Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Hypersensitivity Reactions: Hypersensitivity reactions occur in approximately 2% of patients and include life threatening anaphylactic reactions with respiratory distress, shock, angioedema, urticaria, pruritus.
A death has been reported following IV administration of a similar compound ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Postmarketing Experience Hypersensitivity Reactions: Case series report an overall incidence of hypersensitivity reactions in approximately 2% of patients.
Life threatening anaphylactic reactions have occurred.
Manifestations include respiratory distress, shock, angioedema, urticaria, pruritus.
A death has been reported following administration of a similar compound employed to estimate the depth of a severe burn.
Reactions are more likely to occur in patients with a personal or family history of bronchial asthma, significant allergies, drug reactions or previous reactions to triphenylmethane dyes [see Warnings and Precautions (5) ] .
Laboratory Tests: Isosulfan blue injection 1% interferes with measurements of oxygen saturation by pulse oximetry and of methemoglobin by gas analyzer [see Warnings and Precautions (5) ] .
Skin: transient or long-term (tattooing) blue coloration.
5 WARNINGS AND PRECAUTIONS • Life threatening anaphylactic reactions have occurred after isosulfan blue injection 1% administration.
Monitor patients closely for at least 60 minutes after administration of isosulfan blue injection 1% ( 5.1 ).
• The admixture of isosulfan blue injection 1% with local anesthetics results in an immediate precipitation of 4% to 9% drug complex.
Use a separate syringe for anesthetics ( 5.2 ).
• Isosulfan blue injection 1% interferes with measurements in peripheral blood pulse oximetry.
Like all medications, Isosulfan Blue can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: