Isovue-370 76% Inj, 50ml
WARNING: Some products must not be given into the spine. Very bad and sometimes deadly health problems have happened when these products were given into the spine. This includes coma, heart attack, kidney failure, paralysis, seizures, high body temperature, a muscle problem called rhabdomyolysis, or brain problems like bleeding or swelling. Talk with the doctor. @ COMMON USES: It is used before a CT scan or other test.
Drug Class
Diagnostic agent, Radiographic contrast media
Pharmacologic Class
Non-ionic iodinated contrast medium
Pregnancy Category
Category B
FDA Approved
Jun 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Iopamidol is a special dye that doctors inject into your body, usually into a vein or artery, to help make certain parts of your body, like blood vessels or kidneys, show up more clearly on X-ray pictures (like CT scans). This helps doctors see if there are any problems inside your body.
How to Use This Medicine
Taking Your Medication Correctly
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully read all the information provided to you and follow the instructions closely.
Before receiving this medication, it is essential to be properly hydrated. Consult with your doctor to determine if you need to drink additional fluids before administration.
After receiving this medication, drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. In some cases, other medications may be administered before this drug to help minimize potential side effects.
Storage and Disposal
This injection will be administered in a healthcare setting, and you will not need to store it at home.
Missed Dose
Since this medication is given in a healthcare setting, you will not need to worry about missing a dose. The healthcare provider will administer the medication as scheduled.
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully read all the information provided to you and follow the instructions closely.
Before receiving this medication, it is essential to be properly hydrated. Consult with your doctor to determine if you need to drink additional fluids before administration.
After receiving this medication, drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. In some cases, other medications may be administered before this drug to help minimize potential side effects.
Storage and Disposal
This injection will be administered in a healthcare setting, and you will not need to store it at home.
Missed Dose
Since this medication is given in a healthcare setting, you will not need to worry about missing a dose. The healthcare provider will administer the medication as scheduled.
Lifestyle & Tips
- Drink plenty of fluids before and after the procedure, especially if you have kidney problems, to help flush the dye out of your body.
- Inform your doctor about all medications you are taking, especially for diabetes (like metformin) or kidney problems.
- Inform your doctor about any allergies, especially to iodine or previous contrast dyes.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable based on procedure and patient weight. Typical doses range from 20 mL to 150 mL (or more for specific procedures) of Isovue-370 (370 mg I/mL) administered intravenously or intra-arterially.
Dose Range:
20 - 200 mg
Condition-Specific Dosing:
CT_Angiography:
50-150 mL IV at 3-7 mL/sec
Urography:
50-100 mL IV
Arteriography:
20-100 mL intra-arterially depending on vessel
Pediatric Dosing
Neonatal:
Dosing is weight-based and procedure-specific. Generally 1-3 mL/kg, not to exceed 4 mL/kg or 150 mL total.
Infant:
Dosing is weight-based and procedure-specific. Generally 1-3 mL/kg, not to exceed 4 mL/kg or 150 mL total.
Child:
Dosing is weight-based and procedure-specific. Generally 1-3 mL/kg, not to exceed 4 mL/kg or 150 mL total.
Adolescent:
Dosing is weight-based and procedure-specific. Generally 1-3 mL/kg, not to exceed 4 mL/kg or 150 mL total.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required, but hydration is recommended.
Moderate:
Use with caution. Consider lower doses, extended intervals, and adequate hydration. Risk of contrast-induced nephropathy (CIN) increases.
Severe:
Use with extreme caution. Avoid if possible. If necessary, consider lowest effective dose and ensure adequate hydration. High risk of CIN.
Dialysis:
Can be administered to patients on dialysis. Dialysis can remove iopamidol, so administration may be timed relative to dialysis sessions if rapid removal is desired. No specific dose adjustment for patients already on chronic dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required.
