Injection Type	Concentration (mg Iodine/mL)	Volume to Administer
  Lumbar Myelography	Lumbar	180Use 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
  ,
  2.3 Recommended Dosage for Intra-arterial Procedures in Adults

  The recommended doses for intra-arterial procedures in adults are shown in Table 2.

  Table 2. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intra-arterial Procedures in Adults

  Imaging Procedure		Concentration (mg Iodine/mL)	Volume to Administer per Single Injection for Selective Injection Sites	Maximum Cumulative Total Dose
  Cardiac Ventriculography		350Use 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 mL Abdominal aorta and its branches (celiac, mesenteric, hepatic, and splenic arteries): 30 mL to 60 mL Renal 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 mL Internal carotid artery: 8 mL to 10 mL External carotid artery: 6 mL to 9 mL Vertebral 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/sec Carotid artery: 5 mL to 10 mL at 3 mL/sec to 6 mL/sec Femoral artery: 9 mL to 20 mL at 3 mL/sec to 6 mL/sec Vertebral artery: 4 mL to 10 mL at 2 mL/sec to 8 mL/sec Renal arteries: 6 mL to 12 mL at 3 mL/sec to 6 mL/sec Other branches of aorta (includes subclavian, axillary, innominate, and iliac): 8 mL to 25 mL at 3 mL/sec to 10 mL/sec	250 mL
  ,
  2.4 Recommended Dosage for Intravenous Procedures in Adults

  The recommended doses for intravenous procedures in adults are shown in Table 3.

  Table 3. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intravenous Procedures in Adults

  Imaging Procedure		Concentration (mg Iodine/mL)	Volume to Administer
  Excretory Urography		300Use 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
  		300Use 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
  ,
  2.5 Recommended Dosage for Oral Procedures in Adults

  Recommended Dosage for Radiographic Examination of the GI Tract in Adults

  The recommended dose for radiographic examination of the GI tract in adults is 50 mL to 100 mL of OMNIPAQUE injection 350 mg iodine/mL administered undiluted orally.

  Recommended Dosage for CT of the Abdomen and Pelvis in Conjunction with Intravenous Administration of OMINIPAQUE Injection in Adults

  The recommended oral dose using diluted OMNIPAQUE injection or OMNIPAQUE oral solution and concurrent intravenous doses for CT of the abdomen and pelvis in adults are shown in Table 4.

  Table 4. Recommended Concentrations and Volumes of Diluted OMNIPAQUE Injection or OMNIPAQUE Oral Solution for Oral Administration and Concurrent Intravenous OMNIPAQUE Injection for CT of the Abdomen and Pelvis in Adults

  Concentration (mg Iodine/mL)	Volume to Administer	Administration Instructions
  Oral Dose Using Diluted OMNIPAQUE Injection
  6 mg Iodine/mL to 12 mg Iodine/mL of Diluted OMNIPAQUE InjectionSee Table 5for dilution instructions of OMNIPAQUE injection	500 mL to 1,000 mL	Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume. Use a higher iodine concentration of the diluted product if a smaller volume needs to be administered (see Table 5).
  Oral Dose Using OMNIPAQUE Oral Solution
  9 mg Iodine/mL or 12 mg Iodine/mL of OMNIPAQUE Oral Solution	500 mL to 1,000 mL	Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume.
  Intravenous Dose of OMNIPAQUE injection in Conjunction with Oral Administration
  300Use single-dose containers, 500 mL Imaging 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)].	100 mL to 150 mL	Administer up to 40 minutes AFTER consumption of the oral dose.

  Preparation of Diluted OMNIPAQUE Injection for Oral Administration for CT of the Abdomen and Pelvis in Adults

  • Prepare the diluted OMNIPAQUE injection in water, carbonated beverage, milk, infant formula, or juice just prior to administration according to Table 5.
  • Discard any unused portion after the procedure.

  Table 5. Volumes of OMNIPAQUE Injection and Added Liquid to Dilute OMNIPAQUE Injection for Oral Administration for CT of the Abdomen in Adults

  Concentration of Diluted OMNIPAQUE injection (mg iodine/mL)	Dilution Method 1		Dilution Method 2		Dilution Method 3
  	Volume of OMNIPAQUE 240 mg Iodine/mL (mL)	Volume of Added LiquidUse water, carbonated beverage, milk, infant formula, or juice. (mL)	Volume of OMNIPAQUE 300 mg Iodine/mL (mL)	Volume of Added Liquid (mL)	Volume of OMNIPAQUE 350 mg Iodine/mL (mL)	Volume of Added Liquid (mL)
  6	25	975	20	980	17	983
  9	38	962	30	970	26	974
  12	50	950	40	960	35	965
  15	63	937	50	950	43	957
  18	75	925	60	940	52	948
  21	88	912	70	930	60	940
  ,
  2.6 Recommended Dosage for Intraarticular Procedures in Adults

  • The recommended doses for intraarticular procedures in adults are shown in Table 6.
  • Use passive or active manipulation to disperse the medium throughout the joint space.

