Iopamidol 61% Sdv Inj, 15ml
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
Category B
FDA Approved
Sep 1981
DEA Schedule
Not Controlled
Overview
What is this medicine?
Iopamidol is a special dye that is injected into your body, usually into a vein. It helps doctors see your blood vessels, organs, or other body parts more clearly on X-ray images, like CT scans or angiograms. This helps them diagnose medical conditions.
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 medication will be administered to you in a healthcare setting, so 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 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 medication will be administered to you in a healthcare setting, so 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
- Stay well-hydrated before and after the procedure, especially if you have kidney problems or diabetes, as this helps protect your kidneys.
- Inform your doctor about all your medications, especially metformin, as it may need to be temporarily stopped.
- Inform your doctor about any allergies, especially to iodine, shellfish, or previous contrast dyes.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable, dependent on procedure, patient weight, and specific concentration (e.g., 61% = 300 mgI/mL).
Dose Range:
10 - 200 mg
Condition-Specific Dosing:
angiography:
20-100 mL (e.g., cerebral, peripheral)
CT_scan:
50-150 mL (e.g., head, body)
urography:
50-100 mL
Pediatric Dosing
Neonatal:
0.5-4 mL/kg, max 100 mL, highly individualized based on procedure and weight.
Infant:
0.5-4 mL/kg, max 100 mL, highly individualized based on procedure and weight.
Child:
0.5-4 mL/kg, max 100 mL, highly individualized based on procedure and weight.
Adolescent:
Dosing approaches adult recommendations, typically 0.5-2 mL/kg, max 100-150 mL.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment, but ensure adequate hydration.
Moderate:
Use with caution. Consider lower doses, extended intervals, or alternative imaging. Ensure aggressive hydration.
Severe:
Contraindicated if acute kidney injury or severe chronic kidney disease (eGFR < 30 mL/min/1.73m²) unless benefits outweigh risks and alternative imaging is not feasible. Consider pre-hydration and post-procedure monitoring.
Dialysis:
Can be administered to patients on dialysis. Dialysis can remove iopamidol, so administration before dialysis is preferred if possible. Consult nephrology.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed, as primarily renally excreted.
Pharmacology
Mechanism of Action
Iopamidol is a non-ionic, water-soluble, tri-iodinated benzoic acid derivative. When administered intravascularly, the iodine atoms within the molecule absorb X-rays, creating a temporary difference in radiographic density between the vascular structures or organs containing the contrast agent and the surrounding tissues. This allows for enhanced visualization of blood vessels and various organs during diagnostic imaging procedures (e.g., angiography, CT scans, urography).
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Immediate (after bolus injection)
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)
Elimination:
HalfLife:
Approximately 2 hours (in subjects with normal renal function)
Clearance:
Approximately 100 mL/min (renal clearance)
ExcretionRoute:
Renal (primarily glomerular filtration)
Unchanged:
> 95% (excreted unchanged in urine)
Pharmacodynamics
OnsetOfAction:
Immediate (seconds after injection)
PeakEffect:
Within 1-3 minutes (vascular phase), varies by organ and procedure
DurationOfAction:
Minutes to hours, depending on circulation time, renal function, and specific procedure (e.g., vascular enhancement lasts minutes, renal excretion allows visualization for hours)
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 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, 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: 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 burning, numbness, or tingling sensations
Other Side Effects
Most people do not experience severe side effects, and some may have only minor or no side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
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 list is not exhaustive, and you may experience other 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 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, 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: 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 burning, numbness, or tingling sensations
Other Side Effects
Most people do not experience severe side effects, and some may have only minor or no side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
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 list is not exhaustive, and you may experience other 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, or throat
- Severe dizziness or fainting
- Chest pain or tightness
- Unusual pain, swelling, or redness at the injection site
- Decreased urination or swelling in your legs/feet (signs of kidney problems)
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. 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.
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 interact with this drug, 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 treatments. 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. 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.
