Comparative safety profiles of two enrofloxacin generics after repeated intracrop administration to broilers

  • Abstract
  • Keywords
  • References
  • PDF
  • Abstract

    Clinicochemical, haematological and histopathological alterations were demonstrated in broiler chickens following repeated oral bolus administration of two different enrofloxacin generic preparations, formulated as 10% oral solutions, given at a dose regimen of 10 mg/Kg body weight for 5 consecutive days. The two tested preparations were Enrol® (Medmac®, Jordan), referred thereafter as ENRO-A; and Syvaquinol® (Syva®, Spain), which referred thereafter as ENRO-B. Eighteen broilers chickens, aging 40 days old, divided equally and randomly into three groups, have been used in the present study. ENRO-A or ENRO-B was given via intra-crop route of administration at the above-mentioned dose regimen to birds of the 2nd and the 3rd groups, respectively; where those of the 1st group were given water instead and kept as control. Blood samples were collected from all birds via the wing and metatarsal veins on the 5th day for clinicochemical and haematological examinations. Birds were then humanely sacrificed and liver, kidneys and heart were dissected out for histopathological examination. Results revealed that ENRO-A induced a significant (p<0.05) increase of the activity of alkaline phosphatase compared to ENRO-B as well as control group. Both ENRO-A and ENRO-B caused significant increases in the levels of plasma urea and creatinine concentrations compared to control (p<0.05), with higher significance in case of ENRO-A. Activity of plasma creatine kinase significantly (p<0.05) increased after ENRO-A compared to control and ENRO-B-treated groups. ENRO-A and ENRO-B significantly (p<0.05) increased blood glucose and triglyceride levels compared to that of control. Cholesterol level was increased significantly (p<0.05) only after ENRO-B repeated administration. However, other metabolic parameters showed insignificant changes. Parallel inflammatory and degenerative histopathological changes in the affected organs, except kidneys, have been observed. Nevertheless, administration of either ENRO-A or ENRO-B caused insignificant changes in hematological parameters of the treated chicken groups. Data of the present study may indicate that enrofloxacin may cause organ dysfunction in broilers during the course of therapy based on clinicochemical and histopathological reasons. The data may also indicate that the pharmaceutical technology may be a detrimental factor in safety profiles of generic products based on the differences recorded between the two tested brands.

  • Keywords

    Broiler Chicken; Enrofloxacin; Pharmacovigilance; Safety.

  • References

      [1] Allain CC, Poon LS, Chan CS, Richmond W & Fu PC (1974), Enzymatic determination of total serum cholesterol. Clinical Chemistry 20, 470-475.

      [2] Altreuther P (1987), [Data on chemistry and toxicology of Baytril]. Veterinaer-Medizinische Nachrichten (Germany, FR).

      [3] Anderson AD, Nelson JM, Rossiter S & Angulo FJ (2003), Public health consequences of use of antimicrobial agents in food animals in the United States. Microbial Drug Resistance 9, 373-379.

      [4] Aziz AA (2005), The influence of enrofloxacin on hematological features, total cholesterol, blood glucose and body weight of broilers. Alqadissyia Journal of Veterinary Science 4, 29-33.

      [5] Bancroft JD & Gamble M (2008), Theory and practice of histological techniques: Elsevier Health Sciences.

      [6] Bartels H, Böhmer M & Heierli C (1972), Serum creatinine determination without protein precipitation. Clinica chimica acta 37, 193.

      [7] Bergmeyer H, Herder M & Ref R (1986), International Federation of Clinical Chemistry (IFCC). J Clin Chem Clin Biochem 24, 497-510.

      [8] Bessey O, Oliver H & Jane M (1946), A method for the rapid determination of alkaline phosphatase with five cubic millimeters of serum. Journal of Biological Chemistry 164, 321-329.

      [9] Birkett DJ (2003), Generics-equal or not? Australian Prescriber 26, 85-86.

      [10] Black HR, Quallich H & Gareleck CB (1986), Racial differences in serum creatine kinase levels. The American Journal of Medicine 81, 479-487.

      [11] Clubb SL, Schubot RM, Joyner K, Zinkl JG, Wolf S, Escobar J, Clubb KJ & Kabbur MB (1990), Hematologic and serum biochemical reference intervals in juvenile eclectus parrots (Eclectus roratus). Journal of the Association of Avian Veterinarians 218-225.

