clinvestКачественная клиническая практикаKachestvennaya Klinicheskaya Praktika = Good Clinical Practice2588-05192618-8473ООО «Издательство ОКИclinvest-335Research ArticleНОВЫЕ ЛЕКАРСТВЕННЫЕ СРЕДСТВАNEW DRUGS AND HEALTH TECHNOLOGIESЗетамакс ретард - новая эффективная и безопасная форма азитромицина для однократного приемаМухинаМ. А.

кафедра клинической фармакологии с курсом клинической фармакологии и фармакокинетики ФУВ

clinvest@mail.ruБелоусовЮ. Б.

д.м.н., проф., зав. кафедрой клинической фармакологии с курсом клинической фармакологии и фармакокинетики ФУВ

clinvest@mail.ruРоссийский государственный медицинский университет, г. МоскваRussian FederationГОУ ВПО «Российский национальный исследовательский медицинский университет имени Н.И. Пирогова», МоскваRussian Federation2006270620180227Copyright © Мухина М.А., Белоусов Ю.Б., 20182018Мухина М.А., Белоусов Ю.Б.Мухина М.А., Белоусов Ю.Б.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.clinvest.ru/jour/article/view/335

В статье описана фармакокинетика и фармакодинамика новой формы азитромицина (Зетамакс ретард) для однократного приема для терапии респираторных инфекций.