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 interact with this drug, 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 treatments. 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 crucial that you inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is especially important because this drug can increase the risk of blood clots when used in conjunction with certain procedures. In some cases, blood clots can lead to heart attack and stroke, which can be life-threatening. If you have any questions or concerns, be sure to discuss them with your doctor.
To minimize the risk of tissue damage, it is essential to monitor the injection site closely. If you experience any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid at the injection site, notify your nurse immediately, as this could be a sign that the drug is leaking from the vein.
Your doctor may need to monitor your blood work while you are taking this medication. Be sure to follow their instructions and attend any scheduled appointments.
Additionally, this medication may affect the results of certain laboratory tests. To ensure accurate test results, 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.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, it is essential to discuss the potential benefits and risks of this medication with your doctor.
Special Considerations for Children
When administering this medication to children, it is crucial to use caution, as the risk of side effects may be higher in some pediatric patients. In children under the age of 3, the use of medications like this one has been associated with low thyroid function, which can impact child development. Your child's doctor may need to monitor their thyroid function for an extended period after the injection. If you have any questions or concerns, be sure to discuss them with your child's doctor.
It is crucial that you inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is especially important because this drug can increase the risk of blood clots when used in conjunction with certain procedures. In some cases, blood clots can lead to heart attack and stroke, which can be life-threatening. If you have any questions or concerns, be sure to discuss them with your doctor.
To minimize the risk of tissue damage, it is essential to monitor the injection site closely. If you experience any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid at the injection site, notify your nurse immediately, as this could be a sign that the drug is leaking from the vein.
Your doctor may need to monitor your blood work while you are taking this medication. Be sure to follow their instructions and attend any scheduled appointments.
Additionally, this medication may affect the results of certain laboratory tests. To ensure accurate test results, 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.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, it is essential to discuss the potential benefits and risks of this medication with your doctor.
Special Considerations for Children
When administering this medication to children, it is crucial to use caution, as the risk of side effects may be higher in some pediatric patients. In children under the age of 3, the use of medications like this one has been associated with low thyroid function, which can impact child development. Your child's doctor may need to monitor their thyroid function for an extended period after the injection. If you have any questions or concerns, be sure to discuss them with your child's doctor.
Overdose Information
Overdose Symptoms:
- Acute renal failure
- Fluid and electrolyte imbalance
- Pulmonary edema
- Cardiovascular collapse
- Seizures
What to Do:
Treatment is symptomatic and supportive. Monitor vital signs, fluid and electrolyte balance. Hemodialysis can be used to remove iopamidol from the body. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Major Interactions
- Metformin (in patients with acute kidney injury or severe chronic kidney disease): 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., flu-like symptoms, skin reactions, renal dysfunction).
Moderate Interactions
- Beta-blockers: Increased risk of anaphylactoid reactions and reduced efficacy of epinephrine in treating severe reactions.
- Diuretics: May increase risk of contrast-induced nephropathy due to dehydration.
- Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides): Concomitant use may increase risk of contrast-induced nephropathy.
Monitoring
Baseline Monitoring
Renal function (Serum Creatinine, eGFR)
Rationale: To assess baseline kidney function and risk of contrast-induced nephropathy (CIN).
Timing: Within 30 days prior to procedure, ideally within 7 days for high-risk patients.
Allergy history (especially to iodine or previous contrast media)
Rationale: To identify patients at increased risk for hypersensitivity reactions.
Timing: Pre-procedure patient interview.
Thyroid function (TSH, T4)
Rationale: Iodinated contrast can induce hyperthyroidism in susceptible individuals (e.g., those with latent hyperthyroidism or autonomous thyroid nodules).
Timing: Prior to procedure in patients with known thyroid disease or risk factors.
Hydration status
Rationale: Adequate hydration is crucial for preventing CIN.
Timing: Pre-procedure assessment.
Routine Monitoring
Vital signs (BP, HR, RR, O2 Sat)
Frequency: Pre-procedure, immediately post-injection, and periodically during and after procedure until stable.
Target: Patient's normal range
Action Threshold: Significant deviation from baseline, signs of allergic reaction or hemodynamic instability.
