Omnipaque 140

Name: Omnipaque 140

Commonly used brand name(s)

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

Uses For Omnipaque 140

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.

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

Proper Use of iohexol

This section provides information on the proper use of a number of products that contain iohexol. It may not be specific to Omnipaque 140. Please read with care.

A doctor or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in an artery or a vein, or into your spinal cord. It may also be given by mouth or through your rectum.

Your doctor may also give you medicines (eg, antihistamines, steroids) to prevent allergic reactions.

Drink extra fluids so you will pass more urine while you are receiving this medicine. This may help prevent kidney problems.

Precautions While Using Omnipaque 140

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Tell your doctor if you are pregnant.

This medicine may cause heart attack, stroke, and blood clotting problems during angiographic procedures. Tell your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, faintness, coughing up blood, numbness or weakness in your arm or leg, or on one side of your body, sudden or severe headache, or problems with vision, speech, or walking after receiving this medicine.

Severe kidney problems may occur after receiving this medicine. Tell your doctor right away if you have the following symptoms after receiving the medicine: agitation, confusion, decreased urine output, dizziness, headache, muscle twitching, rapid weight gain, or swelling of the face, ankles, or hands.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a skin rash, itching, shortness of breath, sweating, swelling of the face, tongue, and throat, or tightness in the chest after you receive this medicine.

Make sure your doctor knows if you have had an allergic reaction to any dye or medicine given during a test or procedure.

While using this medicine, you may be exposed to radiation. Talk with your doctor if you have concerns about this.

Make sure any doctor or dentist who treats you knows that you are using iohexol injection. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. You should not receive iohexol injection together with a steroid medicine into your spinal cord.

Omnipaque 140 Side Effects

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:

More common—Oral or rectal route
  • Swelling or pain
Less common—Intravascular route
  • 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
Less common—Oral or rectal route
  • 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
Rare—Intrathecal route
  • 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
Rare—Intravascular route
  • 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
Rare—Oral or rectal route
  • 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:

More common—Intrathecal route
  • Nausea
  • pain in the neck, back, or nerve
More common—Oral or rectal route
  • Abdominal or stomach pain
  • bloated or full feeling
  • diarrhea
  • excess air or gas in the stomach or intestines
  • nausea
  • passing gas
  • vomiting
Less common—Intrathecal route
  • Vomiting
Less common—Intravascular route
  • Bad, unusual, or unpleasant (after) taste
  • change in taste
  • headache
Less common—Oral or rectal route
  • Hives or welts, itching, or skin rash
  • redness of the skin
  • sleepiness or unusual drowsiness
Rare—Intrathecal route
  • 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
Rare—Intravascular route
  • 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.

For Healthcare Professionals

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 (the active ingredient contained in Omnipaque 140) 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 Omnipaque 140 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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