Isovue-370 76% Inj, 500ml
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
Pharmacologic Class
Iodinated contrast media, non-ionic
Pregnancy Category
B
FDA Approved
Dec 1980
DEA Schedule
Not Controlled
Overview
What is this medicine?
Iopamidol is a special dye injected into your body, usually into a vein, to help doctors see your blood vessels and organs more clearly on X-ray or CT scans. It helps highlight certain areas so problems can be found.
How to Use This Medicine
Taking This Medication
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the instructions closely. Before receiving this medication, it is essential to ensure you are not dehydrated. Consult your doctor to determine if you need to consume extra 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.
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 take any action if a dose is missed, as the healthcare provider will manage the administration schedule.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the instructions closely. Before receiving this medication, it is essential to ensure you are not dehydrated. Consult your doctor to determine if you need to consume extra 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.
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 take any action if a dose is missed, as the healthcare provider will manage the administration schedule.
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 conditions.
- Report 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 single doses range from 20 mL to 150 mL, with total doses up to 250 mL depending on the specific diagnostic procedure (e.g., angiography, CT, urography). Concentration is 370 mgI/mL.
Dose Range:
20 - 250 mg
Condition-Specific Dosing:
cerebralAngiography:
5-10 mL per injection, total 30-90 mL
peripheralAngiography:
20-150 mL per injection, total 50-250 mL
CTHead:
50-100 mL
CTBody:
50-150 mL
Urography:
50-100 mL
Pediatric Dosing
Neonatal:
Not established for all procedures; typically 1-3 mL/kg, not to exceed 50 mL total.
Infant:
1-3 mL/kg, not to exceed 50 mL total.
Child:
1-3 mL/kg, not to exceed 100 mL total.
Adolescent:
Dosing similar to adult, adjusted for weight, not to exceed 150 mL total.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required, but ensure adequate hydration.
Moderate:
Use with caution. Ensure adequate hydration. Consider lower doses or alternative imaging if possible. Monitor renal function closely.
Severe:
Contraindicated or use with extreme caution. High risk of acute kidney injury (AKI). Ensure adequate hydration. Consider alternative imaging. If necessary, use lowest possible dose and monitor renal function closely. May require dialysis post-procedure if AKI occurs.
Dialysis:
Iopamidol is dialyzable. If administered to patients on dialysis, consider scheduling administration just prior to dialysis session to facilitate removal.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required, as hepatic metabolism is minimal. However, use with caution in patients with severe multi-organ dysfunction.
Pharmacology
Mechanism of Action
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 blood vessels and organs during diagnostic imaging procedures (e.g., angiography, computed tomography). The iodine atoms in the molecule absorb X-rays, creating contrast.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (following IV bolus)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.16 L/kg (similar to extracellular fluid volume)
ProteinBinding:
< 2%
CnssPenetration:
Limited (does not cross intact blood-brain barrier significantly)
Elimination:
HalfLife:
Approximately 2 hours (in subjects with normal renal function)
Clearance:
Approximately 100 mL/min (renal clearance)
ExcretionRoute:
Renal (primarily via glomerular filtration)
Unchanged:
> 95%
Pharmacodynamics
OnsetOfAction:
Seconds (after IV injection)
PeakEffect:
Seconds to minutes (depending on circulation time and target vessel/organ)
DurationOfAction:
Minutes to hours (depending on blood flow, renal function, and type of procedure; typically 5-15 minutes for vascular enhancement, longer for urinary tract visualization)
Safety & Warnings
Side Effects
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, 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 urinate, 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. 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:
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, 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.
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, 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 urinate, 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. 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:
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, 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.
Seek Immediate Medical Attention If You Experience:
- Difficulty breathing or wheezing
- Hives, rash, or severe itching
- Swelling of the face, lips, tongue, or throat
- Sudden dizziness or lightheadedness
- Severe nausea or vomiting
- Chest pain or discomfort
- Unusual weakness or fatigue
- Changes in urination (less frequent or no urination)
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 to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. 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 previous skin reaction to this medication or a similar drug.
