Full Prescribing
Information
FREQUENTLY ASKED QUESTIONS
Q: How does NAROPIN® compare with bupivacaine in terms of motor function?
Q: How does NAROPIN compare with bupivacaine for labor epidurals?
Q: How does NAROPIN compare with bupivacaine in terms of analgesia?
Q: What are the key safety advantages of NAROPIN compared with bupivacaine?
Q: What are common (≥5%) side effects reported when using NAROPIN?
Q: What concentrations of NAROPIN are available?
Q: What are the advantages of infusion bottles?
Q: What are Polyamp DuoFit® ampules?
Q: How does NAROPIN compare with bupivacaine in terms of motor function?
A: At equivalent concentrations of 0.5%, NAROPIN delivers faster return of motor function following C-sections than bupivacaine.1-3
Duration of Degree 1 Motor Block
(Unable to flex hip, able to flex knee and ankle)
- 72 minutes faster in patients having undergone a C-section (epidural block)2
Duration of Degree 4 Motor Block
(Complete motor paralysis, unable to move foot, knee, or toes)
- 96 minutes faster in patients having undergone a C-section (epidural block)3
Q: How does NAROPIN compare with bupivacaine for labor epidurals?
A: NAROPIN delivers significantly less motor block resulting in more spontaneous vaginal deliveries and fewer instrumented deliveries than bupivacaine.4-6
- 51% of mothers who received NAROPIN had no measurable motor block compared to 42% of bupivacaine patients5
- 58% of mothers who received NAROPIN experienced spontaneous deliveries compared to 49% of bupivacaine patients5
- Smaller proportion of instrumented deliveries among NAROPIN patients compared to bupivacaine patients (27% vs 40%, respectively)5
Q: How does NAROPIN compare with bupivacaine in terms of analgesia?
A: At equivalent concentrations of 0.5%, NAROPIN offers onset, duration, and effectiveness of analgesia similar to bupivacaine in labor and delivery epidurals.1-3Q: What are the key safety advantages of NAROPIN compared with bupivacaine?
A: The most serious safety concerns surrounding the use of local anesthetics involve the cardiovascular and central nervous system. Based on clinical pharmacologic studies, NAROPIN has less risk of cardiotoxicity—ie, significantly less depression of cardiac conductivity (less QRS widening)—as compared to bupivacaine. This cardiovascular depression profile provides an advantage in the event that an inadvertent intravascular injection occurs.7,8
In IV toxicity studies, severity and frequency of CNS symptoms were greater with bupivacaine than NAROPIN.7,8 In fact, recovery from CNS symptoms was 7 minutes shorter with NAROPIN than with bupivacaine (13 min vs 20 min, P<0.05, n=12).8
- NAROPIN has a shorter systemic half-life than bupivacaine, which makes it safer for repeated doses9
- The maximum tolerated concentration of NAROPIN (unbound arterial plasma concentratons at the end of infusion) is twice as high as that of bupivacaine (P<0.001)8
- NAROPIN has a more favorable pregnancy category (Category B) vs bupivacaine (Category C)6,10
Q: What are common (≥5%) side effects reported when using NAROPIN?
A: Like all amide-type 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, parasthesia, headache, pruritis, and back pain.6
Q: What are the recommended concentration, dose, and infusion rates of NAROPIN for its indicated uses?
A: Please see dosing card below.
To enlarge image, please click on dosing card below.
Q: What concentrations of NAROPIN are available?
A: The following concentrations of NAROPIN are available:
2.0 mg/mL (0.2%)
5.0 mg/mL (0.5%)
10.0 mg/mL (1.0%)
Solutions of NAROPIN are available in a range of dosage forms:
Single-dose vials
Sterile-Pak
Polyamp DuoFit® ampules
Infusion bottles
Q: What are the advantages of infusion bottles?
A: Infusion bottles are ideal for prolonged administration, making them convenient and cost-effective for postoperative pain management and labor pain management. They reduce the errors associated with dosing and premixing. Since mixing is not required, they also save time and labor costs and ensure that sterility is maintained throughout use.
Q: What are Polyamp DuoFit® ampules?
A: Polyamp DuoFit® are polypropylene ampules that are designed for needle-free draw up, offering protection from glass shards, needles, and latex. The easy twist-off cap prevents cuts from sharp bands found on vials. Polyamp DuoFit® ampules are compatible with Luer-Lok® and tapered syringes and are available in individual Sterile-Pak outer packaging. The Sterile-Pak enables Polyamp DuoFit® to be placed directly into the sterile field.
Luer-Lok® is a registered trademark of Becton, Dickinson and Company.
REFERENCES
1. Datta S, Camann W, Bader A, VanderBurgh L. Clinical effects and maternal and fetal plasma concentrations of epidural ropivacaine versus bupivacaine for cesarean section. Anesthesiology. 1995;82:1346-1352. 2. Griffin RP, Reynolds F. Extradural anaesthesia for caesarean section: a double-blind comparison of 0.5% ropivacaine with 0.5% bupivacaine. Br J Anaesth. 1995;74:512-516. 3. Crosby E, Sandler A, Finucane B, et al. Comparison of epidural anaesthesia with ropivacaine 0.5% and bupivacaine 0.5% for caesarian section. Can J Anaesth. 1998;45:1066‐1071. 4. Aşik I, Göktuğ A, Gülay I, Alkiş N, Uysalel A. Comparison of bupivacaine 0.2% and ropivacaine 0.2% combined with fentanyl for epidural analgesia during labour. Eur J Anaesthesiol. 2002;19:263-270. 5. Writer WDR, Stienstra R, Eddleston JM, et al. Neonatal outcome and mode of delivery after epidural analgesia for labour with ropivacaine and bupivacaine: a prospective meta-analysis. Br J Anaesth. 1998;81:713-717. 6. NAROPIN Prescribing Information. Data on file. 7. 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. 8. 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. 9. Lee A, Fagan D, Lamont M, Tucker GT, Halldin M, Scott DB. Disposition kinetics of ropivacaine in humans. Anesth Analg. 1989;69:736-738. 10. Sensorcaine [package insert]. Schaumburg, IL: APP Pharmaceuticals, LLC; 2009.
NAROPIN is indicated for the production of regional or local anesthesia for surgery and for acute pain management.
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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®and APP® are registered trademarks of APP Pharmaceuticals, LLC.
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