Isovue-300 61% Inj, 500ml

Iopamidol is a non-ionic, low osmolar, water-soluble iodinated contrast medium. When injected intravascularly, it increases the attenuation of X-rays in the areas where it distributes, allowing for visualization of internal structures (e.g., blood vessels, kidneys, brain) on X-ray images (e.g., CT scans, angiography). The iodine atoms in the molecule are responsible for the X-ray attenuation.

Urgent Side Effects: Seek Medical Help Immediately

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 right away:

Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be fatal.
Kidney problems: Inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Thyroid problems: Weight changes, nervousness, excitability, restlessness, weakness, hair thinning, depression, eye or neck swelling, difficulty focusing, heat or cold intolerance, menstrual changes, shakiness, or sweating.
Cardiovascular issues: Chest pain or pressure, rapid or abnormal heartbeat.
Severe dizziness or fainting.
Shortness of breath.
Blood clots or circulatory problems: Swelling, warmth, numbness, color changes, or pain in a leg or arm.
Neurological problems: Weakness on one side of the body, speech or thinking difficulties, balance changes, drooping on one side of the face, or blurred vision.
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. 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.

Additional Side Effects (Injection into the Spine)

Seizures
Back pain
Stiff neck
Abnormal burning, numbness, or tingling sensations

Other Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you encounter any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Injection into the spine: Headache, upset stomach, vomiting, muscle pain
* All other injection products: Feeling of warmth, hot flashes, upset stomach

Reporting Side Effects

This is not an exhaustive list of potential side effects. If you have questions or concerns, 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 treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
If you are dehydrated, have been experiencing poor nutrition, or have recently used a laxative or diuretic (water pill) before starting this medication.
If you have a medical condition called homocystinuria.
If you have had a skin reaction to this medication or a similar medication in the past.
If you are currently taking metformin.

Additional Considerations for Injection Administered into the Spine:

If you have an active infection.
* If you are taking any medications that may increase the risk of seizures or have taken such a medication within the last 48 hours. There are numerous medications that can increase seizure risk, so it is crucial to consult with your doctor or pharmacist if you are unsure.

This list is not exhaustive, and it is vital to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.

Important Warnings and Precautions for Patients Taking This Medication

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial because combining this drug with certain procedures can increase the risk of blood clots, which may lead to heart attack and stroke, potentially resulting in fatal outcomes. If you have any questions or concerns, discuss them with your doctor.

To minimize the risk of tissue damage, it is vital to monitor the injection site for any signs of redness, burning, pain, swelling, blisters, skin sores, or fluid leakage. Immediately notify your nurse if you experience any of these symptoms, as they may indicate that the drug is leaking from the vein.

Regular blood tests may be necessary to ensure safe treatment. Consult with your doctor to determine the best course of action. Additionally, this medication may interfere with certain laboratory tests, so it is crucial to inform all your healthcare providers and laboratory personnel that you are taking this drug.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the potential benefits and risks of this medication with their doctor.

Special Considerations for Children

When administering this medication to children, exercise caution, as the risk of side effects may be higher in certain pediatric patients. In children under 3 years of age, the use of similar medications has been associated with low thyroid function, which can impact child development. Your child's doctor may recommend regular thyroid function tests for a period after the injection to monitor for potential effects. If you have any questions or concerns, consult with your child's doctor.

• 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 incidence of delayed adverse reactions (e.g., fever, rash, flu-like symptoms, oliguria, renal failure) to contrast media has been reported in patients receiving IL-2.

• Beta-blockers: May blunt the compensatory cardiovascular responses to anaphylaxis, making treatment of severe hypersensitivity reactions more difficult.
• 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.

• Rash
• Hives (urticaria)
• Itching (pruritus)
• Difficulty breathing (dyspnea)
• Wheezing
• Swelling of face, lips, tongue, or throat (angioedema)
• Nausea
• Vomiting
• Headache
• Dizziness
• Flushing
• Feeling of warmth
• Pain or swelling at injection site (extravasation)
• Signs of kidney injury (decreased urine output, swelling in legs/feet, fatigue)

Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus.

Minimal excretion into breast milk. 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.

Dosing is weight-based and procedure-specific. Pediatric patients, especially neonates and infants, may be more susceptible to fluid shifts and electrolyte imbalances. Careful monitoring of hydration status and renal function is crucial. Lower concentrations (e.g., Isovue-200) or lower doses may be preferred for some pediatric procedures.

Elderly patients are more likely to have pre-existing renal impairment, cardiovascular disease, or diabetes, which are risk factors for contrast-induced nephropathy and other adverse reactions. Careful assessment of renal function and hydration status is essential. Use the lowest effective dose.

• Always assess patient's renal function (eGFR) and allergy history prior to administration.
• Ensure adequate hydration before and after contrast administration, especially in patients at risk for contrast-induced nephropathy (CIN).
• Patients on metformin should have it withheld before and for 48 hours after contrast administration, with renal function re-evaluated before restarting.
• Be prepared to manage hypersensitivity reactions, from mild urticaria to severe anaphylaxis. Have resuscitation equipment and medications readily available.
• Non-ionic, low osmolar contrast agents like Iopamidol are generally associated with fewer adverse reactions compared to high osmolar agents.
• Extravasation can occur; monitor injection site closely. Management typically involves elevation, cold compress, and observation.

• Other iodinated contrast media (e.g., Iohexol, Ioversol, Iodixanol, Iopromide)
• Gadolinium-based contrast agents (for MRI)
• Ultrasound contrast agents
• Non-contrast imaging modalities (e.g., non-contrast CT, MRI, ultrasound)

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, and do not take medication prescribed for someone else. 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. Unless instructed otherwise, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper 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, 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.