Isovue-370 76% Inj, 200ml
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, Contrast Media
Pharmacologic Class
Iodinated Contrast Media, Non-ionic
Pregnancy Category
Category B
FDA Approved
May 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medicine is a special dye that helps doctors see your organs and blood vessels more clearly on X-ray pictures, like CT scans or angiograms. It helps highlight areas that might be hard to see otherwise, allowing for better diagnosis.
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 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 side effects.
Storing and Disposing of Your Medication
This injection will be administered in a healthcare setting, and you will not need to store it at home.
What to Do If You Miss a 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 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 side effects.
Storing and Disposing of Your Medication
This injection will be administered in a healthcare setting, and you will not need to store it at home.
What to Do If You Miss a 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
- Stay well-hydrated before and after the procedure, especially if you have kidney problems, as this helps your body clear the dye.
- Inform your doctor about all your medications, allergies (especially to contrast media, iodine, or shellfish), and medical conditions (e.g., kidney disease, diabetes, thyroid problems, asthma, heart conditions) before the procedure.
- Follow all instructions regarding fasting or medication adjustments (e.g., metformin) before the procedure.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable by procedure and patient weight. Typical single injection ranges from 20 mL to 150 mL.
Dose Range:
20 - 200 mg
Condition-Specific Dosing:
Cerebral Angiography:
5-10 mL per injection, total up to 100 mL
Peripheral Angiography:
20-100 mL per injection site, total up to 250 mL
CT Scan (Head/Body):
50-150 mL as a bolus or infusion
Urography:
50-100 mL as a bolus or infusion
Coronary Angiography:
3-10 mL per injection, total up to 250 mL
Pediatric Dosing
Neonatal:
Dosing is weight-based (e.g., 1-3 mL/kg) and procedure-specific. Max total dose often limited (e.g., 4 mL/kg or 100 mL total).
Infant:
Dosing is weight-based (e.g., 1-3 mL/kg) and procedure-specific. Max total dose often limited (e.g., 4 mL/kg or 100 mL total).
Child:
Dosing is weight-based (e.g., 1-3 mL/kg) and procedure-specific. Max total dose often limited (e.g., 4 mL/kg or 100 mL total).
Adolescent:
Dosing is weight-based (e.g., 1-3 mL/kg) and procedure-specific. Max total dose often limited (e.g., 4 mL/kg or 100 mL total).
Dose Adjustments
Renal Impairment:
Mild:
Increased risk of Contrast-Induced Nephropathy (CIN). Ensure adequate hydration. No specific dose adjustment, but careful risk-benefit assessment.
Moderate:
Increased risk of CIN. Ensure adequate hydration. No specific dose adjustment, but careful risk-benefit assessment. Avoid repeat studies within 48-72 hours.
Severe:
High risk of CIN. Ensure adequate hydration. No specific dose adjustment, but careful risk-benefit assessment. Consider alternative imaging. Avoid repeat studies within 48-72 hours.
Dialysis:
Can be dialyzed. Administer prior to dialysis session if possible. No specific dose adjustment, but careful consideration of fluid balance.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
Pharmacology
Mechanism of Action
Iopamidol is a water-soluble, non-ionic, low-osmolar iodinated contrast medium. It enhances the visibility of structures during X-ray procedures by attenuating X-rays. 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.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (after IV bolus)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.16 L/kg (distributes into extracellular fluid)
ProteinBinding:
<2%
CnssPenetration:
Limited (does not cross intact blood-brain barrier)
Elimination:
HalfLife:
Approximately 2 hours (in patients with normal renal function)
Clearance:
Primarily renal (glomerular filtration)
ExcretionRoute:
Urine (primarily), small amount in feces
Unchanged:
>90% excreted unchanged in urine within 24 hours
Pharmacodynamics
OnsetOfAction:
Immediate (upon injection)
PeakEffect:
Immediate (during injection and circulation through target vessel/organ)
DurationOfAction:
Varies by procedure and organ system; typically minutes to hours depending on blood flow and renal excretion
Safety & Warnings
Side Effects
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, redness, swelling, blistering, 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 irregular 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, 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 this medication. These reactions can affect internal 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 sensations: Burning, numbness, or tingling.
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, or muscle pain.
* All other injection products: Feeling of warmth, hot flashes, or 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, 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, redness, swelling, blistering, 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 irregular 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, 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 this medication. These reactions can affect internal 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 sensations: Burning, numbness, or tingling.
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, or muscle pain.
* All other injection products: Feeling of warmth, hot flashes, or 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:
- Itching, rash, hives, or swelling (especially of the face, lips, or throat) â signs of an allergic reaction.
- Difficulty breathing, wheezing, or tightness in the chest.
- Dizziness, lightheadedness, or fainting.
- Severe pain, swelling, or redness at the injection site.
- Nausea, vomiting, or unusual taste in the mouth.
- Any new or worsening symptoms after the procedure, especially decreased urination or swelling in the legs/feet (which could indicate kidney issues).
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 before starting this medication:
Any allergies you have, including allergies to this drug, its components, or other medications, foods, or 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 drug in the past.
If you are currently taking metformin.
Additional Considerations for Injection Administration (Spinal Injection):
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 inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. This will help ensure your safety while taking this medication. Never start, stop, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following conditions and situations before starting this medication:
Any allergies you have, including allergies to this drug, its components, or other medications, foods, or 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 drug in the past.
If you are currently taking metformin.
