Omnipaque 350mg/ml Inj, 200ml

Iohexol is a nonionic, water-soluble, tri-iodinated benzoic acid derivative. It increases the attenuation of X-rays in the body structures where it is distributed, allowing for visualization of internal structures during diagnostic imaging procedures (e.g., X-ray, CT scans). The iodine atoms absorb X-rays, creating a 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.
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:

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 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 treatment:

Allergies: If you are allergic to this medication, any of its components, or other substances, including foods or drugs. Describe your allergic reaction and the symptoms you experienced.
Dehydration or poor nutrition: If you are dehydrated, have been eating poorly, or have recently used a laxative or diuretic.
Previous skin reactions: If you have had a skin reaction to this medication or a similar drug in the past.
Medication interactions: If you are taking metformin or any other medications that may interact with this drug.

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, including any drugs taken within the last 48 hours.
Injection into an artery or vein: Tell your doctor if you have difficulty urinating.
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, disclose 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 suspect you may be pregnant.

Interactions with Other Medications and Health Conditions:

This is not an exhaustive list of potential interactions. It is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist.
Ensure that it is safe to take this medication with all your other medications and health conditions. Do not 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 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 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 affect child development. Your child's thyroid function may need to be monitored for a period after the injection.
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.
* 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, 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 acute kidney injury or severe chronic kidney disease): Risk of lactic acidosis. Discontinue metformin at the time of or prior to the procedure and withhold for 48 hours after, reinitiating only after renal function is stable.
• Interleukin-2 (IL-2): Increased risk of delayed adverse reactions (e.g., fever, rash, flu-like symptoms, renal dysfunction) due to altered distribution and elimination of contrast media.

• Beta-blockers: Increased risk of severe anaphylactoid reactions and reduced efficacy of epinephrine in treating such reactions.
• Diuretics: May increase risk of contrast-induced nephropathy due to dehydration.
• Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides): Increased risk of renal impairment when co-administered, especially in patients with pre-existing renal dysfunction.

• Rash
• Urticaria (hives)
• Pruritus (itching)
• Bronchospasm (wheezing, shortness of breath)
• Angioedema (swelling of face, lips, tongue, throat)
• Hypotension (dizziness, lightheadedness)
• Nausea
• Vomiting
• Headache
• Flushing
• Injection site pain or swelling
• Delayed skin reactions (e.g., maculopapular rash, erythema multiforme)

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 potential benefits outweigh potential risks.

L2 (Safer). Minimal excretion into breast milk. Less than 0.5% of the administered dose is excreted into breast milk within 24 hours. Infant exposure is very low. Breastfeeding can generally continue without interruption.

Dosing is weight-based and requires careful calculation. Pediatric patients, especially neonates and infants, are more susceptible to fluid shifts and temperature changes. Ensure adequate hydration. Risk of contrast-induced nephropathy is generally lower than in adults but still a concern in those with pre-existing renal issues.

Increased risk of contrast-induced nephropathy due to age-related decline in renal function and higher prevalence of comorbidities (e.g., diabetes, hypertension, heart failure). Careful assessment of renal function and hydration status is crucial. Use the lowest effective dose.

• Always assess renal function (eGFR) before administering iodinated contrast, especially in patients with risk factors for kidney disease.
• Ensure adequate hydration before and after contrast administration to minimize the risk of contrast-induced nephropathy (CIN).
• Patients on metformin should have it held before and for 48 hours after contrast administration if there is any risk of acute kidney injury or severe chronic kidney disease, and restarted only after renal function is confirmed stable.
• Pre-medication with corticosteroids and/or antihistamines may be considered for patients with a history of prior contrast reactions or significant allergies, though nonionic contrast agents like Iohexol have a lower incidence of severe reactions.
• Monitor for delayed hypersensitivity reactions, which can occur hours to days after administration.
• Extravasation can occur; ensure proper IV access and monitor injection site. Manage extravasation according to institutional protocol (e.g., elevation, cold compress).

• Iopamidol (Isovue)
• Ioversol (Optiray)
• Iodixanol (Visipaque - iso-osmolar)
• Gadolinium-based contrast agents (for MRI, different mechanism)
• Barium sulfate (for GI tract imaging, different route/mechanism)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure your safety and the safety of others, never share your prescription medications with anyone, and do not take medications that have been prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or the medication's packaging. Instead, consult with your pharmacist to determine the best disposal method, as some communities have drug take-back programs in place.

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 reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance.

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 aid healthcare professionals in providing appropriate treatment.