Cystografin 30% Inj, 300ml
It is used before an x-ray or other test like it.
Drug Class
Diagnostic agent
Pharmacologic Class
Iodinated contrast media
Pregnancy Category
Category C
FDA Approved
Mar 1960
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cystografin is a special liquid containing iodine that helps doctors see your bladder and urinary tract more clearly on X-ray pictures. It's put directly into your bladder through a small tube (catheter) for a test called a cystogram.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the instructions carefully. This medication is administered through a catheter directly into the bladder.
Storing and Disposing of Your Medication
Since this medication is given as an injection in a healthcare setting, you will not need to store it at home. A healthcare professional will administer the medication, and you will not be responsible for storing or disposing of it.
Missing a Dose
As this medication is administered in a healthcare setting, you will not need to worry about missing a dose. The healthcare professionals will ensure that you receive the medication as scheduled.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the instructions carefully. This medication is administered through a catheter directly into the bladder.
Storing and Disposing of Your Medication
Since this medication is given as an injection in a healthcare setting, you will not need to store it at home. A healthcare professional will administer the medication, and you will not be responsible for storing or disposing of it.
Missing a Dose
As this medication is administered in a healthcare setting, you will not need to worry about missing a dose. The healthcare professionals will ensure that you receive the medication as scheduled.
Lifestyle & Tips
- Inform your doctor about any allergies, especially to iodine or previous contrast dyes.
- Report any discomfort or pain during the procedure.
- Drink plenty of fluids after the procedure to help flush out the dye and prevent urinary tract irritation.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For cystography, the bladder is filled with Cystografin 30% solution (undiluted) until the patient feels a sense of fullness or until the desired volume (typically 200-400 mL) is instilled. The solution is instilled via a catheter.
Dose Range:
200 - 400 mg
Condition-Specific Dosing:
cystography:
Instill 200-400 mL into the bladder via catheter.
Pediatric Dosing
Neonatal:
Not established (volume based on bladder capacity, typically 30-50 mL)
Infant:
Dosing based on bladder capacity (e.g., 50-100 mL), instilled via catheter.
Child:
Dosing based on bladder capacity (e.g., 100-200 mL), instilled via catheter.
Adolescent:
Dosing based on bladder capacity (e.g., 200-400 mL), instilled via catheter.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption with intravesical use)
Moderate:
No adjustment needed (minimal systemic absorption with intravesical use)
Severe:
No adjustment needed (minimal systemic absorption with intravesical use)
Dialysis:
No specific considerations for intravesical use, as systemic absorption is minimal.
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption with intravesical use)
Moderate:
No adjustment needed (minimal systemic absorption with intravesical use)
Severe:
No adjustment needed (minimal systemic absorption with intravesical use)
Pharmacology
Mechanism of Action
Diatrizoate meglumine is an iodinated contrast agent. When instilled into the bladder, the iodine atoms within the molecule absorb X-rays, creating a radiopaque image of the bladder and lower urinary tract, allowing for visualization during fluoroscopy or radiography.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible (when administered intravesically to an intact bladder)
Tmax:
Not applicable (immediate effect upon instillation)
FoodEffect:
Not applicable (intravesical administration)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (primarily remains in bladder until voided)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Immediate upon instillation into the bladder
PeakEffect:
Immediate upon complete bladder filling
DurationOfAction:
Duration of the imaging procedure (until voided)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Blood in the urine
Bladder irritation
Difficulty urinating or changes in urine output
* Seizures
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor for advice.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, discuss them with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Blood in the urine
Bladder irritation
Difficulty urinating or changes in urine output
* Seizures
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor for advice.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, discuss them with 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 itching or rash
- Hives
- Difficulty breathing or wheezing
- Swelling of the face, lips, or tongue
- Dizziness or lightheadedness
- Unusual pain or burning during or after urination (though mild irritation is possible)
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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current 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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Thyroid problems have been reported in some individuals taking this drug, and in some cases, treatment was necessary. Be sure to discuss any concerns with your doctor.
This medication may interfere with certain laboratory tests, so it is crucial to notify all of your healthcare providers and laboratory personnel that you are taking this drug.
