Nitazoxanide: A review of its use in the treatment of gastrointestinal infections

Drugs

Volumn 67, Issue 13, 2007, Pages 1947-1967

  Anderson, Vanessa R ^a   Curran, Monique P ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ALBENDAZOLE; ANNITA; ANTIAMEBIC AGENT; AZITHROMYCIN; BITHIONOL; CIPROFLOXACIN; COLUFASE; COTRIMOXAZOLE; DAXON; DEXIDEX; DIIODOHYDROXYQUIN; DILOXANIDE; DRUG METABOLITE; FURAZOLIDONE; IVERMECTIN; KIDONAX; MEBENDAZOLE; MEPACRINE; METRONIDAZOLE; NICLOSAMIDE; NITAZOXANIDE; PARAMIX; PAROMOMYCIN; PLACEBO; PRAZIQUANTEL; PYRANTEL; QUINFAMIDE; RIFABUTIN; TETRACYCLINE; TIABENDAZOLE; TINIDAZOLE; TIZOXANIDE; TIZOXANIDE GLUCURONIDE; TRICLABENDAZOLE; UNCLASSIFIED DRUG; UNINDEXED DRUG; VANCOMYCIN;

ABDOMINAL PAIN; ASCARIASIS; BACTERIAL INFECTION; CESTODIASIS; CLINICAL TRIAL; COLITIS; CONTROLLED CLINICAL TRIAL; CRYPTOSPORIDIUM PARVUM; DIARRHEA; DRUG ABSORPTION; DRUG ACTIVITY; DRUG BIOAVAILABILITY; DRUG DOSAGE FORM COMPARISON; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG ERUPTION; DRUG EXCRETION; DRUG FORMULATION; DRUG HALF LIFE; DRUG INHIBITION; DRUG MECHANISM; DRUG METABOLISM; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTRON TRANSPORT; FOOD; FOOD DRUG INTERACTION; GASTROINTESTINAL INFECTION; GASTROINTESTINAL SYMPTOM; GIARDIA LAMBLIA; GIARDIASIS; HEADACHE; HELMINTHIASIS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HYMENOLEPIS NANA; MAXIMUM PLASMA CONCENTRATION; MINIMUM INHIBITORY CONCENTRATION; MONOTHERAPY; NAUSEA; NONHUMAN; ORAL REHYDRATION THERAPY; PROTOZOAL INFECTION; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; REVIEW; SINGLE DRUG DOSE; TREATMENT OUTCOME; TRICHURIASIS; VIRAL GASTROENTERITIS; VIRUS INFECTION; VOMITING;

ANTI-INFECTIVE AGENTS; ANTIPARASITIC AGENTS; BACTERIAL INFECTIONS; GASTROINTESTINAL DISEASES; HUMANS; INTESTINAL DISEASES, PARASITIC; THIAZOLES; VIRUS DISEASES;

BACTERIA (MICROORGANISMS); BLASTOCYSTIS HOMINIS; CLOSTRIDIUM DIFFICILE; CRYPTOSPORIDIUM PARVUM; ENTAMOEBA HISTOLYTICA; GIARDIA INTESTINALIS; PROTOZOA; ROTAVIRUS; TRICHOMONAS VAGINALIS; VERMES;

EID: 34548345811     PISSN: 00126667     EISSN: 00126667     Source Type: Journal    
DOI: 10.2165/00003495-200767130-00015     Document Type: Review

References (93)

1. Guerrant RL, Van Gilder T, Steiner TS, et al. Practice guidelines for the management of infectious diarrhea. Clin Infect Dis 2001 Feb 1; 32 (3): 331-51
2. Murray TS, Groth ME, Weitzman C, et al. Epidemiology and management of infectious diseases in international adoptees. Clin Microbiol Rev 2005; 18 (3): 510-20
3. Schuster H, Chiodini PL. Parasitic infections of the intestine. Curr Opin Infect Dis 2001; 14 (5): 587-91
4. Romark Pharmaceuticals. Alinia. (Nitazoxanide) tablets. (Nitazoxanide) for oral suspension [online]. Available from URL: http://www.romark.com [Accessed 2006 Nov 24]
5. Fox LM, Saravolatz LD. Nitazoxanide: a new thiazolide antiparasitic agent. Clin Infect Dis 2005 Apr 15; 40 (8): 1173-80
6. Bailey JM, Erramouspe J. Nitazoxanide treatment for giardiasis and cryptosporidiosis in children. Ann Pharmacother 2004 Apr; 38 (4): 634-40
7. Centers for Disease Control and Prevention. Cryptosporidiosis (Cryptosporidium) [online]. Available from URL: http://phil.cdc.gov/phil/home. asp [Accessed 2007 Apr 10]
8. Center for Drug Evaluation and Research. Application number: 21-497, 21-498/S-001. Medical review(s) [online]. Available from URL: www.fda.gov/cder/foi/nda/2004/21-497_21-498s001_Alinia.htm [Accessed 2007 Jan 18]
9. Hoffman PS, Sisson G, Croxen MA, et al. Antiparasitic drug nitazoxanide inhibits the pyruvate oxidoreductases of Helicobacter pylori and selected anaerobic bacteria and parasites, and Campylobacter jejuni. Antimicrob Agents Chemother 2007 Mar; 51 (3): 868-76
10. Müller J, Wastling J, Sanderson S, et al. A novel Giardia lamblia nitroreductase, GlNR1, interacts with nitazoxanide and other thiazolides. Antimicrob Agents Chemother 2007 Jun; 51 (6): 1979-86
11. Esposito M, