Iopamidol 61% Sdv Inj, 30ml
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, Radiographic Contrast Media
Pharmacologic Class
Non-ionic, Iodinated Contrast Media
Pregnancy Category
Category B
FDA Approved
Aug 1985
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 inside your body more clearly, especially blood vessels and organs, to diagnose medical conditions. It's given as an injection, usually into a vein.
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 help minimize potential side effects.
Storage and Disposal
This medication will be administered to you 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. 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 help minimize potential side effects.
Storage and Disposal
This medication will be administered to you 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. Your healthcare provider will administer the medication as scheduled.
Lifestyle & Tips
- Ensure adequate hydration before and after the procedure as advised by your doctor.
- Inform your doctor about all medications you are taking, especially for diabetes (like metformin) or kidney problems.
- Report any allergies, especially to iodine or previous contrast dyes.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies significantly by procedure and route of administration. For example, for cerebral angiography: 5-10 mL (61% solution) per injection, total dose up to 100 mL. For CT head: 50-150 mL (61% solution) IV. For CT abdomen/pelvis: 100-150 mL (61% solution) IV.
Dose Range:
5 - 200 mg
Condition-Specific Dosing:
angiography:
5-10 mL per injection, total up to 100 mL (cerebral); 20-50 mL per injection, total up to 250 mL (peripheral)
CT_head:
50-150 mL IV
CT_body:
100-150 mL IV
urography:
50-100 mL IV
Pediatric Dosing
Neonatal:
Dosing varies by procedure and weight. Generally 1-3 mL/kg, not to exceed 50 mL total.
Infant:
Dosing varies by procedure and weight. Generally 1-3 mL/kg, not to exceed 50 mL total.
Child:
Dosing varies by procedure and weight. Generally 1-3 mL/kg, not to exceed 100 mL total.
Adolescent:
Dosing varies by procedure and weight. Generally 1-3 mL/kg, not to exceed 150 mL total, or adult dose if appropriate.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor renal function.
Moderate:
Use with caution. Consider lower doses and ensure adequate hydration. Monitor renal function closely.
Severe:
Use with extreme caution. Avoid if possible. If necessary, consider lowest effective dose and ensure adequate hydration. Increased risk of acute kidney injury. Dialysis may be considered post-procedure to remove contrast.
Dialysis:
Iopamidol is dialyzable. If administered to patients on dialysis, consider scheduling administration just prior to dialysis session to facilitate removal.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
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. This increased attenuation allows for visualization of internal structures (e.g., blood vessels, kidneys, brain lesions) on radiographic images. The iodine atoms are responsible for the X-ray absorption.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (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 subjects with normal renal function)
Clearance:
Approximately 100 mL/min (renal clearance)
ExcretionRoute:
Primarily renal (glomerular filtration)
Unchanged:
> 95%
Pharmacodynamics
OnsetOfAction:
Seconds (after IV bolus)
PeakEffect:
Minutes (depending on circulation time and organ perfusion)
DurationOfAction:
5-15 minutes (for vascular enhancement), up to 60 minutes (for renal excretion visualization)
Confidence:
Medium
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 immediately or seek emergency 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 speaking, 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 excessive sweating.
Cardiovascular issues: Chest pain or pressure, rapid 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, facial drooping, 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 internal organs and be life-threatening. Seek immediate medical attention 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 Administration)
Seizures
Back pain
Stiff neck
Abnormal burning, numbness, or tingling sensations
Other Possible Side Effects
While many people may not experience side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for guidance:
Injection (Spinal Administration): Headache, nausea or vomiting, muscle pain
* Other Injection Products: Feeling of warmth, hot flashes, upset stomach
Reporting Side Effects
This is not an exhaustive list of potential side effects. If you have questions or concerns, 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 immediately or seek emergency 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 speaking, 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 excessive sweating.
Cardiovascular issues: Chest pain or pressure, rapid 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, facial drooping, 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 internal organs and be life-threatening. Seek immediate medical attention 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 Administration)
Seizures
Back pain
Stiff neck
Abnormal burning, numbness, or tingling sensations
Other Possible Side Effects
While many people may not experience side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for guidance:
Injection (Spinal Administration): Headache, nausea or vomiting, muscle pain
* Other Injection Products: Feeling of warmth, hot flashes, upset stomach
Reporting Side Effects
This is not an exhaustive list of potential side effects. If you have questions or concerns, 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, wheezing, or shortness of breath
- Hives, rash, or severe itching
- Swelling of your face, lips, tongue, or throat
- Dizziness or lightheadedness
- Nausea or vomiting
- Unusual pain, swelling, or redness at the injection site
- Decreased urination or swelling in your legs/feet 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 any 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 Administration (Spinal Injection):
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 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 Administration (Spinal Injection):
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 this drug can increase the risk of blood clots when used in conjunction with certain procedures, which may lead to potentially life-threatening conditions such as heart attack and stroke. 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 may indicate that the drug 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.
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. Children under the age of 3 are at a increased risk of developing low thyroid function, which can impact their development. As a result, your child's thyroid function may need to be monitored for an extended period after receiving the injection. If you have any concerns or questions, consult with your 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 this drug can increase the risk of blood clots when used in conjunction with certain procedures, which may lead to potentially life-threatening conditions such as heart attack and stroke. 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 may indicate that the drug 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.
