Iopamidol 41% 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
Category B
FDA Approved
Mar 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Iopamidol is a special dye used to help doctors see inside your body more clearly with X-rays, like during CT scans or angiograms. It's injected into a vein and helps highlight blood vessels and organs so they show up better on the images.
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 this medication, drink plenty of non-caffeinated liquids unless your doctor instructs you to limit your fluid intake. In some cases, other medications may be administered before this drug to help 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 be responsible for administering 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 this medication, drink plenty of non-caffeinated liquids unless your doctor instructs you to limit your fluid intake. In some cases, other medications may be administered before this drug to help 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 be responsible for administering 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 medications you are taking, especially metformin, and any allergies.
- Report any unusual symptoms during or after the procedure immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable based on procedure and patient weight/condition. For example, for cerebral angiography: 5-10 mL per injection; for CT head: 50-150 mL; for CT abdomen/pelvis: 100-150 mL. Administered as a bolus or infusion.
Dose Range:
5 - 200 mg
Condition-Specific Dosing:
angiography:
5-100 mL depending on vessel and procedure
CT:
50-150 mL depending on body area
urography:
50-100 mL
Pediatric Dosing
Neonatal:
Dosing is weight-based and procedure-specific. Typically 1-3 mL/kg, not to exceed 4 mL/kg or 100 mL total.
Infant:
Dosing is weight-based and procedure-specific. Typically 1-3 mL/kg, not to exceed 4 mL/kg or 100 mL total.
Child:
Dosing is weight-based and procedure-specific. Typically 1-3 mL/kg, not to exceed 4 mL/kg or 100 mL total.
Adolescent:
Dosing is weight-based and procedure-specific. Typically 1-3 mL/kg, not to exceed 4 mL/kg or 100 mL total.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment, but monitor renal function.
Moderate:
Use with caution. Consider lower doses, increased hydration, and alternative imaging if possible. Monitor renal function closely.
Severe:
Use with extreme caution. High risk of contrast-induced nephropathy (CIN). Consider alternative imaging. If necessary, ensure adequate hydration and consider prophylactic measures. Avoid in patients with acute kidney injury.
Dialysis:
Can be used in patients on dialysis, as it is dialyzable. Timing of dialysis post-contrast administration may be considered, but not universally required.
Hepatic Impairment:
Mild:
No specific dose adjustment needed.
Moderate:
No specific dose adjustment needed.
Severe:
No specific dose adjustment needed.
Pharmacology
Mechanism of Action
Iopamidol is a non-ionic, low-osmolar, water-soluble iodinated contrast medium. 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 organs 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:
Immediately after intravenous injection
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.16 L/kg (similar to extracellular fluid volume)
ProteinBinding:
< 2%
CnssPenetration:
Limited (does not cross intact blood-brain barrier)
Elimination:
HalfLife:
Approximately 2 hours (in subjects with normal renal function)
Clearance:
Renal clearance is approximately 100 mL/min/1.73m²
ExcretionRoute:
Renal (glomerular filtration)
Unchanged:
> 90% (excreted unchanged in urine)
Pharmacodynamics
OnsetOfAction:
Immediate (upon injection)
PeakEffect:
Immediate (upon injection, then rapidly distributes)
DurationOfAction:
Short (minutes to hours, depending on circulation and renal function)
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, 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 urinate, changes in urine output, blood in the urine, or significant weight gain.
Thyroid problems: Weight changes, feelings of nervousness, excitability, restlessness, or 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 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, speech or thinking difficulties, balance changes, drooping on one side of the face, or blurred vision.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or other serious reactions, which can occur anywhere from 1 hour to several weeks after receiving the medication. These reactions can affect body organs and be life-threatening. Seek immediate medical 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 (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, muscle pain
* All 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, 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, 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 urinate, changes in urine output, blood in the urine, or significant weight gain.
Thyroid problems: Weight changes, feelings of nervousness, excitability, restlessness, or 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 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, speech or thinking difficulties, balance changes, drooping on one side of the face, or blurred vision.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or other serious reactions, which can occur anywhere from 1 hour to several weeks after receiving the medication. These reactions can affect body organs and be life-threatening. Seek immediate medical 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 (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, muscle pain
* All 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, 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:
- Severe rash or hives
- Difficulty breathing or wheezing
- Swelling of the face, lips, or throat
- Severe dizziness or fainting
- Chest pain
- Sudden weakness or numbness
- 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 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 reaction you experienced, including any symptoms.
If you are dehydrated, have been eating poorly, or have recently used a laxative or diuretic (water pill).
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 drugs that can increase seizure risk, so consult your doctor or pharmacist if you are unsure.
This is not an exhaustive list of all potential interactions between this medication and other substances. Therefore, it is crucial to inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking.
Any natural products or vitamins you are using.
Your complete medical history, including any health problems.
Before starting, stopping, or changing the dose of any medication, consult your doctor to ensure it is safe to do so in conjunction with this medication.
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, such as foods or drugs. Describe the allergic reaction you experienced, including any symptoms.
If you are dehydrated, have been eating poorly, or have recently used a laxative or diuretic (water pill).
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 drugs that can increase seizure risk, so consult your doctor or pharmacist if you are unsure.
This is not an exhaustive list of all potential interactions between this medication and other substances. Therefore, it is crucial to inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking.
Any natural products or vitamins you are using.
Your complete medical history, including any health problems.
Before starting, stopping, or changing the dose of any medication, consult your doctor to ensure it is safe to do so in conjunction with this medication.
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 may indicate that the medication is leaking from the vein.
Your doctor may need to regularly check your blood work to ensure safe treatment. 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 to make an informed decision.
