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Yenidoğanlarda seftriakson kullanımının yan etkilerinin değerlendirilmesi

Year 2022, Volume: 47 Issue: 4, 1641 - 1649, 28.12.2022
https://doi.org/10.17826/cumj.1165896

Abstract

Amaç: Seftriakson yan etkileri nedeniyle yenidoğanda sınırlı kullanıma sahiptir. Yenidoğan enfeksiyonlarında kullanımı ile ilgili sınırlı sayıda çalışma vardır. Bu çalışma ile setriakson alan yenidoğanlarda seftriakson sonrası oluşabilecek yan etkilerin değerlendirilmesi amaçlanmıştır.
Gereç ve Yöntem: Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi Yenidoğan Yoğun Bakım Ünitesi’nde, 2015-2016 yılları arasında yatan bebeklerin seftriakson tedavisi öncesi ve sonrası klinik ve laboratuvar verileri retrospektif olarak incelenmiştir.
Bulgular: Çalışmaya 30 olgu alınmıştır. Bu bebeklerin ortalama gebelik yaşı 37 ± 3,1 (30-41) hafta, seftriakson aldığı süre 7,2 ± 2,2 (2-12) gün bulunmuştur. 30 olgudan alınan idrar kültürlerinde; 17 (%56,6) bebekte üreme saptanmıştır. Bunların 11’inde (%36,6) Escherischia coli (E. coli), 5’inde (%16,7) diğer bakteriler üremiştir. Olguların seftriakson öncesi ve sonrası laboratuvar verilerinde kan üre azotu (BUN), total bilirubin (TB) ve hematokrit değerlerinde anlamlı düşüş saptanmıştır. Seftriakson kullanımına bağlı herhangi bir yan etki izlenmemiştir.
Sonuç: Çalışmamızda seftriakson sonrası komplikasyon görülmemiş olması term veya terme yakın yenidoğanlarda seftriakson kullanımı için cesaret verici olabilir. Fakat, yenidoğanda seftriaksonun yan etkilerinin ve sıklıklarının kesinleştirilmesi ve yenidoğanda kullanılan diğer antibiyotiklere karşı alternatif olup olamayacağının belirlenmesi için daha fazla araştırmalara ihtiyaç vardır.

Thanks

Başta Prf Dr Mehmet Star hocam olmak üzere bu çalışmada desteğini hiçbir zaman esirgemeyen tün hocalarıma ve çalışma arkadaşlarıma sonsuz teşekkürlerimi sunarım.

