Iopamidol 51% Sdv Inj, 10ml

Iopamidol is a non-ionic, low-osmolar iodinated contrast medium. When injected intravascularly, the iodine atoms within the molecule absorb X-rays, creating a temporary difference in radiographic density between the blood vessels/organs and surrounding tissues. This allows for enhanced visualization of vascular structures and specific organs (e.g., kidneys, bladder) during diagnostic imaging procedures such as X-ray, CT, and angiography.

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, 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, feelings of nervousness, excitability, restlessness, or weakness, hair thinning, depression, eye or neck swelling, difficulty focusing, sensitivity to heat or cold, 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, difficulty speaking or thinking, balance changes, drooping on one side of the face, 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 immediate medical help 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 sensations: Burning, numbness, or tingling feelings.

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you are concerned about any of the following side effects or if they persist, contact your doctor:

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 list is not exhaustive. 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:

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.
If you are dehydrated, have been experiencing poor nutrition, or have recently used a laxative or diuretic.
A medical condition called homocystinuria.
Any previous skin reactions to this medication or similar medications.
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. Please consult your doctor or pharmacist if you are unsure, as numerous medications can have this effect.

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. They will help determine the safety of taking this medication in conjunction with your other treatments and health status. 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.

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 medication 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 lab 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 to make an informed decision.

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. Children under the age of 3 are at a higher risk of developing low thyroid function, which can impact their development. As a precaution, your child's thyroid function may need to be monitored for an extended period after receiving the injection. If you have any concerns or questions, consult with your doctor.

• Metformin (in patients with acute or chronic renal impairment, or conditions predisposing to lactic acidosis; should be withheld at the time of or prior to the procedure and for 48 hours afterward, and reinstituted only after renal function is stable)
• Certain beta-blockers (increased risk of severe hypersensitivity reactions, especially in patients with pheochromocytoma or severe cardiovascular disease)

• Interleukin-2 (IL-2) (increased risk of delayed, severe, and prolonged contrast reactions, including fever, rash, flu-like symptoms, and renal dysfunction)
• Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin) (concurrent use may increase the risk of contrast-induced nephropathy, especially in at-risk patients)

• Diuretics (may increase risk of dehydration and subsequent CIN, especially loop diuretics)
• Oral cholecystographic agents (may interfere with visualization if administered prior to Iopamidol for other studies)
• Other drugs affecting renal function (e.g., ACE inhibitors, ARBs) (may increase risk of CIN in susceptible patients)

• None consistently reported as minor interactions with clinical significance for Iopamidol.

• Hives (urticaria)
• Itching (pruritus)
• Rash
• Swelling of face, lips, tongue, or throat (angioedema)
• Difficulty breathing or wheezing (bronchospasm)
• Dizziness or lightheadedness (hypotension)
• Nausea
• Vomiting
• Headache
• Warm sensation or flushing
• Pain or swelling at injection site
• Signs of kidney problems (e.g., decreased urine output, swelling in legs/feet, fatigue) in the days following the procedure

Iopamidol 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. It should be used during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus. Non-contrast imaging modalities should be considered first.

Iopamidol is excreted in human milk in very small amounts. The American College of Radiology (ACR) Manual on Contrast Media states that the amount of contrast medium excreted into breast milk is very small and that absorption from the infant's gastrointestinal tract is negligible. Therefore, it is generally considered safe for breastfeeding to continue without interruption. However, some sources suggest a temporary interruption (e.g., 12-24 hours) as a precaution, though this is often not necessary.

Dosing is weight-based and procedure-specific. Pediatric patients, especially neonates and infants, may be more susceptible to fluid shifts and adverse reactions. Careful attention to hydration, dose calculation, and monitoring for adverse effects (including extravasation) is crucial. Risk of transient hypothyroidism in neonates/infants due to free iodide.

Elderly patients are at increased risk for contrast-induced nephropathy (CIN) due to age-related decline in renal function, comorbidities (e.g., diabetes, heart failure), and polypharmacy. Careful assessment of renal function, adequate hydration, and use of the lowest effective dose are particularly important. Increased risk of cardiovascular events and hypersensitivity reactions.

• Always assess renal function (eGFR) before administering Iopamidol, especially in patients with risk factors for CIN.
• Ensure adequate hydration before and after contrast administration, particularly in at-risk patients, to minimize the risk of CIN.
• Strictly adhere to guidelines for withholding metformin in patients with renal impairment or those at risk for lactic acidosis.
• Obtain a thorough allergy history, including prior reactions to contrast media, and have resuscitation equipment and medications readily available.
• Monitor patients closely for signs of hypersensitivity reactions during and for at least 30-60 minutes after injection.
• Be vigilant for extravasation at the injection site, especially with power injections, and manage promptly if it occurs.
• Iopamidol is non-ionic and low-osmolar, which generally leads to fewer adverse reactions compared to older high-osmolar ionic contrast agents.

• Magnetic Resonance Imaging (MRI) (without gadolinium contrast)
• Ultrasound
• Non-contrast Computed Tomography (CT)
• Endoscopy (for gastrointestinal imaging)
• Nuclear medicine scans

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, 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 to do so by a healthcare professional, 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, who can also inform you about potential drug take-back programs in your area. 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 emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of the incident.