  Table 6. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intraarticular Procedures in Adults

  Imaging Procedure	Location	Concentration (mg Iodine/mL)	Volume to Administer	Double Contrast/Single Contrast
  Arthrography	Knee	240Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].	5 mL to 15 mL	Lower volumes recommended for double-contrast examinations; higher volumes recommended for single-contrast examinations.
  		300	5 mL to 15 mL
  		350	5 mL to 10 mL
  	Shoulder	300	10 mL
  	Temporomandibular	300	0.5 mL to 1 mL
  ,
  2.7 Recommended Dosage for Body Cavity Procedures in Adults

  • The recommended doses for body cavity procedures in adults are shown in Table 7.
  • Volume to administer may vary depending on individual anatomy and/or disease state.

  Table 7. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Body Cavity Procedures in Adults

  Imaging Procedure	Concentration (mg Iodine/mL)	Volume to Administer	Route of Administration
  Endoscopic retrograde pancreatography (ERP) and cholangiopancreatography (ERCP)	240Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].	10 mL to 50 mL	Intraductal
  Herniography	240	15 mL to 20 mL	Intraperitoneal
  	300
  Hysterosalpingography	240	50 mL	Intrauterine
  ,
  2.8 Recommended Dosage for Intrathecal, Intra-arterial, and Intravenous Procedures in Pediatric Patients

  Recommended Dosage for Intrathecal Procedures in Pediatric Patients Aged 2 Weeks and Older

  • Recommended doses based on age for intrathecal procedures in pediatric patients aged 2 weeks and older are shown in Table 8.
  • Administer over 1 minute to 2 minutes.
  • If sequential or repeat examinations are required, allow at least 48 hours for clearance of the drug from the body before repeat administration; however, whenever possible, 5 days to 7 days is recommended.
  • If CT myelography is performed, delay imaging by several hours to reduce the degree of contrast.

  Table 8: Recommended Concentrations and Volumes of OMNIPAQUE Injection Based on Age for Intrathecal Procedure in Pediatric Patients Aged 2 Weeks and Older

  Imaging Procedure	Injection Type	Age	Concentration (mg Iodine/mL)	Volume to Administer
  Myelography Lumbar Thoracic Cervical Total Columnar CT cisternography	Lumbar	2 weeks up to 3 months	180Use single-dose containers .	2 mL to 4 mL
  		3 months up to 36 months		4 mL to 8 mL
  		3 years up to 7 years		5 mL to 10 mL
  		7 years up to 13 years		5 mL to 12 mL
  		13 years to 18 years		6 mL to 15 mL

  Recommended Dosage for Intra-arterial Procedures in Pediatric Patients

  The recommended doses for intra-arterial procedures in pediatric patients are shown in Table 9.

  Table 9. Recommended Concentrations and Volumes of OMNIPAQUE Injection per Body Weight for Intra-arterial Procedures in Pediatric Patients

  Imaging Procedure	Concentration (mg Iodine/mL)	Volume per Body Weight to Administer per Single Injection	Maximum Cumulative Volume
  Cardiac Ventriculography	300Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].	1.75 mL/kg (Range of 1.5 mL/kg to 2 mL/kg)	6 mL/kg up to a total volume of 290 mL
  	350	1.25 mL/kg (Range of 1 mL/kg to 1.5 mL/kg)	5 mL/kg up to a total volume of 250 mL
  Aortography (aortic root, aortic arch, and descending aorta)	350	1 mL/kg	5 mL/kg up to a total volume of 250 mL
  Pulmonary Angiography	350	1 mL/kg	5 mL/kg up to a total volume of 250 mL

  Recommended Dosage for Intravenous Procedures in Pediatric Patients

  The recommended doses for intravenous procedures in pediatric patients are shown in Table 10.