For pediatric patients, this medication should be used with caution, as some children may be at a higher risk of experiencing side effects. Children under the age of 3 are particularly vulnerable to developing low thyroid function after receiving this medication, which can impact their development. As a precaution, your child's thyroid function may need to be monitored for an extended period after the injection. If you have any questions or concerns, 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 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 may indicate that the medication is leaking from the vein.
Your doctor may need to regularly check your blood work to ensure safe treatment. 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 to make an informed decision.
For pediatric patients, this medication should be used with caution, as some children may be at a higher risk of experiencing side effects. Children under the age of 3 are particularly vulnerable to developing low thyroid function after receiving this medication, which can impact their development. As a precaution, your child's thyroid function may need to be monitored for an extended period after the injection. If you have any questions or concerns, consult with your doctor.
Overdose Information
Overdose Symptoms:
- Fluid overload (pulmonary edema, heart failure)
- Electrolyte imbalance
- Acute renal failure
- Severe hypersensitivity reactions
What to Do:
Treatment is symptomatic and supportive. Monitor vital signs, fluid and electrolyte balance. Dialysis may be used to remove Iopamidol from the body in cases of severe overdose or 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 risk factors for lactic acidosis)
- Interleukin-2 (IL-2) (increased risk of delayed adverse reactions)
Moderate Interactions
- Beta-blockers (increased risk of severe hypersensitivity reactions, blunted response to epinephrine)
- Diuretics (increased risk of dehydration and acute kidney injury)
- Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides) (increased risk of acute kidney injury)
Monitoring
Baseline Monitoring
Renal function (serum creatinine, eGFR)
Rationale: To assess risk of contrast-induced nephropathy (CIN) and guide hydration strategies.
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, T4)
Rationale: To assess risk of contrast-induced hyperthyroidism, especially in patients with pre-existing thyroid disease.
Timing: Prior to administration in at-risk patients.
Routine Monitoring
Vital signs (blood pressure, heart rate, respiratory rate)
Frequency: During and immediately after administration, then as clinically indicated.
Target: Within patient's normal range
Action Threshold: Significant deviations (e.g., hypotension, bradycardia, tachycardia, dyspnea) require immediate intervention.
Signs/symptoms of hypersensitivity reaction
Frequency: Continuously during and for at least 30 minutes post-administration.
Target: Absence of symptoms
Action Threshold: Urticaria, angioedema, bronchospasm, hypotension, or anaphylaxis require immediate treatment.
Renal function (serum creatinine)
Frequency: 24-72 hours post-administration in at-risk patients.
Target: Stable or returning to baseline
Action Threshold: Increase in serum creatinine ≥ 0.3 mg/dL or ≥ 50% from baseline indicates CIN.
Symptom Monitoring
- Rash
- Hives (urticaria)
- Itching (pruritus)
- Swelling of face, lips, tongue, or throat (angioedema)
- Difficulty breathing (dyspnea)
- Wheezing
- Cough
- Chest tightness
- Dizziness
- Lightheadedness
- Nausea
- Vomiting
- Headache
- Flushing
- Warm sensation
- Metallic taste in mouth
Special Patient Groups
Pregnancy
Category B. Animal reproduction studies have shown no evidence of fetal harm. However, 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.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified, but generally avoided unless essential.
Second Trimester:
No specific increased risk identified.
Third Trimester:
No specific increased risk identified.
Lactation
L3 (Moderately Safe). Minimal excretion into breast milk. Less than 0.5% of the administered dose is excreted into breast milk within 24 hours. Infant exposure is very low. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Low. Minimal absorption by the infant's gastrointestinal tract. No adverse effects reported in breastfed infants. Some sources suggest a temporary interruption of breastfeeding (e.g., 12-24 hours) may be considered, but is often not necessary.
Pediatric Use
Dosing is weight-based and procedure-specific. Children, especially neonates and infants, are more susceptible to fluid and electrolyte imbalances. Careful monitoring of hydration status and renal function is crucial. Risk of thyroid dysfunction (hypothyroidism) is higher in neonates and infants, requiring monitoring of thyroid function.
Geriatric Use
Increased risk of adverse reactions, particularly contrast-induced nephropathy, due to age-related decline in renal function. Use with caution, ensure adequate hydration, and monitor renal function closely. Lower doses or alternative imaging may be considered.
Clinical Information
Clinical Pearls
- Always assess patient's renal function (eGFR) before administering iodinated contrast media to mitigate the risk of contrast-induced nephropathy (CIN).
- Ensure adequate hydration before and after the procedure, especially in at-risk patients (e.g., elderly, pre-existing renal impairment, diabetes, heart failure).
- 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.
- Pre-medication with corticosteroids and/or antihistamines may be considered for patients with a history of prior contrast reactions or other significant allergies, though it does not guarantee prevention of severe reactions.
- Be prepared to manage acute hypersensitivity reactions, including anaphylaxis, with appropriate medications (e.g., epinephrine, antihistamines, corticosteroids) and resuscitation equipment.
- Iopamidol is a non-ionic, low-osmolar contrast agent, generally associated with a lower incidence of adverse reactions compared to high-osmolar agents.
Alternative Therapies
- Iohexol (Omnipaque)
- Iopromide (Ultravist)
- Ioversol (Optiray)
- Gadolinium-based contrast agents (for MRI, different mechanism)
- Ultrasound (non-ionizing imaging)
- Non-contrast CT or MRI (when appropriate)
Cost & Coverage
Average Cost:
Varies widely by concentration, volume, and supplier. Typically ranges from $50 - $300+ per 50mL vial. per 50mL 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 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, so be sure 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 occurred.