References

  • 1. R. Wise, A. P. Gjllett, J. M. Andrews and K. A. Bedford. Ro 13-9904: a cephalosporin with a high degree of activity and broad antibacterial activity: an invitro comparative study. J Antimicrob Chemother. 1980;6:595–600.
  • 2. Craig WA. Interrelationship between pharmacokinetics and pharmacodynamics in determining dosage regimens for broadspectrum cephalosporins. Diagn Microbiol Infect Dis 1995;22:89–96.
  • 3. Von Martels JZH, Van de Meeberg EK, Holman M, Ligtenberg JJ, Ter Maaten JC. Pseudolithiasis after recent use of ceftriaxone: an unexpected diagnosis in a child with abdominal pain. Am J Emerg Med. 2013;31(8):1294.e5-6
  • 4) Arvidsson A, Alvan G, Angelin B, et al. Ceftriaxone: renal and biliary excretion and effect on the colon microflora. J Antimicrob Chemother 1982;10: 207–15.
  • 5) Lee SP, Lipsky BA, Teefey SA. Gallbladder sludge and antibiotics. Pediatr Infect Dis J 1990;9:422–3.
  • 6. Yaffe SJ, Aranda JV. Neonatal and Pediatric Pharmacology: Therapeutic Principles in Practice. 4th edition (ED L Williams & Wilkins):886, Philadelphia, 2010.
  • 7. Ayele AA, Gebresillassie BM, Erku DA, Gebreyohannes EA, Demssie, DG, Mersha AG, et al. Prospective evaluation of Ceftriaxone use in medical and emergency wards of Gondar university referral hospital, Ethiopia. Pharmacol. Res. Perspect. 2018 Feb;6(1):e00383.
  • 8. Lee H, Jung D, Yeom JS, Son JS, Jung S, Kim YS. Evaluation of cef-triaxone utilization at multi-center study.Korean J Intern Med.2009;24(4):374-80.
  • 9. Ozturk A, Kaya M, Zeyrek D, Ozturk E, Kat N, Ziylan SZ. Ultrasonographic findings in ceftriaxone: associated biliary sludge and pseudolithiasis in children. Acta Radiologica. 2005;46(1): 112-16.
  • 10. Schaad UB, Wedgwood-Krucko J, Tschaeppeler H. Reversible ceftriaxone-associated biliary pseudolithiasis in children. Lancet. 1988;2(8625):1411-3.
  • 11. Ustyol L, Bulut MD, Agengin K, Bala KA, Yavuz A, Bora A. ve ark. Comparative evaluation of ceftriaxoneand cefotaxime-induced biliary pseudolithiasis or nephrolithiasis: A prospective study in 154 children. Hum Exp Toxicol. 2017;36(6): 547-53.
  • 12. Mohkam M, Karimi A, Gharib A, Daneshmand H, Khatami A, Ghojevand N. Ceftriaxone associated nephrolithiasis: a prospective study in 284 children. Pediatr Nephrol. 2007;22(5):690-4.
  • 13. Schmutz HR, Detampel P, Bühler T, Büttler A, Gygax B, Huwyler J. In vitro assessment of the formation of ceftriaxone-calcium precipitates in human plasma. J Pharm Sci. 2011;100(6):2300-10.
  • 14) Riccabona M, Kerbl R, Schwinger W, et al. Ceftriaxone-induced cholelithiasis-a harmless side- effect? Klin Pediatr. 1993;205:421–3.
  • 15) Schaad UB, Suter S, Gianella-Borradori A, Pfenningen J, Auckenthaler R, Bernart O, et al. Acomparison of ceftriaxone and cefuroxime for the treatment of bacterial meningitis in children. N Engl J Med. 1990;322:141–7.
  • 16. Bradley JS, Wassel RT, Lee L, Nambiar S. Intravenous ceftriaxone and calcium in the neonate: assessing the risk for cardiopulmonary adverse events. Pediatrics. 2009;123(4):e609-13.
  • 17. Donnelly PC, Sutich RM, Easton R, Adejumo OA, Lee TA, Logan LK. Ceftriaxone-Associated Biliary and Cardiopulmonary Adverse Events in Neonates: A Systematic Review of the Literature. Pediatr Drugs. 2017;19(1):21-34.
  • 18. Papadopoulou F, Efremidis S, Karyda S, Badouraki M, Karatza E, Panteliadis C, et al, Incidence of ceftriaxone associated gallbladder pseudolithiasis. Acta Paediatrica. 1999;88(12): 1352-5.
  • 19. Pichichero ME. Cephalosporins can be prescribed safely for penicillin-allergic patients. J Fam Pract. 2006;55:106-12.
  • 20. Kim MH, Lee JM. Diagnosis and management of immediate hypersensitivity reactions to cephalosporins. Allergy Asthma Immunol Res. 2014;6(6):485-95.