Pharmacology
Mechanism of Action
Iopamidol is a non-ionic, water-soluble, tri-iodinated benzoic acid derivative. When injected intravascularly, the iodine atoms within the molecule absorb X-rays, creating a contrast between the opacified structures (e.g., blood vessels, urinary tract) and surrounding tissues. This allows for visualization of anatomical structures and pathological conditions during diagnostic imaging procedures.
Pharmacokinetics
Absorption:
Bioavailability:
100% (following intravenous administration)
Tmax:
Immediate (following rapid IV bolus)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.16 L/kg (similar to extracellular fluid volume)
ProteinBinding:
< 2% (very low)
CnssPenetration:
Limited (does not cross intact blood-brain barrier)
Elimination:
HalfLife:
Approximately 2 hours (in subjects with normal renal function)
Clearance:
Primarily renal clearance, approximately 100 mL/min (similar to GFR)
ExcretionRoute:
Renal (glomerular filtration)
Unchanged:
> 95% (excreted unchanged in urine)
Pharmacodynamics
OnsetOfAction:
Immediate (upon injection)
PeakEffect:
Immediate (upon injection, then rapid distribution)
DurationOfAction:
Minutes to hours, depending on blood flow, renal function, and type of procedure (e.g., vascular opacification lasts minutes, urinary tract opacification lasts hours).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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, 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.
Kidney problems: Inability to pass urine, changes in urine output, blood in the urine, or significant weight gain.
Thyroid problems: Weight changes, 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.
Cardiovascular issues: Chest pain or pressure, rapid heartbeat, or abnormal heartbeat.
Severe dizziness or fainting: Sudden dizziness or loss of 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, trouble speaking or thinking, 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. 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.
Additional Side Effects of Spinal Injection:
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 are bothered by any of the following side effects or if they persist, contact your doctor:
Spinal injection: Headache, upset stomach, vomiting, muscle pain
* 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 about side effects, 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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, 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.
Kidney problems: Inability to pass urine, changes in urine output, blood in the urine, or significant weight gain.
Thyroid problems: Weight changes, 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.
Cardiovascular issues: Chest pain or pressure, rapid heartbeat, or abnormal heartbeat.
Severe dizziness or fainting: Sudden dizziness or loss of 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, trouble speaking or thinking, 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. 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.
Additional Side Effects of Spinal Injection:
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 are bothered by any of the following side effects or if they persist, contact your doctor:
Spinal injection: Headache, upset stomach, vomiting, muscle pain
* 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 about side effects, 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.
Seek Immediate Medical Attention If You Experience:
- Difficulty breathing, wheezing, or tightness in the chest
- Hives, rash, or severe itching
- Swelling of the face, lips, tongue, or throat
- Dizziness or lightheadedness
- Sudden weakness or feeling faint
- Severe pain, swelling, or redness at the injection site
- Nausea or vomiting that is severe or persistent
Before Using This Medicine
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:
Allergies: If you are allergic to this medication, any of its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
Dehydration and electrolyte imbalance: If you are dehydrated, have been eating poorly, or have recently used laxatives or diuretics.
Homocystinuria: If you have been diagnosed with this health condition.
Previous skin reactions: If you have experienced a skin reaction to this medication or similar drugs in the past.
Concurrent medications: If you are taking metformin or any other medications that may interact with this drug.
Additional Considerations for Injection Administration (Intrathecal):
Infections: If you have an active infection, inform your doctor before receiving the injection.
Seizure risk: If you are taking medications that may increase the risk of seizures or have taken such medications within the last 48 hours. Consult your doctor or pharmacist if you are unsure about potential interactions.
To ensure your safety, it is crucial to disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter medications
Natural products and vitamins
Existing health problems
Verify that it is safe to take this medication with your current medications and health conditions. Do not initiate, discontinue, or adjust the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:
Allergies: If you are allergic to this medication, any of its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
Dehydration and electrolyte imbalance: If you are dehydrated, have been eating poorly, or have recently used laxatives or diuretics.