  Table 10. Recommended Concentrations and Volumes of OMNIPAQUE Injection per Body Weight for Intravenous Procedures in Pediatric Patients

  Imaging Procedure	Concentration (mg Iodine/mL)	Volume per Body Weight to Administer
  Excretory Urography	300Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].	0.5 mL/kg to 3 mL/kg (Maximum single dose: 116 mL)
  CT of the Head and Body	240	1 mL/kg to 2 mL/kg (with maximum 3 mL/kg) (Maximum single dose: 116 mL)
  	300Use single-dose containers, 500 mL Imaging 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)].
  ,
  2.9 Recommended Dosage for Oral or Rectal and Body Cavity Procedures in Pediatric Patients

  Recommended Dosage for Radiographic Examination of the GI Tract in Pediatric Patients

  • The recommended doses for radiographic examination of the GI tract are shown in Table 11.
  • Administer orally or rectally.

  Table 11. Recommended Concentrations and Volumes of OMNIPAQUE Injection Based on Age for Radiographic Examination of the GI Tract in Pediatric Patients

  Age	Concentration (mg iodine/mL)	Oral Volume	Rectal Volume
  Less than 3 months	180Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)] .	5 mL to 30 mL	May be a larger volume than the volume given orally (up to 300 mL)
  3 months to 3 years	180 , 240 , or 300	Up to 60 mL
  4 years to 10 years		Up to 80 mL
  Greater than 10 years		Up to 100 mL

  Recommended Dosage for CT of the Abdomen and Pelvis in Conjunction with Intravenous Administration of OMNIPAQUE in Pediatric Patients

  The recommended oral dose using diluted OMNIPAQUE injection or OMNIPAQUE oral solution and concurrent intravenous dose for CT of the abdomen and pelvis in pediatric patients are shown in Table 12.

  Table 12. Recommended Concentrations and Volumes of Diluted OMNIPAQUE Injection or OMNIPAQUE Oral Solution for Oral Administration and Concurrent Intravenous OMNIPAQUE Injection for CT of the Abdomen and Pelvis in Pediatric Patients

  Concentration (mg Iodine/mL)	Volume to Administer	Administration Instructions	Maximum Dose by Age or Body Weight
  Oral Dose Using Diluted OMNIPAQUE Injection
  9 mg Iodine/mL to 21 mg Iodine/mL of Diluted OMNIPAQUE InjectionSee Table 13for dilution instructions of OMNIPAQUE injection	180 mL to 750 mL	Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume. Use a higher iodine concentration of the diluted product if a smaller volume needs to be administered (see Table 13).	less than 3 years old: 5 grams iodine 3 years old to 18 years old: 10 grams iodine
  Oral Dose Using OMNIPAQUE Oral Solution
  6 mg Iodine/mL or 12 mg Iodine/mL of OMNIPAQUE Oral Solution	180 mL to 750 mL	Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume.	less than 3 years old: 5 grams iodine 3 years old to 18 years old: 10 grams iodine
  Intravenous Dose in Conjunction with Oral Administration
  240 or 300Use single-dose containers, 500 mL Imaging 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)].	2 mL/kg body weight (with a range of 1 mL/kg to 2 mL/kg)	Administer up to 60 minutes AFTER consumption of the oral dose.	3 mL/kg (maximum single dose: 116 mL)

  Preparation of Diluted OMNIPAQUE Injection for Oral Administration for CT of the Abdomen and Pelvis in Pediatric Patients

  • Prepare the diluted OMNIPAQUE injection in water, carbonated beverage, milk, infant formula, or juice just prior to administration according to Table 13.
  • Discard any unused portion after the procedure.

  Table 13. Volumes of OMNIPAQUE Injection and Added Liquid to Dilute OMNIPAQUE Injection for Oral Administration for CT of the Abdomen and Pelvis in Pediatric Patients

  Concentration of Diluted OMNIPAQUE injection (mg iodine/mL)	Dilution Method 1		Dilution Method 2		Dilution Method 3
  	Volume of OMNIPAQUE 240 mg iodine/mL (mL)	Volume of Added LiquidUse water, carbonated beverage, milk, infant formula, or juice. (mL)	Volume of OMNIPAQUE 300 mg Iodine/mL (mL)	Volume of Added Liquid (mL)	Volume of OMNIPAQUE 350 mg Iodine/mL (mL)	Volume of Added Liquid (mL)
  6	25	975	20	980	17	983
  9	38	962	30	970	26	974
  12	50	950	40	960	35	965
  15	63	937	50	950	43	957
  18	75	925	60	940	52	948
  21	88	912	70	930	60	940

  Recommended Dosage for Voiding Cystourethrography in Pediatric Patients

  • Voiding cystourethrography (VCU) can be performed in conjunction with excretory urography
    [see Dosage and Administration (2.8)]
    .
  • The concentration of diluted OMNIPAQUE injection may vary depending upon the patient's size and age and with the technique and equipment used.
  • Volume ranges of diluted OMNIPAQUE injection 50 mg iodine/mL and 100 mg iodine/mL are shown in Table 14.
  • Dilute OMNIPAQUE injection with Sterile Water for Injection according to Table 15, utilizing aseptic technique, just prior to use.
  • Discard any unused portion after the procedure.