  • 21. Coppini R, Simons SH, Mugelli A, Allegaert K, Clinical research in neonates and infants: Challenges and perspectives. Parmacol Res. 2016;108:80-7
  • 22. Türk Neonatoloji Derneği Yenidoğan Enfeksiyonları Tedavi ve İzlem Rehberi 2014
  • 23. Neofax: A Manual of Drugs Used in Neonatal Care by Barry Mangum and Thomas E. Young. 2014:172
  • 24. Özsüt H. Seftriakson. ANKEM Derg, 2002, 16(3): 404-7
  • 25. US Food and Drug Administration. Information for healthcare professionals: ceftriaxone (marketed as Rocephin) Information 2007. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInforma tionforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm134328.htm. Accessed 20 Apr 2016.
  • 26. US Food and Drug Administration. Information for healthcare professionals: ceftriaxone (marketed as Rocephin) Information 2009. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformati onforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084263.htm. Accessed 20 Apr 2016.
  • 27. Katzung B, Trevor A. Basic and clinical pharmacology. 13th ed. New York: McGrawHill; 2014.
  • 28. Monte SV, Prescott WA, Johnson KK, Kuhman L, Paladino JA. Safety of ceftriaxone sodium at extremes of age. Expert Opin Drug Saf. 2008;7(5):515–23.
  • 29. Hile GB, Musick LK, Dugan JA, Bailey MA, Howington TG. Occurrence of Hyperbilirubinemia in Neonates Given a Short-term Course of Ceftriaxone versus Cefotaxime for Sepsis. J Pediatr Pharmacol Ther. 2021;26(1):99–103
  • 30. Seltsam A, Salama A, Ceftriaxone-induced immune haemolysis: Two case reports and a concise review of the literature. Intensive Care Med., 2000:26: 1390-94.
  • 31. Neuman G, Boodhan S, Wurman I, Ceftriaxone-induced immune hemolytic anemia. Ann. Pharmacother. 2014;48:1594-1604
  • 32. Garratty G, Immune hemolytic anemia caused by drugs. Expert Opin. Drug Saf. 2012;11: 635-42
  • 32. Li J, Li Q, Li X, Li Z, A Fatal Case Report of Ceftriaxone-induced Hemolytic Anemia and Literature Review in Pediatrics. Int. J. Pharmacol. 2018;4 (6): 896-900
  • 34. Romano A, Gaeta F, Valluzzi RL, Caruso C, Alonzi M, Violi M, et al. Diagnosing nonimmediatere actions to cephalosporins. J Allergy Clin Immunol 2012;129(4):1166-9.
  • 35. Yerushalmi J, Zvulunov A, Halevy S. Serum sickness-like reactions. Cutis. 2002; 69(5):395-7.
  • 36. Lam A, Randhawa I, Klaustermeyer W. Cephalosporin induced toxic epidermal necrolysis and subsequent penicillin drugexan them. Allergol Intş 2008;57(3):281-4.
  • 37. Kelkar PS, Li JTC. Cephalosporin allergy. N Engl J Med. 2001 13; 345(11):804-9.
  • 38. Riezzo I, Bello S, Neri M, Turillazzi E, Fineschi V. Ceftriaxone intradermal test-related fatal anaphylactic shock: a medico-legal night mare. Allergy. 2010; 65(1):130-1.
  • 39. Ernst MR, van Dijken PJ, Kabel PJ, Draaisma JM. Anaphylaxis after first exposure to ceftriaxone. Acta Paediatr. 2002; 91(3):355-6
  • 40. Saritas A, Erbas M, Gonen I, et al. Asystole after the first dose of ceftriaxone. Am J Emerg Med. 2012; 30(7):1321.
  • 41. Arslanköylü AE, Kuyucu S, Balcı S, usta y. İlk doz seftriakson enjeksiyonu sonrası anafilaksi. Türk Ped Arş. 2011;46: 81-3
  • 42. Aygün F, Aygün FD, Nepesov S, Çam H, Camcıoğlu Y. İlk Doz Seftriakson Kullanımı Sonrası Anafilaktik Şok Gelişimi. Çocuk Dergisi. 2014;14(3):128-30.
  • 43. Çifçi S, Asıl M, Bıyık M, Yolacan R, Ataseven H, Demir A, İlk Doz Seftriakson Uygulaması Sonrası Gelişen Fatal Anaflaktik Reaksiyon. Selçuk Tıp Derg. 2016;32 32(Ek Sayı): 25-26
  • 44. Calapai G, İmbesi S, Venturo-Spagnolo E, Cafeo V, Milone L, Navarra M, Gantemi S, Fatal Anaphylactic Shock Ceftriaxone-Induced in a 4-Year-Old Child. Pediatric Emergency Care. 2016 january;32(1):p32-33

