Authors
Bel'diev S. N.
MD, PhD, Associate Professor, Chair for Therapy and Cardiology1
Egorova I. V.
MD, PhD, Associate Professor, Chair for Therapy and Cardiology1
Kononova A. G.
MD, PhD, Associate Professor, Chair for Outpatient Therapy and Family Medicine1
Medvedeva I. V.
MD, PhD, Associate Professor, Chair for Therapy and Cardiology1
Platonov D. Yu.
MD, PhD, MPH, Head, Chair for Therapy and Cardiology1
Kolbasnikov S. V.
MD, PhD, Professor, Head, Chair for Outpatient Therapy and Family Medicine1
1 - Tver State Medical University, Tver, Russia
Corresponding Author
Bel'diev Sergej; e-mail: sbeldiev@yandex.ru
Conflict of interest
Authors have no conflict of interest.
Funding
The study had no sponsorship.
Abstract
The article discusses in detail three fairly stable myths about drug interactions of macrolide antibiotic josamycin, which have become widespread in Russian literature over three decades since the drug product was introduced in Russia: 1) josamycin does not affect the metabolism of other drugs; 2) josamycin has a negligible effect on the metabolism of other drugs; 3) josamycin rarely interacts with other drugs.
Key words
Josamycin, drug interactions
DOI
References
1. Yongue J. Origins of innovation in the Japanese pharmaceutical industry: The case of Yamanouchi Pharmaceutical Company (1923-1976). Japanese Research in Business History 2005; 22: 109-135. doi: 10.5029/jrbh.22.109.
2. Lekarstvennye preparaty zarubezhnyh firm v Rossii: spravochnik [Medicines of foreign firms in Russia: reference book]. Moscow: AstraFarmServis, 1993. 720 p. (In Russ.).
3. Gosudarstvennyj reestr lekarstvennyh sredstv. Instrukcija po primeneniju lekarstvennogo preparata dlja medicinskogo primenenija Vilprafen® (dzhozamicin; tabletki, pokrytye plenochnoj obolochkoj) [The State Register of Medicinal Products of the Russian Federation. Vilprafen® (josamycin; film-coated tablets): summary of product characteristics]. URL: https://grls.rosminzdrav.ru (cited: May 30, 2020). (In Russ.).
4. Gosudarstvennyj reestr lekarstvennyh sredstv. Instrukcija (informacija dlja specialistov) po primeneniju lekarstvennogo preparata dlja medicinskogo primenenija Vilprafen® Solutab (dzhozamicin, tabletki dispergiruemye) [The State Register of Medicinal Products of the Russian Federation. Vilprafen® Solutab (josamycin, dispersible tablets): summary of product characteristics]. URL: https://grls.rosminzdrav.ru (cited: May 30, 2020). (In Russ.).
5. Gosudarstvennyj reestr lekarstvennyh sredstv. Instrukcija po primeneniju lekarstvennogo preparata dlja medicinskogo primenenija Vilprafen® (dzhozamicin, granuly dlja prigotovlenija suspenzii dlja priema vnutr') [The State Register of Medicinal Products of the Russian Federation. Vilprafen® (josamycin, granules for oral suspension): summary of product characteristics]. URL: https://grls.rosminzdrav.ru (cited: May 30, 2020). (In Russ.).
6. Larrey D., Tinel M., Pessayre D. Formation of inactive cytochrome P-450 Fe(II)-metabolite complexes with several erythromycin derivatives but not with josamycin and midecamycin in rats. Biochem Pharmacol 1983; 32(9): 1487-1493. doi: 10.1016/0006-2952(83)90470-7.
7. Delaforge M., Jaouen M., Mansuy D. Dual effects of macrolide antibiotics on rat liver cytochrome P-450. Induction and formation of metabolite-complexes: a structure-activity relationship. Biochem Pharmacol 1983; 32(15): 2309-2318. doi: 10.1016/0006-2952(83)90178-8.
8. Brazier J.L., Kofman J., Faucon G., Perrin-Fayolle M., Lepape A., Lanoue R. Retard d'elimination de la theophylline du a la troleandomycine. Absence d'effet de la josamycine [Delay in theophylline elimination due to troleandomycin. No effect of josamycin]. Therapie [Therapy] 1980; 35(4): 545-549. PMID: 6970422. (In French).
9. Grolleau J.Y., Martin M, de la Guerrande B.D., Barrier J., Peltier P. Ergotisme aigu lors d'une association josamycine/tartrate d'ergotamine [Acute ergotism with a therapeutic association josamycin/ergotamine (author's translation)]. Therapie [Therapy] 1981; 36(3): 319-321. PMID: 7292409. (In French).
10. Montastruc J.L., Rascol A. Traitement de la maladie de Parkinson par doses élevées de bromocriptine. Interaction possible avec la josamycine [Treatment of Parkinson's disease with high doses of bromocriptine. Possible interaction with josamycin]. Presse Medicale [Medical Press] 1984; 13: 2267-2268. PMID: 6239177. (In French).
11. Vinçon G., Albin H., Demotes-Mainard F., Guyot M., Bistue C., Loiseau P. Effects of josamycin on carbamazepine kinetics. Eur J Clin Pharmacol 1987; 32(3): 321-323. doi: 10.1007/bf00607583.
12. Hugues F.C., Jouglard J., Le Jeunne C., Moulin M., Begaud B. Accidents psychiques liés à l'inhibition du catabolisme des benzodiazépines [Psychotic disorders linked to the inhibition of benzodiazepine catabolism]. La Revue de Médecine Interne [The Journal of Internal Medicine] 1987; 8(4): 433-436. doi: 10.1016/s0248-8663(87)80021-8. (In French).
13. Kreft-Jais C., Billaud E.M., Gaudry C., Bedrossian J. Effect of josamycin on plasma cyclosporine levels. Eur J Clin Pharmacol 1987; 32(3): 327-328. doi: 10.1007/bf00607585.
14. Pavesio D., Mora P., Leone L., Moresco V., Girardo G. Interazione macrolidi-teofillina (Esperienze in pediatria) [Macrolide-theophylline interaction. (Experiences in pediatrics)]. Minerva Pediatrica [Minerva Pediatr] 1989; 41: 323-328. PMID: 2601650. (In Italian).
15. Periti P., Mazzei T., Mini E., Novelli A. Pharmacokinetic drug interactions of macrolides. Clin Pharmacokinet 1992; 23(2): 106-131. doi: 10.2165/00003088-199223020-00004.
16. Vasiliev M.M., Smirnova A.A. Vil'prafen (dzhozamicin) v terapii bol'nyh urogenital'nym hlamidiozom: posobie dlja vrachej [Vilprafen (josamycin) in the treatment of patients with urogenital chlamydia: a manual for doctors]. Moscow, 2000. 16 p. (In Russ.).
17. Belousov Yu.B., Karpov O.I., Belousov D.Yu., Beketov A.S., Popova N.Yu., Boyko E.A. Mesto dzhozamicina v lechenii urogenital'nogo hlamidioza: farmakojekonomicheskoe obosnovanie [The place of josamycin in the treatment of urogenital chlamydia: pharmacoeconomic rationale]. Mezhdunarodnyj medicinskij zhurnal [International Medical Journal] 2006; (1): 86-93. (In Russ.).
18. Fofanova I.Yu., Prilepskaya V.N. Vozmozhnosti terapii urogenital'noj mikoplazmennoj infekcii pri beremennosti [Treatment options for urogenital mycoplasma infection during pregnancy]. Trudnyj pacient [Difficult Patient] 2009; 7(12): 17-23. (In Russ.).
19. Molochkov V.A., Gushshin A.E., Balyura E.V. Vil'prafen v kompleksnom lechenii hronicheskogo urogenital'nogo hlamidioza [Vilprafen in the complex treatment of chronic urogenital chlamydia]. Sechenovskij vestnik [Sechenov Medical Journal] 2013; 1(11): 55-58. (In Russ.).
20. Khokhlova T.A., Polyakova A.S., Bakradze M.B. Mesto dzhozamicina v terapii ostryh respiratornyh infekcij bakterial'noj jetiologii u detej [Josamicyn in the treatment of bacterial acute respiratory infections in children]. Medicinskij sovet [Medical Council] 2015; (1): 7-11. doi: 10.21518/2079-701X-2015-1-7-11. (In Russ.).
21. Tyutyunnik V.L., Veresova A.A., Sirotkina E.A., Kan N.E. Vospalitel'nye zabolevanija organov malogo taza: osnovnye principy terapii [Pelvic inflammatory disease: basic principles of therapy]. Medicinskij sovet [Medical Council] 2018; (12): 160-163. doi: 10.21518/2079-701X-2018-12-160-163. (In Russ.).
22. Strachunsky L.S., Kozlov S.N. Makrolidy v sovremennoj klinicheskoj praktike [Macrolides in modern clinical practice]. Smolensk: Rusich, 1998. 302 p. (In Russ.).
23. Strachunsky L.S., Belousov Yu.B., Kozlov S.N. (eds). Prakticheskoe rukovodstvo po antiinfekcionnoj himioterapii [Practical guide to anti-infectious chemotherapy]. Moscow: Borges, 2002. 384 p. (In Russ.).