  Table 14. Volume Ranges of Diluted OMNIPAQUE Injection for VCU in Pediatric Patients

  Concentration of Diluted OMNIPAQUE InjectionSee Table 15below for dilution instructions of OMNIPAQUE injection. (mg iodine/mL)	Volume to Administer
  50	50 mL to 600 mL by intravesical administration
  100	50 mL to 300 mL by intravesical administration

  Table 15. Volumes of OMNIPAQUE Injection and Sterile Water for Injection to Dilute OMNIPAQUE Injection for VCU in Pediatric Patients

  Concentration of Diluted OMNIPAQUE injection (mg iodine/mL)	Dilution Method 1		Dilution Method 2		Dilution Method 3
  	Volume of OMNIPAQUE 240 mg Iodine/mL (mL)	Volume of Sterile Water for Injection (mL)	Volume of OMNIPAQUE 300 mg Iodine/mL (mL)	Volume of Sterile Water for Injection (mL)	Volume of OMNIPAQUE 350 mg Iodine/mL (mL)	Volume of Sterile Water for Injection (mL)
  50	100	380	100	500	100	600
  60	100	300	100	400	100	483
  70	100	243	100	330	100	400
  80	100	200	100	275	100	338
  90	100	167	100	233	100	289
  100	100	140	100	200	100	250
  )
• See full prescribing information for complete dosing and administration information. (
  2 DOSAGE AND ADMINISTRATION

  • For each imaging procedure, specific dosage forms, concentrations, and presentations are recommended.
  • Individualize the concentration and volume according to the specific dosing tables and accounting for factors such as age, body weight, and condition of the patient, and the equipment and imaging technique used.
  • See full prescribing information for complete dosing and administration information.

  2.1 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 (5.4)].
  • 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.

  2.2 Recommended Dosage for Intrathecal Procedures in Adults

  • The recommended doses for intrathecal procedures in adults are shown in Table 1.
  • Administer over 1 minute to 2 minutes.
  • If sequential or repeat examinations are required, allow at least 48 hours for clearance of the drug from the body before repeat administration; however, whenever possible, 5 days to 7 days is recommended.
  • If CT myelography is performed, delay imaging by several hours to reduce the degree of contrast.

  Table 1. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intrathecal Procedures in Adults

  Imaging Procedure	Injection Type	Concentration (mg Iodine/mL)	Volume to Administer
  Lumbar Myelography	Lumbar	180Use 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

  2.3 Recommended Dosage for Intra-arterial Procedures in Adults

  The recommended doses for intra-arterial procedures in adults are shown in Table 2.

  Table 2. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intra-arterial Procedures in Adults

  Imaging Procedure		Concentration (mg Iodine/mL)	Volume to Administer per Single Injection for Selective Injection Sites	Maximum Cumulative Total Dose
  Cardiac Ventriculography		350Use 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 mL Abdominal aorta and its branches (celiac, mesenteric, hepatic, and splenic arteries): 30 mL to 60 mL Renal 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 mL Internal carotid artery: 8 mL to 10 mL External carotid artery: 6 mL to 9 mL Vertebral 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/sec Carotid artery: 5 mL to 10 mL at 3 mL/sec to 6 mL/sec Femoral artery: 9 mL to 20 mL at 3 mL/sec to 6 mL/sec Vertebral artery: 4 mL to 10 mL at 2 mL/sec to 8 mL/sec Renal arteries: 6 mL to 12 mL at 3 mL/sec to 6 mL/sec Other branches of aorta (includes subclavian, axillary, innominate, and iliac): 8 mL to 25 mL at 3 mL/sec to 10 mL/sec	250 mL

  2.4 Recommended Dosage for Intravenous Procedures in Adults

  The recommended doses for intravenous procedures in adults are shown in Table 3.

  Table 3. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intravenous Procedures in Adults

  Imaging Procedure		Concentration (mg Iodine/mL)	Volume to Administer
  Excretory Urography		300Use 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
  		300Use 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

  2.5 Recommended Dosage for Oral Procedures in Adults

  Recommended Dosage for Radiographic Examination of the GI Tract in Adults

  The recommended dose for radiographic examination of the GI tract in adults is 50 mL to 100 mL of OMNIPAQUE injection 350 mg iodine/mL administered undiluted orally.

