Omnipaque 180mg/ml Inj, 10ml

Iohexol is a non-ionic, water-soluble, tri-iodinated benzoic acid derivative. When administered, it increases the attenuation of X-rays in the body structures where it distributes. The iodine atoms absorb X-rays, creating a contrast between the enhanced structures and surrounding tissues, allowing for visualization of blood vessels, organs, and other body cavities during radiographic procedures.

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 immediate medical attention:

Allergic reactions: Rash, hives, itching, redness, swelling, blistering, 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 excessive sweating.
Injection-related side effects:
+ Chest pain or pressure, rapid heartbeat, or abnormal heartbeat.
+ Weakness on one side of the body, difficulty speaking or thinking, 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.
Spinal injection side effects: A burning, numbness, or tingling sensation that is not normal.
Liquid formulation 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 unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:

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
Injection-related side effects (if given into the spine):
+ Dizziness
+ Back pain
+ Neck pain
+ Stiff neck
* Liquid formulation side effects:
+ Stomach pain or diarrhea
+ Gas

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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:

Allergies: If you are allergic to this drug, any of its components, or other medications, foods, or substances, notify your doctor. Describe the allergic reaction and its symptoms.
Dehydration and electrolyte imbalance: If you are dehydrated, have been eating poorly, or have recently used a laxative or diuretic, inform your doctor.
Previous skin reactions: If you have experienced a skin reaction to this medication or a similar drug in the past, tell your doctor.
Metformin use: If you are taking metformin, notify your doctor.

Additional considerations for specific administration routes:

Spinal injection: 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.
Injection into an artery or vein: Notify your doctor if you are unable to urinate.
* 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 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 breastfeeding: 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 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 problems. Verify that it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or adjust 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 regularly. Additionally, this medication may interfere with certain lab tests, so be sure to notify all your healthcare providers and lab personnel 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, this medication should be used with caution, as the risk of side effects may be higher in some children.

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

Injection Administration

If this medication is administered via injection into an artery or vein, be aware of the following risks:

In children under 3 years of age, this medication may cause low thyroid function, which can impact child development. Your child's thyroid function may need to be monitored for an extended period after the injection.
Rarely, life-threatening or fatal heart problems, including low blood pressure and heart attack, have been associated with this medication. Discuss these risks with your doctor.
* When used in conjunction with certain procedures, this medication may increase the risk of blood clots, which can lead to heart attack and stroke, potentially resulting in death. If you have questions or concerns, consult your doctor.

Intraspinal Injection

If this medication is administered via injection into the spine, be aware that it may increase the risk of seizures, particularly in individuals 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 risk factors for lactic acidosis)
• Interleukin-2 (IL-2)

• Beta-blockers
• Diuretics
• Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides)

• Rash
• Hives (urticaria)
• Itching (pruritus)
• Swelling of face, lips, tongue, or throat (angioedema)
• Difficulty breathing (dyspnea, bronchospasm)
• Wheezing
• Cough
• Dizziness
• Lightheadedness
• Nausea
• Vomiting
• Headache
• Fever
• Chills
• Pain or swelling at injection site
• Changes in vision (transient)

Category B. Studies in animals have shown no evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefits outweigh the potential risks.

L1 - Safest. Minimal excretion into breast milk. The amount absorbed by the infant is negligible. Breastfeeding can generally continue without interruption.

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, dose calculation, and monitoring is essential. Risk of contrast-induced nephropathy is generally lower than in adults but still requires caution in at-risk infants.

Elderly patients are more likely to have pre-existing renal impairment, cardiovascular disease, or diabetes, increasing their risk for adverse reactions, particularly contrast-induced acute kidney injury. Careful assessment of renal function and hydration status is crucial. Use the lowest effective dose.

• Always assess renal function (eGFR) before administering iohexol, especially in patients with risk factors for CI-AKI (e.g., diabetes, pre-existing renal disease, heart failure).
• Ensure adequate hydration before and after contrast administration to minimize the risk of CI-AKI.
• Patients on metformin should have it withheld before and for 48 hours after contrast administration if there is a risk of CI-AKI, and restarted only after renal function is confirmed to be stable.
• Be prepared for hypersensitivity reactions, ranging from mild urticaria to severe anaphylaxis. Have emergency equipment and medications readily available.
• For intrathecal use, ensure the correct concentration (e.g., 180 mgI/mL) and strict aseptic technique to prevent neurotoxicity or infection.
• Warm the contrast medium to body temperature before injection to reduce viscosity and improve patient comfort, especially for high flow rates or viscous solutions.

• Iopamidol (Isovue)
• Ioversol (Optiray)
• Iodixanol (Visipaque - iso-osmolar)
• Gadolinium-based contrast agents (for MRI, different mechanism)
• Ultrasound
• Non-contrast CT or MRI

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 use, do not share your medication with others, and never take medication that has been prescribed for someone else. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing them down the toilet or pouring them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the best method for disposing of your medication, consult with your pharmacist, who can provide guidance on safe disposal methods or inform you about potential drug take-back programs in your area.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist to see if this is the case. If you have any questions or concerns about your medication, do not hesitate to 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 it was taken, as this will be essential for receiving appropriate treatment.