      [12] Doumas BT & Biggs HG (1972), Determination of serum globulins. In: Cooper GR, editor. Standard Methods of Clinical Chemistry. New York, NY: Academic Press. p 175.

      [13] Ehmeza N, Elmajdoub A & El-Mahmoudy A (2016), Comparative pharmacokinetics and absolute bioavailabilities of two enrofloxacin generic preparations after single intracrop bolus administrations to broiler chickens. International Journal of Pharmacology and Toxicology 4, 115-122.

      [14] FDA U (2005), Food and Drug Administration final decision of the Commissioner. Docket no. 2000n-1571. Withdrawal of approval of the new animal drug application for enrofloxacin in poultry. In.

      [15] Fossati P & Prencipe L (1982), Serum triglycerides determined colorimetrically with an enzyme that produces hydrogen peroxide. Clinical Chemistry 28, 2077-2080.

      [16] Gellert M, Mizuuchi K, O'Dea MH, Itoh T & Tomizawa J-I (1977), Nalidixic acid resistance: a second genetic character involved in DNA gyrase activity. Proceedings of the National Academy of Sciences 74, 4772-4776.

      [17] Heitzman RJ (1997), Enrofloxacin In: Identity. Berkshire, United Kingdom. p 31-44.

      [18] Ibrahim IG, Atmaca N, Kanici A & Yarsan E (2011), Evaluation of effects of enrofloxacin on some haematological parameters in broilers. Atatürk Üniversitesi Veteriner Bilimleri Dergisi 6, 97-102.

      [19] Ibrahim IG & Yarsan E (2009), Pharmacokinetics of enrofloxacin in broiler chicks. Sudan Journal of Veterinary Research 24, 1-4.

      [20] Krieg M, Gunsser K, Steinhagen-Thiessen E & Becker H (1986), Comparative quantitative clinico-chemical analysis of the characteristics of 24-hour urine and morning urine. Journal of clinical chemistry and clinical biochemistry Zeitschrift fur klinische Chemie und klinische Biochemie 24, 863-869.

      [21] Küng K, RIOND JL & Wanner M (1993), Pharmacokinetics of enrofloxacin and its metabolite ciprofloxacin after intravenous and oral administration of enrofloxacin in dogs. Journal of Veterinary Pharmacology and Therapeutics 16, 462-468.

      [22] Marshall W (1988), Plasma proteins. Illustrated textbook of clinical chemistry. In: londres: gower Medical Publishing.

      [23] Merk Index (2001), Enrofloxacin, 13th ed. White house statio, New jersey, USA: Merk and company incorporation.

      [24] Midha KK & McKay G (2009), Bioequivalence; its history, practice, and future. The AAPS journal 11, 664-670.

      [25] Rao G, Ramesh S, Ahmad A, Tripathi H, Sharma L & Malik J (2002), Disposition kinetics of enrofloxacin and ciprofloxacin following intravenous administration of enrofloxacin in goats. Small Ruminant Research 44, 9-15.

      [26] Schmidt F (1961), Enzymatic determination of glucose and fructose simultaneously. Klinische Wochenschrift 39, 1244-1247.

      [27] Sumano L, Gutierrez O & Zamora Q (2003), Strategic administration of enrofloxacin in poultry to achieve higher maximal serum concentrations. The Veterinary Journal 165, 143-148.

      [28] Sureshkumar V, Sarathchandra G & Ramesh J (2013a), Biochemical, histopathological and ultra structural profile after pulsed water medication of enrofloxacin in broiler chickens. Veterinary World 6, 668-673.

      [29] Sureshkumar V, Sarathchandra G & Ramesh J (2013b), Veterinary pharmacovigilance evaluation on impact of enrofloxacin administration on antioxidant status in broiler chicken. International Journal of Current Microbiology and Applied Sciences 2, 335-341.

      [30] Tietz NW (1995), Clinical guide to laboratory tests WB Saunders. Philadelphia, PA.




Article ID: 6426
DOI: 10.14419/ijbr.v4i2.6426

Copyright © 2012-2015 Science Publishing Corporation Inc. All rights reserved.