  Recommended Dosage for CT of the Abdomen and Pelvis in Conjunction with Intravenous Administration of OMINIPAQUE Injection in Adults

  The recommended oral dose using diluted OMNIPAQUE injection or OMNIPAQUE oral solution and concurrent intravenous doses for CT of the abdomen and pelvis in adults are shown in Table 4.

  Table 4. Recommended Concentrations and Volumes of Diluted OMNIPAQUE Injection or OMNIPAQUE Oral Solution for Oral Administration and Concurrent Intravenous OMNIPAQUE Injection for CT of the Abdomen and Pelvis in Adults

  Concentration (mg Iodine/mL)	Volume to Administer	Administration Instructions
  Oral Dose Using Diluted OMNIPAQUE Injection
  6 mg Iodine/mL to 12 mg Iodine/mL of Diluted OMNIPAQUE InjectionSee Table 5for dilution instructions of OMNIPAQUE injection	500 mL to 1,000 mL	Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume. Use a higher iodine concentration of the diluted product if a smaller volume needs to be administered (see Table 5).
  Oral Dose Using OMNIPAQUE Oral Solution
  9 mg Iodine/mL or 12 mg Iodine/mL of OMNIPAQUE Oral Solution	500 mL to 1,000 mL	Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume.
  Intravenous Dose of OMNIPAQUE injection in Conjunction with Oral Administration
  300Use single-dose containers, 500 mL Imaging 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)].	100 mL to 150 mL	Administer up to 40 minutes AFTER consumption of the oral dose.

  Preparation of Diluted OMNIPAQUE Injection for Oral Administration for CT of the Abdomen and Pelvis in Adults

  • Prepare the diluted OMNIPAQUE injection in water, carbonated beverage, milk, infant formula, or juice just prior to administration according to Table 5.
  • Discard any unused portion after the procedure.

  Table 5. Volumes of OMNIPAQUE Injection and Added Liquid to Dilute OMNIPAQUE Injection for Oral Administration for CT of the Abdomen in Adults

  Concentration of Diluted OMNIPAQUE injection (mg iodine/mL)	Dilution Method 1		Dilution Method 2		Dilution Method 3
  	Volume of OMNIPAQUE 240 mg Iodine/mL (mL)	Volume of Added LiquidUse water, carbonated beverage, milk, infant formula, or juice. (mL)	Volume of OMNIPAQUE 300 mg Iodine/mL (mL)	Volume of Added Liquid (mL)	Volume of OMNIPAQUE 350 mg Iodine/mL (mL)	Volume of Added Liquid (mL)
  6	25	975	20	980	17	983
  9	38	962	30	970	26	974
  12	50	950	40	960	35	965
  15	63	937	50	950	43	957
  18	75	925	60	940	52	948
  21	88	912	70	930	60	940

  2.6 Recommended Dosage for Intraarticular Procedures in Adults

  • The recommended doses for intraarticular procedures in adults are shown in Table 6.
  • Use passive or active manipulation to disperse the medium throughout the joint space.

  Table 6. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intraarticular Procedures in Adults

  Imaging Procedure	Location	Concentration (mg Iodine/mL)	Volume to Administer	Double Contrast/Single Contrast
  Arthrography	Knee	240Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].	5 mL to 15 mL	Lower volumes recommended for double-contrast examinations; higher volumes recommended for single-contrast examinations.
  		300	5 mL to 15 mL
  		350	5 mL to 10 mL
  	Shoulder	300	10 mL
  	Temporomandibular	300	0.5 mL to 1 mL

  2.7 Recommended Dosage for Body Cavity Procedures in Adults

  • The recommended doses for body cavity procedures in adults are shown in Table 7.
  • Volume to administer may vary depending on individual anatomy and/or disease state.

  Table 7. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Body Cavity Procedures in Adults

  Imaging Procedure	Concentration (mg Iodine/mL)	Volume to Administer	Route of Administration
  Endoscopic retrograde pancreatography (ERP) and cholangiopancreatography (ERCP)	240Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].	10 mL to 50 mL	Intraductal
  Herniography	240	15 mL to 20 mL	Intraperitoneal
  	300
  Hysterosalpingography	240	50 mL	Intrauterine

  2.8 Recommended Dosage for Intrathecal, Intra-arterial, and Intravenous Procedures in Pediatric Patients

  Recommended Dosage for Intrathecal Procedures in Pediatric Patients Aged 2 Weeks and Older

  • Recommended doses based on age for intrathecal procedures in pediatric patients aged 2 weeks and older are shown in Table 8.
  • Administer over 1 minute to 2 minutes.
  • If sequential or repeat examinations are required, allow at least 48 hours for clearance of the drug from the body before repeat administration; however, whenever possible, 5 days to 7 days is recommended.
  • If CT myelography is performed, delay imaging by several hours to reduce the degree of contrast.