If you are pregnant, planning to become pregnant, or are breastfeeding, you must consult with your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Thyroid problems have been reported in some individuals taking this drug, and in some cases, treatment was necessary. Be sure to discuss any concerns with your doctor.
This medication may interfere with certain laboratory tests, so it is crucial to notify all of your healthcare providers and laboratory personnel that you are taking this drug.
If you are pregnant, planning to become pregnant, or are breastfeeding, you must consult with your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with intravesical administration due to minimal systemic absorption. If significant systemic absorption occurred (e.g., bladder perforation), symptoms could include severe allergic reactions, cardiovascular effects, or renal impairment.
What to Do:
If systemic overdose is suspected, treatment is supportive. For allergic reactions, administer antihistamines, corticosteroids, and/or epinephrine as needed. In case of severe reactions, call 911 or emergency services. For general concerns, call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Patient history (allergies, especially to iodine or contrast media)
Rationale: To identify potential hypersensitivity reactions.
Timing: Prior to administration
Renal function (e.g., serum creatinine, GFR)
Rationale: While systemic absorption is minimal, severe renal impairment could theoretically increase risk if significant absorption occurs (e.g., bladder perforation).
Timing: Prior to administration (especially if systemic absorption is a concern)
Routine Monitoring
Vital signs (blood pressure, heart rate, respiratory rate)
Frequency: During and immediately after instillation
Target: Within patient's normal limits
Action Threshold: Significant deviations from baseline or signs of allergic reaction
Observation for signs of allergic reaction (e.g., rash, urticaria, dyspnea, angioedema)
Frequency: During and for a short period after the procedure
Target: Absence of symptoms
Action Threshold: Any signs of hypersensitivity
Patient comfort and bladder distension
Frequency: During instillation
Target: Patient reports fullness without severe pain
Action Threshold: Severe pain or discomfort, indicating overdistension or irritation
Symptom Monitoring
- Rash
- Urticaria (hives)
- Pruritus (itching)
- Dyspnea (shortness of breath)
- Wheezing
- Angioedema (swelling of face, lips, tongue)
- Hypotension
- Nausea
- Vomiting
- Bladder discomfort or pain during instillation
Special Patient Groups
Pregnancy
Category C. While animal studies have shown adverse effects, human data are limited. However, due to minimal systemic absorption when administered intravesically, the risk to the fetus is considered low. Use only if clearly needed and the potential benefit outweighs the potential risk.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
L3 (Moderately Safe). Minimal amounts of diatrizoate meglumine are excreted into breast milk following systemic administration, and even less is expected with intravesical administration due to minimal absorption. Infant exposure is likely very low. Consider temporarily interrupting breastfeeding for 12-24 hours if concerns exist, though generally not necessary.
Infant Risk:
Low risk of adverse effects to the breastfed infant.
Pediatric Use
Cystografin is commonly used in pediatric patients for cystography. Dosing is adjusted based on the child's age, weight, and bladder capacity. Close monitoring for bladder distension and discomfort is important.
Geriatric Use
No specific dose adjustments are typically required for geriatric patients for intravesical administration due to minimal systemic absorption. However, older patients may have increased sensitivity to bladder distension or be more prone to urinary tract infections post-catheterization.
Clinical Information
Clinical Pearls
- Cystografin is for intravesical (bladder) use only; it is NOT for intravenous injection.
- Ensure the patient is adequately hydrated before and after the procedure to help prevent urinary tract irritation.
- Always check for patient allergies, especially to iodine or previous contrast media, before administration.
- The solution should be warmed to body temperature before instillation for patient comfort.
- Monitor for signs of bladder overdistension during instillation, such as severe pain or discomfort.
Alternative Therapies
- Other iodinated contrast agents for cystography (e.g., Iohexol, Iopamidol, though diatrizoate is common for this use)
- Ultrasound (for bladder imaging, though may not provide the same detail for reflux or urethral anatomy)
- MRI (less common for routine cystography, but can be used for complex cases)
Cost & Coverage
Average Cost:
Not available per 300ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often covered for diagnostic procedures)
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 or take someone else's medication. 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 correct 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 ingestion to ensure timely and effective treatment.