Iopamidol 41% Sdv Inj, 10ml
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 1982
DEA Schedule
Not Controlled
Overview
What is this medicine?
Iopamidol is a special dye that helps doctors see inside your body more clearly on X-rays or CT scans. It contains iodine, which temporarily makes certain parts of your body, like blood vessels or organs, show up better on the images. It's usually given as an injection.
How to Use This Medicine
Taking Your Medication Correctly
To ensure safe and effective use of this medication, 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 be properly hydrated. Your doctor may advise you to drink extra fluids before administration to prevent dehydration.
After receiving this medication, drink plenty of non-caffeinated liquids unless your doctor instructs you to limit your fluid intake. In some cases, your doctor may prescribe other medications to be taken before this drug to minimize potential 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 professionals will administer the medication as scheduled.
To ensure safe and effective use of this medication, 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 be properly hydrated. Your doctor may advise you to drink extra fluids before administration to prevent dehydration.
After receiving this medication, drink plenty of non-caffeinated liquids unless your doctor instructs you to limit your fluid intake. In some cases, your doctor may prescribe other medications to be taken before this drug to minimize potential 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 professionals will administer the medication as scheduled.
Lifestyle & Tips
- Stay well-hydrated before and after the procedure, especially if you have kidney problems, to help your kidneys clear the dye.
- Inform your doctor about all your medications, especially metformin, and any allergies, particularly to iodine or previous contrast dyes.
- Follow all instructions given by your healthcare provider regarding fasting or medication adjustments before the procedure.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable depending on the diagnostic procedure and specific formulation (concentration). For Iopamidol 41% (200 mgI/mL), common uses include myelography (intrathecal), arthrography (intra-articular), and specific vascular studies. Doses range from 1 mL to 100 mL or more, based on the specific procedure and patient weight. For myelography, typical intrathecal doses are 5-15 mL (1000-3000 mgI). For arthrography, 1-10 mL (200-2000 mgI) intra-articular.
Dose Range:
1 - 100 mg
Condition-Specific Dosing:
myelography:
5-15 mL intrathecal (200 mgI/mL)
arthrography:
1-10 mL intra-articular (200 mgI/mL)
angiography_peripheral:
20-100 mL IV (higher concentrations typically used)
CT_enhancement:
50-150 mL IV (higher concentrations typically used)
Pediatric Dosing
Neonatal:
Dosing is weight-based and procedure-specific. Caution advised due to immature renal function. Typically 1-3 mL/kg, not exceeding 4 mL/kg or 100 mL total, for IV administration. Intrathecal doses are significantly lower.
Infant:
Dosing is weight-based and procedure-specific. Caution advised due to immature renal function. Typically 1-3 mL/kg, not exceeding 4 mL/kg or 100 mL total, for IV administration. Intrathecal doses are significantly lower.
Child:
Dosing is weight-based and procedure-specific. Typically 1-3 mL/kg, not exceeding 4 mL/kg or 100 mL total, for IV administration. Intrathecal doses are significantly lower.
Adolescent:
Dosing is weight-based and procedure-specific, often approaching adult doses for IV administration. Intrathecal doses are significantly lower.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment for IV administration, but ensure adequate hydration. For intrathecal use, renal impairment is less directly relevant to the dose but overall patient status is important.
Moderate:
Increased risk of contrast-induced acute kidney injury (CI-AKI). Hydration is critical. Consider lower doses or alternative imaging modalities. For IV administration, use the lowest effective dose. For intrathecal use, systemic absorption is minimal.
Severe:
High risk of CI-AKI. Avoid if possible. If essential, use lowest effective dose, ensure aggressive hydration, and consider dialysis post-procedure for IV administration. For intrathecal use, systemic absorption is minimal, but caution with overall patient status.
Dialysis:
Iopamidol is dialyzable. If IV administration is necessary, administer immediately prior to dialysis session to facilitate removal. For intrathecal use, dialysis is not typically a primary consideration for drug removal.
Hepatic Impairment:
Mild:
No specific dose adjustment required as Iopamidol is not metabolized by the liver.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required.
