Isovue-300 61% Inj, 50ml

Iopamidol is a non-ionic, water-soluble, tri-iodinated benzoic acid derivative. When injected intravascularly, it increases the attenuation of X-rays in the areas of the body where it distributes. The iodine atoms in the molecule absorb X-rays, creating a contrast between the opacified structures (e.g., blood vessels, urinary tract) and surrounding tissues, allowing for visualization on radiographic images.

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, 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.
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 irregular heartbeat.
Severe dizziness or fainting: Sudden loss of balance or consciousness.
Respiratory problems: Shortness of breath.
Blood clots or circulatory issues: Swelling, warmth, numbness, color changes, or pain in a leg or arm.
Neurological problems: Weakness on one side of the body, difficulty speaking or thinking, balance changes, facial drooping, or blurred vision.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or other serious reactions, which can occur anywhere from 1 hour to several weeks after receiving the medication. These reactions can affect body organs and be life-threatening. 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)

If you receive this medication via spinal injection, you may also experience:

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

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you notice 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 and situations 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 any symptoms that occurred.
If you are dehydrated, have been experiencing poor nutrition, or have recently used a laxative or diuretic (water pill).
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 Administration (Intrathecal):

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 you determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Warnings and Cautions 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.

Be aware that this medication can cause tissue damage if it leaks from the vein during administration. Monitor the injection site closely and immediately report any signs of redness, burning, pain, swelling, blisters, skin sores, or fluid leakage to your nurse.

Regular blood tests may be necessary to monitor your condition. Consult with your doctor to determine the frequency of these tests.

This medication may interfere with certain laboratory tests, so it is vital 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 populations. 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 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 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 anaphylaxis, making treatment of severe hypersensitivity reactions more difficult.
• Diuretics: May increase the risk of contrast-induced nephropathy, especially in dehydrated patients.
• Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides): Concomitant use may increase the risk of contrast-induced nephropathy.

• Rash
• Hives (urticaria)
• Itching (pruritus)
• Swelling of face, lips, tongue, or throat (angioedema)
• Difficulty breathing (dyspnea, bronchospasm)
• Wheezing
• Cough
• Dizziness or lightheadedness
• Nausea
• Vomiting
• Headache
• Flushing
• Injection site pain or swelling
• Chest pain
• Palpitations
• Signs of kidney injury (decreased urine output, swelling)

Iopamidol is Pregnancy Category B. Animal reproduction studies have shown no evidence of fetal harm. 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. Fetal thyroid function should be monitored if exposure occurs.

Iopamidol is excreted into breast milk in small amounts. Due to poor oral absorption by the infant, systemic exposure is minimal. The American College of Radiology (ACR) and European Society of Urogenital Radiology (ESUR) generally consider iodinated contrast agents compatible with breastfeeding. A common recommendation is to consider temporarily interrupting breastfeeding for 12-24 hours after contrast administration, though this is often not strictly necessary.

Dosing is weight-based and procedure-dependent. Pediatric patients, especially neonates and infants, may be more susceptible to fluid shifts and adverse reactions. Careful attention to hydration status, dose calculation, and monitoring is crucial. Renal function should be assessed.

Elderly patients are at increased risk for contrast-induced nephropathy due to age-related decline in renal function, comorbidities (e.g., diabetes, hypertension), and polypharmacy. Careful assessment of renal function, hydration, and potential drug interactions is essential. Use the lowest effective dose and ensure adequate hydration.

• Always assess patient's renal function (Cr, eGFR) and allergy history prior to contrast administration.
• Ensure adequate hydration before and after the procedure, especially in patients at risk for contrast-induced nephropathy (CIN).
• For patients on Metformin, follow institutional guidelines for withholding and restarting the medication to prevent lactic acidosis. Typically, withhold at time of or prior to procedure and for 48 hours after, restarting only after renal function is stable.
• Be prepared for hypersensitivity reactions, ranging from mild (urticaria) to severe (anaphylaxis). Have emergency equipment and medications readily available.
• Extravasation can occur; monitor injection site closely. Manage with cold compresses and elevation.
• Non-ionic contrast agents like Iopamidol generally have a lower incidence of adverse reactions compared to older ionic agents.
• Consider premedication with corticosteroids and antihistamines for patients with a history of previous contrast reactions or significant allergies, as per institutional protocols.

• Other iodinated contrast media (e.g., Iohexol, Ioversol, Iodixanol, Iopromide)
• Gadolinium-based contrast agents (for MRI, different mechanism)
• Ultrasound (non-ionizing, no contrast or microbubble contrast)
• Non-contrast CT or MRI (when sufficient for diagnosis)

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; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. 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 come with 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred to ensure prompt and effective treatment.