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Indigo Carmine Warnings, Precautions, Pregnancy, Nursing, Abuse - Indigotindisulfonate

WARNINGS

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

PRECAUTIONS

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

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. lndigotindisulfonate 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.

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