Education Hub
Resources
01 · Article
An Evidence-Based Assessment of Local Anesthetic Allergy Risk and Clinical Safety
ENDURA-KT is a preservative-free combination of 0.2% tetracaine, 0.4% lidocaine and 1:250,000 epinephrine. Tetracaine, an ester local anesthetic, has been used in medicine since the 1930s and lidocaine an amide, has been in use since 1948. The combination of these drugs is not new. Since 1994, “LET” gel containing 0.5% tetracaine, 4% lidocaine, and 1:1000 epinephrine has been widely utilized to anesthetize lacerations in a pediatric ER setting prior to wound closure. LET is also a cGMP compounded product. Pliaglis Cream, an FDA-approved combination containing 7% lidocaine and 7% tetracaine, is a topical preparation designed to produce cutaneous anesthesia prior to dermatologic procedures.
02 · FDA-registered cGMP facility
For more information
FDA: Compounding and the FDA, Questions and Answers: https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
FDA: Information for Outsourcing Facilities: https://www.fda.gov/drugs/human-drug-compounding/information-outsourcing-facilities
FDA: Human Drug Compounding Laws: https://www.fda.gov/drugs/human-drug-compounding/human-drug-compounding-laws
FDA: Promotion of Compounded Drugs: https://www.fda.gov/drugs/human-drug-compounding/fda-telehealth-companies-what-know-when-promoting-compounded-drugs
OurPharma: Company and Facility: https://ourpharma.net/company/
OurPharma: Quality FAQs and Contact: https://ourpharma.net/contact-us/
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