Overview
11 DESCRIPTION BLUDIGO (indigotindisulfonate sodium injection, USP) is a sterile deep blue diagnostic dye for intravenous use. Each mL contains 8 mg indigotindisulfonate sodium (equivalent to 7.2 mg indigotindisulfonate) and may also contain citric acid and sodium citrate to adjust pH value between 3 and 6.5 and has an osmolality ≤0.05 osmol/kg.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Indigotindisulfonate is a dye excreted by the kidney through tubular secretion and enhances visualization of the ureteral orifices by its deep blue color. 12.2 Pharmacodynamics The blue color is detectable at the ureteral orifices within 4 minutes to 9 minutes after the intravenous injection. 12.3 Pharmacokinetics The pharmacokinetic properties of BLUDIGO are presented in Table 2 . Table 2. Pharmacokinetics of Indigotindisulfonate in Healthy Adults Following Intravenous Administration of BLUDIGO 5 mL (40 mg) a Unchanged drug C max = maximum plasma concentration; AUC 0-INF =area under the plasma concentration-time curve from time of administration extrapolated to infinity; CV=coefficient of variation BLUDIGO 5 mL (40 mg) General Information...
Indications
- 1 INDICATIONS AND USAGE BLUDIGO is indicated for use 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. BLUDIGO is a diagnostic dye indicated for use 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. ( 1 )
Common Doses
- 5 mL
Dosage
2 DOSAGE AND ADMINISTRATION Recommended dose is 5 mL given intravenously over 1 minute. ( 2.1 ) Monitor blood pressure and heart rhythm during and after injection. ( 2.2 ) 2.1 Recommended Dosage The recommended dose of BLUDIGO is 5 mL given as an intravenous injection over 1 minute. The blue color is detectable at the ureteral orifices within 4 minutes to 9 minutes after the intravenous injection. 2.2 Important Administration Instructions Monitor blood pressure and cardiac rhythm during and following the injection [see Warnings and Precautions ( 5.1 )] . Use immediately after opening ampule.
Contraindications
- 4 CONTRAINDICATIONS BLUDIGO is contraindicated in patients with known hypersensitivity to indigotindisulfonate or any of its components [see Warnings and Precautions ( 5.2 )] . Known hypersensitivity to indigotindisulfonate or any of its components. ( 4 )
Side Effects
- 6 ADVERSE REACTIONS Clinically significant adverse reactions are described elsewhere in the labeling: Cardiovascular Reactions [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Adverse reactions (≥ 1%) are constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1–800-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.