Evaluation of side effects of ceftriaxone use in newborns

Year 2022, Volume: 47 Issue: 4, 1641 - 1649, 28.12.2022
https://doi.org/10.17826/cumj.1165896

Abstract

Purpose: Ceftriaxone is used sparingly in newborns due to its side effects. There are limited studies about its use in neonatal infections. In this study, it was aimed to evaluate the side effects that may occur after ceftriaxone therapy in newborns.
Materials and Methods: The clinical and laboratory data before (baseline) and after ceftriaxone treatment of newborns hospitalized in the Newborn Intensive Care Unit of Cukurova University Medical Faculty, Balcalı Hospital between 2015 - 2016 were retrospectively analyzed.
Results: Thirty cases were included in the study. The mean gestational age of these babies was 37 ± 3.1 (30-41) weeks, and mean duration of ceftriaxone treatment was 7.2 ± 2.2 (2-12) days. Urine cultures were obtained from all patients and microorganism growth was detected in 17 (56.6%) infants. Escherichia coli grew in 11 (36.6%) cultures while other bacteria were identified in 5 (16.7%) cases. Compared to baseline, significant decreases were found in blood urea nitrogen, total bilirubin and hematocrit values after ceftriaxone therapy. No side effects related to the use of ceftriaxone were observed.
Conclusion: The fact that no complications were observed after ceftriaxone in our study may be encouraging, both for the use of ceftriaxone in term or near-term newborns and for conducting extensive studies. More research is needed to investigate the side effects of ceftriaxone in newborns and to determine whether it can be an alternative to other antibiotics.

References

  • 1. R. Wise, A. P. Gjllett, J. M. Andrews and K. A. Bedford. Ro 13-9904: a cephalosporin with a high degree of activity and broad antibacterial activity: an invitro comparative study. J Antimicrob Chemother. 1980;6:595–600.
  • 2. Craig WA. Interrelationship between pharmacokinetics and pharmacodynamics in determining dosage regimens for broadspectrum cephalosporins. Diagn Microbiol Infect Dis 1995;22:89–96.
  • 3. Von Martels JZH, Van de Meeberg EK, Holman M, Ligtenberg JJ, Ter Maaten JC. Pseudolithiasis after recent use of ceftriaxone: an unexpected diagnosis in a child with abdominal pain. Am J Emerg Med. 2013;31(8):1294.e5-6
  • 4) Arvidsson A, Alvan G, Angelin B, et al. Ceftriaxone: renal and biliary excretion and effect on the colon microflora. J Antimicrob Chemother 1982;10: 207–15.
  • 5) Lee SP, Lipsky BA, Teefey SA. Gallbladder sludge and antibiotics. Pediatr Infect Dis J 1990;9:422–3.
  • 6. Yaffe SJ, Aranda JV. Neonatal and Pediatric Pharmacology: Therapeutic Principles in Practice. 4th edition (ED L Williams & Wilkins):886, Philadelphia, 2010.
  • 7. Ayele AA, Gebresillassie BM, Erku DA, Gebreyohannes EA, Demssie, DG, Mersha AG, et al. Prospective evaluation of Ceftriaxone use in medical and emergency wards of Gondar university referral hospital, Ethiopia. Pharmacol. Res. Perspect. 2018 Feb;6(1):e00383.
  • 8. Lee H, Jung D, Yeom JS, Son JS, Jung S, Kim YS. Evaluation of cef-triaxone utilization at multi-center study.Korean J Intern Med.2009;24(4):374-80.
  • 9. Ozturk A, Kaya M, Zeyrek D, Ozturk E, Kat N, Ziylan SZ. Ultrasonographic findings in ceftriaxone: associated biliary sludge and pseudolithiasis in children. Acta Radiologica. 2005;46(1): 112-16.
  • 10. Schaad UB, Wedgwood-Krucko J, Tschaeppeler H. Reversible ceftriaxone-associated biliary pseudolithiasis in children. Lancet. 1988;2(8625):1411-3.
  • 11. Ustyol L, Bulut MD, Agengin K, Bala KA, Yavuz A, Bora A. ve ark. Comparative evaluation of ceftriaxoneand cefotaxime-induced biliary pseudolithiasis or nephrolithiasis: A prospective study in 154 children. Hum Exp Toxicol. 2017;36(6): 547-53.
  • 12. Mohkam M, Karimi A, Gharib A, Daneshmand H, Khatami A, Ghojevand N. Ceftriaxone associated nephrolithiasis: a prospective study in 284 children. Pediatr Nephrol. 2007;22(5):690-4.
  • 13. Schmutz HR, Detampel P, Bühler T, Büttler A, Gygax B, Huwyler J. In vitro assessment of the formation of ceftriaxone-calcium precipitates in human plasma. J Pharm Sci. 2011;100(6):2300-10.
  • 14) Riccabona M, Kerbl R, Schwinger W, et al. Ceftriaxone-induced cholelithiasis-a harmless side- effect? Klin Pediatr. 1993;205:421–3.
  • 15) Schaad UB, Suter S, Gianella-Borradori A, Pfenningen J, Auckenthaler R, Bernart O, et al. Acomparison of ceftriaxone and cefuroxime for the treatment of bacterial meningitis in children. N Engl J Med. 1990;322:141–7.
  • 16. Bradley JS, Wassel RT, Lee L, Nambiar S. Intravenous ceftriaxone and calcium in the neonate: assessing the risk for cardiopulmonary adverse events. Pediatrics. 2009;123(4):e609-13.
  • 17. Donnelly PC, Sutich RM, Easton R, Adejumo OA, Lee TA, Logan LK. Ceftriaxone-Associated Biliary and Cardiopulmonary Adverse Events in Neonates: A Systematic Review of the Literature. Pediatr Drugs. 2017;19(1):21-34.
  • 18. Papadopoulou F, Efremidis S, Karyda S, Badouraki M, Karatza E, Panteliadis C, et al, Incidence of ceftriaxone associated gallbladder pseudolithiasis. Acta Paediatrica. 1999;88(12): 1352-5.
  • 19. Pichichero ME. Cephalosporins can be prescribed safely for penicillin-allergic patients. J Fam Pract. 2006;55:106-12.
  • 20. Kim MH, Lee JM. Diagnosis and management of immediate hypersensitivity reactions to cephalosporins. Allergy Asthma Immunol Res. 2014;6(6):485-95.
  • 21. Coppini R, Simons SH, Mugelli A, Allegaert K, Clinical research in neonates and infants: Challenges and perspectives. Parmacol Res. 2016;108:80-7
  • 22. Türk Neonatoloji Derneği Yenidoğan Enfeksiyonları Tedavi ve İzlem Rehberi 2014
