indigotindisulfonate sodium (Rx)

1-10%

Constipation (5%)

Nausea (3.3%)

Vomiting (3.3%)

Abdominal pain (3.3%)

Pyrexia (3.3%)

ALT increase (3.3%)

Dysuria (1.7%)

Postmarketing Reports

Cardiovascular disorders: Cardiac arrest, arrhythmia, asystole, atrioventricular block second degree, hypotension, elevation in blood pressure, bradycardia, tachycardia

General disorders and administration site conditions: Injection site discoloration

Immune system disorders: anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, erythema

Contraindications

Hypersensitivity to indigotindisulfonate or any of its components

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 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 potential for artifactual reduction in SpO2 when anesthetized patients are administered indigotindisulfonate

Pregnancy

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 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 on regarding effects on breastfed infants or milk production

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Dye excreted by kidneys through tubular secretion that enhances visualization of ureteral orifices by its deep blue color

Absorption

Peak plasma concentration: 6.33 mcg/mL

AUC: 1.15 mcg·hr/mL

Distribution

Vd: 10.7 L

Protein bound: ~90%

Metabolism

Primary metabolic pathways: Oxidative metabolism

Elimination

Half-life: 12 min

Clearance: 7.08 L/hr (urinary); 40.2 L/hr (total)

Preparation

Monitor blood pressure and cardiac rhythm during and following injection

Use immediately after opening ampule

Withdraw ampule contents through <5-micron filter straw/filter needle to ensure withdrawn solution contains no particulates

Visually inspect withdrawn solution for particulate matter and discoloration before administering; do not administer with infusion assemblies used with other diluents or drugs

Discard any unused portion

Storage

Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

Store in original carton to protect from light

Do not refrigerate or freeze

Use immediately after opening ampule