Iopamidol 61% Sdv Inj, 50ml
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
Pregnancy Category
Not available
FDA Approved
Aug 1982
DEA Schedule
Not Controlled
Overview
What is this medicine?
Iopamidol is a special dye used during X-ray tests like CT scans or angiograms. It helps doctors see your blood vessels and organs more clearly on the images, which helps them diagnose medical conditions.
How to Use This Medicine
Taking Your Medication Correctly
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully read all the information provided to you and follow the instructions closely.
Before receiving this medication, it is essential to be properly hydrated. Your doctor may advise you to drink extra fluids before administration to prevent dehydration. After receiving the 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. Your healthcare provider will administer the medication as scheduled.
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully read all the information provided to you and follow the instructions closely.
Before receiving this medication, it is essential to be properly hydrated. Your doctor may advise you to drink extra fluids before administration to prevent dehydration. After receiving the 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. Your healthcare provider will administer the medication as scheduled.
Lifestyle & Tips
- Stay well-hydrated before and after the procedure, especially if you have kidney problems.
- Inform your doctor about all your medications, allergies, and medical conditions, especially kidney disease, diabetes, thyroid problems, or asthma.
- Follow any specific 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 based on procedure, route, and patient weight. For Iopamidol 61% (300 mgI/mL), typical doses range from 10 mL to 200 mL.
Dose Range:
10 - 200 mg
Condition-Specific Dosing:
cerebralAngiography:
5-10 mL per injection, total up to 100 mL
peripheralAngiography:
20-90 mL per injection, total up to 250 mL
coronaryAngiography:
3-10 mL per injection, total up to 200 mL
urography:
50-100 mL IV
CT_head:
50-150 mL IV
CT_body:
50-200 mL IV
Pediatric Dosing
Neonatal:
Dosing highly individualized based on procedure and weight. Generally 1-3 mL/kg, not to exceed 4 mL/kg or 100 mL total.
Infant:
Dosing highly individualized based on procedure and weight. Generally 1-3 mL/kg, not to exceed 4 mL/kg or 100 mL total.
Child:
Dosing highly individualized based on procedure and weight. Generally 1-3 mL/kg, not to exceed 4 mL/kg or 100 mL total.
Adolescent:
Dosing highly individualized based on procedure and weight. Generally 1-3 mL/kg, not to exceed 4 mL/kg or 100 mL total.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally required, but hydration is important.
Moderate:
Use with caution. Consider lower doses, extended intervals, and adequate hydration. Monitor renal function.
Severe:
Use with caution. Avoid if possible. If necessary, consider lowest effective dose and monitor renal function closely. Increased risk of contrast-induced nephropathy (CIN).
Dialysis:
Iopamidol is dialyzable. If patient is on dialysis, administer prior to dialysis session if possible, or consider dialysis post-procedure to remove contrast.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required as it is primarily renally excreted.
Severe:
No specific dose adjustment required as it is primarily renally excreted.
Pharmacology
Mechanism of Action
Iopamidol is a non-ionic, low-osmolar, water-soluble iodinated contrast medium. When injected intravascularly, the iodine atoms within the molecule absorb X-rays, creating a temporary difference in radiographic density between the blood vessels/organs and surrounding tissues, allowing for visualization during diagnostic imaging procedures.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravascular administration)
Tmax:
Immediately after injection (IV/IA)
FoodEffect:
Not applicable (parenteral 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:
Approximately 100 mL/min (renal clearance)
ExcretionRoute:
Primarily renal (glomerular filtration)
Unchanged:
> 90% (within 24 hours)
Pharmacodynamics
OnsetOfAction:
Immediate (upon injection)
PeakEffect:
Varies by site of injection and circulation time (e.g., seconds for arterial, minutes for venous/organ opacification)
DurationOfAction:
Transient (minutes to hours, depending on circulation and renal function)
Confidence:
High
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, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be fatal.
Kidney problems: Inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Thyroid problems: Weight changes, nervousness, excitability, restlessness, weakness, hair thinning, depression, eye or neck swelling, difficulty focusing, heat or cold intolerance, menstrual changes, shakiness, or sweating.
