Indigotindisulfonate Sodium

Indigotindisulfonate Sodium is used as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures.

• Indigotindisulfonate Sodium is available under the following different brand names: Bludigo

Common side effects of Indigotindisulfonate Sodium include:

• constipation,
• nausea
• vomiting 
• abdominal pain
• fever
• elevated ALT levels
• dysuria

Serious side effects of Indigotindisulfonate Sodium include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• dizziness

Rare side effects of Indigotindisulfonate Sodium include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection

• 8 mg/mL (5-mL ampule)

Diagnostic Aid for Cystoscopy

Adult dosage

• 5 mL IV over 1 minute
• Blue color detectable at ureteral orifices within 4-9 minutes after IV injection

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Indigotindisulfonate Sodium has no noted severe interactions with any other drugs.
• Indigotindisulfonate Sodium has no noted serious interactions with any other drugs.
• Indigotindisulfonate Sodium has no noted moderate interactions with any other drugs.
• Indigotindisulfonate Sodium has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to indigotin-disulfonate or any of its components

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Indigotindisulfonate Sodium?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Indigotindisulfonate Sodium?”

Cautions

• Severe or life-threatening cardiovascular reactions (eg, cardiac arrest, arrhythmia, asystole, second-degree atrioventricular block, hypotension, elevated blood pressure, bradycardia, tachycardia) reported generally within 60 minutes following administration
• Patients with hypertension, heart rate, and conduction disorders, or medications causing bradycardia may be at increased risk for elevated blood pressure, hypotension, and bradycardia; closely monitor blood pressure and cardiac rhythm during and following the injection; interrupt administration if reactions observed
• Serious anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, or erythema were reported; monitor for anaphylactic reactions and have emergency equipment and trained personnel readily available
• May interfere with light absorption and transiently interfere with pulse oximetric methods; be aware of the potential for artifactual reduction in SpO2 when anesthetized patients are administered indigotin-disulfonate

Pregnancy and Lactation

• Available data on use in pregnant females over several decades have not identified a drug-associated risk of adverse maternal and fetal adverse effects
• Use during the first trimester of pregnancy is rare; thus, data are insufficient to evaluate for a drug-associated risk of major birth defects and miscarriage
• Lactation
  • Unknown if present in animal or human milk
  • Transfer into breastmilk is likely to be low and adverse effects on breastfed infants are not expected
  • There are no data regarding the effects on breastfed infants or milk production