24. Strachunsky L.S., Belousov Yu.B., Kozlov S.N. (eds). Prakticheskoe rukovodstvo po antiinfekcionnoj himioterapii [Practical guide to anti-infectious chemotherapy]. Smolensk: MAKMAH, 2007. 464 p. (In Russ.).
25. Bachmann K., Jauregui L., Chandra R., Thakker K. Influence of a 3-day regimen of azithromycin on the disposition kinetics of cyclosporine A in stable renal transplant patients. Pharmacol Res 2003; 47(6): 549-554. doi: 10.1016/s1043-6618(03)00018-5.
26. Azanza J.R., Catalán M., Alvarez M.P., Sádaba B., Honorato J., Llorens R. et al. Possible interaction between cyclosporine and josamycin: a description of three cases. Clin Pharmacol Ther 1992; 51(5): 572-575. doi: 10.1038/clpt.1992.65.
27. Koraksan (ivabradin) – novyj preparat dlja lechenija stabil'noj stenokardii [Coraxan (ivabradine) – a new drug for the treatment of stable angina pectoris]. Klinicheskaja farmakologija i terapija [Clinical Pharmacology and Therapy] 2006; (1): 80. (In Russ.).
28. Gosudarstvennyj reestr lekarstvennyh sredstv. Instrukcija po medicinskomu primeneniju preparata Koraksan (ivabradin; tabletki, pokrytye plenochnoj obolochkoj) [The State Register of Medicinal Products of the Russian Federation. Coraxan (ivabradine; film-coated tablets): summary of product characteristics]. URL: https://grls.rosminzdrav.ru (cited: May 30, 2020). (In Russ.).
29. Kosarev V.V., Babanov S.A. Makrolidy v lechenii infekcij bakterial'noj prirody [Macrolides in the treatment of bacterial infections]. Trudnyj pacient [Difficult Patient] 2009; 7(11): 23-25. (In Russ.).
30. Tatochenko V.K. Dzhozamicin v pediatricheskoj praktike [Josamycin in pediatric practice]. Pediatria [Pediatrics] 2011; 90(5): 124-128. (In Russ.).
31. Pikuza O.I., Zakirova A.M., Ibragimova Zh.R., Pikuza A.V., Rashitov L.F. Jeffektivnost' i bezopasnost' primenenija makrolidov v terapii vnebol'nichnyh pnevmonij u detej [Efficiency and safety of macrolids in therapy of community-acquired pneumonia in children]. Lechashhij vrach [Lechaschii Vrach Journal] 2015; 9: 47. (In Russ.).
32. Spornye voprosy gastroprotekcii u komorbidnyh pacientov terapevticheskogo i kardiologicheskogo profilja [Controversial issues of gastroprotection in comorbid therapeutic and cardiological patients]. Jeffektivnaja farmakoterapija [Effective Pharmacotherapy] 2019; 15(18): 88-96. (In Russ.).
33. Sánchez Romero A., Calzado Solaz C. Posible interacción entre josamicina y amitriptilina [A possible interaction between josamycin and amitriptyline]. Medicina Clínica [Clinical Medicine (Barcelona)] 1992; 98(7): 279. PMID: 1560711. (In Spanish).
34. Auzepy P., Graïni L., Dechaubry V. Accident hémorragique grave par interaction josamycine-acénocoumarol [Haemorrhagic accident due to josamycine acenocoumarol interaction]. Réanimation Urgences [Emergency Resuscitation] 1993; 2(2): 120-123. doi: 10.1016/S1164-6756(05)80357-3. (in French).
35. Echizen H., Kawasaki H., Chiba K., Tani M., Ishizaki T. A potent inhibitory effect of erythromycin and other macrolide antibiotics on the mono-N-dealkylation metabolism of disopyramide with human liver microsomes. J Pharmacol Exp Ther 1993; 264(3): 1425-1431. PMID: 8450476.
36. Borron S.W., Scherrmann J.M., Baud F.J. Markedly altered colchicine kinetics in a fatal intoxication: examination of contributing factors. Hum Exp Toxicol 1996; 15(11): 885-890. doi: 10.1177/096032719601501104.
37. Bohets H., Lavrijsen K., Hendrickx J., van Houdt J., van Genechten V., Verboven P., et al. Identification of the cytochrome P450 enzymes involved in the metabolism of cisapride: in vitro studies of potential co-medication interactions. Br J Pharmacol 2000; 129(8): 1655-1667. doi: 10.1038/sj.bjp.0703246.
