Indigo Carmine

Dosage Form: injection, solution
Indigo Carmine INJECTION (Indigotindisulfonate Sodium Injection, USP)

Rx Only

DESCRIPTION

Each mL contains: Indigotindisulfonate Sodium 8 mg, Water for Injection q.s. pH adjusted, when necessary, with Citric Acid and/or Sodium Citrate. Sterile, nonpyrogenic.

Sufficient Indigo Carmine is contained in each 5 mL ampule to permit accurate withdrawal and administration of the full dose. It gives a deep blue solution when dissolved in water.

The structural formula is:

CLINICAL PHARMACOLOGY

Indigo Carmine is excreted largely by the kidneys, retaining its blue color during passage through the body.

Elimination of the dye begins soon after injection, appearing in the urine within 10 minutes in average cases. The biological half-life is 4 to 5 minutes following intravenous injection. Larger quantities are necessary when intramuscular injection is employed. Appearance time and elimination are delayed following intramuscular injection.

INDICATIONS AND USAGE

Originally employed as a kidney function test, the chief application of Indigo Carmine at present is localizing ureteral orifices during cystoscopy and ureteral catheterization.

CONTRAINDICATIONS

Indigo Carmine is contraindicated in patients who have previously experienced an adverse reaction following its use.

WARNINGS

An occasional idiosyncratic drug reaction may occur. A mild pressor effect may be encountered in some patients.

PRECAUTIONS

Pregnancy

Pregnancy Category C:

Animal Reproduction studies have not been conducted with indigotindisulfonate sodium injection. It is also not known whether indigotindisulfonate sodium injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Indigotindisulfonate sodium injection should be given to a pregnant woman only if clearly needed.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Indigo Carmine is administered to a nursing woman.

ADVERSE REACTIONS

SeeWARNINGS.

DRUG ABUSE AND DEPENDENCE

Indigo Carmine is not a controlled substance listed in any of the Drug Enforcement Administration Schedules. Its use is not known to lead to dependence or abuse.

OVERDOSAGE

There are no data available describing the signs, symptoms or laboratory findings accompanying overdosage.

No discernible symptoms of toxicity have been observed in mice with an intravenous dose of 200 mg/kg. After intravenous administration the LD50was established at 300 mg/kg in mice.

DOSAGE AND ADMINISTRATION

Indigo Carmine solution is injected either by the intravenous or intramuscular route, and its appearance at the ureteral orifices is watched with the cystoscope in place. The intravenous method is preferred because a 5 mL injection is sufficient. A lesser dosage in infants, children and underweight patients will prevent skin coloration.

Since precipitation of indigotindisulfonate sodium may occur, Indigo Carmine Solution must not be diluted prior to injection or injected with infusion assemblies which were used with other solutions.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

PROTECT FROM LIGHT. Indigo Carmine should be stored in the dark, away from direct light, preferably in the original package.

Store at 20 to 25 C (68 to 77 F); excursions permitted to 15 to 30 C (59 to 86 F) (See USP Controlled Room Temperature).

HOW SUPPLIED

Indigo Carmine Injection

NDC 0517-0375-10 5 mL ampules packaged in boxes of 10

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

IN0375

Rev. 1/09

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 5 mL Carton

Indigo Carmine INJECTION

(Indigotindisulfonate Sodium Injection, USP)

0.8% Solution

NDC 0517-0375-10

10 x 5 mL AMPULES

Rx Only

FOR INTRAVENOUS OR INTRAMUSCULAR USE

Each mL contains: Indigotindisulfonate Sodium 8 mg, Water for Injection q.s. pH adjusted, when necessary, with Citric Acid and/or Sodium Citrate.

Sterile, nonpyrogenic.

WARNING:PROTECT FROM LIGHT. Store at 20 -25 C (68 -77F); excursions permitted to 15 -30 C (59 -86 F) (See USP Controlled Room Temperature).

Directions for Use: See Package Insert.

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Rev. 11/05

Indigo Carmine  Indigo Carmine  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0517-0375 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INDIGOTINDISULFONATE SODIUM (INDIGOTINDISULFONIC ACID) INDIGOTINDISULFONATE SODIUM 8 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE   SODIUM CITRATE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0517-0375-10 10 AMPULE In 1 BOX contains a AMPULE 1 5 mL In 1 AMPULE This package is contained within the BOX (0517-0375-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		09/30/1990

Labeler - American Regent, Inc. (622781813)

Revised: 12/2011American Regent, Inc.