Indigo Carmine

(BAN, USAN, rINN)

💊 Chemical information

Blue X; Ceruleinum; CI Food Blue 1; Colour Index No. 73015; Disodium Indigotin-5,5′-disulphonate; E132; FD & C Blue No. 2; Indicarminum; Indigo Karmin; Indigotina; Indigotindisulfonate Sodium; Indigotine; Indygokarmin; Sodium Indigotindisulphonate.
Disodium 3,3′-dioxo-2,2′-bi-indolinylidene-5,5′-disulphonate.
Chemical formula: C16H8N2Na2O8S2 = 466.4.
CAS — 483-20-5 (indigotin-5,5 -disulphonic acid); 86022-0 (indigo carmine).
ATC — V04CH02.
ATC Vet — QV04CH02.

Pharmacopoeias.

In It., Jpn, and US.

USP 31

(Indigotindisulfonate Sodium). A dusky, purplish-blue powder, or blue granules having a coppery lustre. Soluble 1 in 100 of water; slightly soluble in alcohol; practically insoluble in most other organic solvents. Its solutions have a blue or bluishpurple colour. Store in airtight containers at a temperature of 25°, excursions permitted between 15° and 30°. Protect from light.

💊 Adverse Effects and Precautions

Indigo carmine may cause nausea, vomiting, hypertension, and bradycardia, and occasionally, hypersensitivity reactions such as skin rash, pruritus, and bronchoconstriction. Skin discoloration may occur after large parenteral doses.

Hypersensitivity.

Cardiac arrest after a dose of indigo carmine 80 mg intravenously resulted in the deaths of 2 elderly patients.1Both had a history of asthmatic bronchitis. A life-threatening anaphylactoid reaction associated with indigo carmine use has also been reported, although the authors commented that such events are rare.2
1. Voiry AM, et al. Deux accidents mortels lors d’une injection peropératoire de carmin d’indigo. Ann Med Nancy 1976; 15: 413–19
2. Gousse AE, et al. Life-threatening anaphylactoid reaction associated with indigo carmine intravenous injection. Urology 2000; 56: 508.

💊 Uses and Administration

On intravenous injection indigo carmine is rapidly excreted, principally by the kidneys. It has been used in a test of renal function, but has largely been replaced by agents that give more precise results. It is used as a marker dye, particularly in urological procedures, when it is given in a usual dose of 40 mg, preferably by intravenous injection but sometimes intramuscularly. It has also been used as a marker dye in amniocentesis. Indigo carmine has been used as a blue dye in medicinal preparations but it is relatively unstable. It has also been investigated as a dye-spray in the detection of colorectal adenomas. It is used as a food colour.

💊 Preparations

USP 31: Indigotindisulfonate Sodium Injection.
Published May 08, 2019.