Omnipaque 140mg/ml Inj, 50ml

Iohexol is a nonionic, water-soluble, tri-iodinated benzoic acid derivative. When injected intravascularly, it increases the attenuation of X-rays in the areas of the body being examined, allowing for visualization of internal structures (e.g., blood vessels, organs) on radiographic images. The iodine atoms absorb X-rays, creating contrast.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Allergic Reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be fatal.
Thyroid Problems: Changes in weight, feeling nervous, excitable, restless, or weak, hair thinning, depression, eye or neck swelling, difficulty focusing, trouble with heat or cold, menstrual changes, shakiness, or sweating.
Injection-Related Side Effects:
+ Chest pain or pressure, rapid heartbeat, or abnormal heartbeat.
+ Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision.
+ Severe dizziness or fainting.
+ Shortness of breath, significant weight gain, or swelling in the arms or legs.
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm.
+ Seizures.
+ Changes in vision.
Tissue Damage: If the medication leaks from the vein, it can cause tissue damage. Inform your nurse if you experience redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.
Severe Skin Reactions: These can occur anywhere from 1 hour to several weeks after receiving the medication and may include:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions that can affect body organs and be life-threatening.
+ Symptoms may include red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands. Seek medical help immediately if you experience any of these symptoms.
Spinal Injection Side Effects: A burning, numbness, or tingling sensation that is not normal.
Liquid Form Side Effects: Swelling.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

Common Side Effects:
+ Upset stomach or vomiting
+ Headache
Injection-Related Side Effects:
+ Dizziness (if given in an artery or vein)
+ Feeling of warmth
+ Changes in taste
+ Dizziness (if given into the spine)
+ Back pain
+ Neck pain
+ Stiff neck
Liquid Form Side Effects:
+ Stomach pain or diarrhea
+ Gas

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions before starting this medication:

Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
If you are dehydrated, have been eating poorly, or have recently used a laxative or diuretic.
If you have had a skin reaction to this medication or a similar drug in the past.
If you are taking metformin.

Additional Considerations for Specific Administration Routes:

If you will be receiving this medication via spinal injection:
+ Inform your doctor if you have an active infection.
+ Disclose any medications you are taking that may increase the risk of seizures or if you have taken such a medication within the last 48 hours. Your doctor or pharmacist can help you identify these medications.
If you will be receiving this medication via injection into an artery or vein:
+ Tell your doctor if you are unable to urinate.
* If this medication will be used before an x-ray of the uterus and fallopian tubes:
+ Inform your doctor if you are currently menstruating, have a genital infection, or have a known or suspected growth in the reproductive tract.
+ Share your history if you have had a curettage or conization procedure within the past 30 days.
+ Inform your doctor if you have had a pregnancy terminated within the past 6 months.
+ Do not take this medication if you are pregnant or suspect you may be pregnant.

Interactions with Other Medications and Health Conditions:

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. Ensure it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may need to monitor your blood work, and this medication may affect certain lab tests. Be sure to notify all your healthcare providers and lab workers that you are taking this drug.

If you experience any signs of kidney problems, such as difficulty urinating, changes in urine output, bloody, brown, or foamy urine, shortness of breath, cough, or swelling in your face, feet, or hands, contact your doctor immediately.

Special Considerations

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Similarly, if the patient is a child, this medication should be used with caution, as the risk of side effects may be higher in some children.

If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.

Injection (Given in an Artery or Vein)

In children under 3 years of age, the use of medications like this one has been associated with low thyroid function, which can impact child development. If the patient is a child, your doctor may recommend monitoring their thyroid function for a period after the injection. If you have questions or concerns, consult your doctor.

Rarely, life-threatening or fatal heart problems, including low blood pressure and heart attack, have been reported with this medication. Discuss these risks with your doctor.

Additionally, health problems like blood clots have occurred with this medication when used in conjunction with certain procedures. In some cases, blood clots can lead to heart attack and stroke, which can be fatal. If you have questions, consult your doctor.

Injection (Given into the Spine)

This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.

• Metformin (in patients with renal impairment or acute kidney injury): Risk of lactic acidosis. Metformin should be withheld at the time of or prior to the procedure and for 48 hours after, and reinstituted only after renal function has been re-evaluated and found to be normal.
• Interleukin-2 (IL-2) therapy: Increased risk of delayed adverse reactions (e.g., fever, flu-like symptoms, rash, oliguria, renal failure) due to potential for enhanced contrast retention.

• Beta-blockers: Increased risk of anaphylactoid reactions and reduced efficacy of epinephrine in treating severe reactions.
• Diuretics: May increase risk of contrast-induced nephropathy due to dehydration.
• Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin): Concomitant use may increase risk of contrast-induced nephropathy.
• Oral cholecystographic agents: May interfere with visualization if administered prior to iohexol.

• Hives
• Itching
• Rash
• Swelling of face/throat/tongue
• Difficulty breathing
• Wheezing
• Lightheadedness
• Dizziness
• Nausea
• Vomiting
• Headache
• Warm sensation
• Metallic taste
• Chest pain
• Shortness of breath
• Flushing
• Chills
• Fever
• Pain or discomfort at injection site

Category B. Animal studies have not shown fetal harm. Limited human data suggest low risk. Use only if clearly needed and potential benefits outweigh risks. Consider non-iodinated alternatives if available and appropriate.

L2 (Safer). Iohexol is minimally excreted into breast milk and poorly absorbed by the infant's GI tract. Infant exposure is very low. Breastfeeding can generally continue without interruption. If concerns exist, a temporary interruption (e.g., 12-24 hours) and discarding milk may be considered, but is often not necessary.

Dosing is weight-based and procedure-specific. Children, especially neonates and infants, are more susceptible to fluid shifts and temperature changes. Careful attention to hydration and temperature regulation is crucial. Renal function should be assessed. Risk of contrast-induced nephropathy is generally lower than in adults but still a consideration in vulnerable populations.

Increased risk of contrast-induced nephropathy due to age-related decline in renal function, comorbidities (e.g., diabetes, heart failure), and polypharmacy. Careful assessment of renal function and hydration status is essential. Use lowest effective dose and ensure adequate pre- and post-hydration.

• Always assess renal function (CrCl or eGFR) before administering iohexol, especially in high-risk patients.
• Ensure adequate hydration before and after contrast administration to minimize the risk of contrast-induced nephropathy (CIN).
• Patients on metformin should have it withheld before and for 48 hours after contrast administration, with renal function re-evaluated before restarting.
• Be prepared for hypersensitivity reactions, ranging from mild to severe anaphylaxis. Have resuscitation equipment and medications readily available.
• Nonionic contrast agents like iohexol generally have a lower incidence of adverse reactions compared to ionic agents.
• For intrathecal use, ensure the correct concentration and volume are used, as higher concentrations or volumes can lead to neurotoxicity.

• Other iodinated contrast media (e.g., Ioversol, Iopamidol, Iodixanol)
• Gadolinium-based contrast agents (for MRI, different mechanism)
• Ultrasound with contrast (e.g., microbubble agents)
• Non-contrast imaging modalities (e.g., plain X-ray, non-contrast CT, MRI, ultrasound)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.