About Naropin > Benefits vs Bupivacaine > Safety and Tolerability

Safety and Tolerability

Choose NAROPIN® for Greater Safety vs Bupivacaine1-5

In clinical studies, NAROPIN has shown to have significantly fewer cardiovascular and central nervous system (CNS) side effects than similar doses of bupivacaine.1,2

NAROPIN has a more favorable pregnancy category (Category B) vs bupivacaine (Category C)4,5


Chart 1: Significantly Fewer Cardiovascular Side Effects1

NAROPIN results in less depression of cardiac conductivity than bupivacaine.1



Chart 2: Reduced Cardiac Toxicity vs Bupivicaine1,2

QRS widening with NAROPIN was similar to placebo and significantly less than bupivicaine (P<0.01).1
A significantly higher dose of NAROPIN was tolerated vs bupivicaine.2




NAROPIN Has a Lower Risk of Systemic Toxicity vs Bupivacaine1-3

At equivalent concentrations, NAROPIN offers a lower risk of systemic toxicity than bupivacaine1,2

  • NAROPIN has a shorter systemic half-life than bupivacaine, which makes it safer for repeated doses3
  • The maximum tolerated concentration of NAROPIN (unbound arterial plasma concentrations at the end of infusion) is twice as high as that of bupivacaine (P<0.001)2


Chart 3: Greater Tolerability vs Bupivacaine1,2

A significantly higher dose of NAROPIN was tolerated vs bupivacaine.1




Shorter Duration of CNS Symptoms With NAROPIN1,2

CNS symptoms were less frequent and less severe with NAROPIN vs bupivacaine.1,2

Chart 4: The Time From the End of Infusion to the Disappearance of All Symptoms Was Significantly Shorter With NAROPIN (13 minutes) vs Bupivacaine (20 minutes) (P<0.05).2





NAROPIN is indicated for the production of local or regional anesthesia for surgery and for acute pain management.


References: 1. Scott DB, Lee A, Fagan D, Bowler GMR, Bloomfield P, Lundh R. Acute toxicity of ropivacaine compared with that of bupivacaine. Anesth Analg. 1989;69:563-569. 2. Knudsen K, Beckman SM, Blomberg S, Sjövall J, Edvardsson N. Central nervous and cardiovascular effects of i.v. infusions of ropivacaine, bupivacaine and placebo in volunteers. Br J Anaesth. 1997;78:507-514. 3. Lee A, Fagan D, Lamont M, Tucker GT, Halldin M, Scott DB. Disposition kinetics of ropivacaine in humans. Anesth Analg.1989;69(6):736-738. 4. NAROPIN Prescribing Information. Data on file. 5. Sensorcaine [package insert]. Schaumburg, IL: APP Pharmaceuticals, LLC; 2009.


Important Safety Information

Using NAROPIN beyond recommended doses to increase motor block or duration of sensory block may negate its favorable cardiovascular advantages, in the event that an inadvertent intravascular injection occurs.
Like all amide-type local anesthetics, NAROPIN may be associated with adverse reactions. In clinical trials, side effects were mild and transient and may reflect the procedures, patient health status, and/or other medications used. Adverse events reported at a rate of ≥5%: hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain.

New Safety Information

 There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. NAROPIN is not approved for this use.

Please see Full Prescribing Information at www.naropin-us.com.

NAROPIN® and logo are registered trademarks of APP Pharmaceuticals, LLC.
®
and APP® are registered trademarks of APP Pharmaceuticals, LLC.
©2010, APP Pharmaceuticals, LLC. All Rights Reserved.