Cystografin-Dilute 18% 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 B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cystografin-Dilute 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) and is not injected into your blood.
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 is 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 injection, and you will not be responsible for storing or disposing of it.
What to Do If a Dose Is Missed
As this medication is administered in a healthcare setting, you will not need to take any action if a dose is missed. The healthcare professionals will be responsible for ensuring you receive the correct dosage as prescribed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is 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 injection, and you will not be responsible for storing or disposing of it.
What to Do If a Dose Is Missed
As this medication is administered in a healthcare setting, you will not need to take any action if a dose is missed. The healthcare professionals will be responsible for ensuring you receive the correct dosage as prescribed by your doctor.
Lifestyle & Tips
- No specific lifestyle changes are required before or after the procedure, other than those related to the underlying medical condition.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
200-400 mL instilled into the bladder
Dose Range:
200 - 400 mg
Condition-Specific Dosing:
cystography:
Instill slowly via catheter until bladder is adequately distended or patient feels discomfort.
Pediatric Dosing
Neonatal:
Not established (volume varies greatly, typically 50-100 mL)
Infant:
Volume varies with age and bladder capacity, typically 50-150 mL
Child:
Volume varies with age and bladder capacity, typically 100-300 mL
Adolescent:
Volume varies with age and bladder capacity, typically 200-400 mL
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations for instillation (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Diatrizoate meglumine is an iodinated contrast agent that opacifies structures in the path of the X-ray beam. When instilled into the bladder, it provides radiographic contrast by absorbing X-rays, allowing visualization of the bladder and lower urinary tract.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal (<1%) from intact bladder mucosa
Tmax:
Not applicable for systemic absorption; immediate opacification upon instillation
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Not applicable (minimal systemic distribution)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (primarily expelled from bladder)
Clearance:
Not applicable (primarily expelled from bladder)
ExcretionRoute:
Primarily expelled from bladder; if absorbed, excreted unchanged renally
Unchanged:
100% (if absorbed systemically)
Pharmacodynamics
OnsetOfAction:
Immediate upon instillation
PeakEffect:
Immediate upon instillation
DurationOfAction:
As long as the contrast agent remains in the bladder
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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious side effect:
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 or seek medical help.
Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
Visit the FDA's MedWatch website at https://www.fda.gov/medwatch to report side effects online.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious side effect:
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 or seek medical help.
Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
Visit the FDA's MedWatch website at https://www.fda.gov/medwatch to report side effects online.
Seek Immediate Medical Attention If You Experience:
- Severe itching or rash after the procedure
- Difficulty breathing or wheezing
- Swelling of the face, lips, or tongue
- Unusual pain or discomfort in the bladder area that persists 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:
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions.
* Any existing health problems, as this medication may affect your condition or interact with other health issues.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions.
* Any existing health problems, as this medication may affect your condition or interact with other health issues.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
Precautions & Cautions
It is essential to inform all 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 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 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 proper instillation due to minimal systemic absorption. If significant absorption occurs (e.g., through damaged mucosa), symptoms could include: severe allergic reactions, cardiovascular effects (hypotension, arrhythmia), renal impairment (rare).
What to Do:
Discontinue administration, remove contrast from bladder if possible. Symptomatic and supportive treatment. For systemic reactions, manage as per standard contrast reaction protocols (e.g., antihistamines, corticosteroids, epinephrine). Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Allergy history (especially to iodine or contrast media)
Rationale: To identify patients at risk for hypersensitivity reactions.
Timing: Prior to administration
Renal function (e.g., serum creatinine, BUN)
Rationale: While systemic absorption is minimal, severe mucosal damage could lead to increased absorption, making renal function relevant for excretion.
Timing: Prior to administration (if concerns about mucosal integrity)
Routine Monitoring
Patient comfort and vital signs
Frequency: During and immediately after instillation
Target: Stable
Action Threshold: Signs of discomfort, pain, or changes in vital signs warrant immediate assessment.
Signs of allergic reaction (e.g., rash, itching, dyspnea)
Frequency: During and for a period after the procedure
Target: Absence of symptoms
Action Threshold: Any signs of hypersensitivity require immediate medical intervention.
Symptom Monitoring
- Hives
- Itching
- Rash
- Difficulty breathing
- Swelling of face, lips, tongue, or throat
- Dizziness
- Nausea
- Vomiting
- Bladder discomfort or pain during instillation
Special Patient Groups
Pregnancy
Cystografin-Dilute is Pregnancy Category B. Studies in animals have not shown risk, but human studies are limited. Due to minimal systemic absorption when instilled into the bladder, the risk to the fetus is considered low.
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
Caution should be exercised. While minimal systemic absorption is expected, it is unknown if diatrizoate meglumine is excreted in human milk following bladder instillation. Given the low systemic exposure, the risk to the nursing infant is likely low.
Infant Risk:
Low
Pediatric Use
Used in pediatric patients for cystography. Dosing volume is adjusted based on age and bladder capacity. Safety and efficacy are established.
Geriatric Use
No specific dose adjustments are typically required for geriatric patients. Use with caution in patients with pre-existing conditions that might increase the risk of adverse reactions, though systemic absorption is minimal.
Clinical Information
Clinical Pearls
- Ensure the patient has no known allergies to iodine or contrast media before administration.
- Administer slowly to avoid bladder spasm and discomfort.
- The concentration (18%) is specifically for retrograde administration and should NOT be used intravenously.
- Ensure proper catheter placement to prevent extravasation of contrast material.
- Monitor for signs of bladder irritation or infection post-procedure, although rare.
Alternative Therapies
- Other iodinated contrast agents for retrograde urography (e.g., Iohexol, Iopamidol, specifically formulated for this route)
- Ultrasound (for bladder imaging)
- MRI (for bladder imaging, though less common for routine cystography)
Cost & Coverage
Average Cost:
Varies widely per 300ml bottle
Generic Available:
Yes
Insurance Coverage:
Typically covered under diagnostic imaging procedures (medical benefit)
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. Unless instructed otherwise, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper 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 was taken to ensure prompt and effective treatment.