OMNIPAQUE

OMNIPAQUE- iohexol injection, solution
GE Healthcare Inc.

WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION

See full prescribing information for complete boxed warning

Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )].

1 INDICATIONS AND USAGE

1.1 Intrathecal Administration

Adults

OMNIPAQUE 180, 240, and 300

  • Myelography (lumbar, thoracic, cervical, total columnar)
  • Computerized Tomography (CT) (myelography, cisternography, ventriculography)

Pediatrics

OMNIPAQUE 180

  • Myelography (lumbar, thoracic, cervical, total columnar)
  • CT (myelography, cisternography)

1.2 Intravascular Administration

Adults

OMNIPAQUE 140

  • Intra-arterial digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels

OMNIPAQUE 240

  • CT head imaging
  • Peripheral venography (phlebography)

OMNIPAQUE 300

  • Aortography including studies of the aortic arch, abdominal aorta and its branches
  • CT head and body imaging
  • Cerebral arteriography
  • Peripheral venography (phlebography)
  • Peripheral arteriography
  • Excretory urography

OMNIPAQUE 350

  • Angiocardiography (ventriculography, selective coronary arteriography)
  • Aortography including studies of the aortic root, aortic arch, ascending aorta, abdominal aorta and its branches
  • CT head and body imaging
  • Intravenous digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels
  • Peripheral arteriography
  • Excretory urography

Pediatrics

OMNIPAQUE 240

  • CT head and body imaging

OMNIPAQUE 300

  • Angiocardiography (ventriculography)
  • Excretory urography
  • CT head and body imaging

OMNIPAQUE 350

  • Angiocardiography (ventriculography, pulmonary arteriography, venography, and studies of the collateral arteries)
  • Aortography including the aortic root, aortic arch, ascending and descending aorta

1.3 Oral or Rectal Administration

Adults

OMNIPAQUE 350

  • Oral radiographic examination of the gastrointestinal tract

Pediatrics

OMNIPAQUE 180, 240 and 300

  • Oral and rectal radiographic examination of the gastrointestinal tract

1.4 Oral Administration in Conjunction with Intravenous Administration

Diluted OMNIPAQUE Injection

Adults

OMNIPAQUE 240, 300 and 350 diluted and administered orally in conjunction with OMNIPAQUE 300 administered intravenously

  • CT of the abdomen

Pediatrics

OMNIPAQUE 240, 300 and 350 diluted and administered orally in conjunction with OMNIPAQUE 240 or OMNIPAQUE 300 administered intravenously

  • CT of the abdomen

OMNIPAQUE Oral Solution

Adults

OMNIPAQUE oral solution 9 and 12 administered orally in conjunction with OMNIPAQUE 300 administered intravenously

  • CT of the abdomen

Pediatrics

OMNIPAQUE oral solution 9 and 12 administered orally in conjunction with OMNIPAQUE 240 or OMNIPAQUE 300 administered intravenously

  • CT of the abdomen

1.5 Intraarticular Administration

Adults

OMNIPAQUE 240, 300, and 350

  • Arthrography

1.6 Body Cavity Administration

Adults

OMNIPAQUE 240

  • Endoscopic retrograde pancreatography (ERP) and cholangiopancreatography (ERCP)
  • Herniography
  • Hysterosalpingography

OMNIPAQUE 300

  • Hysterosalpingography

Pediatrics

OMNIPAQUE 240, 300 and 350 diluted

  • Voiding cystourethrography (VCU)

