Omnipaque 300mg/ml Inj, 30ml

Iohexol is a non-ionic, water-soluble, tri-iodinated benzoic acid derivative. When administered intravascularly, it increases the attenuation of X-rays in the areas where it distributes, allowing for visualization of blood vessels and organs during diagnostic imaging procedures (e.g., CT, angiography, urography). The iodine atoms absorb X-rays, creating 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 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, sensitivity to heat or cold, menstrual changes, shakiness, or excessive sweating.
Injection-Related Side Effects:
+ Chest pain or pressure, rapid or abnormal 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. Seek medical help immediately if you experience any of these symptoms.
Spinal Injection Side Effects: A burning, numbness, or tingling sensation that is not normal.
Liquid Form 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:
+ Dizziness (if given in an artery or vein)
+ Feeling of warmth
+ Changes in taste
+ Dizziness (if given into the spine)
+ Back pain
+ Neck pain
+ Stiff neck
Liquid Form 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 with 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.
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 medications 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.

Important Warnings:

Do not take this medication if you are pregnant or may be pregnant.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe treatment.
Do not initiate, stop, or modify the dosage 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 or concerns, 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 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 is stable.
• Interleukin-2 (IL-2): Increased risk of delayed, severe, or prolonged adverse reactions (e.g., flu-like symptoms, skin reactions, renal dysfunction).

• Beta-blockers: May blunt the compensatory cardiovascular responses to contrast media-induced hypotension or anaphylactoid reactions, making them more difficult to treat.
• 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.

• Signs of allergic reaction (hives, itching, rash, swelling of face/throat, difficulty breathing)
• Chest pain or discomfort
• Shortness of breath
• Dizziness or lightheadedness
• Nausea or vomiting
• Headache
• Pain or swelling at injection site (extravasation)
• Symptoms of contrast-induced nephropathy (decreased urine output, swelling, fatigue)

Iohexol is classified as Pregnancy Category B. Animal studies have shown no evidence of 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. Consider non-ionizing imaging modalities if possible.

Iohexol is minimally excreted into breast milk. The amount ingested by the infant is very small and absorption from the infant's GI tract is negligible. Generally considered compatible with breastfeeding. Some sources suggest temporary interruption of breastfeeding for 24 hours, but this is often not necessary based on current data.

Dosing is weight-based. Children, especially neonates and infants, are more susceptible to fluid shifts and temperature changes. Careful attention to hydration status and body temperature is crucial. Risk of contrast-induced nephropathy is generally lower than in adults but still present in at-risk children.

Elderly patients (over 65 years) are at increased risk for contrast-induced nephropathy, especially if they have pre-existing renal impairment, diabetes, heart failure, or are dehydrated. 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 at-risk patients (diabetes, pre-existing CKD, elderly).
• Ensure adequate hydration before and after the procedure to minimize the risk of contrast-induced nephropathy.
• Patients on metformin should have it withheld before and for 48 hours after contrast administration if there is any risk of renal impairment, and reinstituted only after renal function is confirmed stable.
• Be prepared to manage hypersensitivity reactions, from mild urticaria to severe anaphylaxis. Have resuscitation equipment and medications readily available.
• Extravasation can occur; monitor injection site for pain, swelling, or redness. Management typically involves elevation, cold compress, and observation.
• Non-ionic contrast agents like iohexol generally have a lower incidence of adverse reactions compared to older ionic agents.

• Other iodinated contrast media (e.g., Ioversol, Iopamidol, Iodixanol)
• Gadolinium-based contrast agents (for MRI)
• Ultrasound with or without contrast
• Non-contrast CT or MRI studies

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. 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 your pharmacist or healthcare provider. For guidance on the best disposal method, consult your pharmacist, who may also be aware of local drug take-back programs. Some medications may come with an additional 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.