Homocystinuria: If you have been diagnosed with this health condition.
Previous skin reactions: If you have experienced a skin reaction to this medication or similar drugs in the past.
Concurrent medications: If you are taking metformin or any other medications that may interact with this drug.
Additional Considerations for Injection Administration (Intrathecal):
Infections: If you have an active infection, inform your doctor before receiving the injection.
Seizure risk: If you are taking medications that may increase the risk of seizures or have taken such medications within the last 48 hours. Consult your doctor or pharmacist if you are unsure about potential interactions.
To ensure your safety, it is crucial to disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter medications
Natural products and vitamins
Existing health problems
Verify that it is safe to take this medication with your current medications and health conditions. Do not initiate, discontinue, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
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 this drug can increase the risk of blood clots when used in conjunction with certain procedures, which may lead to potentially life-threatening conditions such as heart attack and stroke. 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 can indicate that the drug is leaking from the vein.
Regular blood tests may be necessary to monitor your condition while taking this medication. Consult with your doctor to determine the best course of action. Additionally, this drug may interfere with certain laboratory tests, so it is crucial to inform all your healthcare providers and lab personnel that you are taking this medication.
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. Children under the age of 3 may be at risk of developing low thyroid function, which can impact their development. Your child's doctor may recommend regular thyroid function tests after the injection to monitor for any potential issues. If you have any questions or concerns, consult with your child's doctor.
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 this drug can increase the risk of blood clots when used in conjunction with certain procedures, which may lead to potentially life-threatening conditions such as heart attack and stroke. 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 can indicate that the drug is leaking from the vein.
Regular blood tests may be necessary to monitor your condition while taking this medication. Consult with your doctor to determine the best course of action. Additionally, this drug may interfere with certain laboratory tests, so it is crucial to inform all your healthcare providers and lab personnel that you are taking this medication.
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. Children under the age of 3 may be at risk of developing low thyroid function, which can impact their development. Your child's doctor may recommend regular thyroid function tests after the injection to monitor for any potential issues. If you have any questions or concerns, consult with your child's doctor.
Overdose Information
Overdose Symptoms:
- Fluid overload (pulmonary edema)
- Electrolyte imbalance
- Acute renal failure
- Cardiovascular collapse
What to Do:
Treatment is supportive. Monitor vital signs, fluid and electrolyte balance. Hemodialysis can be used to remove iopamidol from the body if necessary, especially in patients with renal failure. Call 1-800-222-1222 (Poison Control) for specific guidance.
Drug Interactions
Major Interactions
- Metformin (in patients with renal impairment or acute kidney injury): Increased risk of lactic acidosis. Metformin should be withheld at the time of or prior to the contrast procedure and for 48 hours afterward, and reinstituted only after renal function has been re-evaluated and found to be normal.
- Interleukin-2 (IL-2): Increased risk of delayed, severe, or protracted contrast reactions (e.g., fever, rash, flu-like symptoms, hypotension, oliguria).
Moderate Interactions
- Beta-blockers: May blunt the compensatory cardiovascular responses to contrast media-induced hypotension or anaphylaxis, making treatment 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.
Confidence Interactions
Monitoring
Baseline Monitoring
Renal function (e.g., serum creatinine, eGFR)
Rationale: To assess risk of contrast-induced nephropathy (CIN) and guide metformin management.
Timing: Prior to administration, especially in patients with risk factors for CIN.
Allergy history (especially to contrast media or iodine)
Rationale: To identify patients at increased risk for hypersensitivity reactions and determine need for premedication.
Timing: Prior to administration.
Hydration status
Rationale: Adequate hydration helps reduce the risk of CIN.
Timing: Prior to administration.
Routine Monitoring
Vital signs (blood pressure, heart rate, respiratory rate)
Frequency: Before, during, and immediately after injection, then periodically for 30-60 minutes post-injection.