Additional Considerations for Injection Administration (Spinal Injection):
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 inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. This will help ensure your safety while taking this medication. Never start, stop, or modify the dosage of any medication without first 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 combining this medication 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 laboratory 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 populations. Children under the age of 3 may be at 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 questions or concerns, consult with your 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 combining this medication 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 laboratory 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 populations. Children under the age of 3 may be at 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 questions or concerns, consult with your doctor.
Overdose Information
Overdose Symptoms:
- Exaggerated side effects such as severe allergic reactions (anaphylaxis), cardiovascular collapse, acute renal failure, or fluid overload (especially in patients with heart failure).
What to Do:
Call 1-800-222-1222 (Poison Control). Treatment is supportive, focusing on maintaining vital functions, managing fluid and electrolyte balance, and treating specific symptoms. Hemodialysis can remove iopamidol from the body.
Drug Interactions
Major Interactions
- Metformin (risk of lactic acidosis in patients with acute kidney injury or severe chronic kidney disease)
- Beta-blockers (may blunt response to epinephrine in case of severe allergic reaction)
- Interleukin-2 (IL-2) (increased risk of delayed, severe reactions)
Moderate Interactions
- Diuretics (may increase risk of CIN due to dehydration)
- Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides - additive risk of CIN)
Monitoring
Baseline Monitoring
Renal function (Serum Creatinine, eGFR)
Rationale: To assess risk of Contrast-Induced Nephropathy (CIN).
Timing: Prior to contrast administration (within 30 days, ideally within 7 days for high-risk patients).
Allergy history (especially to contrast media, iodine, or other drugs)
Rationale: To identify patients at increased risk of hypersensitivity reactions.
Timing: Prior to contrast administration.
Thyroid function (TSH, T4)
Rationale: To identify patients at risk of thyroid storm or hyperthyroidism exacerbation (especially in patients with pre-existing thyroid disease).
Timing: Prior to contrast administration for high-risk patients.
Routine Monitoring
Vital signs (BP, HR, RR, O2 Sat)
Frequency: Before, during, and immediately after injection, then periodically for 30-60 minutes.
Target: Within patient's normal limits.
Action Threshold: Significant deviations (e.g., hypotension, bradycardia, desaturation) require immediate intervention.
Injection site assessment
Frequency: During and immediately after injection.
Target: No swelling, pain, or redness.
Action Threshold: Signs of extravasation (swelling, pain, redness) require immediate action.
Signs/symptoms of allergic reaction
Frequency: Continuously monitored during and for at least 30-60 minutes post-injection.
Target: Absence of rash, urticaria, dyspnea, angioedema.
Action Threshold: Any signs of reaction require immediate intervention.
Symptom Monitoring
- Hypersensitivity reactions (urticaria, pruritus, rash, angioedema, bronchospasm, laryngeal edema, anaphylaxis)
- Extravasation (pain, swelling, redness at injection site)
- Contrast-Induced Nephropathy (CIN) (decreased urine output, elevated creatinine, fatigue, swelling - typically delayed onset 24-72 hours post-injection)
- Cardiovascular events (arrhythmias, chest pain, hypotension, hypertension)
- Neurological events (seizures, confusion, headache)
- Thyroid dysfunction (hyperthyroidism, thyroid storm - delayed onset)
Special Patient Groups
Pregnancy
Category B. Animal studies show no evidence of harm, but no adequate and well-controlled studies in pregnant women. Use only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
No specific data suggesting increased risk of teratogenicity.
Second Trimester:
No specific data.
Third Trimester:
No specific data.
Lactation
Considered safe. Minimal excretion into breast milk (less than 0.5% of dose). Poor oral absorption by the infant. Breastfeeding can generally continue without interruption.
Infant Risk:
Low. Infant exposure is minimal.
Pediatric Use
Dosing is weight-based and procedure-specific. Children, especially neonates and infants, may be more susceptible to fluid shifts and adverse reactions. Careful monitoring of hydration status and renal function is crucial.
Geriatric Use
Increased risk of Contrast-Induced Nephropathy (CIN) due to age-related decline in renal function. Careful assessment of renal function and hydration status is essential. May also be more susceptible to cardiovascular adverse events.
Clinical Information
Clinical Pearls
- Always assess renal function (eGFR) before administering iodinated contrast, especially in patients with risk factors for CIN (e.g., pre-existing renal impairment, diabetes, heart failure, dehydration, concomitant nephrotoxic drugs).
- Ensure adequate hydration before and after contrast administration to minimize the risk of CIN.
- Patients with a history of previous contrast reactions should be pre-medicated with corticosteroids and/or antihistamines, or an alternative imaging modality should be considered.
- Monitor for extravasation at the injection site; manage with cold compresses and elevation. Severe extravasation may require surgical consultation.
- Be prepared to manage acute hypersensitivity reactions, including anaphylaxis, with appropriate medications (epinephrine, antihistamines, corticosteroids) and resuscitation equipment.
- For patients on metformin, follow institutional guidelines regarding temporary discontinuation (typically 48 hours post-contrast) to prevent lactic acidosis in case of CIN.
Alternative Therapies
- Other iodinated contrast media (e.g., Iohexol, Iodixanol, Iopromide, Ioxaglate)
- Non-iodinated contrast media (e.g., Gadolinium-based contrast agents for MRI, Barium sulfate for GI studies)
- Non-contrast imaging modalities (e.g., Ultrasound, MRI without contrast, plain X-rays)
Cost & Coverage
Average Cost:
Not available (highly variable by institution, contract, and specific product size/concentration) per 200ml vial
Generic Available:
Yes
Insurance Coverage:
Generally covered by medical insurance for medically necessary diagnostic procedures.
General Drug Facts
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 or pharmacist. 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 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.