Pharmacy & Therapeutics - May 2008 - (Page 302) Pharmaceutical Approval Update Table 2 Surface Area Covered by Package Sizes of Fibrin Sealant (Artiss) Approximate Area Requiring Skin Graft Fixation 100 200 cm2 500 cm2 cm2 Required Package Size of Sealant 2 mL 4 mL 10 mL Drug Utilization Evaluation: Daptomycin continued from page 287 the emergence of resistance to cyclic lipopeptide antibiotics and will preserve this agent’s role in the antimicrobial armamentarium against bacterial infections. REFERENCES 1. Daptomycin (Cubicin), package insert. Lexington, Mass.: Cubist; September 2003. 2. World Health Organization (WHO). Collaborating Centre for Drug Statistics Methodology. Anatomical Therapeutic Chemical (ATC) Index with Defined Daily Doses (DDDs). Oslo, Norway: WHO; Januar y 2008. Available at: www.whocc.no/atcddd. Accessed January 17, 2008. 3. Tedesco KL, Rybak MJ. Daptomycin. Pharmacotherapy 2004;24: 41–57. 4. Carpenter CF, Chambers HF. Daptomycin: Another novel agent for treating infections due to drug-resistant gram-positive pathogens. Clin Infect Dis 2004;38:994–1000. 5. Sakoulas G, Eliopoulos GM, Alder J, et al. Efficacy of daptomycin in experimental endocarditis due to methicillin-resistant Staphylococcus aureus. Antimicrob Agents Chemother 2003;47:1714–1718. 6. Daptomycin (Cubicin), package insert. Lexington, Mass.: Cubist; May 2006. 7. Fowler VG, Boucher HW, Corey GR, et al. Daptomycin versus standard therapy for bacteremia and endocarditis caused by Staphylococcus aureus. N Engl J Med 2006;355:653–665. 8. Sakoulas G, Golan Y, Lamp KC, Friedrich LV, Russo R. Daptomycin in the treatment of bacteremia. Am J Med 2007;120: S21–S27. 9. Levine DP, Lamp KC. Daptomycin in the treatment of patients with infective endocarditis: Experience from a registry. Am J Med 2007;120:S28–S33. 10. Lamp KC, Friedrich LV, Mendez-Vigo L, Russo R. Clinical experience with daptomycin for the treatment of patients with osteomyelitis. Am J Med 2007;120:S13–S20. 11. Pai MP, Norenberg JP, Anderson T, et al. Influence of morbid obesity on the single-dose pharmacokinetics of daptomycin. Antimicrob Agents Chemother 2007;51:2741–2747. 12. Pai MP, Mercier RC, Allen SE. Using vancomycin concentrations for dosing daptomycin in a morbidly obese patient with renal insufficiency. Ann Pharmacother 2006;40:553–558. 13. Benvenuto M, Benziger DP, Yankelev, Vigliani G. Pharmacokinetics and tolerability of daptomycin at doses up to 12 milligrams per kilogram of body weight once daily in healthy volunteers. Antimicrob Agents Chemother 2006;50:3245–3249. 14. Veligandla SR, Louie KR, Malesker MA, et al. Muscle pain associated with daptomycin. Ann Pharmacother 2004;38:1860–1862. 15. Papadopoulos S, Ball AM, Liewer SE, et al. Rhabdomyolysis during therapy with daptomycin. Clin Infect Dis 2006;42:e108–e110. 16. Daptomycin (Cubicin), package insert. Lexington, Mass.: Cubist; October 2007. 17. Patel JB, Jevitt LA, Hageman J, et al. An association between reduced susceptibility to daptomycin and reduced susceptibility to vancomycin in Staphylococcus aureus. Clin Infect Dis 2006;42: 1652–1653. 18. Clinical and Laboratory Standards Institute (CLSI). Performance standards for antimicrobial susceptibility testing: 17th Informational Standard M100-S17. Wayne, PA: CLSI; January 2007. 19. Munoz-Price LS, Lolans K, Quinn JP. Emergence of resistance to daptomycin during treatment of vancomycin-resistant Enterococcus faecalis infection. Clin Infect Dis 2005;41:565–567. 20. Mariani PG, Sader HS, Jones RN. Development of decreased susceptibility to daptomycin and vancomycin in a Staphylococcus aureus strain during prolonged therapy. J Antimicrob Chemother 2006;58:481–483. 21. Hirschwerk D, Ginocchio CC, Bythrow M, Condon S. Diminished susceptibility to daptomycin accompanied by clinical failure in a patient with methicillin-resistant Staphylococcus aureus bacteremia. Infect Control Hosp Epidemiol 2006;27:315–317. 22. Skiest DJ. Treatment failure resulting from resistance of Staphylococcus aureus to daptomycin. J Clin Microbiol 2006;44: 655–656. I Baxter Healthcare. Application Precautions: The sealant is applied as a thin layer. Excessive clot thickness may negatively interfere with the product’s efficacy and with wound healing. Clinicians must use caution when applying the sealant and while using pressurized gas. Any application of pressurized gas carries a potential risk of air embolism, tissue rupture, or gas entrapment with compression, which may be life-threatening. The sealer protein and thrombin solutions can be denatured by alcohol, iodine, or heavy metal ions. If any of these substances have been used to clean the wound, the area must be thoroughly rinsed before the sealant is applied, and the area should be made as dry as possible. Adverse Events: The following adverse drug events reflect those reported in postmarketing experience with Baxter’s fibrin sealant, and they can reasonably be expected to occur with Artiss: anaphylactic responses, hypersensitivity, bradycardia, tachycardia, dyspnea, nausea, hives, flushing, impaired healing, edema, pyrexia, and seroma. Dosage and Administration: This product is intended for topical use only and should not be injected. The required dose depends on the size of the surface to be covered (Table 2). The aerosolized sealant is applied to the wound in a painting motion from side to side to achieve a single thin layer. The wound bed glistens in the area to which fibrin sealant has been applied. Any areas not covered by fibrin sealant are clearly visible. The skin graft is attached to the wound bed immediately after the sealant has been sprayed. The surgeon has approximately 60 seconds to manipulate and position the graft prior to polymerization. To prevent adherence, the surgeon wets the gloves with normal saline before touching the sealant. After the graft is applied, it is held in the desired position by gentle compression for at least three minutes to ensure that the sealant sets properly and adheres firmly to the surrounding tissue. The solidified fibrin sealant reaches its final strength approximately two hours later. Commentar y: The approval of Artiss fibrin sealant can help surgeons to fine-tune graft placement on burn sites. The fibrinogen and thrombin proteins in the sealant are derived from human plasma that is collected from FDA-licensed plasma centers. Both proteins undergo purification and virus-inactivation treatments to reduce the risk of blood-transmissible infections. In clinical trials, this sealant was as good, within a statistical error, as using staples to attain complete wound closure. Source: www.baxter.com 302 P&T® • May 2008 • Vol. 33 No. 5 http://www.whocc.no/atcddd http://www.baxter.com
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