38. Allongement de l'intervalle QT et antihistaminiques H1 [QT prolongation and H1 antihistamines]. La Revue Prescrire [Prescrire Rev] 2002; 22(230); 494. (in French).
39. Zhou S.F., Xue C.C., Yu X.Q., Li C., Wang G. Clinically important drug interactions potentially involving mechanism-based inhibition of cytochrome P450 3A4 and the role of therapeutic drug monitoring. Ther Drug Monit 2007; 29(6): 687-710. doi: 10.1097/FTD.0b013e31815c16f5.
40. Crosta L., Candiloro V., Meli M., Tolomeo M., Rausa L., Dusonchet L. Lacidipine and josamycin: two new multidrug resistance modulators. Anticancer Res 1994; 14(6B): 2685-2689. PMID: 7872702.
41. Wang L., Kitaichi K., Hui C.S., Takagi K., Takagi K., Sakai M., et al. Reversal of anticancer drug resistance by macrolide antibiotics in vitro and in vivo. Clin Exp Pharmacol Physiol 2000; 27(8): 587-593. doi: 10.1046/j.1440-1681.2000.03308.x.
42. Cambonie G., Sabatier E., Guillaumont S., Masson F., Charbit J., Pidoux O., et al. Digoxine-josamycine : une interaction dangereuse chez l’enfant [Digoxin-josamycin: a dangerous drug interaction in children]. Arch Pediatr 2006; 13(8): 1118-1120. doi: 10.1016/j.arcped.2006.04.021. (In French).
43. Moiseev S.V. Dzhozamicin: otlichitel'nye osobennosti i perspektivy primenenija [Josamycin: distinctive features and application prospects]. Klinicheskaja farmakologija i terapija [Clinical Pharmacology and Therapy] 2005; 14(4): 66-71. (In Russ.).
44. Diskussionnye voprosy terapii urogenital'nyh infekcij [Discussion questions of the treatment of urogenital infections]. Jeffektivnaja farmakoterapija [Effective Pharmacotherapy] 2015; (33): 34-40. (In Russ.).
45. Pokhaznikova M.A. Vnebol'nichnaja pnevmonija u vzroslyh: osobennosti vedenija v ambulatornyh uslovijah [Community-acquired pneumonia in adults: outpatient treatment]. Rossijskij semejnyj vrach [Russian Family Doctor] 2016; 20(1): 4-16. doi: 10.17816/RFD201614-16. (In Russ.).
46. Zaitzev A.A. Vnebol'nichnaja pnevmonija: jepidemiologija, diagnostika i antimikrobnaja terapija [Community-acquired pneumonia: epidemiology, diagnostics and antimicrobal therapy]. Terapija [Therapy] 2018; 1(19): 63-71. (In Russ.).
47. Penalba C., Bellahcen R. Un cas d'Ergotisme mineur par association de josamycine et de tartrate d'Ergotamine [A case of minor ergotism by combination of josamycin and ergotamine tartrate]. Médecine et Maladies Infectieuses [Medicine and Infectious Diseases] 1986; 16(11): 619. doi: 10.1016/S0399-077X(86)80070-1. (In French).
48. Juge S., Lauby V., Mallaret M., Musiedlak G., Stanke F., Bessard G. Les interactions entre les dérivés de l’ergot de seigle et les macrolides sont toujours d’actualité: les méfaits de l’automédication [The interactions between ergot derivatives and macrolides are still relevant today: the harmful effects of self-medication]. La Revue de Médecine Interne [The Journal of Internal Medicine] 16(4):295-295. doi: 10.1016/0248-8663(96)80714-4. (In French).
49. Bel'diev S.N., Berezina E.I., Gavrilenko N.G., Egorova I.V., Medvedeva I.V., Platonov D.Yu. Germanskoe nabljudatel'noe issledovanie perenosimosti kishechnorastvorimoj formy acetilsalicilovoj kisloty i ego opisanie v otechestvennyh publikacijah 2009-2018 gg. [German observational study of the tolerability of enteric-coated acetylsalicylic acid and its presentation in Russian publications 2009-2018]. Medicina [Medicine] 2019; 7(1): 26-41. doi: 10.29234/2308-9113-2019-7-1-26-41. (In Russ.).
50. Bel'diev S.N., Egorova I.V., Gavrilenko N.G., Berezina E.I., Medvedeva I.V., Platonov D.Yu. Otrazhenie zarubezhnyh dannyh ob ul'cerogennom dejstvii nikorandila v otechestvennyh publikacijah 2009-2018 godov [The reflection of foreign data on nicorandil-induced ulcerations in Russian publications in 2009-2018 years]. Medicina [Medicine] 2019; 7(2): 40-58. doi: 10.29234/2308-9113-2019-7-2-40-58. (In Russ.).
