Product Information
Registration Status: ActiveSIN11374P
INDIGO CARMINE INJECTION 20mg/5ml is approved to be sold in Singapore with effective from 2000-08-16. It is marketed by PHEBRA (SE ASIA) PTE LTD, with the registration number of SIN11374P.
This product contains Indigo Carmine 4mg in the form of INJECTION. It is approved for INTRAVENOUS, INTRAMUSCULAR use.
This product is manufactured by Hospira Australia Pty Ltd in AUSTRALIA.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Indolesulfonic acid is a blue-colored dye used a marker in urological procedures, also known as _indigo carmine_ [L2219]. Indigo carmine, or 5, _5'-indigodisulfonic acid_ sodium salt, also known as _indigotine_ or _FD& C Blue #2 _is a pH indicator with the chemical formula C16H8N2Na2O8S2. It is approved for use as a food dye in the United States and the EU and has the E number E132 [L2216]
Indication
This drug was initially used as a kidney function test. The main application of indigo carmine at this time is localizing and visualizing ureteral orifices during cystoscopy and ureteral catheterization procedures [L2215].
Mechanism of Action
Indigo carmine works as a dye that accumulates in crevices, cysts, and foveolae and stains the tissue blue [L2224]. According to one study, the primary action of indigo carmine appears to be at the level of nitric oxide generation and/or its release from the endothelium. In addition to this, indigo carmine appears to inhibit vascular smooth muscle _guanylyl cyclase_. Therefore, indigo carmine may increase blood pressure by interfering with these nitric oxide-mediated vasodilatory mechanisms [A32490].
Pharmacokinetics
- Absorption
- Biologically inert [L2223].
- Distribution
- Metabolism
- Moreover, incubation of 35S-Indigo Carmine with intestinal contents of rats for 48 h suggested that isatin-5-sulphonic acid and 5-sulphoanthranilic acid may possibly be metabolites formed by intestinal bacterial metabolism of the drug. By comparison to the data obtained after intravenous administration, it was determined that the data available on the absorption, metabolism, and excretion indicated that Indigo Carmine or its metabolites were poorly absorbed [L2222].
- Elimination
Toxicity
After intravenous administration, the LD80 was measured at 300 mg/kg in the mouse [L2215]. Nausea, vomiting, hypertension, bradycardia and infrequently, rash, pruritus, and bronchoconstriction. Skin discoloration may occur at high doses. Anaphylaxis is a serious adverse event that has been occasionally reported [L2219]. Animal studies have not been conducted with indigotindisulfonate. It is also unknown whether indigotindisulfonate sodium injection poses a risk of fetal harm when administered to a pregnant woman or whether it may affect reproduction. Indigotindisulfonate sodium injection should be given to a pregnant woman only if absolutely necessary [L2215]. It is not known whether this drug is excreted in human breastmilk [L2215].
Active Ingredient/Synonyms
2-(1,3-Dihydro-3-oxo-5-sulpho-2H-indol-2-ylidene)-3-oxoindoline-5-sulphonic acid | 5,5'-indigotindisulfonic Acid | Blue X | Indigo carmine acid | indigo carmine free acid | indigo-5,5'-disulfonic acid | Indigotindisulfonate | Saxon blue | Indigotindisulfonic Acid |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.