Iopamidol 61% Sdv Inj, 100ml
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
Aug 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Iopamidol is a special dye, also called a contrast agent, that doctors inject into your body, usually into a vein. It helps make your blood vessels and organs show up more clearly on X-ray pictures, like CT scans or angiograms, so doctors can see if there are any problems.
How to Use This Medicine
Taking Your 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 guidelines.
Before receiving this medication, it is essential to ensure you are not dehydrated. Consult your doctor to determine if you need to drink additional fluids beforehand.
After administration, 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 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 professionals 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 guidelines.
Before receiving this medication, it is essential to ensure you are not dehydrated. Consult your doctor to determine if you need to drink additional fluids beforehand.
After administration, 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 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 professionals will manage the administration schedule.
Lifestyle & Tips
- Stay well-hydrated before and after the procedure, especially if you have kidney problems or diabetes. Your doctor or nurse will give you specific instructions.
- Inform your doctor about all medications you are taking, especially for diabetes (like metformin) or kidney conditions.
- Report any allergies, especially to iodine, shellfish, or previous contrast dyes.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable based on procedure and patient weight. For CT angiography, typically 50-150 mL (300 mgI/mL) administered intravenously.
Dose Range:
10 - 200 mg
Condition-Specific Dosing:
CT_Head:
50-100 mL (300 mgI/mL) IV
CT_Body:
75-150 mL (300 mgI/mL) IV
Angiography_Cerebral:
5-10 mL (300 mgI/mL) per injection, total up to 100 mL
Angiography_Peripheral:
20-60 mL (300 mgI/mL) per injection, total up to 200 mL
Urography:
50-100 mL (300 mgI/mL) IV
Pediatric Dosing
Neonatal:
0.5-4 mL/kg (300 mgI/mL) IV, max 4 mL/kg or 100 mL total, whichever is less. Dosing highly individualized.
Infant:
0.5-4 mL/kg (300 mgI/mL) IV, max 4 mL/kg or 100 mL total, whichever is less. Dosing highly individualized.
Child:
0.5-4 mL/kg (300 mgI/mL) IV, max 4 mL/kg or 100 mL total, whichever is less. Dosing highly individualized.
Adolescent:
0.5-4 mL/kg (300 mgI/mL) IV, max 4 mL/kg or 100 mL total, whichever is less. Dosing highly individualized.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment, but monitor renal function closely. Ensure adequate hydration.
Moderate:
Use with caution. Consider lower doses, extended intervals, or alternative imaging. Ensure aggressive hydration. Avoid in patients on metformin unless metformin is held.
Severe:
Use with extreme caution; generally avoided if possible. High risk of contrast-induced nephropathy (CIN). Consider alternative imaging. If necessary, ensure aggressive hydration and consider dialysis timing if already on dialysis.
Dialysis:
Can be used in patients on dialysis; however, timing of dialysis post-contrast administration is not critical for drug removal as it is not metabolized. Risk of CIN is not applicable if patient is anuric on dialysis, but volume overload can be an issue.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No dose adjustment needed.
Pharmacology
Mechanism of Action
Iopamidol is a non-ionic, water-soluble, tri-iodinated benzoic acid derivative. When injected intravascularly, it increases the attenuation of X-rays in the areas of the body where it distributes, allowing for visualization of blood vessels and other structures during diagnostic imaging procedures (e.g., angiography, computed tomography). The iodine atoms within the molecule are responsible for the X-ray attenuation.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Seconds (after 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)
Elimination:
HalfLife:
Approximately 2 hours (in patients with normal renal function)
Clearance:
Renal clearance is approximately 100 mL/min/1.73m²
ExcretionRoute:
Primarily renal (glomerular filtration)
Unchanged:
> 95%
Pharmacodynamics
OnsetOfAction:
Immediate (seconds after injection)
PeakEffect:
Varies by circulation time and site of injection (e.g., arterial phase for angiography, minutes for CT enhancement)
DurationOfAction:
Minutes to hours, depending on blood flow and renal excretion (e.g., vascular enhancement lasts minutes, urinary tract opacification lasts hours)
Confidence:
Medium
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.
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, 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 this 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 do not go away, 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 possible 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.
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, 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 this 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 do not go away, 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 possible 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:
- Sudden rash or hives
- Itching
- Swelling of your face, lips, or throat
- Difficulty breathing or wheezing
- Dizziness or feeling faint
- Nausea or vomiting
- Unusual pain or swelling at the injection site
- Any new or worsening symptoms after the procedure
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 the symptoms that occurred.
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 Administered into the Spine:
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 have this effect, 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 whether it is safe to take this medication in conjunction 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 the symptoms that occurred.
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 Administered into the Spine:
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 have this effect, 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 whether it is safe to take this medication in conjunction 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 essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial because combining this drug with certain procedures can increase the risk of blood clots, which may lead to a heart attack or stroke, potentially resulting in death. 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 frequency of these tests. 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 drug.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the potential benefits and risks of this medication with their doctor.
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 after receiving this medication, 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 drug with certain procedures can increase the risk of blood clots, which may lead to a heart attack or stroke, potentially resulting in death. 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 frequency of these tests. 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 drug.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the potential benefits and risks of this medication with their doctor.
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 after receiving this medication, 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 (e.g., 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 in cases of severe overdose or renal failure. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Major Interactions
- Metformin (in patients with renal impairment or risk factors for lactic acidosis): Concurrent use can increase the risk of metformin-associated 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 has been re-evaluated and found to be normal.
