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OMNIPAQUE is a brand name for Iohexol, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 12/2023 4 DOSAGE AND ADMINISTRATION 12/2023 8 ADVERSE REACTIONS 12/2023 14 CLINICAL TRIALS 12/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES…
Verbatim from this product's HC label. Tap a section to expand.
12/2023 8 ADVERSE REACTIONS 12/2023 14 CLINICAL TRIALS 12/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 5 2 CONTRAINDICATIONS ..................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration ....................................................................................................... 20 5 OVERDOSAGE.............................................................................................................
21
12/2023 14 CLINICAL TRIALS 12/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 5 2 CONTRAINDICATIONS ..................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration ....................................................................................................... 20 5 OVERDOSAGE.............................................................................................................
21 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 21 7 WARNINGS AND PRECAUTIONS ................................................................................. 1 Special Populations................................................................................................
Use the recommended Omnipaque (iohexol) concentration for the particular procedure to be undertaken. Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out only by physicians with the prerequisite training and with a thorough knowledge of the particular procedure to be performed and who are thoroughly familiar with the emergency treatment of all adverse reactions to contrast media.
In addition to the following information, generally accepted contraindications, warnings, precautions and adverse reactions commonly related to the use of radiopaque contrast media should be kept in mind during administration of Omnipaque.
Carcinogenesis and Mutagenesis Please refer to animal data in section 16 NON-CLINICAL TOXICOLOGY. Cardiovascular Disease Caution is advised in patients with severe cardiovascular disease. Extravasation Extravasation of contrast media may on rare occasions give rise to local pain, edema and erythema, which usually recedes without sequelae.
However, inflammation and even tissue necrosis have been seen. Elevating and cooling the affected site is recommended as routine measures. Surgical decompression may be necessary in cases of compartment syndrome. 1 Dosing Considerations Hepatic/Biliary/Pancreatic Administration of water-soluble contrast media should be deferred for 48 hours in patients with hepatic or biliary disorders who have recently been administered cholecystographic agents, as renal toxicity has been reported in the literature in such patients who received conventional contrast agents.
Hepatorenal Disease Patients with significant hepatorenal disease should not be examined unless the possibility of benefit clearly outweighs the additional risk. As with other iodinated contrast media, the use of Omnipaque is not recommended in patients with anuria or severe oliguria.
• Omnipaque (iohexol) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Omnipaque is contraindicated in patients with clinically significant impairment of both hepatic and renal function.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1 Pregnant Women ................................................................................................. 2 Breast-feeding ......................................................................................................
3 Pediatrics .............................................................................................................. 4 Geriatrics ..............................................................................................................
30 OMNIPAQUE (iohexol injection USP) Page 3 of 59 8 ADVERSE REACTIONS ................................................................................................. 1 Adverse Reaction Overview ...................................................................................
2 Clinical Trial Adverse Reactions ............................................................................. 1 Clinical Trial Adverse Reactions – Pediatrics .................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................
5 Post-Market Adverse Reactions ............................................................................ 39 9 DRUG INTERACTIONS ................................................................................................. 4 Drug-Drug Interactions ..........................................................................................
5 Drug-Food Interactions.......................................................................................... 6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions.........................................................................
41 10 CLINICAL PHARMACOLOGY ........................................................................................ 2 Pharmacodynamics ......................................................................................... 3 Pharmacokinetics ............................................................................................
42 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 43 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 43 PART II: SCIENTIFIC INFORMATION ........................................................................................
44 13 PHARMACEUTICAL INFORMATION ............................................................................. 44 14 CLINICAL TRIALS .........................................................................................................
1 Clinical Trials by Indication .............................................................................. 45 15 MICROBIOLOGY .........................................................................................................
50 16 NON-CLINICAL TOXICOLOGY ...................................................................................... 51 PATIENT MEDICATION INFORMATION ...................................................................................
55 OMNIPAQUE (iohexol injection USP) Page 4 of 59 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS OMNIPAQUE (iohexol injection USP) is indicated for: Subarachnoid Omnipaque 240 (iohexol 240 mg I/mL) and Omnipaque 300 (iohexol 300 mg I/mL) are indicated for subarachnoid administration in adults for lumbar, thoracic, cervical and total columnar myelography.
Delayed CT scans of the spinal subarachnoid space and of the intracranial CSF spaces may be obtained at the appropriate time following myelography, taking advantage of delayed opacification by the physiological cephalad circulation of the […]
OMNIPAQUE (iohexol injection USP) Page 23 of 59 Contrast media-induced nephrotoxicity, presenting as transient impairment of renal function, may occur after intravascular Omnipaque administration. Patients with pre-existing renal impairment, diabetes mellitus, sepsis, hypotension, dehydration, cardiovascular disease, elderly patients, and patients with multiple myeloma, hypertension, patients on medications which alter renal function and patients with hyperuricemia, are at increased risk of this condition.
Patients with both renal impairment and diabetes are at the highest risk for contrast media- induced nephrotoxicity. Please refer to Renal subheading for further information. Hypersensitivity Caution is advised in patients with a history of bronchial asthma or other allergic manifestations or of sensitivity to iodine.
The possibility of hypersensitivity including serious, life-threatening, fatal anaphylactic/anaphylactoid reactions should always be considered. The majority of serious undesirable effects occur within the first 30 minutes. Late onset (that is 1 hour or more after application) hypersensitivity reactions can occur.
Patients should be observed for at least 30 minutes after administration of Omnipaque. Serious or fatal reactions have been associated with the administration of water-soluble contrast media. It is of utmost importance that a course of action be carefully planned in advance for immediate treatment of serious reactions, and that adequate facilities and appropriate personnel be readily available in case a severe reaction should occur.
Before any contrast medium is injected, the patient should be questioned for a history of allergy or bronchial asthma. Although a history of allergy may imply a greater than usual risk, it does not arbitrarily contraindicate the use of the medium, but does warrant special precaution.
A previous reaction to a contrast medium or a history of iodine sensitivity is not an absolute contraindication to the use of iohexol, however, extreme caution should be exercised in injecting these patients and prophylactic therapy should be considered.
Additionally, the possibility of an idiosyncratic reaction in patients who have previously received a contrast medium without ill effect should always be considered. 5 to 1 mL of the contrast agent, before injection of the full dose, has been employed in an attempt to predict severe or fatal adverse reactions.
The preponderance of recent scientific literature, however, now demonstrates that this provocative test procedure is not reliably predictive of serious or fatal reactions. Severe reactions and fatalities have occurred with the full dose after a non-reactive test dose, and with or without a history of allergy.
No conclusive relationship between severe or fatal reactions and antigen-antibody reactions or other manifestations of allergy has been established. A history of allergy may be more useful in predicting reactions and warrants special attention when administering the drug.
1 Dosing Considerations). OMNIPAQUE (iohexol injection USP) Page 24 of 59 Immune Caution should be exercised in performing contrast medium examination in patients with endotoxemia and in those with elevated body temperature. Monitoring and Laboratory Tests Thyroid function should be checked in neonates during the first week of life, following administration of iodinated contrast agents to the mother during pregnancy.
Multiple Myeloma Some clinicians consider multiple myeloma a contraindication to the use of contrast media because of the possibility of producing transient to fatal renal failure. If a decision to use Omnipaque is made, the patient should be well hydrated beforehand, since dehydration favours protein precipitation in the renal tubules.
A minimal diagnostic dose should be used and renal function and extent of urinary […]