Omnipaque 350mg/ml Inj, 150ml

Iohexol is a non-ionic, water-soluble, tri-iodinated benzoic acid derivative. When injected intravascularly, it increases the attenuation of X-rays in the areas of the body where it distributes. The iodine atoms within the molecule absorb X-rays, creating a contrast between the vascular structures or organs containing the contrast medium and the surrounding tissues, thereby enhancing visualization in diagnostic imaging 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 speaking, 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 or irregular heartbeat.
+ Weakness on one side of the body, difficulty speaking or thinking, balance problems, 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.
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 are concerned about any of the following side effects or if they persist, contact your doctor:

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 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 treatment:

Allergies: If you are allergic to this medication, any of its components, or other drugs, foods, or substances, notify your doctor. Describe the allergic reaction and its symptoms.
Dehydration, poor nutrition, or recent use of laxatives or diuretics (water pills): Inform your doctor if you are dehydrated, have been eating poorly, or have used these medications before taking this drug.
Previous skin reactions: If you have experienced a skin reaction to this medication or similar drugs in the past, tell your doctor.
Metformin use: Inform your doctor if you are taking metformin.

Additional Considerations for Specific Administration Routes:

Spinal injection: If you have an infection or are taking medications that may increase the risk of seizures, or have taken such a medication within the last 48 hours, inform your doctor. Many drugs can increase seizure risk, so ask your doctor or pharmacist if you are unsure.
Injection into an artery or vein: If you are unable to urinate, notify your doctor.
Use before an x-ray of the uterus and fallopian tubes: Inform your doctor if you are menstruating, have a genital infection, or have or may have a growth in the reproductive tract. Also, notify your doctor if you have had a curettage (tissue removal) or conization (cervix biopsy) within the past 30 days, or if you have had a pregnancy terminated within the last 6 months.
Pregnancy: 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 problems. Verify that it is safe to take this medication with all your other medications and health conditions before starting treatment. Do not initiate, stop, or modify 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 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, 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 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 potential risks. Additionally, the use of this medication with certain procedures has been linked to health problems, such as blood clots, which can increase the risk of heart attack and stroke, potentially leading to fatal outcomes. If you have questions, talk to 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 acute kidney injury or severe chronic kidney disease): Increased 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): Increased risk of delayed adverse reactions (e.g., fever, rash, flu-like symptoms, renal dysfunction) following contrast administration in patients who have recently received IL-2 therapy.

• Beta-blockers: May blunt the compensatory cardiovascular responses to contrast media-induced hypotension or anaphylactoid reactions.
• Diuretics: May increase the risk of contrast-induced nephropathy due to dehydration.
• Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides): Concomitant use may increase the risk of contrast-induced nephropathy.

• Hives
• Rash
• Itching
• Swelling of face, lips, tongue, or throat
• Difficulty breathing or wheezing
• Lightheadedness or dizziness
• Nausea
• Vomiting
• Headache
• Flushing
• Warm sensation
• Pain or discomfort at injection site
• Signs of extravasation (swelling, pain, redness at injection site)
• Symptoms of acute kidney injury (decreased urine output, swelling, fatigue)

Category B. Animal studies have not shown harm, but human data are limited. Use only if clearly needed and the potential benefits outweigh the potential risks. Consider non-iodinated imaging alternatives if possible.

L3 (Moderately Safe). Iohexol is minimally excreted into breast milk and poorly absorbed by the infant's gastrointestinal tract. Interruption of breastfeeding is generally not necessary. If concerns exist, a temporary interruption (e.g., 12-24 hours) with discarding milk can be considered, but is often not recommended by major guidelines.

Dosing is weight-based and requires careful calculation. Children, especially neonates and infants, are more susceptible to fluid shifts and temperature changes. Careful monitoring of hydration, vital signs, and renal function is essential. Risk of thyroid dysfunction in neonates should be considered.

Increased risk of contrast-induced nephropathy (CIN) due to age-related decline in renal function, comorbidities (e.g., diabetes, heart failure), and polypharmacy. Careful assessment of renal function, adequate hydration, and use of the lowest effective dose are crucial. Monitor for signs of CIN post-procedure.

• Always assess renal function (eGFR) before administering iohexol, especially in high-risk patients (e.g., diabetes, pre-existing CKD, heart failure).
• Ensure adequate hydration before and after the procedure to minimize the risk of contrast-induced nephropathy (CIN). Oral or intravenous hydration may be necessary.
• For patients with a history of moderate to severe allergic reactions to contrast media, consider pre-medication with corticosteroids and/or antihistamines, or use an alternative imaging modality.
• Metformin should be withheld in patients with acute kidney injury or severe chronic kidney disease 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.
• Monitor patients closely for immediate and delayed hypersensitivity reactions. Have emergency equipment and medications readily available.
• Extravasation can occur; ensure proper IV access and monitor the injection site. Manage extravasation according to institutional protocols.

• Other non-ionic iodinated contrast media (e.g., Ioversol, Iopamidol, Iodixanol)
• Ionic iodinated contrast media (e.g., Diatrizoate, Iothalamate - generally higher osmolarity and higher risk of adverse reactions)
• Gadolinium-based contrast agents (for MRI, different mechanism and indications)
• Non-contrast imaging modalities (e.g., ultrasound, non-contrast CT, non-contrast MRI) when appropriate.

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further evaluation and 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 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 down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate.

Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. 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 detailed information about the medication taken, including the dosage and time of ingestion, to ensure prompt and effective treatment.