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 drugs that can interact with this medication in this way; consult your doctor or pharmacist if you are unsure.
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 if it is safe to take this medication with your other treatments and health issues. Never start, stop, or adjust the dosage of any medication without first consulting 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, such as foods or drugs. 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 previous skin reaction to this medication or a similar drug.
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 drugs that can interact with this medication in this way; consult your doctor or pharmacist if you are unsure.
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 if it is safe to take this medication with your other treatments and health issues. Never start, stop, or adjust 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 leakage, such as redness, burning, pain, swelling, blisters, skin sores, or fluid leakage. Immediately notify your nurse if you experience any of these symptoms.
Regular blood tests may be necessary to monitor your condition. 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.
For pediatric patients, this medication should be used with caution, as the risk of side effects may be higher in some children. In children under 3 years of age, there is a risk of developing low thyroid function, which can impact child 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 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 leakage, such as redness, burning, pain, swelling, blisters, skin sores, or fluid leakage. Immediately notify your nurse if you experience any of these symptoms.
Regular blood tests may be necessary to monitor your condition. 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.
For pediatric patients, this medication should be used with caution, as the risk of side effects may be higher in some children. In children under 3 years of age, there is a risk of developing low thyroid function, which can impact child 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, heart failure)
- Electrolyte imbalance
- Acute renal failure
- Seizures
- Cardiovascular collapse
What to Do:
Treatment is symptomatic and supportive. Monitor vital signs, fluid and electrolyte balance. Hemodialysis may be used to remove Iopamidol from the body in cases of severe overdose or renal failure. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Metformin (in patients with renal impairment or risk of AKI): Increased risk of lactic acidosis. Metformin should be withheld at the time of or prior to the contrast study and for 48 hours after, and reinstituted only after renal function has been re-evaluated and found to be normal.
- Interleukin-2 (IL-2): Increased risk of delayed adverse reactions (e.g., fever, rash, flu-like symptoms, oliguria, renal failure) in patients who have received IL-2 within several weeks prior to contrast administration.
Moderate Interactions
- Beta-adrenergic blocking agents: May blunt the compensatory cardiovascular responses to contrast-induced hypotension or anaphylaxis, making treatment more difficult.
- Diuretics: May increase the risk of acute kidney injury due to dehydration, especially in patients with pre-existing renal impairment.
- Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin): Concomitant use may increase the risk of contrast-induced nephropathy (CIN).
Monitoring
Baseline Monitoring
Renal function (Serum Creatinine, eGFR)
Rationale: To assess baseline kidney function and identify patients at risk for contrast-induced nephropathy (CIN).
Timing: Within 48 hours prior to contrast administration, especially for at-risk patients.
Allergy history (especially to iodine or previous contrast media)
Rationale: To identify patients at increased risk for hypersensitivity reactions.
Timing: Prior to contrast administration.
Hydration status
Rationale: Adequate hydration is crucial to prevent CIN.
Timing: Prior to contrast administration.
Thyroid function (TSH, T4)
Rationale: Iodinated contrast can induce hyperthyroidism or hypothyroidism in susceptible individuals.
Timing: Prior to contrast administration in patients with known or suspected thyroid disease.
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, respiratory distress) require immediate intervention.
Signs of hypersensitivity/anaphylaxis
Frequency: Continuously during and for at least 30-60 minutes post-injection.
Target: Absence of symptoms
Action Threshold: Rash, urticaria, bronchospasm, angioedema, hypotension, laryngeal edema.
Renal function (Serum Creatinine)
Frequency: 48-72 hours post-contrast in at-risk patients (e.g., pre-existing renal impairment, diabetes, heart failure, elderly).
Target: Return to baseline or stable
Action Threshold: Increase in serum creatinine by âĨ 0.3 mg/dL or âĨ 50% from baseline within 48-72 hours.