Target: Within patient's normal range
Action Threshold: Significant deviations (e.g., hypotension, bradycardia, tachycardia, respiratory distress) require immediate intervention.
Signs/symptoms of hypersensitivity reaction (e.g., rash, urticaria, dyspnea, angioedema, hypotension)
Frequency: Continuously during and for at least 30-60 minutes post-injection.
Target: Absence of symptoms
Action Threshold: Any signs of reaction require immediate medical attention and treatment.
Injection site for extravasation
Frequency: During and immediately after injection.
Target: Absence of swelling, pain, redness
Action Threshold: Signs of extravasation require immediate cessation of injection and local management.
Symptom Monitoring
- Rash
- Urticaria (hives)
- Pruritus (itching)
- Dyspnea (shortness of breath)
- Wheezing
- Cough
- Angioedema (swelling of face, lips, tongue)
- Hypotension
- Bradycardia
- Tachycardia
- Nausea
- Vomiting
- Headache
- Dizziness
- Flushing
- Chills
- Fever (especially delayed reactions)
- Pain or swelling at injection site
Special Patient Groups
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. Use during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus. The fetus is exposed to iodine, which could potentially affect thyroid function.
Trimester-Specific Risks:
First Trimester:
Potential theoretical risk of thyroid effects due to iodine exposure, though unlikely with single dose.
Second Trimester:
Potential theoretical risk of thyroid effects due to iodine exposure, though unlikely with single dose.
Third Trimester:
Potential theoretical risk of thyroid effects due to iodine exposure, though unlikely with single dose. Fetal thyroid function should be monitored if exposure occurs.
Lactation
Iopamidol is excreted in human milk in very small amounts (less than 0.5% of the administered dose). Due to minimal absorption from the infant's gastrointestinal tract, adverse effects on the breastfed infant are considered unlikely. Most guidelines suggest that breastfeeding can be continued without interruption or with a brief interruption (e.g., 12-24 hours) if the mother prefers.
Infant Risk:
L2 (Safer - limited data suggest no increase in adverse effects)
Pediatric Use
Dosing is weight-based and procedure-specific. Pediatric patients, especially neonates and infants, may be more susceptible to fluid shifts, electrolyte imbalances, and temperature changes. Careful monitoring of hydration status and vital signs is crucial. Risk of contrast-induced nephropathy should be considered, especially in those with pre-existing renal impairment.
Geriatric Use
Elderly patients are more likely to have pre-existing renal impairment, cardiovascular disease, and diabetes, increasing their risk for adverse reactions such as contrast-induced nephropathy and hypersensitivity reactions. Careful assessment of renal function and hydration status is essential. Use the lowest effective dose.
Clinical Information
Clinical Pearls
- Always ensure adequate hydration before and after contrast administration, especially in patients at risk for contrast-induced nephropathy.
- Premedication with corticosteroids and/or antihistamines may be considered for patients with a history of prior contrast reaction or other significant allergies, though it does not guarantee prevention of reactions.
- Have emergency equipment and medications (e.g., epinephrine, antihistamines, corticosteroids, oxygen) readily available for immediate treatment of hypersensitivity reactions.
- Carefully check patient's medication list for metformin and manage according to institutional protocols.
- Educate patients about potential delayed reactions (e.g., skin rash, flu-like symptoms) that can occur hours to days after administration.
Alternative Therapies
- Iohexol (Omnipaque)
- Iopromide (Ultravist)
- Ioversol (Optiray)
- Iodixanol (Visipaque - iso-osmolar contrast media, potentially lower risk of CIN in high-risk patients)
Cost & Coverage
Average Cost:
Varies widely by volume and supplier, typically $50 - $300+ per 50mL vial per 50mL vial
Generic Available:
Yes
Insurance Coverage:
Generally covered by medical insurance for diagnostic imaging procedures, often under medical benefit rather than pharmacy benefit.
General Drug Facts
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 ingestion.