Зетамакс ретардазитромицинреспираторные инфекцииReferencesAbdel-Rahman S.M., Kearns G.L. The pharmacokinetic-pharmacodynamic interface: determinants of anti-infective drug action and efficacy in pediatrics. In: Feigin RD, Cherry JD, Demmler G. J., Kaplan S.C., eds. Textbook of pediatric infectious diseases. 5th ed. Philadelphia: Saunders, 2004: 2965-2987.Abdel-Rahman S.M., Kearns G.L. The pharmacokinetic-pharmacodynamic interface: determinants of anti-infective drug action and efficacy in pediatrics. In: Feigin RD, Cherry JD, Demmler G. J., Kaplan S.C., eds. Textbook of pediatric infectious diseases. 5th ed. Philadelphia: Saunders, 2004: 2965-2987.Hunstad D.A., St. Jeme, J.W. III. Molecular determinants of microbial pathogenesis. In: Feigin R.D., Cherry J.D., Demmler G.J., Kaplan S.C., eds. Textbook of pediatric infectious diseases. 5th ed. Philadelphia: Saunders, 2004: 2-20.Hunstad D.A., St. Jeme, J.W. III. Molecular determinants of microbial pathogenesis. In: Feigin R.D., Cherry J.D., Demmler G.J., Kaplan S.C., eds. Textbook of pediatric infectious diseases. 5th ed. Philadelphia: Saunders, 2004: 2-20.Amsden G.W., Baird I.М., Simon S. еt al. Еfiсасу and safety of azithromycin vs. levof1oxacin in the outpatient treatment of acute bacterial exacerbations of chronic bronchitis. Chest. 2003; 123:772-777.Amsden G.W., Baird I.М., Simon S. еt al. Еfiсасу and safety of azithromycin vs. levof1oxacin in the outpatient treatment of acute bacterial exacerbations of chronic bronchitis. Chest. 2003; 123:772-777.DeAbate С.А., Mathew С.Р., Wamer J.H. еt al. Тhe safety and еffiсасу of short course (5-day) moxif1oxacin vs. azithromycin in the treatment of patients with acute exacerbation of chronic bronchitis. Respir Med. 2000; 94: 1029-1037.DeAbate С.А., Mathew С.Р., Wamer J.H. еt al. Тhe safety and еffiсасу of short course (5-day) moxif1oxacin vs. azithromycin in the treatment of patients with acute exacerbation of chronic bronchitis. Respir Med. 2000; 94: 1029-1037.Ноереlmаn I.М., Mollers M.J., уаn Schie М.Н. еt al. А short (3-day) course of azithromycin tablets versus а 10-day course of amoxicillin-clavulanic (Q 2005 Lippincott Williams -Wilkins acid (co-amoxiclav) in the treatment of adults with lower respiratory tract infections and effects оn long-term outcome. Int J Antimicrob Agents. 1998;9: 141-146.Ноереlmаn I.М., Mollers M.J., уаn Schie М.Н. еt al. А short (3-day) course of azithromycin tablets versus а 10-day course of amoxicillin-clavulanic (Q 2005 Lippincott Williams -Wilkins acid (co-amoxiclav) in the treatment of adults with lower respiratory tract infections and effects оn long-term outcome. Int J Antimicrob Agents. 1998;9: 141-146.American Thoracic Society. Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1995; 152: S78-S120.American Thoracic Society. Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1995; 152: S78-S120.Niedennan M.S., McCombs J.S., Unger A.N. еt al. Treatment cost of acute exacerbations of chronic bronchitis. сип Ther. 1999; 21: 576-591.Niedennan M.S., McCombs J.S., Unger A.N. еt al. Treatment cost of acute exacerbations of chronic bronchitis. сип Ther. 1999; 21: 576-591.Burrows В., Earle R.Н. Course and prognosis of chronic obstructive lung disease: а prospective study of 200 patients. N Engl J Med 1969; 280: 397-404.Burrows В., Earle R.Н. Course and prognosis of chronic obstructive lung disease: а prospective study of 200 patients. N Engl J Med 1969; 280: 397-404.Белоусов Ю.Б., Шатунов С.М. Антибактериальная химиотерапия. 2001; М.: Ремедиум, 2001.Белоусов Ю.Б., Шатунов С.М. Антибактериальная химиотерапия. 2001; М.: Ремедиум, 2001.Лукьянов С.В. Макролиды в терапии инфекций дыхательной системы. Клиническая фармакология макролидов. Consilium medium 2004; 6: 2004.Лукьянов С.В. Макролиды в терапии инфекций дыхательной системы. Клиническая фармакология макролидов. Consilium medium 2004; 6: 2004.Синопальников А.И., Гучев И.А. Макролиды: современная концепция применения. РМЖ. 2003; 11; 2.Синопальников А.И., Гучев И.А. Макролиды: современная концепция применения. РМЖ. 2003; 11; 2.Rothennel C.D. Single-dose azithromycin for acute otitis media: а phannacokinetic/phannacodynamic rationale. Curr Ther Res 2003; 64: Suppl А: А4-АI5.Rothennel C.D. Single-dose azithromycin for acute otitis media: а phannacokinetic/phannacodynamic rationale. Curr Ther Res 2003; 64: Suppl А: А4-АI5.Mandell G.L. Delivery of antibiotics bу phagocytes. J Infect Dis. 1994; 19: 922-925.Mandell G.L. Delivery of antibiotics bу phagocytes. J Infect Dis. 1994; 19: 922-925.Schentag J.J., Ballow С.Н. Tissue-directed phannacokinetics. Ат J Med. 1991;91(suppl 3A):5S-IIS.Schentag J.J., Ballow С.Н. Tissue-directed phannacokinetics. Ат J Med. 1991;91(suppl 3A):5S-IIS.Mandell G.L. Delivery of antibiotics bу phagocytes. J Infect Dis. 1994;19:922-925.Mandell G.L. Delivery of antibiotics bу phagocytes. J Infect Dis. 1994;19:922-925.Schentag J.J., Ballow С.Н. Tissue-directed phannacokinetics. Аm J Med. 1991; 91(suppl 3A): 5S-IIS.Schentag J.J., Ballow С.