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

  • OMNIPAQUE 140, 180, 240, 300 and 350 are indicated for intravascular, oral, rectal, intraarticular, and body cavity administration. OMNIPAQUE 180, 240, and 300 are indicated for intrathecal administration [ seeBoxed Warning,Contraindications (4), and Warnings and Precautions (5.1)].
  • Use sterile technique for all handling and administration of OMNIPAQUE for intravascular, intrathecal, intraarticular, and body cavity administration.
  • OMNIPAQUE oral solution 9 and 12 are indicated for oral use only [ seeContraindications (4)and Warnings and Precautions (5.2)].
  • Do not use if tamper-evident ring is broken or missing.
  • OMNIPAQUE injection may be administered at either body (37°C, 98.6°F) or room temperature (20° to 25°C, 68° to 77°F).
  • Inspect OMNIPAQUE injection for particulate matter or discoloration before administration, whenever solution and container permit. Do not administer if OMNIPAQUE injection contains particulate matter or is discolored.
  • Do not mix OMNIPAQUE injection with, or inject in intravenous lines containing, other drugs or total nutritional admixtures.
  • Use the lowest dose necessary to obtain adequate visualization.
  • Individualize the volume, strength, and rate of administration of OMNIPAQUE injection. 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.
  • Avoid extravasation when administering OMNIPAQUE injection intravascularly, especially in patients with severe arterial or venous disease [ seeWarnings and Precautions (5.6)] .
  • Hydrate patients before and after intravascular administration of OMNIPAQUE injection [ seeWarnings and Precautions (5.4)] .
  • Each bottle of OMNIPAQUE injection and oral solution is intended for one procedure only. Discard any unused portion.

2.2 Intrathecal Dosage and Administration

  • Rate of injection: Injection should be made slowly over 1 to 2 minutes
  • Repeat procedures: If sequential or repeat examinations are required, a suitable interval of time between administrations should be observed to allow for normal clearance of the drug from the body; at least 48 hours should be allowed before repeat examination; however, whenever possible, 5 days to 7 days is recommended.
  • If computerized tomographic (CT) myelography follows myelography, delay imaging several hours to allow the degree of contrast to decrease.
TABLE 1 — INTRATHECAL ADULTS
The usual recommended total doses for use in lumbar, thoracic, cervical, and total columnar myelography in adults are 1,200 mg iodine to 3,100 mg iodine (see below).
STUDY TYPE INJECTION TYPE CONCENTRATION (mg iodine/mL) VOLUME (mL)
* A total dose of 3,100 mg iodine or a concentration of 300 mg iodine/mL should not be exceeded in adults.
LUMBAR MYELOGRAPHY LUMBAR OMNIPAQUE 180 OMNIPAQUE 240 10 to 17 7 to 12.5
THORACIC MYELOGRAPHY LUMBAR CERVICAL OMNIPAQUE 240 OMNIPAQUE 300 6 to 12.5 6 to 10
CERVICAL MYELOGRAPHY LUMBAR OMNIPAQUE 240 OMNIPAQUE 300 6 to 12.5 6 to 10
CERVICAL MYELOGRAPHY C1-2 OMNIPAQUE 180 OMNIPAQUE 240 OMNIPAQUE 300 7 to 10 6 to 12.5 4 to 10
TOTAL COLUMNAR MYELOGRAPHY LUMBAR OMNIPAQUE 240 OMNIPAQUE 300 6 to 12.5 6 to 10
TABLE 2 – INTRATHECAL PEDIATRICS
The usual recommended total doses for lumbar, thoracic, cervical, and/or total columnar myelography by lumbar puncture in children are 360 mg iodine to 2700 mg iodine (see below). Actual volumes administered depend largely on patient age and the following guidelines are recommended.
AGE STUDY TYPE INJECTION TYPE CONCENTRATION (mg iodine/mL) VOLUME (mL)
*A total dose of 2,700 mg iodine or a concentration of 180 mg iodine/mL should not be exceeded in a single myelographic examination in pediatrics.
0 up to 3 mos. LUMBAR, THORACIC, CERVICAL AND/OR TOTAL COLUMNAR MYELOGRAPHY LUMBAR PUNCTURE OMNIPAQUE 180 2 to 4
3 up to 36 mos. OMNIPAQUE 180 4 to 8
3 up to 7 yrs. OMNIPAQUE 180 5 to 10
7 up to 13 yrs. OMNIPAQUE 180 5 to 12
13 to 18 yrs. OMNIPAQUE 180 6 to 15

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