Iohexol Injection, Oral, Rectal

In the U.S.

• Omnipaque 140
• Omnipaque 180
• Omnipaque 240
• Omnipaque 300
• Omnipaque 350
• Omnipaque Flexipak

Available Dosage Forms:

• Solution

Therapeutic Class: Radiological Non-Ionic Contrast Media

Iohexol injection is used to help diagnose or find problems in the brain, back, heart, head, blood vessels, and other parts of the body. It is an iodinated contrast agent. Contrast agents are used to create a clear picture of the different parts of the body during certain medical procedures such as CT scans and angiography.

Iohexol may also be given orally or rectally to help diagnose or find problems in the joints, stomach or intestines, pancreas, and other parts of the body.

iohexol is to be given only by or under the supervision of a doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Swelling or pain

• Arm, back, or jaw pain
• chest pain or discomfort
• chest tightness or heaviness
• difficulty breathing
• dizziness
• fainting
• fast, slow, or irregular heartbeat
• nausea
• shortness of breath
• sweating
• swelling in the throat

• Blurred vision
• confusion
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat
• sweating
• unusual tiredness or weakness

• Blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• confusion
• dizziness or lightheadedness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• feeling of constant movement of self or surroundings
• headache
• nervousness
• pounding in the ears
• seizures
• slow or fast heartbeat
• sweating
• unusual tiredness or weakness

• Blurred vision
• confusion
• dilated neck veins
• dizziness or lightheadedness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• extreme fatigue
• fast, pounding, or irregular heartbeat or pulse
• feeling cold
• feeling of constant movement of self or surroundings
• fever
• irregular breathing
• pale skin
• seizures
• sensation of spinning
• swelling of the face, fingers, feet, or lower legs
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• weight gain

• Muscle weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Nausea
• pain in the neck, back, or nerve

• Abdominal or stomach pain
• bloated or full feeling
• diarrhea
• excess air or gas in the stomach or intestines
• nausea
• passing gas
• vomiting

• Vomiting

• Bad, unusual, or unpleasant (after) taste
• change in taste
• headache

• Hives or welts, itching, or skin rash
• redness of the skin
• sleepiness or unusual drowsiness

• Change in color vision
• continuing ringing or buzzing or other unexplained noise in the ears
• difficulty seeing at night
• drowsiness
• hearing loss
• increased sensitivity of the eyes to sunlight
• loss of appetite
• sensation of spinning

• Acid or sour stomach
• anxiety
• belching
• chills
• cold sweats
• coma
• cool, pale skin
• cough
• depression
• diarrhea
• dry mouth
• heartburn
• hives or welts, itching, or rash
• increased hunger
• indigestion
• nightmares
• redness of the skin
• runny nose
• shakiness
• sleepiness or unusual drowsiness
• slurred speech
• sneezing
• stomach discomfort, upset, or pain
• stuffy nose
• uncontrolled eye movements
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Applies to iohexol: injectable solution

General

The most frequently reported adverse reactions are headache, mild to moderate pain including backache, neckache and stiffness, nausea, and vomiting. These reactions usually occur 1 to 10 hours after injection, and almost all occur within 24 hours. They are usually mild to moderate in degree, lasting for a few hours, and usually disappearing within 24 hours.[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (oral/body cavity routes)
Common (1% to 10%): Nausea, vomiting, pancreatitis (endoscopic retrograde cholangiopancreatography), lower abdominal pain (hysterosalpingography)
Uncommon (0.1% to 1%): Abdominal pain, stomach ache
Rare (0.01% to 0.1%): Diarrhea
Very rare (less than 0.01%): Tenderness and/or enlargement of the salivary glands ("iodide mumps"), abdominal discomfort
Frequency not reported: Aggravation of pancreatitis, acute pancreatitis[Ref]