Н. Tissue-directed phannacokinetics. Аm J Med. 1991; 91(suppl 3A): 5S-IIS.Schentag J.J., Ballow С.Н. Tissue-directed phannacokinetics. Аm J Med. 1991; 91(suppl 3A): 5S-IIS.Schentag J.J., Ballow С.Н. Tissue-directed phannacokinetics. Аm J Med. 1991; 91(suppl 3A): 5S-IIS.Mandell L.A., Bartlett J.G., Dowell S.F. et al. Update of practice guidelines for the management of community-acquired pneumonia in immunocompetent adults. CID 2003; 37: 1405-33.Mandell L.A., Bartlett J.G., Dowell S.F. et al. Update of practice guidelines for the management of community-acquired pneumonia in immunocompetent adults. CID 2003; 37: 1405-33.Чучалин А.Г., Синопальников А.И., Яковлев С.В. и др. Внебольничная пневмония у взрослых: практические рекомендации по диагностике, лечению и профилактике. Пособие для врачей. М., 2003. С. 53.Чучалин А.Г., Синопальников А.И., Яковлев С.В. и др. Внебольничная пневмония у взрослых: практические рекомендации по диагностике, лечению и профилактике. Пособие для врачей. М., 2003. С. 53.Bartlett J.G., Dowell S.F., Mandell L.A. et al. Practice guidelines for the management of community-acquired pneumonia in adults. Infectious Diseases Society of America. Clin Infect Dis 2000; 31: 347-382.Bartlett J.G., Dowell S.F., Mandell L.A. et al. Practice guidelines for the management of community-acquired pneumonia in adults. Infectious Diseases Society of America. Clin Infect Dis 2000; 31: 347-382.Синопальников А.И. Новые горизонты применения макролидов при инфекциях дыхательных путей. (Материалы 14 конгресса ECCMID). Российские медицинские вести. 2004. 2.Синопальников А.И. Новые горизонты применения макролидов при инфекциях дыхательных путей. (Материалы 14 конгресса ECCMID). Российские медицинские вести. 2004. 2.Baldwin D.R., Wise R., Andrews J.M. еt al. Azithromycin concentrations аt the sites of pulmonary infection. Eur Respir J. 1990; 3: 886-890.Baldwin D.R., Wise R., Andrews J.M. еt al. Azithromycin concentrations аt the sites of pulmonary infection. Eur Respir J. 1990; 3: 886-890.Block S., Arrieta A., Seibel M., McLinn S., Eppes S., Murphy M.J. Single-dose (30 mg/kg) azithromycin compared with amoxicillin/clavulanate for the treatment of uncomplicated acute otitis media. Curr Ther Res 2003; 64: Suppl A: A30-42.Block S., Arrieta A., Seibel M., McLinn S., Eppes S., Murphy M.J. Single-dose (30 mg/kg) azithromycin compared with amoxicillin/clavulanate for the treatment of uncomplicated acute otitis media. Curr Ther Res 2003; 64: Suppl A: A30-42.Dunne M.W., Khurana C., Mohs A.A. et al. Efficacy of single-dose azithromycin in treatment of acute otitis media in children after a baseline tympanocentesis. Antimicrob Agents Chemother 2003; 47: 2663-5.Dunne M.W., Khurana C., Mohs A.A. et al. Efficacy of single-dose azithromycin in treatment of acute otitis media in children after a baseline tympanocentesis. Antimicrob Agents Chemother 2003; 47: 2663-5.Dunne M.W., Latiolais T., Lewis B. et al. Randomized, double-blind study of the clinical efficacy of 3 days of azithromycin compared with co-amoxiclav for the treatment of acute otitis media. J Antimicrob Chemother 2003; 52: 469-472.Dunne M.W., Latiolais T., Lewis B. et al. Randomized, double-blind study of the clinical efficacy of 3 days of azithromycin compared with co-amoxiclav for the treatment of acute otitis media. J Antimicrob Chemother 2003; 52: 469-472.Rothermel C. Single-dose azithromycin for acute otitis media: a pharmacokinetic/pharmacodynamic rationale. Curr Ther Res 2003; 64: Suppl A. A4-15.Rothermel C. Single-dose azithromycin for acute otitis media: a pharmacokinetic/pharmacodynamic rationale. Curr Ther Res 2003; 64: Suppl A. A4-15.Rapp R.P. Pharmacokinetics and pharmacodynamics of intravenous and oral azithromycin: enhanced tissue activity and minimal drug inter-actions. Аnn Phannacother. 1998; 32: 785-793.Rapp R.P. Pharmacokinetics and pharmacodynamics of intravenous and oral azithromycin: enhanced tissue activity and minimal drug inter-actions. Аnn Phannacother. 1998; 32: 785-793.Girard D., Finegan S.M., Cimochowski C.R. еt аl. Accelerated dosing of azithromycin in preclinical infection models. Orlando, Fla: 102nd American Society for Microbiology General Meeting, Abstract. А-57.Girard D., Finegan S.M., Cimochowski C.R. еt аl. Accelerated dosing of azithromycin in preclinical infection models. Orlando, Fla: 102nd American Society for Microbiology General Meeting, Abstract. А-57.Kamicker B.J. In rodent models, а single dose of azithromycin was more effective than dosing split over 3 or 5 days. Washington, DC: 44th ICAAC; October 30-November 2, 2004.Kamicker B.J. In rodent models, а single dose of azithromycin was more effective than dosing split over 3 or 5 days. Washington, DC: 44th ICAAC; October 30-November 2, 2004.Drehobl M.A. et al. Chest. 2005; 128: 2230-2237.Drehobl M.A. et al. Chest. 2005; 128: 2230-2237.Kegel S. et al. ECCMID, 2005.Kegel S. et al. ECCMID, 2005.D'Ignazio J. et al. Antimicrom agent. Chemother. 2005; 49: 4035-41.D'Ignazio J. et al. Antimicrom agent. Chemother. 