Omnipaque 300mg/ml Inj, 500ml

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 where it is distributed, allowing for visualization of internal structures (e.g., blood vessels, urinary tract, brain, spinal cord) 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 experience 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 experience any of the following side effects or any other symptoms that bother you or do not go away, 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
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 about side effects, contact 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.
A history of skin reactions to this medication or similar drugs.
Current use of 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.
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 suspected or confirmed growth in the reproductive tract. Also, notify your doctor if you have undergone 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. Therefore, 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 with your doctor to ensure safe use and minimize potential interactions.

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 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 (if 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 an extended 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 occurred with this medication. Consult your doctor to discuss the risks. Additionally, health problems like blood clots have been reported with this medication when used in conjunction with certain procedures, which can increase the risk of heart attack and stroke. If you have questions, talk to your doctor.

Injection (if given into the spine)

This medication may increase the risk of seizures in some individuals, particularly 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): 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 is stable.
• Interleukin-2 (IL-2): Increased risk of delayed, severe, or prolonged adverse reactions (e.g., fever, rash, flu-like symptoms, renal dysfunction).

• Beta-blockers: May blunt the compensatory cardiovascular responses to contrast media-induced hypotension or anaphylaxis, making treatment more difficult.
• Diuretics: May increase the risk of contrast-induced nephropathy due to dehydration.
• Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin): Concomitant use may increase the risk of contrast-induced nephropathy.
• Oral cholecystographic agents: May interfere with the diagnostic efficacy of subsequent iodinated contrast media.

• Rash
• Urticaria (hives)
• Pruritus (itching)
• Dyspnea (shortness of breath)
• Wheezing
• Cough
• Angioedema (swelling of face, lips, tongue)
• Hypotension (low blood pressure)
• Tachycardia (rapid heart rate)
• Bradycardia (slow heart rate)
• Nausea
• Vomiting
• Headache
• Dizziness
• Seizures (rare, especially with intrathecal use)
• Decreased urine output (sign of CIN)
• Flushing
• Warm sensation

Iohexol is classified as Pregnancy Category B. Studies in animals have shown no evidence of impaired fertility or harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus.

Iohexol is excreted into human breast milk in small amounts. However, absorption from the infant's gastrointestinal tract is minimal. The American College of Radiology (ACR) and European Society of Urogenital Radiology (ESUR) generally state that breastfeeding can continue without interruption after administration of iodinated contrast media. If concerns exist, a temporary interruption of breastfeeding for 12-24 hours may be considered, with milk expressed and discarded during this period.

Dosing is weight-based and varies significantly by procedure. Careful attention to hydration is crucial to prevent contrast-induced nephropathy. Pediatric patients, especially neonates and infants, may be more susceptible to fluid shifts and electrolyte imbalances. Lower concentrations and volumes should be used when clinically appropriate.

Elderly patients are at increased risk for contrast-induced nephropathy, especially those with pre-existing renal impairment, diabetes, or cardiovascular disease. Close monitoring of renal function before and after the procedure, and ensuring adequate hydration, are essential. Lower doses or alternative imaging modalities should be considered in high-risk individuals.

• Always assess renal function (eGFR) before administering iodinated contrast, especially in patients with risk factors for CIN.
• Ensure adequate hydration before and after contrast administration to minimize the risk of CIN.
• Pre-medication with corticosteroids and/or antihistamines may be considered for patients with a history of moderate to severe allergic reactions to contrast media, though it does not guarantee prevention.
• Warm the contrast medium to body temperature before injection to reduce viscosity and improve patient comfort.
• Monitor patients closely for immediate and delayed hypersensitivity reactions for at least 30-60 minutes post-injection.
• For patients on metformin, follow institutional guidelines regarding withholding and reinitiating the drug around contrast administration to prevent lactic acidosis.
• Iohexol is generally considered safe for intrathecal use (e.g., myelography, CT cisternography) due to its low neurotoxicity, but specific concentrations and volumes must be strictly adhered to for these indications.

• Other non-ionic iodinated contrast media (e.g., Ioversol, Iopamidol, Iopromide)
• Ionic iodinated contrast media (less commonly used due to higher osmolality and side effect profile)
• Gadolinium-based contrast agents (for MRI, different mechanism of action)
• Barium sulfate (for GI tract imaging)
• Ultrasound (non-ionizing imaging modality)
• Non-contrast CT or MRI (when contrast is not essential or contraindicated)

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. 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 information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate treatment.