Included as part of the "PRECAUTIONS" Section
Life-threatening anaphylactic reactions (respiratory distress, shock, angioedema) have occurred after
Lymphazurin 1% administration. Reactions are more likely to occur in patients with a history of
bronchial asthma, allergies, drug reactions or previous reactions to triphenylmethane dyes. Monitor
patients closely for at least 60 minutes after administration of Lymphazurin 1%. Trained personnel
should be available to administer emergency care including resuscitation.
Precipitation Of Lymphazurin 1% By Lidocaine
The admixture of Lymphazurin 1% (with local anesthetics (i.e. lidocaine)) in the same syringe results in
an immediate precipitation of 4 – 9% drug complex. Use a separate syringe to administer a local
Interference With Oxygen Saturation And Methemoglobin Measurements
Lymphazurin 1% interferes with measurements of oxygen saturation in peripheral blood by pulse
oximetry and can cause falsely low readings. The interference effect is maximal at 30 minutes and
minimal generally by four hours after administration. Arterial blood gas analysis may be needed to
verify decreased arterial partial pressure of oxygen.
Lymphazurin 1% may also cause falsely elevated readings of methemoglobin by arterial blood gas
analyzer. Therefore, co-oximetry may be needed to verify methemoglobin level.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of
Lymphazurin 1%. Reproduction studies in animals have not been conducted and, therefore, it is unknown
if a problem concerning mutagenesis or impairment of fertility in either males or females exists.
Pregnancy Category C
Animal reproduction studies have not been conducted with Lymphazurin 1%. It
is not known whether Lymphazurin 1% can cause fetal harm when administered to a pregnant woman or
can affect reproduction capacity. Lymphazurin 1% should be given to a pregnant woman only if clearly
Use In Specific Populations
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 Lymphazurin™ 1% (isosulfan blue) is administered to a nursing
Safety and effectiveness of Lymphazurin™ 1% (isosulfan blue) in children have not been established.