Indigo carmine 40mg/10ml solution for injection vials

Toxicity information regarding indigotindisulfonic acid is not readily available. Patients experiencing an overdose are at an increased risk of severe adverse effects such as cardiac arrest, arrhythmia, asystole, second degree atrioventricular block, hypotension, elevation in blood pressure, bradycardia, and tachycardia.
[L42600]
Symptomatic and supportive measures are recommended.

The use of indigotindisulfonate sodium in pregnant women has not been associated with a higher risk of adverse maternal and fetal adverse effects. The use of this dye in the first trimester is rare; therefore, data are insufficient to evaluate the risk of major birth defects and miscarriage associated with the use of indigotindisulfonate sodium.
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It is not known whether this drug is excreted in human breastmilk.

Fertility studies with indigotindisulfonate sodium using the intravenous route of administration have not been conducted.
[L42600]


Carcinogenicity studies evaluating the effects of the intravenous administration of indigotindisulfonate sodium have not been performed. In mice, the long term subcutaneous administration of indigotindisulfonate sodium did not have carcinogenic effects.
[L42600]
Indigotindisulfonate sodium was not genotoxic in Ames assays. The in vitro mutagenicity of this dye was inconclusive, and in vivo studies suggest that orally administered indigotindisulfonate was not mutagenic.
[L42600]
The oral LD₅₀ of indigotindisulfonate sodium in rats is 2000 mg/kg.
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