Stability and antimicrobial effectiveness of treprostinil sodium in Sterile Diluent for Flolan

International Journal of Clinical Practice

Volumn 64, Issue 7, 2010, Pages 885-891

  Zaccardelli, D ^a   Phares, K ^a   Jeffs, R ^a   Doran, A ^a   Wade, M ^a  

^a UNITED THERAPEUTICS CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DILUENT; UNIPROST;

ANTIMICROBIAL ACTIVITY; ARTICLE; ASPERGILLUS NIGER; CANDIDA ALBICANS; CHEMICAL ANALYSIS; COLONY FORMING UNIT; CONTROLLED STUDY; DILUTION; DRUG EFFICACY; GRAM NEGATIVE BACTERIUM; HUMIDITY; INOCULATION; NONHUMAN; PH; PRIORITY JOURNAL; PSEUDOMONAS AERUGINOSA; RISK FACTOR; STAPHYLOCOCCUS AUREUS;

ANTI-INFECTIVE AGENTS; ANTIHYPERTENSIVE AGENTS; BACTERIA; BACTERIAL INFECTIONS; CATHETERIZATION, CENTRAL VENOUS; DRUG STABILITY; EPOPROSTENOL; EQUIPMENT CONTAMINATION; FUNGI; HUMANS; INFUSIONS, INTRAVENOUS; MYCOSES; SODIUM CHLORIDE; TIME FACTORS; WATER;

EID: 77952690215     PISSN: 13685031     EISSN: 17421241     Source Type: Journal    
DOI: 10.1111/j.1742-1241.2009.02307.x     Document Type: Article

References (28)

1. McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med 2003 348: 1123 1133.
2. O'Grady NP, Alexander M, Dellinger EP et al. Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis 2002 35: 1281 1307. (Pubitemid 35448956) (Pubitemid 35448956)
3. Heron M, Hoyert DL, Murphy SL, Xu J, Kochanek KD, Tejada-Vera B. Deaths: Final Data for 2006. Hyattsville, MD: US Dept of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics. Natl Vital Stat Rep 2009 57: 1 80.
4. Pittet D, Tarara D, Wenzel RP. Nosocomial bloodstream infection in critically ill patients: excess length of stay, extra costs, and attributable mortality. JAMA 1994 271: 1598 1601.
5. Smith RL, Meixler SM, Simberkoff MS. Excess mortality in critically ill patients with nosocomial bloodstream infections. Chest 1991 100: 164 167.
6. Humbert M, Sitbon O, Simonneau G. Treatment of pulmonary arterial hypertension. N Engl J Med 2004 351: 1425 1436.
7. Centers for Disease Control and Prevention. Bloodstream infections among patients treated with intravenous epoprostenol or intravenous treprostinil for pulmonary arterial hypertension-seven sites, United States, 2003-2006. MMWR Morb Mortal Wkly Rep 2007 56: 170 172.
8. Akagi S, Matsubara H, Ogawa A et al. Prevention of catheter-related infections using a closed hub system in patients with pulmonary arterial hypertension. Circ J 2007 71: 559 564.
9. Kallen AJ, Lederman E, Balaji A et al. Bloodstream infections in patients given treatment with intravenous prostanoids. Infect Control Hosp Epidemiol 2008 29: 342 349.
10. Oudiz RJ, Widlitz A, Beckmann XJ et al. Micrococcus-associated central venous catheter infection in patients with pulmonary arterial hypertension. Chest 2004 126: 90 4.
11. Edwards JR, Peterson KD, Andrus ML et al. National Healthcare Safety Network (NHSN) report, data summary for 2006 through 2007, issued November 2008. Am J Infect Control 2008 36: 609 626.
12. Remodulin [package insert].
13. Yap RL, Mermel LA. Micrococcus infection in patients receiving epoprostenol by continuous infusion. Eur J Clin Microbiol Infect Dis 2003 22: 704 705.
14. Doran AK, Ivy DD, Barst RJ et al. Guidelines for the prevention of central venous catheter-related bloodstream infections with prostanoid therapy for pulmonary arterial hypertension. Adv Pulm Hyperten 2008 7: 245 248.
15. Flolan [package insert].
16. Phares KR, Weiser WE, Miller SP, Myers MA, Wade M. Stability and preservative effectiveness of treprostinil sodium after dilution in common intravenous diluents. Am J Health Syst Pharm 2003 60: 916 922.
17. United States Pharmacopeia. pH (general information chapter 791). In: Wadsworth JT, ed. The United States Pharmacopeia. 25th rev., and The National Formulary. 20th edn.
18. United States Pharmacopeia. Antimicrobial effectiveness testing (general information chapter 51). In: Wadsworth JT, ed. The United States Pharmacopeia. 25th rev., and The National Formulary. 20th edn.
19. European Pharmacopoeia. Efficacy of antimicrobial preservation (chapter 5.1.3). In: Council of Europe, ed. European Pharmacopoeia. 4th edn.
20. United States Pharmacopeia. Microbial limit tests (general chapter 61). In: Wadsworth JT, ed. The United States Pharmacopeia. 25th rev., and The National Formulary. 20th edn.
21. Sutton SVW, Porter D. Development of the antimicrobial effectiveness test as USP chapter <51>. PDA J Pharm Sci Technol 2002 56: 300 311.
22. Crnich CJ, Maki DG. The promise of novel technology for the prevention of intravascular device-related bloodstream infection. II. Long-term devices. Clin Infect Dis 2002 34: 1362 1368.
23. Salzman MB, Rubin LG. Relevance of the catheter hub as a portal for microorganisms causing catheter-related bloodstream infections. Nutrition 1997 13 (4 suppl 15S 7S.
24. Ivy D, Calderbank M, Wagner B et al. Closed-hub systems with protected connections reduce risk of catheter-related bloodstream infection in pediatric patients receiving intravenous prostanoid therapy for pulmonary hypertension. Infect Control Hosp Epidemiol. 2009 30: 823 829.
25. Magee JT, Burnett IA, Hindmarch JM, Spencer RC. Micrococcus and Stomatococcus spp. from human infections. J Hosp Infect 1990 16: 67 73.
26. Ramos ER, Hachem R, Youssef S, Fang X, Jiang Y, Raad I. The crucial role of catheters in micrococcal bloodstream infections in cancer patients. Infect Control Hosp Epidemiol 2009 30: 83 5.
27. Peces R, Gago E, Tejada F, Laures AS, Alvarez-Grande J. Relapsing bacteraemia due to Micrococcus luteus in a haemodialysis patient with a Perm-Cath catheter. Nephrol Dial Transplant 1997 12: 2428 2429.
28. Raad I, Hachem R, Hanna H et al. Sources and outcome of bloodstream infections in cancer patients: the role of central venous catheters. Eur J Clin Microbiol Infect Dis 2007 26: 549 556.