" Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol.
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Life-threatening anaphylactic reactions (respiratory distress, shock, angioedema) have occurred after Lymphazurin (isosulfan blue) 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 (isosulfan blue) 1%. Trained personnel should be available to administer emergency care including resuscitation.
Precipitation of Lymphazurin (isosulfan blue) 1% by Lidocaine
The admixture of Lymphazurin (isosulfan blue) 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 anesthetic.
Interference with Oxygen Saturation and Methemoglobin Measurements
Lymphazurin (isosulfan blue) 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 (isosulfan blue) 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 (isosulfan blue) 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 (isosulfan blue) 1%. It is not known whether Lymphazurin (isosulfan blue) 1% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Lymphazurin (isosulfan blue) 1% should be given to a pregnant woman only if clearly needed.
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 mother.
Safety and effectiveness of Lymphazurin™ 1% (isosulfan blue) in children have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/21/2008
Additional Lymphazurin Information
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