Cardiovascular issues: Chest pain or pressure, rapid heartbeat, or irregular heartbeat.
Severe dizziness or fainting.
Shortness of breath.
Blood clots or circulatory problems: Swelling, warmth, numbness, color changes, or pain in a leg or arm.
Neurological problems: Weakness on one side of the body, difficulty 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 this medication. These reactions can affect body organs and be life-threatening. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.
Additional Side Effects (Injection into the Spine)
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 concerned about any of the following side effects or if they persist, 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, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Allergic reactions: Rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be fatal.
Kidney problems: Inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Thyroid problems: Weight changes, nervousness, excitability, restlessness, weakness, hair thinning, depression, eye or neck swelling, difficulty focusing, heat or cold intolerance, menstrual changes, shakiness, or sweating.
Cardiovascular issues: Chest pain or pressure, rapid heartbeat, or irregular heartbeat.
Severe dizziness or fainting.
Shortness of breath.
Blood clots or circulatory problems: Swelling, warmth, numbness, color changes, or pain in a leg or arm.
Neurological problems: Weakness on one side of the body, difficulty 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 this medication. These reactions can affect body organs and be life-threatening. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.
Additional Side Effects (Injection into the Spine)
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 concerned about any of the following side effects or if they persist, 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, 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 or wheezing
- Hives, rash, or severe itching
- Swelling of the face, lips, tongue, or throat
- Dizziness or feeling faint
- Severe nausea or vomiting
- 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 and situations 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 reactions you have experienced, including the symptoms.
If you are dehydrated, have been experiencing poor nutrition, or have recently used laxatives or diuretics (water pills).
If you have a medical condition called homocystinuria.
If you have had a skin reaction to this medication or similar medications 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 medications within the last 48 hours. There are numerous medications that can increase seizure risk, so 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 medications and health conditions. 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 and situations 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 reactions you have experienced, including the symptoms.
If you are dehydrated, have been experiencing poor nutrition, or have recently used laxatives or diuretics (water pills).
If you have a medical condition called homocystinuria.
If you have had a skin reaction to this medication or similar medications 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 medications within the last 48 hours. There are numerous medications that can increase seizure risk, so 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 medications and health conditions. 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 redness, burning, pain, swelling, blisters, skin sores, or fluid leakage. Immediately notify your nurse if you experience any of these symptoms, as they can indicate that the medication is leaking from the vein.
Regular blood tests may be necessary to ensure safe treatment. Consult with your doctor to determine the best course of action. Additionally, this medication may interfere with certain laboratory tests, so it is crucial to inform all your healthcare providers and lab 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 to make an informed decision.
Special Considerations for Children
When administering this medication to children, exercise caution, as the risk of side effects may be higher in certain pediatric populations. 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 potential effects. 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 redness, burning, pain, swelling, blisters, skin sores, or fluid leakage. Immediately notify your nurse if you experience any of these symptoms, as they can indicate that the medication is leaking from the vein.
Regular blood tests may be necessary to ensure safe treatment. Consult with your doctor to determine the best course of action. Additionally, this medication may interfere with certain laboratory tests, so it is crucial to inform all your healthcare providers and lab 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 to make an informed decision.
Special Considerations for Children
When administering this medication to children, exercise caution, as the risk of side effects may be higher in certain pediatric populations. 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 potential effects. If you have any questions or concerns, consult with your child's doctor.
Overdose Information
Overdose Symptoms:
- Fluid overload (pulmonary edema)
- Electrolyte imbalance
- 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. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Major Interactions
- Metformin (in patients with renal impairment or acute kidney injury risk)
- Interleukin-2 (increased risk of delayed reactions)
Moderate Interactions
- Beta-blockers (increased risk of severe anaphylactoid reactions, blunted response to epinephrine)
- Diuretics (increased risk of dehydration and CIN)
- Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cyclosporine, cisplatin - increased risk of CIN)
- Oral cholecystographic agents (may interfere with visualization)
Monitoring
Baseline Monitoring
Renal function (serum creatinine, eGFR)
Rationale: To assess baseline kidney function and risk of contrast-induced nephropathy (CIN).
Timing: Prior to contrast administration, especially in patients with risk factors.
Thyroid function (TSH, T3, T4)
Rationale: Iodinated contrast can induce hyperthyroidism or hypothyroidism, especially in susceptible individuals.
Timing: Consider in patients with pre-existing thyroid disease or risk factors.
Allergy history
Rationale: To identify patients at higher risk for hypersensitivity reactions.
Timing: Prior to contrast administration.
Hydration status
Rationale: Adequate hydration is crucial for preventing CIN.
Timing: Prior to contrast administration.
Routine Monitoring
Vital signs (BP, HR, RR, O2 sat)
Frequency: During and immediately after injection, then as clinically indicated.
Target: Within patient's normal range.
Action Threshold: Significant deviations (e.g., hypotension, bradycardia, respiratory distress) require immediate intervention.
Signs/symptoms of hypersensitivity reaction
Frequency: Continuously during and for at least 30-60 minutes post-injection.
Target: Absence of symptoms.
Action Threshold: Rash, urticaria, angioedema, bronchospasm, hypotension, anaphylaxis.
Renal function (serum creatinine)
Frequency: 24-72 hours post-procedure in high-risk patients.
Target: Stable or returning to baseline.
Action Threshold: Increase in serum creatinine by âĨ 0.3 mg/dL or âĨ 50% from baseline within 48-72 hours.
Symptom Monitoring
- Hives
- Itching
- Rash
- Swelling (face, throat, tongue)
- Difficulty breathing
- Wheezing
- Cough
- Dizziness
- Lightheadedness
- Nausea
- Vomiting
- Headache
- Warm sensation
- Metallic taste
- Chest pain
- Palpitations
- Seizures
- Changes in consciousness
Special Patient Groups
Pregnancy
Risk Summary: Limited data on Iopamidol use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. Animal reproduction studies have not demonstrated teratogenicity. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
No specific data indicating increased risk, but generally avoid non-essential procedures.
Second Trimester:
No specific data indicating increased risk.
Third Trimester:
No specific data indicating increased risk. Potential for transient hypothyroidism in the neonate due to iodine exposure, though rare.
Lactation
Risk Summary: Limited data indicate that Iopamidol is minimally excreted into human milk. The amount of iodine transferred to the breastfed infant is small. Consider temporarily interrupting breastfeeding for 24 hours after administration to minimize infant exposure, though this is often not considered necessary by many guidelines.
Infant Risk:
Low risk of adverse effects. Potential for transient thyroid suppression in the infant, but generally considered negligible.
Pediatric Use
Dosing must be carefully calculated based on weight and procedure. Pediatric patients, especially neonates and infants, are more susceptible to fluid shifts, electrolyte imbalances, and hypothermia. Close monitoring of hydration and vital signs is essential. Higher risk of contrast-induced nephropathy in neonates with immature renal function.
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 and hydration status is crucial. Use the lowest effective dose.
Clinical Information
Clinical Pearls
- Always assess patient's renal function (eGFR) prior to administration, especially in high-risk groups (elderly, diabetics, pre-existing renal disease).
- Ensure adequate hydration before and after contrast administration to minimize the risk of contrast-induced nephropathy.
- Patients on metformin should have it withheld before and for 48 hours after contrast administration if there is a risk of acute kidney injury, and restarted only after renal function is confirmed to be normal.
- Be prepared for hypersensitivity reactions, ranging from mild to severe anaphylaxis. Have resuscitation equipment and medications (epinephrine, antihistamines, corticosteroids) 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.
- Extravasation can occur; monitor injection site for swelling, pain, or redness. Management typically involves elevation, cold compresses, and observation.
Alternative Therapies
- Iohexol (Omnipaque)
- Iopromide (Ultravist)
- Ioversol (Optiray)
- Gadolinium-based contrast agents (for MRI, different mechanism)
- Barium sulfate (for GI tract imaging, different mechanism)
Cost & Coverage
Average Cost:
Varies widely by volume and supplier, typically $50 - $300+ per 50 mL vial
Generic Available:
Yes
Insurance Coverage:
Generally covered by medical insurance as part of a diagnostic procedure.
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 to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the proper disposal method, consult your pharmacist, as they may be aware of drug take-back programs in your area. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.