  Table 8: Recommended Concentrations and Volumes of OMNIPAQUE Injection Based on Age for Intrathecal Procedure in Pediatric Patients Aged 2 Weeks and Older

  Imaging Procedure	Injection Type	Age	Concentration (mg Iodine/mL)	Volume to Administer
  Myelography Lumbar Thoracic Cervical Total Columnar CT cisternography	Lumbar	2 weeks up to 3 months	180Use single-dose containers .	2 mL to 4 mL
  		3 months up to 36 months		4 mL to 8 mL
  		3 years up to 7 years		5 mL to 10 mL
  		7 years up to 13 years		5 mL to 12 mL
  		13 years to 18 years		6 mL to 15 mL

  Recommended Dosage for Intra-arterial Procedures in Pediatric Patients

  The recommended doses for intra-arterial procedures in pediatric patients are shown in Table 9.

  Table 9. Recommended Concentrations and Volumes of OMNIPAQUE Injection per Body Weight for Intra-arterial Procedures in Pediatric Patients

  Imaging Procedure	Concentration (mg Iodine/mL)	Volume per Body Weight to Administer per Single Injection	Maximum Cumulative Volume
  Cardiac Ventriculography	300Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].	1.75 mL/kg (Range of 1.5 mL/kg to 2 mL/kg)	6 mL/kg up to a total volume of 290 mL
  	350	1.25 mL/kg (Range of 1 mL/kg to 1.5 mL/kg)	5 mL/kg up to a total volume of 250 mL
  Aortography (aortic root, aortic arch, and descending aorta)	350	1 mL/kg	5 mL/kg up to a total volume of 250 mL
  Pulmonary Angiography	350	1 mL/kg	5 mL/kg up to a total volume of 250 mL

  Recommended Dosage for Intravenous Procedures in Pediatric Patients

  The recommended doses for intravenous procedures in pediatric patients are shown in Table 10.

  Table 10. Recommended Concentrations and Volumes of OMNIPAQUE Injection per Body Weight for Intravenous Procedures in Pediatric Patients

  Imaging Procedure	Concentration (mg Iodine/mL)	Volume per Body Weight to Administer
  Excretory Urography	300Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].	0.5 mL/kg to 3 mL/kg (Maximum single dose: 116 mL)
  CT of the Head and Body	240	1 mL/kg to 2 mL/kg (with maximum 3 mL/kg) (Maximum single dose: 116 mL)
  	300Use single-dose containers, 500 mL Imaging 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)].

  2.9 Recommended Dosage for Oral or Rectal and Body Cavity Procedures in Pediatric Patients

  Recommended Dosage for Radiographic Examination of the GI Tract in Pediatric Patients

  • The recommended doses for radiographic examination of the GI tract are shown in Table 11.
  • Administer orally or rectally.

  Table 11. Recommended Concentrations and Volumes of OMNIPAQUE Injection Based on Age for Radiographic Examination of the GI Tract in Pediatric Patients

  Age	Concentration (mg iodine/mL)	Oral Volume	Rectal Volume
  Less than 3 months	180Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)] .	5 mL to 30 mL	May be a larger volume than the volume given orally (up to 300 mL)
  3 months to 3 years	180 , 240 , or 300	Up to 60 mL
  4 years to 10 years		Up to 80 mL
  Greater than 10 years		Up to 100 mL

  Recommended Dosage for CT of the Abdomen and Pelvis in Conjunction with Intravenous Administration of OMNIPAQUE in Pediatric Patients

  The recommended oral dose using diluted OMNIPAQUE injection or OMNIPAQUE oral solution and concurrent intravenous dose for CT of the abdomen and pelvis in pediatric patients are shown in Table 12.