51. Bel'diev S.N., Egorova I.V., Platonov D.Yu. Rekomendacii po primeneniju peroral'nyh antikoaguljantov u pacientov pozhilogo vozrasta: kriterii Birsa i dokazatel'naja medicina [Recommendations on the use of oral anticoagulants in elderly patients: Beers criteria and evidence-based medicine]. Medicina [Medicine] 2019; 7(4): 1-11. doi: 10.29234/2308-9113-2019-7-4-1-11. (In Russ.).
52. Bel'diev S.N., Egorova I.V., Kononova A.G., Medvedeva I.V., Platonov D.Yu., Kolbasnikov S.V. Spornye voprosy jeradikacii Helicobacter pylori u pacientov, prinimajushhih prjamye oral'nye antikoaguljanty [Controversial issues of Helicobacter pylori eradication in patients taking direct oral anticoagulants]. Jeffektivnaja farmakoterapija [Effective Pharmacotherapy] 2020; 16 (1): 84-90. doi: 10.33978/2307-3586-2020-16-1-84-90. (In Russ.).
53. Gosudarstvennyj reestr lekarstvennyh sredstv. Instrukcija po primeneniju lekarstvennogo preparata dlja medicinskogo primenenija Klacid (klaritromicn; tabletki, pokrytye plenochnoj obolochkoj) [The State Register of Medicinal Products of the Russian Federation. Klacid (clarithromycin; film-coated tablets): summary of product characteristics]. URL: https://grls.rosminzdrav.ru (cited: May 30, 2020). (In Russ.).
54. Bel'diev S.N., Medvedeva I.V., Platonov D.Yu. Lekarstvennye vzaimodejstvija novyh peroral'nyh antikoaguljantov: vnutri i vne jacheek tablicy [Drug interactions of new oral anticoagulants: inside and outside table cells]. Racional'naja farmakoterapija v kardiologii [Rational Pharmacotherapy in Cardiology]. 2017; 13(5): 716-724. doi: 10.20996/1819-6446-2017-13-5-716-724. (In Russ.).
55. Cornett E., Novitch M.B., Kaye A.D., Pann C.A., Bangalore, H.S., Allred G., et al. Macrolide and fluoroquinolone mediated cardiac arrhythmias: clinical considerations and comprehensive review. Postgrad Med 2017; 129(7): 715‐724. doi: 10.1080/00325481.2017.1362938.
56. Vermeer L.M., Isringhausen C.D., Ogilvie B.W., Buckley D.B. Evaluation of ketoconazole and its alternative clinical CYP3A4/5 inhibitors as inhibitors of drug transporters: the in vitro effects of ketoconazole, ritonavir, clarithromycin, and itraconazole on 13 clinically-relevant drug transporters. Drug Metab Dispos 2016; 44(3): 453‐459. doi: 10.1124/dmd.115.067744.
57. Sychev D.A. Rekomendacii dlja farmacevticheskih kompanij po izucheniju biotransformacii i transporterov novyh lekarstvennyh sredstv: dizajn issledovanij, analiz dannyh i vnesenie informacii v instrukcii po primeneniju [Recommendations for pharmaceutical companies on the study of biotransformation and transporters of new drugs: research design, data analysis and entering information in the instructions for use]. Moscow: 2009. URL: http://www.regmed.ru/Content/Doc.aspx?id=26a9128c-ee32-4469-9c64-5c666339049e (cited: May 30, 2020). (In Russ.).
58. Savelieva I., Camm A.J. If inhibition with ivabradine: electrophysiological effects and safety. Drug Saf 2008; 31(2): 95‐107. doi: 10.2165/00002018-200831020-00001.
59. Zakharov A.V., Varlamova E.V., Lagunin A.A., Dmitriev A.V., Muratov E.N., Fourches D., et al. QSAR modeling and prediction of drug-drug interactions. Mol Pharm 2016; 13(2): 545‐556. doi: 10.1021/acs.molpharmaceut.5b00762.
60. Chebotarev V.V., Aschakov M.S., Chebotareva N.V., Shchetinin E.V. Makrolidy v lechenii urogenital'noj infekcii: dokazannaja jeffektivnost' ili marketingovaja politika farmacevticheskih kompanij? [Macrolides in the treatment of urogenital infections: proven efficacy or marketing policy of pharmaceutical companies?] Medicina [Medicine] 2018; 6(1): 25-41. doi: 10.29234/2308-9113-2018-6-1-25-41. (In Russ.).