Pharmacology
Mechanism of Action
Iopamidol is a non-ionic, water-soluble, tri-iodinated benzoic acid derivative. When administered, the iodine atoms within the molecule absorb X-rays, creating a temporary difference in radiographic density between structures containing the contrast medium and surrounding tissues. This allows for enhanced visualization of blood vessels, organs, and other body cavities during diagnostic imaging procedures (e.g., X-ray, CT scans).
Pharmacokinetics
Absorption:
Bioavailability:
100% (following intravenous administration)
Tmax:
Immediate (following intravenous bolus)
FoodEffect:
Not applicable (administered parenterally)
Distribution:
Vd:
Approximately 0.16 L/kg (similar to extracellular fluid volume)
ProteinBinding:
< 2%
CnssPenetration:
Limited (does not cross intact blood-brain barrier; however, it is administered intrathecally for myelography)
Elimination:
HalfLife:
Approximately 2 hours (in subjects with normal renal function)
Clearance:
Primarily renal glomerular filtration
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 90-100% (within 24 hours)
Pharmacodynamics
OnsetOfAction:
Immediate (upon administration)
PeakEffect:
Immediate (upon distribution to target area)
DurationOfAction:
Minutes to hours, depending on blood flow, renal function, and specific procedure (e.g., vascular enhancement lasts minutes, urinary tract opacification lasts 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 when taking this medication. If you experience 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 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. 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 of Injection (Spinal)
If you receive this medication via spinal injection, you may experience:
Seizures.
Back pain.
Stiff neck.
Abnormal sensations: Burning, numbness, or tingling feelings.
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other unusual symptoms, contact your doctor:
Injection (Spinal): 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 when taking this medication. If you experience 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 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. 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 of Injection (Spinal)
If you receive this medication via spinal injection, you may experience:
Seizures.
Back pain.
Stiff neck.
Abnormal sensations: Burning, numbness, or tingling feelings.
Other Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other unusual symptoms, contact your doctor:
Injection (Spinal): 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:
- Difficulty breathing, wheezing, or tightness in the chest
- Swelling of the face, lips, tongue, or throat
- Hives, rash, or severe itching
- Sudden dizziness or lightheadedness
- Rapid or irregular heartbeat
- Nausea or vomiting
- Unusual pain or swelling at the injection site
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 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 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 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 combination 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 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 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 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 combination 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 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 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. Children under the age of 3 may be at risk of developing low thyroid function, which can impact their development. Your child's doctor may recommend regular thyroid function tests after administering this medication. 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 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 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. Children under the age of 3 may be at risk of developing low thyroid function, which can impact their development. Your child's doctor may recommend regular thyroid function tests after administering this medication. If you have any questions or concerns, consult with your child's doctor.
Overdose Information
Overdose Symptoms:
- Severe hypotension (low blood pressure)
- Pulmonary edema
- Cardiac arrest
- Seizures (especially with intrathecal overdose)
- Renal failure
What to Do:
Overdose is rare but can occur. Treatment is symptomatic and supportive. Maintain airway, breathing, and circulation. Administer IV fluids, vasopressors for hypotension. Hemodialysis can remove Iopamidol from the bloodstream. For intrathecal overdose, CSF removal may be considered. Call 1-800-222-1222 (Poison Control Center) 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., fever, rash, flu-like symptoms, hypotension, oliguria) to contrast media in patients who have received IL-2 within weeks prior to contrast administration.
Moderate Interactions
- Beta-blockers: May blunt the compensatory cardiovascular responses to hypotension and may increase the risk of severe anaphylactoid reactions.
- Diuretics: May increase the risk of contrast-induced nephropathy due to dehydration.
- Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides): Concomitant use may increase the risk of contrast-induced nephropathy.
Monitoring
Baseline Monitoring
Renal function (Serum Creatinine, eGFR)
Rationale: To assess baseline kidney function and risk of contrast-induced acute kidney injury (CI-AKI).
Timing: Prior to administration, especially in patients with risk factors for renal impairment.
Allergy history (especially to iodine or previous contrast media)
Rationale: To identify patients at increased risk for hypersensitivity reactions.
Timing: Prior to administration.
Thyroid function (TSH, T3, T4)
Rationale: Iodinated contrast can affect thyroid function, especially in patients with pre-existing thyroid disease. May be considered in specific cases.