  Table 12. Recommended Concentrations and Volumes of Diluted OMNIPAQUE Injection or OMNIPAQUE Oral Solution for Oral Administration and Concurrent Intravenous OMNIPAQUE Injection for CT of the Abdomen and Pelvis in Pediatric Patients

  Concentration (mg Iodine/mL)	Volume to Administer	Administration Instructions	Maximum Dose by Age or Body Weight
  Oral Dose Using Diluted OMNIPAQUE Injection
  9 mg Iodine/mL to 21 mg Iodine/mL of Diluted OMNIPAQUE InjectionSee Table 13for dilution instructions of OMNIPAQUE injection	180 mL to 750 mL	Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume. Use a higher iodine concentration of the diluted product if a smaller volume needs to be administered (see Table 13).	less than 3 years old: 5 grams iodine 3 years old to 18 years old: 10 grams iodine
  Oral Dose Using OMNIPAQUE Oral Solution
  6 mg Iodine/mL or 12 mg Iodine/mL of OMNIPAQUE Oral Solution	180 mL to 750 mL	Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume.	less than 3 years old: 5 grams iodine 3 years old to 18 years old: 10 grams iodine
  Intravenous Dose in Conjunction with Oral Administration
  240 or 300Use single-dose containers, 500 mL Imaging 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)].	2 mL/kg body weight (with a range of 1 mL/kg to 2 mL/kg)	Administer up to 60 minutes AFTER consumption of the oral dose.	3 mL/kg (maximum single dose: 116 mL)

  Preparation of Diluted OMNIPAQUE Injection for Oral Administration for CT of the Abdomen and Pelvis in Pediatric Patients

  • Prepare the diluted OMNIPAQUE injection in water, carbonated beverage, milk, infant formula, or juice just prior to administration according to Table 13.
  • Discard any unused portion after the procedure.

  Table 13. Volumes of OMNIPAQUE Injection and Added Liquid to Dilute OMNIPAQUE Injection for Oral Administration for CT of the Abdomen and Pelvis in Pediatric Patients

  Concentration of Diluted OMNIPAQUE injection (mg iodine/mL)	Dilution Method 1		Dilution Method 2		Dilution Method 3
  	Volume of OMNIPAQUE 240 mg iodine/mL (mL)	Volume of Added LiquidUse water, carbonated beverage, milk, infant formula, or juice. (mL)	Volume of OMNIPAQUE 300 mg Iodine/mL (mL)	Volume of Added Liquid (mL)	Volume of OMNIPAQUE 350 mg Iodine/mL (mL)	Volume of Added Liquid (mL)
  6	25	975	20	980	17	983
  9	38	962	30	970	26	974
  12	50	950	40	960	35	965
  15	63	937	50	950	43	957
  18	75	925	60	940	52	948
  21	88	912	70	930	60	940

  Recommended Dosage for Voiding Cystourethrography in Pediatric Patients

  • Voiding cystourethrography (VCU) can be performed in conjunction with excretory urography
    [see Dosage and Administration (2.8)]
    .
  • The concentration of diluted OMNIPAQUE injection may vary depending upon the patient's size and age and with the technique and equipment used.
  • Volume ranges of diluted OMNIPAQUE injection 50 mg iodine/mL and 100 mg iodine/mL are shown in Table 14.
  • Dilute OMNIPAQUE injection with Sterile Water for Injection according to Table 15, utilizing aseptic technique, just prior to use.
  • Discard any unused portion after the procedure.

  Table 14. Volume Ranges of Diluted OMNIPAQUE Injection for VCU in Pediatric Patients

  Concentration of Diluted OMNIPAQUE InjectionSee Table 15below for dilution instructions of OMNIPAQUE injection. (mg iodine/mL)	Volume to Administer
  50	50 mL to 600 mL by intravesical administration
  100	50 mL to 300 mL by intravesical administration

  Table 15. Volumes of OMNIPAQUE Injection and Sterile Water for Injection to Dilute OMNIPAQUE Injection for VCU in Pediatric Patients

  Concentration of Diluted OMNIPAQUE injection (mg iodine/mL)	Dilution Method 1		Dilution Method 2		Dilution Method 3
  	Volume of OMNIPAQUE 240 mg Iodine/mL (mL)	Volume of Sterile Water for Injection (mL)	Volume of OMNIPAQUE 300 mg Iodine/mL (mL)	Volume of Sterile Water for Injection (mL)	Volume of OMNIPAQUE 350 mg Iodine/mL (mL)	Volume of Sterile Water for Injection (mL)
  50	100	380	100	500	100	600
  60	100	300	100	400	100	483
  70	100	243	100	330	100	400
  80	100	200	100	275	100	338
  90	100	167	100	233	100	289
  100	100	140	100	200	100	250

  2.10 Directions for Use of the 500 mL Bottles of OMNIPAQUE Injection 300 mg Iodine/mL and 350 mg Iodine/mL as Imaging Bulk Package

  • OMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in 500 mL bottles may be used as an Imaging Bulk Package (IBP) for intravenous use

    [see Dosage and Administration (2.4, 2.8)]

