ORABLOC ARTICAINE HCL 4% AND EPI

WARNINGS AND PRECAUTIONS:

Orabloc® is an amide local anesthetic containing a vasoconstrictor indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental sodium metabisulfite.

Orabloc® is contraindicated in patients who are hypersensitive to products containing sulfites. Products containing sulfites may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.

Reactions to Orabloc® (pain and headache, for example, or convulsions or respiratory arrest following accidental intravascular injection) are characteristic of those associated with other amide-type local anaesthetics. Accidental intravascular injection may be associated with convulsion, followed by central nervous system or cardio-respiratory depression and coma, progressing ultimately to respiratory arrest. Dental practitioners and/or clinicians who employ local anaesthetic agents should be well versed in diagnosis and management of emergencies that may arise from their use.

Administration of Orabloc® results in a 3 to 5 fold increase in plasma epinephrine concentrations compared to baseline; however, in healthy adults it does not appear to be associated with marked increases in blood pressure or heart rate, except in the case of accidental intravascular injection. Inform patients in advance of the possibility of temporary loss of sensation and muscle function following infiltration and nerve block injections. Instruct patients not to eat or drink until normal sensation returns.

SDS Sheets

Manufacturer No: 2101052