Nervous system

Rarely, headaches may be severe or persist for days. Headache is often accompanied by nausea and vomiting and tends to be more frequent and persistent in patients not optimally hydrated.
Aseptic meningitis syndrome was usually preceded by pronounced headaches, nausea and vomiting. Onset usually occurred about 12 to 18 hours postprocedure. Prominent features were meningismus, fever, sometimes with oculomotor signs and mental confusion. Lumbar puncture revealed a high white cell count, high protein content often with a low glucose level and with absence of organisms. The condition usually started to clear spontaneously about 10 hours after onset, with complete recovery over 2 to 3 days.[Ref]

Very common (10% or more): Headache (may be severe and prolonged)
Common (1% to 10%): Dizziness (2%), neuralgia
Uncommon (0.1% to 1%): Aseptic meningitis syndrome (including chemical meningitis), visual hallucinations, somnolence, hemiparesis, transient ischemic attack, cerebral infarction, syncope
Rare (0.01% to 0.1%): Seizure, neurological changes, drowsiness, transitory peripheral neuropathies (sensory and/or motor or nerve root disturbances, myelitis, persistent leg muscle pain or weakness, 6th nerve palsy, or cauda equina syndrome)
Very rare (less than 0.01%): Dysgeusia (transient metallic taste), disturbance in consciousness, transient contrast-induced encephalopathy (including transient memory loss, coma, stupor, retrograde amnesia), sensory abnormalities (including hypoesthesia), paraesthesia, tremor
Frequency not reported: Syncope vasovagal, motor dysfunction (including speech disorder, aphasia, dysarthria), disorientation, abnormal electroencephalogram, meningism[Ref]

Other

Very common (10% or more): Pain
Common (1% to 10%): Feeling hot
Uncommon (0.1% to 1%): Discomfort, fever, hives
Rare (0.01% to 0.1%): Pyrexia, asthenic conditions (including malaise, fatigue), feeling of heaviness, tinnitus, vertigo
Very rare (less than 0.01%): Shivering (chills)
Frequency not reported: Transient hearing loss[Ref]

Metabolic

Common (1% to 10%): Blood amylase increased
Uncommon (0.1% to 1%): Hypoglycemia in pediatrics (0.3%)
Rare (less than 0.1%): Loss of appetite
Frequency not reported: Iodism[Ref]

Musculoskeletal

Severe pain may often result from undue use of pressure or the injection of large volumes. Joint swelling after injection is less with iohexol than with high osmolar ionic contrast medium. These types of reactions are generally procedurally dependent and of greater frequency when double-contrast technique is employed.[Ref]

Common (1% to 10%): Back pain
Rare (less than 0.1%): Neck pain, pain in extremity, hypertonia
Frequency not reported: Muscle spasm, arthralgia, arthritis, muscle cramps, fasciculation or myoclonia, spinal convulsion, spasticity, stiff neck[Ref]

Ocular

Common (1% to 10%): Vision abnormalities (including blurred vision and photomas) (2%)
Uncommon (0.1% to 1%): Nystagmus (less than 0.3%)
Rare (less than 0.1%): Photophobia, ocular muscles weakness
Frequency not reported: Transient cortical blindness[Ref]

Renal

Common (1% to 10%): Transient increase in serum creatinine (contrast induced nephropathy may occur)
Rare (less than 0.1%): Impairment of renal function including acute renal failure[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Angina, chest pain, anemia in pediatrics(0.3%)
Rare (0.01% to 0.1%): Bradycardia, arrhythmia, hypotension, hypertension
Very rare (less than 0.01%): Myocardial infarction, flushing
Frequency not reported: Severe cardiac complications (including cardiac arrest, cardio-respiratory arrest), spasm of coronary arteries, chest pain, shock, arterial spasm, ischemia, thrombophlebitis, thrombosis[Ref]

Dermatologic

Uncommon (0.1% to 1%): Urticaria, purpura, abscess, pruritus
Frequency not reported: Severe pustular or exfoliative or bullous dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, rash with eosinophilia and systemic symptoms, psoriasis flare-up[Ref]

Respiratory

Uncommon (0.1% to 1%): Dyspnea, rhinitis, coughing, laryngitis
Rare (0.01% to 0.1%): Cough
Very rare (less than 0.01%): Non-cardiogenic pulmonary edema
Frequency not reported: Severe respiratory symptoms and signs, bronchospasm, laryngospasm, asthma attack[Ref]

Genitourinary

Rare (less than 0.1%): Difficulty in micturition[Ref]

Hypersensitivity

The hypersensitivity reactions may appear either immediately after the injection or up to a few days later.
Hypersensitivity reactions may occur irrespectively of the dose and mode of administration, and mild symptoms may represent the first signs of a serious anaphylactoid reaction/shock.[Ref]

Rare (less than 0.1%): Hypersensitivity (including dyspnea, rash, erythema, urticaria, pruritus, skin reaction, vasculitis, angioneurotic edema, laryngeal edema, laryngospasm, bronchospasm or non-cardiogenic pulmonary edema)
Frequency not reported: Anaphylactic/anaphylactoid reaction, anaphylactic/anaphylactoid shock[Ref]

Endocrine

Very rare (less than 0.01%): Sweating
Frequency not reported: Thyrotoxicosis, transient hypothyroidism (premature infants, neonates premature breast fed infant, and in other children)[Ref]

Local

Frequency not reported: Administration site reactions, including extravasation[Ref]

Psychiatric

Frequency not reported: Confusion, anxiety[Ref]

Some side effects of iohexol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Summary of Use during Lactation

Limited information indicates that maternal doses of iohexol up to 45.3 grams (containing 21 grams of iodine) produce low levels in milk. In addition, because iohexol is poorly absorbed orally, it is not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants. Guidelines developed by several professional organizations state that breastfeeding need not be disrupted after a nursing mother receives a iodine-containing contrast medium.[1][2][3][4]

Drug Levels

Maternal Levels. Four mothers who were 1 week to 14 months postpartum received iohexol by rapid intravenous injection. Three received a dose of 50 mL (37.8 grams; 17.5 grams of iodine) and one received 60 mL (45.3 grams; 21 grams of iodine). Milk samples of 10 mL were collected 9 times over the 48 hours after the injection. The average iohexol milk concentration over the first 24 hours was 24.6 mg/L in the 3 women 1 week to 4 months postpartum and 130.5 mg/L in the one woman who was 14 months postpartum and weaning her infant. The authors calculated that the average amount of iohexol received by the first 3 infants over the first 24 hours would be 3.7 mg/kg or 0.5% of the weight-adjusted maternal dosage.[5]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Diatrizoate

References

1. American College of Radiology Committee on Drugs and Contrast Media. Administration of contrast media to breast-feeding mothers. In, ACR manual on contrast media. 2015;Version 10.1:99-100. http://www.acr.org/~/media/ACR/Documents/PDF/QualitySafety/Resources/Contrast%20Manual/2015_Contrast_Media.pdf

2. Webb JA, Thomsen HS, Morcos SK et al. The use of iodinated and gadolinium contrast media during pregnancy and lactation. Eur Radiol. 2005;15:1234-40. PMID: 15609057

3. Chen MM, Coakley FV, Kaimal A, Laros RK Jr. Guidelines for computed tomography and magnetic resonance imaging use during pregnancy and lactation. Obstet Gynecol. 2008;112:333-40. PMID: 18669732

4. American College of Obstetricians and Gynecologists Committee on Obstetric Practice. Committee Opinion No. 656: Guidelines for Diagnostic Imaging During Pregnancy and Lactation. Obstet Gynecol. 2016;127:e75-e80. DOI: doi:10.1097/AOG.0000000000001316

5. Nielsen ST, Matheson I, Rasmussen JN et al. Excretion of iohexol and metrizoate in human breast milk. Acta Radiol. 1987;28:523-6. PMID: 2960342

Substance Name

Iohexol

CAS Registry Number

66108-95-0

Drug Class

Contrast Agents

Diagnostic Agents