Full Prescribing
Information
Safety and Tolerability
NAROPIN® Provides Greater Safety Over Bupivacaine1-3
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):736‐8. 4. Albright G. Cardiac arrest following regional anesthesia with etidocaine or bupivacaine. Anesthesiology. 1979;51:285‐287. Br JAnaesth. 1997;78:507‐514. 5. NAROPIN Prescribing Information. Data on file. 6. Sensorcaine [package insert]. Schaumburg, IL: APP Pharmaceuticals, LLC; 2009.
NAROPIN® Provides Greater Safety Over Bupivacaine1-3
Significantly fewer cardiovascular side effects1,2
- Less depression of cardiac conductivity
- Significantly higher dose of NAROPIN tolerated vs bupivacaine
Lower risk of systemic toxicity than bupivacaine1-3
In labor and delivery, serious maternal cardiotoxicity has been reported after inadvertent i.v. bupivacaine administration, which may lead to treatment-resistant cardiac arrest.4
- 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
NAROPIN has a more favorable pregnancy category (Category B) vs bupivacaine (Category C)5,6
Severity and frequency of symptoms were greater with bupivacaine1,2
NAROPIN is indicated for the production of regional or local 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):736‐8. 4. Albright G. Cardiac arrest following regional anesthesia with etidocaine or bupivacaine. Anesthesiology. 1979;51:285‐287. Br JAnaesth. 1997;78:507‐514. 5. NAROPIN Prescribing Information. Data on file. 6. 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.
®
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.
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