Symptom Monitoring
- Nausea
- Vomiting
- Headache
- Dizziness
- Warm sensation
- Flushing
- Metallic taste
- Hives/Rash
- Itching
- Shortness of breath
- Wheezing
- Swelling of face/throat
- Chest pain
- Palpitations
- Seizures
- Changes in consciousness
Special Patient Groups
Pregnancy
Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus. Consider non-iodinated imaging alternatives if possible.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified beyond general contrast exposure.
Second Trimester:
No specific increased risk identified.
Third Trimester:
Potential for transient hypothyroidism in the neonate due to iodine exposure, especially with repeated doses. Neonatal thyroid function monitoring may be considered.
Lactation
L2 - Likely compatible. Minimal excretion into breast milk (less than 0.5% of the administered dose). The amount absorbed by the infant is negligible. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Most guidelines suggest no interruption of breastfeeding is necessary.
Infant Risk:
Low risk. Minimal systemic absorption by the infant. No adverse effects reported in breastfed infants.
Pediatric Use
Dosing is weight-based and varies by procedure. Pediatric patients, especially neonates and infants, are more susceptible to fluid shifts and electrolyte imbalances. Careful attention to hydration and renal function is crucial. Risk of thyroid dysfunction in neonates/infants should be considered.
Geriatric Use
Increased risk of 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 and hydration status is essential. Use the lowest effective dose.
Clinical Information
Clinical Pearls
- Always assess renal function (eGFR/creatinine) before administering iodinated contrast, especially in at-risk patients.
- Ensure adequate hydration before and after contrast administration to minimize the risk of contrast-induced nephropathy (CIN).
- Patients on metformin should have the drug withheld before and for 48 hours after contrast administration, with renal function re-evaluated before restarting.
- Be prepared for hypersensitivity reactions, ranging from mild to severe anaphylaxis. Have resuscitation equipment and medications readily available.
- Non-ionic, low-osmolar contrast agents like Iopamidol are generally preferred due to a lower incidence of adverse reactions compared to high-osmolar agents.
- Monitor patients for delayed reactions, which can occur hours to days after administration, especially in those with a history of previous reactions or IL-2 therapy.
Alternative Therapies
- Iohexol (Omnipaque)
- Iopromide (Ultravist)
- Ioversol (Optiray)
- Iodixanol (Visipaque - iso-osmolar)
- Gadolinium-based contrast agents (for MRI, different mechanism)
- Ultrasound
- Non-contrast CT or MRI
Cost & Coverage
Average Cost:
Not available per 500ml vial
Generic Available:
Yes
Insurance Coverage:
Typically covered by medical insurance for diagnostic imaging procedures. Coverage tier varies by plan and formulary.
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.
To ensure safe use, do not share your medication with others, and never take medication that has been prescribed to someone else. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or the medication's packaging. If you are unsure about the best method for disposing of your medication, consult with your pharmacist, who can provide guidance on safe disposal practices. Additionally, you may want to inquire about drug take-back programs available in your area, which can provide a safe and environmentally responsible way to dispose of unwanted medications.
It is also important to note that some medications may come with an additional patient information leaflet. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and guidance.
In the event of a suspected overdose, it is critical to seek immediate medical attention. Contact your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide as much information as possible about the overdose, including the name of the medication, the amount taken, and the time it was ingested. This information will help healthcare professionals provide the most effective treatment and care.
To ensure safe use, do not share your medication with others, and never take medication that has been prescribed to someone else. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or the medication's packaging. If you are unsure about the best method for disposing of your medication, consult with your pharmacist, who can provide guidance on safe disposal practices. Additionally, you may want to inquire about drug take-back programs available in your area, which can provide a safe and environmentally responsible way to dispose of unwanted medications.
It is also important to note that some medications may come with an additional patient information leaflet. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and guidance.
In the event of a suspected overdose, it is critical to seek immediate medical attention. Contact your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide as much information as possible about the overdose, including the name of the medication, the amount taken, and the time it was ingested. This information will help healthcare professionals provide the most effective treatment and care.