  • 23. Neofax: A Manual of Drugs Used in Neonatal Care by Barry Mangum and Thomas E. Young. 2014:172
  • 24. Özsüt H. Seftriakson. ANKEM Derg, 2002, 16(3): 404-7
  • 25. US Food and Drug Administration. Information for healthcare professionals: ceftriaxone (marketed as Rocephin) Information 2007. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInforma tionforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm134328.htm. Accessed 20 Apr 2016.
  • 26. US Food and Drug Administration. Information for healthcare professionals: ceftriaxone (marketed as Rocephin) Information 2009. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformati onforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084263.htm. Accessed 20 Apr 2016.
  • 27. Katzung B, Trevor A. Basic and clinical pharmacology. 13th ed. New York: McGrawHill; 2014.
  • 28. Monte SV, Prescott WA, Johnson KK, Kuhman L, Paladino JA. Safety of ceftriaxone sodium at extremes of age. Expert Opin Drug Saf. 2008;7(5):515–23.
  • 29. Hile GB, Musick LK, Dugan JA, Bailey MA, Howington TG. Occurrence of Hyperbilirubinemia in Neonates Given a Short-term Course of Ceftriaxone versus Cefotaxime for Sepsis. J Pediatr Pharmacol Ther. 2021;26(1):99–103
  • 30. Seltsam A, Salama A, Ceftriaxone-induced immune haemolysis: Two case reports and a concise review of the literature. Intensive Care Med., 2000:26: 1390-94.
  • 31. Neuman G, Boodhan S, Wurman I, Ceftriaxone-induced immune hemolytic anemia. Ann. Pharmacother. 2014;48:1594-1604
  • 32. Garratty G, Immune hemolytic anemia caused by drugs. Expert Opin. Drug Saf. 2012;11: 635-42
  • 32. Li J, Li Q, Li X, Li Z, A Fatal Case Report of Ceftriaxone-induced Hemolytic Anemia and Literature Review in Pediatrics. Int. J. Pharmacol. 2018;4 (6): 896-900
  • 34. Romano A, Gaeta F, Valluzzi RL, Caruso C, Alonzi M, Violi M, et al. Diagnosing nonimmediatere actions to cephalosporins. J Allergy Clin Immunol 2012;129(4):1166-9.
  • 35. Yerushalmi J, Zvulunov A, Halevy S. Serum sickness-like reactions. Cutis. 2002; 69(5):395-7.
  • 36. Lam A, Randhawa I, Klaustermeyer W. Cephalosporin induced toxic epidermal necrolysis and subsequent penicillin drugexan them. Allergol Intş 2008;57(3):281-4.
  • 37. Kelkar PS, Li JTC. Cephalosporin allergy. N Engl J Med. 2001 13; 345(11):804-9.
  • 38. Riezzo I, Bello S, Neri M, Turillazzi E, Fineschi V. Ceftriaxone intradermal test-related fatal anaphylactic shock: a medico-legal night mare. Allergy. 2010; 65(1):130-1.
  • 39. Ernst MR, van Dijken PJ, Kabel PJ, Draaisma JM. Anaphylaxis after first exposure to ceftriaxone. Acta Paediatr. 2002; 91(3):355-6
  • 40. Saritas A, Erbas M, Gonen I, et al. Asystole after the first dose of ceftriaxone. Am J Emerg Med. 2012; 30(7):1321.
  • 41. Arslanköylü AE, Kuyucu S, Balcı S, usta y. İlk doz seftriakson enjeksiyonu sonrası anafilaksi. Türk Ped Arş. 2011;46: 81-3
  • 42. Aygün F, Aygün FD, Nepesov S, Çam H, Camcıoğlu Y. İlk Doz Seftriakson Kullanımı Sonrası Anafilaktik Şok Gelişimi. Çocuk Dergisi. 2014;14(3):128-30.
  • 43. Çifçi S, Asıl M, Bıyık M, Yolacan R, Ataseven H, Demir A, İlk Doz Seftriakson Uygulaması Sonrası Gelişen Fatal Anaflaktik Reaksiyon. Selçuk Tıp Derg. 2016;32 32(Ek Sayı): 25-26
  • 44. Calapai G, İmbesi S, Venturo-Spagnolo E, Cafeo V, Milone L, Navarra M, Gantemi S, Fatal Anaphylactic Shock Ceftriaxone-Induced in a 4-Year-Old Child. Pediatric Emergency Care. 2016 january;32(1):p32-33
There are 44 citations in total.

Details

Primary Language Turkish
Subjects Clinical Sciences
Journal Section Research
Authors

Mustafa Akçalı 0000-0002-0496-542X

Hüseyin Şimşek 0000-0002-3453-6802

Ferda Özlü 0000-0002-2092-8426

Hacer Yapıcıoğlu 0000-0001-6295-553X

Mehmet Satar 0000-0002-5718-0503

Publication Date December 28, 2022
Acceptance Date November 28, 2022
Published in Issue Year 2022 Volume: 47 Issue: 4

Cite

MLA Akçalı, Mustafa et al. “Yenidoğanlarda Seftriakson kullanımının Yan Etkilerinin değerlendirilmesi”. Cukurova Medical Journal, vol. 47, no. 4, 2022, pp. 1641-9, doi:10.17826/cumj.1165896.