Iodixanol

Do not allow yourself to become dehydrated during the first few days after receiving iodixanol. Call your doctor if you have any vomiting or diarrhea during this time. Follow your doctor's instructions about the types and amount of fluids you should drink.

Other drugs may interact with iodixanol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Iodixanol is in a group of drugs called radiopaque (RAY dee oh payk) contrast agents. Iodixanol contains iodine, a substance that absorbs x-rays. Radiopaque contrast agents are used to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Iodixanol is used to help diagnose certain disorders of the brain, blood vessels, heart, kidneys, and other internal organs.

Iodixanol may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, iodixanol may cause a severe drug reaction that can affect many parts of the body. This type of reaction can start several weeks after you begin using this medicine. Seek medical treatment if you have new or worsening symptoms of fever, facial swelling, a red or blistering skin rash, flu symptoms, swollen glands, feeling weak or tired, severe tingling or numbness, upper stomach pain, loss of appetite, jaundice (yellowing of the skin or eyes), weight loss, pain or burning when you urinate, lower back pain, swelling in your legs or feet, cough, chest pain, or trouble breathing.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• swelling, rapid weight gain, little or no urinating;

• wheezing or trouble breathing;

• a seizure (convulsions);

• thyroid symptoms--extreme tired feeling, dry skin, joint pain or stiffness, muscle pain or weakness, hoarse voice, feeling more sensitive to cold temperatures, weight gain;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• pain or warm feeling when the medicine is injected;

• dizziness, spinning sensation;

• numbness or tingly feeling;

• vision changes;

• sleep problems (insomnia);

• headache, migraine;

• chest pain;

• nausea, vomiting, diarrhea;

• agitation, anxiety, nervousness;

• skin rash, itching; or

• changes in your sense of taste or smell.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
• Your blood work may need to be checked. Talk with your doctor.
• Blood clots have happened with iodixanol when used with some heart procedures. Sometimes, blood clots may cause heart attack and stroke, which may be deadly. Talk with the doctor.
• Very bad health problems, paralysis, and death have happened when contrast has been given into blood vessels in the spinal cord. Talk with the doctor.
• Thyroid problems have happened after use of this medicine. Some people had to be treated for these thyroid problems. Talk with the doctor.
• If you have sickle cell disease, talk with your doctor.
• A very bad and sometimes deadly reaction has happened with iodixanol. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your child's health care providers and lab workers that your child takes this medicine.
• If you are 65 or older, use iodixanol with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use iodixanol as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• This medicine is given as a shot into a vein or artery only.
• You will need to be sure that you are not dehydrated before getting this medicine. Check with your doctor to see if you need to drink extra fluids before getting iodixanol.
• Drink lots of noncaffeine liquids after using this medicine unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

Applies to iodixanol: injectable solution

General

Serious reactions as well as fatalities are only seen on very rare occasions. Serious adverse reactions may include acute/chronic renal failure, anaphylactic or anaphylactoid shock, hypersensitivity reaction followed by cardiac reactions (Kounis' syndrome), cardiac or cardio-respiratory arrest and myocardial infarction.[Ref]

Genitourinary

Very common (10% or more): Vaginal hemorrhage (intrathecal)
Uncommon (0.1% to 1%): Hematuria[Ref]

Cardiovascular

Common (1% to 10%): Angina pectoris, chest pain
Uncommon (0.1% to 1%): Arrhythmias, cardiac failure, conduction abnormalities, hypotension, myocardial infarction, flushing, peripheral ischemia.
Rare (0.01% to 0.1%): Hypotension
Very rare (less than 0.01%): Hypertension, ischemia
Frequency not reported: Ventricular hypokinesia, myocardial ischemia, arterial spasm, thrombosis, thrombophlebitis, thrombocytopenia, cardiorespiratory arrest, spasm of coronary arteries, shock[Ref]

Dermatologic

Common (1% to 10%): Nonurticarial rash, erythema, pruritus, rash, urticaria
Uncommon (0.1% to 1%): Hematoma, increased sweating
Very rare (less than 0.01%): Angioedema
Frequency not reported: Severe pustular or bullous skin reactions, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms, drug eruption, dermatitis allergic, skin exfoliation[Ref]

Gastrointestinal

Common (1% to 10%): Nausea
Uncommon (0.1% to 1%): Diarrhea, vomiting, dyspepsia
Very rare (less than 0.01%): Abdominal pain, abdominal discomfort
Frequency not reported: Acute pancreatitis, pancreatitis aggravated, salivary gland enlargement[Ref]

Local

Common (1% to 10%): Injection site pain[Ref]

Nervous system

Common (1% to 10%): Headache, migraine, paresthesia
Uncommon (0.1% to 1%): Nervousness, dizziness, sensory disturbance, syncope, parosmia, cerebral vascular disorder, convulsions, hypoesthesia, stupor
Very rare (less than 0.01%): Cerebrovascular accident, amnesia
Frequency not reported: Disturbances in consciousness, coma, motor dysfunction, transient contrast induced encephalopathy (including hallucination), tremor
Postmarketing reports: Dyskinesia[Ref]

Ocular

Common (1% to 10%): Scotoma
Uncommon (0.1% to 1%): Abnormal vision
Frequency not reported: Transient blindness[Ref]

Other

Common (1% to 10%): Vertigo
Uncommon (0.1% to 1%): Edema, fatigue, malaise, tinnitus, feeling hot
Rare (0.01% to 0.1%): Pain, pyrexia, shivering (chills), administration site reactions including
extravasation
Very rare (less than 0.01%): Feeling cold, asthenic conditions
Frequency not reported: Iodism[Ref]

Hypersensitivity

Hypersensitivity reactions usually present as respiratory or cutaneous symptoms like dyspnea, rash, erythema, urticaria, pruritus, skin reaction, angioneurotic edema, hypotension, fever, laryngeal edema, bronchospasm or pulmonary edema. They 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]

Uncommon (0.1% to 1%): Pharyngeal edema
Frequency not reported: Anaphylactoid reaction, anaphylactoid shock[Ref]

Psychiatric

Uncommon (0.1% to 1%): Agitation, anxiety, insomnia, confusion[Ref]

Renal

Uncommon (0.1% to 1%): Abnormal renal function, acute renal failure[Ref]

Respiratory

Uncommon (0.1% to 1%): Asthma, bronchitis, dyspnea, pulmonary edema, rhinitis
Rare (less than 0.1%): Cough
Frequency not reported: Non-cardiogenic pulmonary edema, respiratory arrest, respiratory failure
Postmarketing reports: Pulmonary embolism, respiratory depression[Ref]

Musculoskeletal

Rare (less than 0.1%): Back pain
Frequency not reported: Arthralgia
Postmarketing reports: Polymyalgia rheumatica[Ref]

Hematologic

Postmarketing reports: Hemorrhage[Ref]

Metabolic

Postmarketing reports: Hypoglycemia[Ref]

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

Intra-arterial Administration:

Aortography: 30 to 70 mL (320 mgI/mL)
Major Branches of Aorta: 10 to 70 mL (320 mgI/mL)
Aortofemoral Runoffs: 20 to 90 mL (320 mgI/mL)
Max Total Dose: Usually not to exceed 250 mL

Intra-arterial Administration:

Renal Arteries 8 to 18 mL (320 mgI/mL)
Max Total Dose: Usually not to exceed 250 mL

Intravenous administration of iodixanol injection (270 mgI/mL) is recommended.

Greater than 12 years of age:

Venography:
Per Lower Extremity:
50 to 100 mL (270 mgI/ mL)
Maximum Total Volume: 250 mL

Iodixanol has been shown to be dialyzable.

Summary of Use during Lactation

Intravenous iodinated contrast media are poorly excreted into breastmilk and poorly absorbed orally so they are not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants. One report of very small amounts of iodine from iodixanol in breastmilk supports this generalization. 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. A mother was given 100 mL of iodixanol (containing 320 mg of iodine per mL) intravenously immediately postpartum for diagnosis of sever abdominal pain. She was found to have a hematoma resulting in acute tubular necrosis with a serum creatinine of 2.5 mg/dL (222 micromoles/L). Breastmilk samples taken on days 1 and 4 postpartum contained 55 and 28 mg/L of iodine, respectively. The authors calculated that the infant would receive 0.017% of the total administered maternal dose of iodine on day 1 and 0.05% on day 4 postpartum.[5] However, these values could be somewhat different in a patient with normal kidney function.

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, Iohexol

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. Chruscicki A, Morton AR, Akbari A et al. Composition of human breast milk in acute kidney injury. Obstetric Med. 2017;10:79-82. PMID: 28680467