Omnipaque 350mg/ml Inj, 100ml

Iohexol is a non-ionic, water-soluble, tri-iodinated benzoic acid derivative. It enhances the visibility of structures in diagnostic imaging by absorbing X-rays. When injected intravascularly, it distributes into the extracellular fluid space, providing contrast for blood vessels and tissues. The iodine atoms in the molecule are responsible for the X-ray attenuation.

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 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 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 poor nutrition: 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: If you have an infection or are taking medications that may increase the risk of seizures, or have taken such a medication in the last 48 hours, inform your doctor. Many medications 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: If you are menstruating, have a genital infection, or have or may have a growth in the reproductive tract, inform your doctor. Additionally, if you have had a curettage or conization procedure within the past 30 days, or if you have had a pregnancy terminated within the past 6 months, notify your doctor.

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. 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.
It is crucial to verify 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 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 (Arterial or Venous Administration)

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.

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.

Additionally, health problems like blood clots have occurred with this medication when used in conjunction with certain procedures, which can increase the risk of heart attack and stroke. If you have questions, consult your doctor.

Injection (Intraspinal Administration)

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)
• Interleukin-2 (IL-2) (increased risk of delayed adverse reactions)

• Beta-blockers (increased risk of anaphylactoid reactions, blunted response to epinephrine)
• Diuretics (increased risk of dehydration and contrast-induced nephropathy)
• Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin) (increased risk of renal impairment)
• Oral cholecystographic agents (may impair visualization)

• Hives
• Itching
• Rash
• Swelling of face, lips, tongue, or throat
• Difficulty breathing or wheezing
• Dizziness or lightheadedness
• Nausea
• Vomiting
• Headache
• Flushing
• Chest pain
• Abdominal pain
• Changes in urine output (decreased)

Iohexol is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus. Minimize fetal exposure by using the lowest effective dose.

Iohexol is excreted into breast milk in very small amounts (less than 0.5% of the administered dose). The amount absorbed by the infant is negligible. The American College of Radiology (ACR) and European Society of Urogenital Radiology (ESUR) 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 can be considered, but is generally not necessary.

Dosing must be carefully calculated based on weight and procedure. Children, especially neonates and infants, are more susceptible to fluid shifts and temperature changes. Use the lowest effective dose and ensure adequate hydration. Risk of thyroid dysfunction (hypothyroidism) in neonates and infants is a concern, especially in premature infants or those with underlying thyroid conditions; monitoring of thyroid function may be warranted.

Elderly patients are more likely to have impaired renal function, cardiovascular disease, and diabetes, increasing their risk for contrast-induced nephropathy and other adverse reactions. Careful assessment of renal function and hydration status is crucial. Use the lowest effective dose and ensure adequate hydration. Monitor closely for adverse effects.

• Always assess renal function (eGFR) before administering iodinated contrast, especially in patients with risk factors for CIN (e.g., pre-existing renal impairment, diabetes, dehydration, heart failure).
• Ensure adequate hydration before and after contrast administration, particularly in high-risk patients. Isotonic saline is generally preferred for prophylaxis against CIN.
• Patients on metformin should have it withheld at the time of or prior to the procedure and for 48 hours afterward, and restarted only after renal function has been re-evaluated and found to be normal, to prevent lactic acidosis.
• Be prepared for hypersensitivity reactions, ranging from mild (urticaria) to severe (anaphylaxis). Have emergency equipment and medications (epinephrine, antihistamines, corticosteroids) readily available.
• For patients with a history of previous contrast reactions, premedication with corticosteroids and antihistamines may be considered, though it does not guarantee prevention of a reaction.
• Iohexol is a non-ionic contrast agent, which generally has a lower incidence of adverse reactions compared to older ionic agents due to lower osmolality.

• Iopamidol (Isovue)
• Ioversol (Optiray)
• Iodixanol (Visipaque - iso-osmolar contrast agent, potentially lower risk of CIN in high-risk patients)
• Gadolinium-based contrast agents (for MRI, different mechanism, different risks)
• 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 promptly. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Additionally, some medications may have a separate patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, 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 to ensure prompt and effective treatment.