Cystografin 30% Inj, 100ml

Manufacturer BRACCO DIAGNOSTICS Active Ingredient Diatrizoate Meglumine(dye a tri ZOE ate MEG loo meen) Pronunciation dye a tri ZOE ate MEG loo meen
It is used before an x-ray or other test like it.
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Drug Class
Diagnostic agent
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Pharmacologic Class
Iodinated contrast media
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Pregnancy Category
C
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FDA Approved
Aug 1971
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Cystografin is a special liquid containing iodine that helps doctors see your bladder and urinary tubes (urethra) clearly on X-ray pictures. It's put directly into your bladder through a small tube (catheter) and is used to check for problems like blockages or reflux.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided to you. 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 You Miss 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.
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Lifestyle & Tips

  • No specific lifestyle changes are required before or after the procedure, other than those related to the underlying medical condition.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Retrograde instillation of 50-100 mL into the bladder
Dose Range: 50 - 100 mg

Condition-Specific Dosing:

cystourethrography: 50-100 mL instilled into the bladder via catheter until bladder is full or patient feels discomfort.
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Pediatric Dosing

Neonatal: Dosing based on bladder capacity, typically 10-20 mL or until bladder is full.
Infant: Dosing based on bladder capacity, typically 20-50 mL or until bladder is full.
Child: Dosing based on bladder capacity, typically 50-100 mL or until bladder is full.
Adolescent: Dosing similar to adult, 50-100 mL or until bladder is full.
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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 retrograde use (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

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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 that outlines the bladder and urethra, allowing for visualization of their anatomy and pathology during fluoroscopy or radiography.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal (negligible systemic absorption from intact bladder mucosa)
Tmax: Not applicable (local instillation)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable (minimal systemic distribution)
ProteinBinding: Minimal (if systemically absorbed)
CnssPenetration: Limited (if systemically absorbed)

Elimination:

HalfLife: Not applicable (minimal systemic absorption)
Clearance: Not applicable (minimal systemic absorption)
ExcretionRoute: Primarily excreted unchanged via urine if systemically absorbed (which is minimal from bladder)
Unchanged: Not applicable (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Immediate upon instillation
PeakEffect: Immediate during imaging
DurationOfAction: Duration of imaging procedure (typically minutes to an hour)
Confidence: High

Safety & Warnings

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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.

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. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe pain or burning during or after the procedure
  • Hives, rash, itching, or swelling (especially of the face, lips, or tongue)
  • Difficulty breathing or wheezing
  • Dizziness or lightheadedness
  • Fever or chills after the procedure (rare, seek medical attention)
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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 you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
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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.
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Overdose Information

Overdose Symptoms:

  • Unlikely with retrograde instillation due to minimal systemic absorption. Local symptoms might include bladder distension, discomfort, or spasm if excessive volume is instilled.

What to Do:

If excessive volume is instilled, the contrast can be drained. For systemic reactions (extremely rare with this route), management is supportive, similar to allergic reactions. Call 911 or poison control (1-800-222-1222) for severe reactions.

Drug Interactions

Monitoring

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Baseline Monitoring

Patient history (allergies, especially to iodine or contrast media)

Rationale: To identify potential hypersensitivity reactions.

Timing: Prior to procedure

Bladder capacity assessment (especially in pediatric patients)

Rationale: To determine appropriate volume for instillation.

Timing: Prior to procedure

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Routine Monitoring

Patient comfort/discomfort

Frequency: During instillation and imaging

Target: Minimal discomfort

Action Threshold: Significant pain or bladder spasm may require stopping instillation or adjusting rate.

Signs of allergic reaction (e.g., rash, itching, dyspnea)

Frequency: During and immediately after procedure

Target: Absence of symptoms

Action Threshold: Any signs of allergic reaction require immediate medical intervention.

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Symptom Monitoring

  • Bladder discomfort or pain
  • Urinary urgency or frequency
  • Signs of allergic reaction (e.g., hives, itching, rash, swelling of face/throat, difficulty breathing)
  • Fever or chills (rare, may indicate infection)

Special Patient Groups

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Pregnancy

Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. However, due to minimal systemic absorption from retrograde instillation, the risk to the fetus is considered very 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.
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Lactation

L3 (Moderately Safe). Diatrizoate meglumine is minimally absorbed systemically from the bladder. If any is absorbed, it is excreted in breast milk in very small amounts. Due to poor oral absorption by the infant, significant exposure is unlikely. Breastfeeding can generally continue.

Infant Risk: Low risk. Minimal systemic absorption by mother, minimal transfer to milk, and poor oral absorption by infant.
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Pediatric Use

Dosing is based on bladder capacity, which varies significantly with age. Care should be taken to avoid over-distension of the bladder. The procedure is generally well-tolerated in pediatric patients.

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Geriatric Use

No specific dose adjustments are typically needed. Consider potential for prostatic hypertrophy in males, which may affect catheterization or bladder emptying. Otherwise, generally well-tolerated.

Clinical Information

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Clinical Pearls

  • Cystografin is for retrograde (bladder) use only; it is NOT for intravenous administration.
  • Ensure proper catheter placement and sterile technique to prevent urinary tract infections.
  • Warm the solution to body temperature before instillation to minimize bladder spasm and discomfort.
  • Monitor for bladder distension and patient discomfort during instillation; stop if significant pain occurs.
  • While systemic reactions are rare, be prepared for potential hypersensitivity reactions, especially in patients with a history of allergies or previous contrast reactions (though less common with this route).
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Alternative Therapies

  • Other iodinated contrast agents for cystography (e.g., Iohexol, Iopamidol, or other diatrizoate formulations diluted for retrograde use).
  • Saline (for basic bladder distension, but without radiopacity).
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Cost & Coverage

Average Cost: Not available (varies by supplier and contract) per 100 mL bottle
Generic Available: Yes
Insurance Coverage: Typically covered under diagnostic imaging procedures (Part B for Medicare)
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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 to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. 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 the incident.