- Interleukin-2 (IL-2): Patients receiving IL-2 may experience a delayed reaction (e.g., fever, rash, flu-like symptoms, oliguria, renal failure) to contrast media, sometimes occurring days after administration.
Moderate Interactions
- Beta-blockers: May blunt the compensatory cardiovascular responses to anaphylaxis, making treatment of severe hypersensitivity reactions more difficult.
- Diuretics: May increase the risk of contrast-induced nephropathy due to dehydration.
- Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin): Concurrent use may increase the risk of contrast-induced nephropathy, especially in patients with pre-existing renal impairment.
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 contrast administration, 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: Prior to contrast administration.
Thyroid function (TSH, T4)
Rationale: To assess for pre-existing thyroid conditions, especially in patients with known or suspected hyperthyroidism, as iodine can exacerbate it.
Timing: If clinically indicated, prior to contrast administration.
Medication reconciliation (especially metformin, beta-blockers, nephrotoxic drugs)
Rationale: To identify potential drug interactions.
Timing: Prior to contrast administration.
Routine Monitoring
Vital Signs (BP, HR, RR, O2 Sat)
Frequency: Pre-procedure, immediately post-injection, and periodically for 15-30 minutes post-procedure, or until stable.
Target: Within patient's normal limits.
Action Threshold: Significant deviations (e.g., hypotension, bradycardia, tachycardia, desaturation) warrant immediate assessment and intervention.
Signs/Symptoms of Hypersensitivity Reaction
Frequency: Continuously during and for at least 30 minutes post-injection.
Target: Absence of symptoms.
Action Threshold: Any signs of rash, urticaria, pruritus, angioedema, bronchospasm, dyspnea, hypotension, or anaphylaxis require immediate medical intervention.
Injection Site Assessment
Frequency: During and immediately after injection.
Target: Absence of pain, swelling, redness.
Action Threshold: Signs of extravasation (pain, swelling, erythema) require immediate cessation of injection and appropriate management.
Renal function (Serum Creatinine, eGFR)
Frequency: 48-72 hours post-contrast administration for high-risk patients (e.g., pre-existing renal impairment, diabetes, dehydration, elderly, concurrent nephrotoxic drugs).
Target: Return to baseline or stable.
Action Threshold: Increase in serum creatinine by ≥ 0.3 mg/dL or ≥ 50% from baseline within 48-72 hours suggests CIN and requires further evaluation and management.
Symptom Monitoring
- Rash
- Hives (urticaria)
- Itching (pruritus)
- Swelling of face, lips, tongue, or throat (angioedema)
- Difficulty breathing (dyspnea, bronchospasm)
- Wheezing
- Cough
- Dizziness
- Lightheadedness
- Fainting
- Nausea
- Vomiting
- Headache
- Flushing
- Chills
- Fever
- Injection site pain or swelling
- Changes in urine output (decreased)
Special Patient Groups
Pregnancy
Iopamidol is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Risk appears low based on animal data, but human data are limited. Avoid elective procedures.
Second Trimester:
Risk appears low based on animal data, but human data are limited. Avoid elective procedures.
Third Trimester:
Risk appears low based on animal data, but human data are limited. Avoid elective procedures. Potential for transient hypothyroidism in the neonate due to free iodide, though rare with non-ionic agents.
Lactation
Iopamidol is excreted in human milk in very small amounts (L1 - safest). Due to its low protein binding, rapid renal excretion, and poor oral absorption by the infant, the amount absorbed by the infant is negligible. Breastfeeding can generally be continued without interruption.
Infant Risk:
Very low risk. Minimal excretion into breast milk and poor oral absorption by the infant. No adverse effects reported in breastfed infants.
Pediatric Use
Dosing is weight-based and must be carefully calculated. Children, especially neonates and infants, are more susceptible to fluid and electrolyte imbalances and hypothermia. Careful attention to hydration status and body temperature is crucial. Risk of contrast-induced nephropathy is generally lower than in adults but still a concern in those with pre-existing renal impairment.
Geriatric Use
Elderly patients are at increased risk for contrast-induced nephropathy due to age-related decline in renal function, co-morbidities (e.g., diabetes, heart failure), and polypharmacy. Careful assessment of renal function and hydration status is essential. Use the lowest effective dose and ensure adequate hydration.
Clinical Information
Clinical Pearls
- Always assess patient's renal function (eGFR) and allergy history prior to contrast administration.
- Ensure adequate hydration before and after the procedure, especially in high-risk patients for CIN.
- Hold metformin for 48 hours post-contrast in patients with renal impairment or risk factors for lactic acidosis, and recheck renal function before restarting.
- Be prepared to manage hypersensitivity reactions; have emergency equipment and medications readily available.
- Extravasation can occur; monitor injection site closely. If extravasation occurs, stop injection immediately, elevate limb, apply cold compress, and monitor.
- Non-ionic contrast agents like Iopamidol generally have a lower incidence of adverse reactions compared to older ionic agents.
Alternative Therapies
- Iohexol (Omnipaque)
- Iodixanol (Visipaque)
- Iopromide (Ultravist)
- Ioversol (Optiray)
- Gadolinium-based contrast agents (for MRI, e.g., Gadoterate meglumine, Gadobutrol)
- Ultrasound
- Non-contrast CT or MRI
Cost & Coverage
Average Cost:
Highly variable, typically $50 - $300+ per 100mL vial (61% solution)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (usually covered by medical benefit for diagnostic procedures)
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 guidance. To ensure safe use, never share your medication with others or 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 dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. 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 amount, and the time it was taken, as this will aid in providing appropriate care.
Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. 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 amount, and the time it was taken, as this will aid in providing appropriate care.