Regulatory Decision Summary for Sensorcaine, Sensorcaine With Epinephrine
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
This Supplement to a New Drug Submission (SNDS) for Sensorcaine was filed to warn not to use Sensorcaine formulations with epinephrine in labour analgesia except as a test dose. This warning was included in the Product Monograph under Warnings and Precautions, Special Populations, and Dosage and Administration. Other revisions included a clarification of the wording for pediatric use and the management of hypertension and bradycardia.
Why was the decision issued?
When used as instructed under professional care, bupivacaine, with a longer duration of action, is a useful choice for regional anaesthesia and analgesia. Its uses have been well-studied and well-practiced in anaesthetic care, with commensurate management practices for risk and uncertainty. The addition of epinephrine reduces the speed of absorption of bupivacaine and enhances the local effects of bupivacaine, but it is either contraindicated or not recommended in areas supplied by end arteries or with poor circulation. Epinephrines effect in reducing uterine contractility is well understood and labelled. The current clarification of the use instructions of the bupivacaine formulations with epinephrine in labour analgesia is expected to reduce uncertainties associated with their use in labour analgesia.
Both hypotension and bradycardia are clearly recognized as adverse reactions to regional anesthetic procedures of sufficient size. They are by and large independent of the choice of a particular local anaesthetic. Effective recognition and management of these adverse reactions are a standard part of the local anaesthetic training and practice. In summary, the benefit-harm-uncertainty profiles of bupivacaine formulations remain favourable.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.