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. Children under the age of 3 are at a increased risk of developing low thyroid function, which can impact their development. As a result, your child's thyroid function may need to be monitored for an extended period after receiving the injection. If you have any concerns or questions, consult with your doctor.
Overdose Information
Overdose Symptoms:
- Acute renal failure
- Cardiovascular collapse
- Pulmonary edema
- Seizures
- Coma
What to Do:
Treatment is symptomatic and supportive. Maintain airway, breathing, and circulation. Monitor renal function. Iopamidol is dialyzable, so hemodialysis may be used to remove excess contrast in severe cases, especially with renal impairment. 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): Increased 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 adverse reactions (e.g., fever, rash, flu-like symptoms, renal dysfunction) due to altered contrast distribution and elimination.
Moderate Interactions
- Beta-blockers: Increased risk of severe hypersensitivity reactions and reduced efficacy of epinephrine in treating such reactions.
- Diuretics (especially loop diuretics): Increased risk of acute kidney injury, particularly in dehydrated patients.
- Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin): Concomitant use increases 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 nephropathy.
Timing: Prior to administration, especially in patients with risk factors.
Allergy history (especially to iodine or previous contrast media)
Rationale: To identify patients at increased risk of 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.
Timing: Consider in patients with known or suspected thyroid dysfunction.
Hydration status
Rationale: Dehydration increases the risk of contrast-induced nephropathy.
Timing: Prior to administration.
Routine Monitoring
Vital signs (BP, HR, RR, O2 Sat)
Frequency: Before, during, and immediately after administration, 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 minutes after administration.
Target: Absence of symptoms
Action Threshold: Rash, urticaria, angioedema, bronchospasm, hypotension, anaphylaxis require immediate treatment.
Renal function (Serum Creatinine, eGFR)
Frequency: 48-72 hours post-procedure in high-risk patients (e.g., pre-existing renal impairment, diabetes, heart failure, elderly).
Target: Within baseline or acceptable increase
Action Threshold: Increase in serum creatinine by âĨ 0.3 mg/dL or âĨ 50% from baseline within 48-72 hours.
Symptom Monitoring
- Rash
- Urticaria (hives)
- Pruritus (itching)
- Angioedema (swelling of face, lips, tongue)
- Bronchospasm (wheezing, shortness of breath)
- Hypotension (dizziness, lightheadedness)
- Nausea
- Vomiting
- Headache
- Dizziness
- Extravasation (pain, swelling, redness at injection site)
- Signs of acute kidney injury (decreased urine output, edema)
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. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus. Avoid unnecessary radiation exposure during pregnancy.
Trimester-Specific Risks:
First Trimester:
Potential for fetal exposure, but no known teratogenic effects from Iopamidol itself. Radiation exposure is the primary concern.
Second Trimester:
Similar to first trimester, primary concern is radiation exposure.
Third Trimester:
Similar to first trimester, primary concern is radiation exposure. Potential for transient hypothyroidism in the neonate due to iodine load, though rare with non-ionic agents.
Lactation
Iopamidol is excreted in human milk in very small amounts. The American Academy of Pediatrics considers iodinated contrast agents compatible with breastfeeding. Lactation Risk Category L2 (Safer).
Infant Risk:
Minimal risk to the infant. Less than 0.5% of the administered dose is excreted into breast milk within 24 hours. Absorption from the infant's GI tract is minimal. A theoretical risk of transient thyroid suppression in the infant exists, but is considered very low with non-ionic agents. If concerns exist, breastfeeding can be interrupted for 24 hours after administration, and milk can be expressed and discarded during this period.
Pediatric Use
Dosing is weight-based. Pediatric patients, especially neonates and infants, are more susceptible to fluid shifts and electrolyte imbalances. Careful attention to hydration status and renal function is crucial. Higher risk of acute kidney injury in neonates and infants with immature renal function. Avoid extravasation due to potential for tissue damage.
Geriatric Use
Elderly patients are at increased risk for contrast-induced nephropathy due to age-related decline in renal function, comorbidities (e.g., diabetes, heart failure), and polypharmacy. Careful assessment of renal function and hydration status is essential. Use the lowest effective dose. 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 the procedure to minimize the risk of contrast-induced nephropathy.
- Patients with a history of severe allergic reactions to contrast media may require premedication (e.g., corticosteroids, antihistamines) or an alternative imaging modality.
- Closely monitor patients for hypersensitivity reactions during and for at least 30 minutes after injection, as delayed reactions can occur.
- Inform diabetic patients taking metformin about the need to withhold the drug before and after the procedure based on renal function.
- Extravasation can occur; monitor injection site and manage according to institutional protocol (e.g., elevation, cold compress).
Alternative Therapies
- Iohexol (Omnipaque)
- Iopromide (Ultravist)
- Ioversol (Optiray)
- Iodixanol (Visipaque - iso-osmolar contrast agent, potentially lower CIN risk in high-risk patients)
- 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, typically $50 - $300+ per 30 mL vial (61% solution)
Generic Available:
Yes
Insurance Coverage:
Typically 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 promptly. 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 otherwise, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities offer 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 for more information. 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 happened to ensure prompt and effective treatment.