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BUPivacaine 0.25% & 0.5% injection - Labelling

June 11 , 2018

The Issue:
There is a shortage of BUPivacaine injection from multiple manufacturers (Pfizer and Aspen Pharma). Our current supplier of BUPivacaine with available stock is SteriMax. The SteriMax product has an added warning on its label stating “ not for use in obstetrics.”

With respect to the comment ‘not for use in obstetrics’, references warn of the risks of using 0.75% isotonic concentrations in pregnancy and also the risk of paracervical blocks using bupivacaine1, but aside from these two specific details a 0.25% or 0.5% preservative free bupivacaine product can safely be used at term to provide obstetrical anesthesia or analgesia.1,,2

Key changes include:

  • Physicians should be aware of the added warning on labels of SteriMax brand BUPivacaine 10 mL and 20 mL vials.
  • The SteriMax brand BUPivacaine is preservative free and identical in composition to the previous products from Pfizer or Aspen Pharma.

Action:
Please post this notice in your area and ensure all staff are informed about the change.

Contact:
Please contact your site pharmacy department with any questions or concerns.

References:
1. Lexi-Comp OnlineTM , Hudson, Ohio: Lexi-Comp, Inc.; June 4, 2018.
2. Product Monograph Bupivacaine Injection; Sterimax; July 10, 2015.

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