Omnipaque 240mg/ml Inj, 10ml

Iohexol is a non-ionic, low-osmolar, water-soluble iodinated contrast medium. When administered intravascularly, it increases the attenuation of X-rays in the areas where it distributes, allowing for visualization of blood vessels and organs during radiographic procedures. The iodine atoms in the molecule are responsible for the X-ray attenuation.

Urgent Side Effects: Seek Medical Help Right Away

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

Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty 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: Weight changes, nervousness, excitability, restlessness, weakness, hair thinning, depression, eye or neck swelling, difficulty focusing, heat or cold intolerance, 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, speech or thinking difficulties, balance changes, 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, which 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 formulation side effects: Swelling.

Other Side Effects

Most medications can cause side effects, but many people experience none or only mild side effects. If you are concerned about any of the following side effects or if they persist, contact your doctor or seek medical attention:

Common side effects:
+ Upset stomach or vomiting
+ Headache
Injection-related side effects (if given in an artery or vein):
+ Dizziness
+ Feeling of warmth
+ Changes in taste
Spinal injection side effects:
+ Dizziness
+ Back pain
+ Neck pain
+ Stiff neck
* Liquid formulation side effects:
+ Stomach pain or diarrhea
+ Gas

This is not an exhaustive list of potential 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 to ensure safe use of this medication:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Describe the allergic reaction and its symptoms.
If you are dehydrated, have been experiencing poor nutrition, or have recently used a laxative or diuretic.
If you have had a previous skin reaction to this medication or a similar drug.
If you are currently taking metformin.

Additional Considerations for Specific Administration Routes:

Injection into the spine: Inform your doctor if you have an active infection or are taking medications that may increase the risk of seizures, or if you have taken such a medication within the last 48 hours. There are numerous medications that can increase seizure risk, so consult your doctor or pharmacist if you are unsure.
Injection into an artery or vein: Tell your doctor if you are experiencing urinary retention.
Use before an x-ray of the uterus and fallopian tubes: Inform your doctor if you are menstruating, have a genital infection, or have a known or suspected growth in the reproductive tract. Also, notify your doctor if you have had a curettage or conization procedure within the past 30 days, or if you have had a pregnancy terminated within the last 6 months.

Pregnancy and This Medication:

Do not take this medication if you are pregnant or may be pregnant.

Interactions with Other Medications and Health Conditions:

This is not an exhaustive list of all potential interactions. It is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health conditions you have.
Before starting, stopping, or changing the dose of any medication, consult your doctor to ensure it is safe to do so in conjunction with this medication.

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 years or older, use this medication with caution, as you may be more susceptible to side effects. Similarly, if the patient is a child, use this medication 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 benefits and risks of this medication 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 need to monitor their thyroid function for a period after the injection. If you have questions or concerns, discuss them with your doctor.

Rarely, life-threatening or fatal heart problems, including low blood pressure and heart attack, have been reported with this medication. Consult your doctor to discuss the risks and benefits.

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 or concerns, discuss them with 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, an iodinated contrast imaging procedure in patients with known acute kidney injury or severe chronic kidney disease (GFR <30 mL/min/1.73m2) or in patients undergoing intra-arterial iodinated contrast where the risk of AKI is high. Metformin should be re-evaluated 48 hours after the imaging procedure and reinstituted only if renal function is stable.
• Interleukin-2 (IL-2): Increased risk of delayed adverse reactions (e.g., fever, rash, flu-like symptoms, arthralgia, myalgia, pruritus, hypotension, oliguria, renal dysfunction) following contrast administration in patients who have received IL-2 within 2 weeks prior.

• Beta-blockers: Increased risk of vasovagal reactions (e.g., bradycardia, hypotension) due to blunted compensatory responses.
• Diuretics: May increase risk of contrast-induced nephropathy due to dehydration.
• Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides): Concomitant use may increase the risk of contrast-induced nephropathy, especially in patients with pre-existing renal impairment.

• Nausea
• Vomiting
• Headache
• Dizziness
• Warm sensation
• Flushing
• Metallic taste
• Itching
• Hives (urticaria)
• Rash
• Difficulty breathing (dyspnea)
• Swelling of face/throat (angioedema)
• Chest pain
• Palpitations
• Seizures
• Confusion
• Signs of extravasation (pain, swelling, redness at injection site)

Category B. Animal studies have not shown fetal harm, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefits outweigh the potential risks to the fetus. Consider non-ionizing imaging modalities if possible.

L2 (Safer). Iohexol is minimally excreted into breast milk, and oral absorption by the infant is very low. The American College of Radiology (ACR) and European Society of Urogenital Radiology (ESUR) state that breastfeeding can continue without interruption after administration of iodinated contrast media. If there is concern, a temporary interruption of breastfeeding for 12-24 hours can be considered, but it is generally not necessary.

Dosing is weight-based and highly individualized. Pediatric patients, especially neonates and infants, may be more susceptible to fluid and electrolyte imbalances and temperature fluctuations. Careful monitoring of hydration and vital signs is essential. Risk of contrast-induced nephropathy should be considered, especially in those with pre-existing renal issues.

Elderly patients are more likely to have pre-existing renal impairment, cardiovascular disease, and diabetes, increasing their risk for contrast-induced nephropathy and other adverse reactions. Careful assessment of renal function, hydration status, and comorbidities is crucial. Use the lowest effective dose and ensure adequate hydration.

• Always assess renal function (eGFR) before administering iodinated contrast, especially in patients with risk factors for CIN (e.g., diabetes, pre-existing renal disease, heart failure, age >70).
• Ensure adequate hydration before and after the procedure to minimize the risk of CIN. Oral or intravenous hydration protocols may be used.
• Carefully review medication list for metformin. If patient is on metformin, follow institutional guidelines for withholding and re-initiating the drug.
• Pre-medication with corticosteroids and/or antihistamines may be considered for patients with a history of prior contrast reaction or severe allergies, though non-ionic contrast agents have a lower incidence of reactions.
• Monitor patients closely for immediate and delayed hypersensitivity reactions. Have emergency equipment and medications readily available.
• For intra-arterial injections, be aware of the potential for pain or warmth at the injection site and transient hemodynamic changes.

• Iodixanol (Visipaque) - another non-ionic, iso-osmolar iodinated contrast medium, often preferred in high-risk patients for CIN.
• Iopamidol (Isovue) - another non-ionic, low-osmolar iodinated contrast medium.
• Iopromide (Ultravist) - another non-ionic, low-osmolar iodinated contrast medium.
• Gadolinium-based contrast agents (e.g., Gadoterate meglumine, Gadobutrol) - used in MRI, not X-ray/CT. Different safety profile (e.g., NSF risk).
• Ultrasound - non-ionizing imaging modality.
• MRI (without contrast) - non-ionizing imaging modality.

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others, and do not take medication prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. Many communities have drug take-back programs, which your pharmacist can help you locate.

Some medications may have additional patient information leaflets available. Your pharmacist can provide this information upon request. If you have any questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider for personalized guidance.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time of ingestion, to ensure prompt and effective treatment.