Signs and symptoms of allergic reaction (e.g., rash, urticaria, dyspnea, hypotension)
Frequency: Continuously during and for at least 30 minutes post-injection.
Target: Absence of symptoms
Action Threshold: Any new onset of symptoms.
Injection site assessment (pain, swelling, redness)
Frequency: During and immediately after injection.
Target: Absence of symptoms
Action Threshold: Signs of extravasation or local irritation.
Renal function (Serum Creatinine, eGFR)
Frequency: 24-72 hours post-procedure for high-risk patients (e.g., pre-existing renal impairment, diabetes, heart failure, large contrast volume).
Target: Baseline values
Action Threshold: Increase in serum creatinine by ≥ 0.3 mg/dL or ≥ 50% from baseline within 48-72 hours.
Symptom Monitoring
- Hives
- Rash
- Itching
- Swelling of face, lips, tongue, or throat
- Difficulty breathing or wheezing
- Chest tightness
- Dizziness or lightheadedness
- Nausea
- Vomiting
- Headache
- Flushing
- Injection site pain or swelling
- Decreased urine output (sign of CIN)
- Fatigue (sign of CIN)
Special Patient Groups
Pregnancy
Category B. Studies in animals have shown no evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks to the fetus.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified, but generally avoided if possible due to lack of human data.
Second Trimester:
No specific increased risk identified.
Third Trimester:
No specific increased risk identified. Fetal thyroid function should be monitored if exposure occurs near term, as iodine can cross the placenta.
Lactation
L3 (Moderately Safe). Minimal amounts of iopamidol are excreted into breast milk (typically < 0.5% of the administered dose). The amount absorbed by the infant is negligible. Breastfeeding can generally be continued without interruption. If concerns exist, a temporary interruption of breastfeeding for 24 hours after administration is an option, but usually not necessary.
Infant Risk:
Low risk of adverse effects to the infant.
Pediatric Use
Dosing is weight-based and highly individualized according to the specific diagnostic procedure. Pediatric patients, especially neonates and infants, are more susceptible to fluid and electrolyte imbalances and may have immature renal function, requiring careful monitoring and hydration. Risk of contrast-induced nephropathy is generally lower than in adults but still requires caution in at-risk infants.
Geriatric Use
Elderly patients are at increased risk for contrast-induced nephropathy due to age-related decline in renal function, pre-existing renal impairment, diabetes, and cardiovascular disease. Careful assessment of renal function, adequate hydration, and use of the lowest effective dose are crucial. Monitor closely for adverse reactions.
Clinical Information
Clinical Pearls
- Always assess renal function (eGFR) before administering iodinated contrast, especially in patients with risk factors for CIN.
- Ensure adequate hydration before and after contrast administration, particularly in high-risk patients.
- Carefully review medication list for metformin; hold metformin in at-risk patients and recheck renal function before restarting.
- Have emergency equipment and medications (e.g., epinephrine, antihistamines, corticosteroids) readily available for managing hypersensitivity reactions.
- Non-ionic contrast agents like iopamidol have a lower incidence of adverse reactions compared to older ionic agents.
- Extravasation can occur; monitor injection site closely. Management typically involves elevation, cold compress, and observation.
Alternative Therapies
- Other non-ionic iodinated contrast media (e.g., Iohexol, Iopromide, Iodixanol)
- Gadolinium-based contrast agents (for MRI, different mechanism, different risks)
- Ultrasound
- Non-contrast CT or MRI
- Nuclear medicine studies
Cost & Coverage
Average Cost:
Varies widely by institution, contract, and volume. Typically ranges from $50 - $200+ per 15mL vial. per 15mL vial
Generic Available:
Yes
Insurance Coverage:
Generally covered by medical insurance as part of a diagnostic procedure. Coverage tier depends on specific plan and formulary.
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to consult your doctor for further evaluation and guidance.
To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not flush them down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the best disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to 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 quantity, and the time it was taken, as this will aid in prompt and effective treatment.
To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not flush them down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the best disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to 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 quantity, and the time it was taken, as this will aid in prompt and effective treatment.