    .
  • When used as an IBP, check the appropriate box on the container label to indicate that the selected container is to be utilized as an Imaging Bulk Package. This container is for use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this IBP. See device labeling for information on devices indicated for use with this IBP and techniques to help assure safe use.
  • Use the OMNIPAQUE IBP and 0.9% Sodium Chloride Injection USP in a room designated for radiological procedures that involve administration of a contrast agent.
  • Using aseptic technique, penetrate the container closure only one time with a suitable sterile component of the automated contrast injection system, contrast management system, or contrast media transfer set cleared for use with the OMNIPAQUE IBP.
  • If 0.9% Sodium Chloride Injection USP is used with the OMNIPAQUE IBP, prepare the 0.9% Sodium Chloride Injection USP sterile port in accordance with the dosage and administration section of its approved prescribing information and affix the saline tag provided with the OMNIPAQUE IBP on the 0.9% Sodium Chloride Injection USP container.
  • Once the OMNIPAQUE IBP and 0.9% Sodium Chloride Injection containers are punctured, do not remove them from the work area during the entire period of use. Maintain the OMNIPAQUE IBP in an inverted position such that container contents are in continuous contact with the dispensing set.
  • After the container closure is punctured, if the integrity of the OMNIPAQUE IBP, the 0.9% Sodium Chloride Injection, and the delivery system cannot be assured through direct continuous supervision, discard the IBP, 0.9% Sodium Chloride Injection USP, and all associated disposables for the contrast media transfer set.
  • A maximum time from initial puncture is 8 hours. Discard any unused portion.

  2.11 Directions for Use of the 500 mL Bottles of OMNIPAQUE Injection 300 mg Iodine/mL and 350 mg Iodine/mL as Pharmacy Bulk Package

  • OMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in 500 mL bottles contain many single doses and may be used as a Pharmacy Bulk Package (PBP).
  • When used as a PBP, check the appropriate box on the container label to indicate that the selected container is to be utilized as a Pharmacy Bulk Package. This container is not for direct infusion; it is for use in pharmacy admixture service to dispense aliquots using a suitable dispensing set under a laminar flow hood or equivalent clean air compounding area using aseptic technique.
  • Penetrate the container closure only one time, utilizing a suitable transfer device and aseptic technique.
  • The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 8 hours from initial closure entry is permitted to complete fluid transfer operations.
  • Do not remove the container from the aseptic area during the entire 8-hour period.
  • The temperature of the container should not exceed 37°C (98.6°F), after the closure has been entered.
  • Discard any unused portion after 8 hours from the initial closure entry.

  2.12 Directions for Use of the 150 mL Bottles of OMNIPAQUE Injection 300 mg Iodine/mL and 350 mg Iodine/mL with an Automated Contrast Injection System or Contrast Management System

  • OMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in 150 mL bottles may be used with a contrast media management system cleared for use with OMNIPAQUE injection 300 mg iodine/mL and 350 mg iodine/mL in 150 mL bottles.
  • See device labeling for information on device indications, instructions for use, and techniques to help assure safe use.
  • Using aseptic technique, penetrate the container closure only one time with a suitable sterile component of the contrast media management system cleared for use with OMNIPAQUE 300 mg iodine/mL and 350 mg iodine/mL in 150 mL bottles.
  • Once the container is punctured, do not remove the bottle from the work area during the entire period of use.
  • Maximum use time is 4 hours after initial puncture.
  • Each bottle is for one procedure only. Discard unused portion.
  )

Injection and Oral Solution: Colorless to pale yellow solution available in the following presentations:

• Lactation: A lactating woman may pump and discard breast milk for 10 hours after OMNIPAQUE administration. (
  8.2 Lactation

  Risk Summary

  Published literature reports that breast feeding after intravenous iohexol administration to the mother would result in the infant receiving an oral dose of approximately 0.7% of the maternal intravenous dose; however, lactation studies have not been conducted with oral, intrathecal, or intracavity administration of iohexol. There is no information on the effects of the drug on the breastfed infant or on milk production. Iodinated contrast agents are excreted unchanged in human milk in very low amounts with poor absorption from the gastrointestinal tract of a breastfed infant. Exposure to iohexol to a breastfed infant can be minimized by temporary discontinuation of breastfeeding (see Clinical Considerations). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for OMNIPAQUE and any potential adverse effects on the breastfed infant from OMNIPAQUE or from the underlying maternal condition.

  Clinical Considerations

  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 elimination half-lives) after OMNIPAQUE administration to minimize drug exposure to a breastfed infant.
  )