2005; 49: 4035-41.Lim W.S., van der Eerden M.M., Laing R. et al. Defining community acquired pneumonia severity on presentation to hospital: an international derivation and validation study. Thorax. 2003; 58: 377-382.Lim W.S., van der Eerden M.M., Laing R. et al. Defining community acquired pneumonia severity on presentation to hospital: an international derivation and validation study. Thorax. 2003; 58: 377-382.Murray J.J. et al. Otolaringol-Head Neck Surg. 2005; 133: 194-201.Murray J.J. et al. Otolaringol-Head Neck Surg. 2005; 133: 194-201.Rothermel C.D. Single-dose azithromycin for acute otitis media: a pharmacokinetic/pharmacodynami rationale. Curr Ther Res 2003; 64: SupplA: A4-A15.Rothermel C.D. Single-dose azithromycin for acute otitis media: a pharmacokinetic/pharmacodynami rationale. Curr Ther Res 2003; 64: SupplA: A4-A15.Girard A.D., Girard D., English A.R. et al. Pharmacokinetic and in vivo studies with azithromycin (CP-62,993), a new macrolide with a next end ed half-life and excel enttissued istribution.Girard A.D., Girard D., English A.R. et al. Pharmacokinetic and in vivo studies with azithromycin (CP-62,993), a new macrolide with a next end ed half-life and excel enttissued istribution.Antimicrob Agents Chemother. 1987;32: 1948-1954; 37. Thornsberry C., Ogilvie P.T., Holley H.P. Jr., Sahm D.F. Survey of susceptibilities of Streptococcus pneumoniae, Haemophilus infeuenzae, and Moraxella catarrhalis isolates to 26 antimicrobial agents: a prospective US study. Antimicrob Agents Chemother. 1999; 43: 2612-2623.Antimicrob Agents Chemother. 1987;32: 1948-1954; 37. Thornsberry C., Ogilvie P.T., Holley H.P. Jr., Sahm D.F. Survey of susceptibilities of Streptococcus pneumoniae, Haemophilus infeuenzae, and Moraxella catarrhalis isolates to 26 antimicrobial agents: a prospective US study. Antimicrob Agents Chemother. 1999; 43: 2612-2623.Foulds G., Johnson R.B. Selection of dose regimens of azithromycin. J Antimicrob Chemother1993; 31: SupplE: 39-50.Foulds G., Johnson R.B. Selection of dose regimens of azithromycin. J Antimicrob Chemother1993; 31: SupplE: 39-50.Pukander J., Rautianen M. Penetration of azithromycin into middle ear effusions in acute and secretory otitis media in children. J Antimicrob Chemother 1996; 37: Suppl C: 53-61.Pukander J., Rautianen M. Penetration of azithromycin into middle ear effusions in acute and secretory otitis media in children. J Antimicrob Chemother 1996; 37: Suppl C: 53-61.Arguedas A., Loaiza C., Perez A., Gutierrez A., Herrera M.L., Rothermel C.D. A pilot study of single-dose azithromycin versus 3-day azithromycin or single-dose ceftriaxone for uncomplicated acute otitis media in children. Curr Ther Res 2003; 64: Suppl A: A16-A29.Arguedas A., Loaiza C., Perez A., Gutierrez A., Herrera M.L., Rothermel C.D. A pilot study of single-dose azithromycin versus 3-day azithromycin or single-dose ceftriaxone for uncomplicated acute otitis media in children. Curr Ther Res 2003; 64: Suppl A: A16-A29.Dunne M.W., Khurana C., Arguedas A. et al. Efficacy of single dose azithromycin in thetreatment of acute otitis media in children receiving a baseline tympanocentesis. Antimicrob Agents Chemother. 2003; 47: 2663-2665.Dunne M.W., Khurana C., Arguedas A. et al. Efficacy of single dose azithromycin in thetreatment of acute otitis media in children receiving a baseline tympanocentesis. Antimicrob Agents Chemother. 2003; 47: 2663-2665.File T.M. et al. Chest 2004; 125: 1888-901.File T.M. et al. Chest 2004; 125: 1888-901.Brunton S. et al. Am J Manag Care 2004; 10: 689-96.Brunton S. et al. Am J Manag Care 2004; 10: 689-96.Kardas Р. Patient соmрliапсе with antibiotic treatrnent for respiratory tract infections. J Antimicrob Chemother 2002; 49: 897-903.Kardas Р. Patient соmрliапсе with antibiotic treatrnent for respiratory tract infections. J Antimicrob Chemother 2002; 49: 897-903.Halpem М.Т., Higashi М.К., Bakst A.W. еt аl. The economic impact of acute exacerbations of chronic bronchitis in the United States and Canada: а literature review. J Manag Care Phann 2003; 9: 353-359.Halpem М.Т., Higashi М.К., Bakst A.W. еt аl. The economic impact of acute exacerbations of chronic bronchitis in the United States and Canada: а literature review. J Manag Care Phann 2003; 9: 353-359.Pichichero М.Е. Short course antibiotic therapy for respiratory infections: а review of the evidence. Pediatr Infect Dis J 2000; 19: 929-937.Pichichero М.Е. Short course antibiotic therapy for respiratory infections: а review of the evidence. Pediatr Infect Dis J 2000; 19: 929-937.FDA. Labelling Requirements for Systemic Antibacterial Drug Products Intended for Human use. Available at:http://www.fda.gov/ocIopacoml hottopicslanti_resist. htrnl. Accessed June 28, 2004.FDA. Labelling Requirements for Systemic Antibacterial Drug Products Intended for Human use. Available at:http://www.fda.gov/ocIopacoml hottopicslanti_resist. htrnl. Accessed June 28, 2004.

The authors declare that there are no conflicts of interest present.