Omnipaque 300mg/ml Inj, 50ml

Iohexol is a non-ionic, water-soluble, iodinated radiographic contrast medium. It enhances visualization of structures or fluids in the body by absorbing X-rays. The iodine atoms in the molecule absorb X-rays, creating a difference in density that is detectable by imaging equipment. It is distributed into the extracellular fluid space.

Important Side Effects to Report to Your Doctor 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, 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, fast heartbeat, or abnormal heartbeat.
+ Weakness on one side of the body, trouble speaking or thinking, change 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, change of color, 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:

Common side effects:
+ Upset stomach or vomiting
+ Headache
Injection-related side effects (if given in an artery or vein):
+ Dizziness
+ Feeling of warmth
+ Change 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:

Any allergies you have, including allergies to this drug, its components, or other medications, foods, or substances. 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 skin reaction to this medication or a similar drug in the past.
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 many 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 problems you have. 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 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 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, 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 acute kidney injury risk)
• Interleukin-2 (IL-2) (increased risk of delayed adverse reactions)
• Beta-blockers (increased risk of severe hypersensitivity reactions, reduced efficacy of epinephrine)

• Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin) (increased risk of CIN)
• Diuretics (increased risk of dehydration and CIN)

• Rash
• Hives (urticaria)
• Itching (pruritus)
• Swelling of face, lips, tongue, or throat (angioedema)
• Difficulty breathing (dyspnea, bronchospasm)
• Wheezing
• Cough
• Dizziness
• Lightheadedness
• Nausea
• Vomiting
• Headache
• Flushing
• Chest pain or discomfort
• Injection site pain or swelling

Category B. Studies in animals have shown no evidence of harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus. Consider non-iodinated imaging alternatives if possible.

L2 (Safer). Iohexol is excreted in breast milk in very small amounts. The amount absorbed by the infant is negligible. Generally considered safe for breastfeeding. However, some guidelines suggest temporary interruption of breastfeeding (e.g., 12-24 hours) as a precaution, though this is often not necessary.

Dosing is weight-based. Children, especially neonates and infants, are more susceptible to fluid and electrolyte imbalances and hypothermia. Careful monitoring of hydration status and body temperature is crucial. Increased risk of thyroid dysfunction in neonates/infants, especially premature infants, due to immature thyroid axis.

Increased risk of contrast-induced nephropathy (CIN) due to age-related decline in renal function. More susceptible to adverse reactions, including cardiovascular events. Careful assessment of renal function and hydration status is essential. Use lowest effective dose.

• Always assess renal function (eGFR) and allergy history before administering iodinated contrast media.
• Ensure adequate hydration before and after contrast administration, especially in patients at risk for CIN.
• Patients on metformin should have their renal function assessed. If eGFR < 30 mL/min/1.73m² or if acute kidney injury is anticipated, metformin should be withheld for 48 hours after contrast and reinstituted only after renal function is stable.
• Be prepared for immediate treatment of hypersensitivity reactions, including anaphylaxis. Have emergency medications (epinephrine, antihistamines, corticosteroids) readily available.
• Extravasation can occur; monitor injection site closely. If extravasation occurs, stop injection, elevate limb, apply cold compress, and monitor for skin integrity changes.
• Patients with a history of asthma or allergies are at increased risk for hypersensitivity reactions.
• Consider premedication with corticosteroids and antihistamines for patients with a history of moderate to severe contrast reactions.

• Other non-ionic iodinated contrast media (e.g., Ioversol, Iopamidol, Iodixanol)
• Gadolinium-based contrast agents (for MRI)
• Barium sulfate (for GI tract imaging)
• Ultrasound (non-ionizing imaging)
• Non-contrast CT or MRI (if diagnostic information can be obtained without contrast)

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 your pharmacist or healthcare provider. If you are unsure about the correct 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 have additional patient information leaflets available. Your pharmacist can provide more information on this. If you have any questions or concerns about your medication, it is recommended that you 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred, to ensure prompt and effective treatment.