Iohexol - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Iohexol. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
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 ]. 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 )
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Life-threatening or fatal reactions can occur.
Always have emergency equipment and trained personnel available.
Acute Kidney Injury: Acute injury including renal failure can occur.
Minimize dose and maintain adequate hydration to minimize risk.
Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration.
Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity.
5.1 Risks Associated with Intrathecal Administration of OMNIPAQUE Injection 140 mg Iodine/mL and 350 mg Iodine/mL Use only the iodine concentrations and presentations recommended for intrathecal procedures [see Dosage and Administration (2.2 , 2.8) ].
Intrathecal administration of OMNIPAQUE of a wrong iodine concentration, even if inadvertent, can cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema.
5.2 Risks Associated with Parenteral Administration of OMNIPAQUE Oral Solution Adverse reactions such as hemolysis may occur if OMNIPAQUE oral solution is administered intravenously or intraarterially due to low osmolality [see Description ] .
OMNIPAQUE oral solution is for oral use only.
5.3 Hypersensitivity Reactions OMNIPAQUE can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis.
Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock.
Most severe reactions develop shortly after the start of the injection (within 1 to 3 minutes), but delayed reactions can also occur.
There is an increased risk in patients with a history of a previous reaction to contrast agent and known allergic disorders (i.e., bronchial asthma, drug, or food allergies) or other hypersensitivities.
Premedication with antihistamines or corticosteroids 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 OMNIPAQUE administration.
Monitor all patients for hypersensitivity reactions.
5.4 Acute Kidney Injury Acute kidney injury, including renal failure, may occur after parenteral administration of OMNIPAQUE.
Risk factors include: pre-existing renal impairment, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma/paraproteinaceous diseases, repetitive and/or large doses of an iodinated contrast agent.
Use the lowest necessary dose of OMNIPAQUE in patients with renal impairment.
Adequately hydrate patients prior to and following parenteral administration of OMNIPAQUE.
Do not use laxatives, diuretics, or preparatory dehydration prior to OMNIPAQUE administration.
5.5 Cardiovascular Adverse Reactions Life-threatening or fatal cardiovascular reactions including hypotension, shock, cardiac arrest have occurred with the parenteral administration of OMNIPAQUE.
Most deaths occur during injection or five to ten minutes later, with cardiovascular disease as the main aggravating factor.
Cardiac decompensation, serious arrhythmias, and myocardial ischemia or infarction can occur during coronary arteriography and ventriculography.
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