Omnipaque 350mg/ml Inj, 500ml

Iohexol is a non-ionic, water-soluble, iodinated radiographic contrast medium. 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.

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), and other serious reactions. Sometimes, these reactions can affect internal organs and be fatal. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin.
+ Red or irritated eyes.
+ Sores in your 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 Side Effects

Most people do not experience significant side effects, but some may occur. If you are bothered by 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 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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. 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 drugs 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 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 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.
Always check with your doctor before starting, stopping, or changing the dose of any medication to ensure safe treatment.

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, 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 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 a 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.

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 anticipated renal impairment, due to 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 is stable.)
• Interleukin-2 (increased incidence of delayed adverse reactions including fever, flu-like symptoms, and renal dysfunction)

• Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin, amphotericin B): Increased risk of contrast-induced nephropathy (CIN).
• Beta-blockers: May blunt the hemodynamic response to contrast-induced anaphylaxis.
• Diuretics: May increase risk of CIN due to dehydration.

• Oral cholecystographic agents: May interfere with visualization due to residual contrast in the biliary system.
• Anticoagulants (e.g., warfarin, heparin): Theoretical increased risk of bleeding with invasive angiographic procedures, though not a direct drug interaction with iohexol itself.

• Nausea
• Vomiting
• Headache
• Dizziness
• Warm sensation
• Flushing
• Metallic taste
• Hives
• Itching
• Rash
• Difficulty breathing
• Wheezing
• Swelling of face/throat
• Chest pain
• Palpitations
• Lightheadedness
• Fainting
• Injection site pain or swelling
• Signs of kidney problems (decreased urine output, swelling in legs/feet, fatigue)

Category B. Animal reproduction studies have shown no evidence of fetal harm. However, there are no adequate and well-controlled studies in pregnant women. Iohexol should be used during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus.

Iohexol is excreted in human milk in very small amounts (less than 0.5% of the administered dose). The amount absorbed by the infant is negligible. Generally considered safe for breastfeeding. However, some sources suggest temporary interruption of breastfeeding for 24 hours after administration to minimize infant exposure, though this is often not necessary.

Dosing is weight-based and procedure-dependent. Careful attention to hydration is crucial to prevent contrast-induced nephropathy. Infants and young children may be more susceptible to fluid shifts and temperature changes.

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

• Always assess renal function (eGFR) before administering iohexol, especially in patients with risk factors for CIN.
• Ensure adequate hydration before and after contrast administration to minimize the risk of CIN.
• For patients with a history of previous contrast reactions, consider pre-medication with corticosteroids and/or antihistamines, or use an alternative imaging modality.
• Warm the contrast medium to body temperature before injection to reduce viscosity and improve patient comfort.
• Monitor for extravasation at the injection site, especially with power injections, as it can cause local tissue injury.
• Educate patients about potential delayed hypersensitivity reactions that can occur hours to days after the procedure.
• In patients on metformin, ensure appropriate withholding and re-initiation protocols are followed to prevent lactic acidosis.

• Other non-ionic iodinated contrast media (e.g., Iopamidol, Ioversol, Iodixanol)
• Ionic iodinated contrast media (less common due to higher osmolarity and adverse event rates)
• Gadolinium-based contrast agents (for MRI, different mechanism and indications)
• Non-contrast imaging modalities (e.g., ultrasound, non-contrast CT, non-contrast 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 someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

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

Some medications may come with an additional patient information leaflet; check with your pharmacist to determine if this applies to your prescription. If you have any questions or concerns about your medication, it is important 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 critical information, including the name of the medication taken, the amount, and the time it was taken, to ensure prompt and effective treatment.