Timing: Prior to administration if clinically indicated.
Routine Monitoring
Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate, Oxygen Saturation)
Frequency: Before, during, and immediately after administration, then periodically for 30-60 minutes.
Target: Within patient's normal limits.
Action Threshold: Significant deviations (e.g., hypotension, bradycardia, dyspnea) require immediate intervention.
Signs/Symptoms of Hypersensitivity Reaction
Frequency: Continuously during and for at least 30-60 minutes post-administration.
Target: Absence of rash, urticaria, angioedema, bronchospasm, hypotension.
Action Threshold: Any signs of reaction require immediate medical attention.
Injection Site Assessment
Frequency: During and immediately after injection.
Target: Absence of pain, swelling, redness, or extravasation.
Action Threshold: Signs of extravasation require immediate management.
Symptom Monitoring
- Rash
- Urticaria (hives)
- Pruritus (itching)
- Angioedema (swelling of face, lips, tongue, throat)
- Dyspnea (shortness of breath)
- Bronchospasm/Wheezing
- Hypotension
- Tachycardia/Bradycardia
- Nausea/Vomiting
- Dizziness/Lightheadedness
- Headache
- Seizures (rare, especially with intrathecal use if dose exceeded or patient predisposition)
- Pain or discomfort at injection site
Special Patient Groups
Pregnancy
Category B. Animal studies have not shown harm, but human data are limited. 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:
Limited data, but generally considered low risk for structural anomalies. Avoid elective procedures.
Second Trimester:
Generally considered safe if medically necessary.
Third Trimester:
Generally considered safe if medically necessary. Theoretical risk of transient hypothyroidism in the neonate due to iodine exposure, though rarely clinically significant.
Lactation
L1 (Safest). Minimal excretion into breast milk and poor oral absorption by the infant. Breastfeeding can generally continue without interruption. If concerns exist, a temporary interruption (e.g., 24 hours) and discarding milk is an option, but usually not necessary.
Infant Risk:
Very low risk to the infant.
Pediatric Use
Dosing is weight-based and procedure-specific. Children, especially neonates and infants, are more susceptible to fluid shifts and electrolyte imbalances. Immature renal function may prolong elimination. Higher risk of adverse reactions in very young or critically ill children. Careful hydration and monitoring are essential.
Geriatric Use
Increased risk of contrast-induced acute kidney injury (CI-AKI) due to age-related decline in renal function and higher prevalence of comorbidities (e.g., diabetes, hypertension, heart failure). Careful assessment of renal function and hydration status is crucial. Use the lowest effective dose.
Clinical Information
Clinical Pearls
- Always assess renal function (eGFR) before administering iodinated contrast, especially in at-risk patients.
- Ensure adequate hydration before and after contrast administration to minimize the risk of contrast-induced acute kidney injury (CI-AKI).
- Carefully screen for allergies to iodine or previous contrast media; premedication with corticosteroids and antihistamines may be considered for high-risk patients.
- Monitor patients closely for signs of hypersensitivity reactions during and for at least 30-60 minutes after administration.
- For patients on metformin, follow institutional guidelines for withholding and restarting the medication to prevent lactic acidosis.
- Iopamidol 41% (200 mgI/mL) is a lower concentration often preferred for myelography, arthrography, or when lower iodine load is desired, compared to higher concentrations (e.g., 300-370 mgI/mL) used for general angiography or CT.
- Extravasation can occur; monitor injection site and manage according to protocol if it happens.
Alternative Therapies
- Other non-ionic iodinated contrast media (e.g., Iohexol, Iopromide, Iodixanol)
- Ionic iodinated contrast media (less common due to higher osmolality and adverse reaction rates)
- Gadolinium-based contrast agents (for MRI, different mechanism, different risks)
- Non-contrast imaging modalities (e.g., ultrasound, non-contrast CT, non-contrast MRI) when appropriate.
Cost & Coverage
Average Cost:
Varies widely by concentration, volume, and supplier. For 41% (200 mgI/mL) 10mL, typically in the range of $20-$50 per vial. per 10mL vial
Generic Available:
Yes
Insurance Coverage:
Typically covered by medical insurance for diagnostic procedures. Coverage tier varies by plan and formulary.
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. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of the incident.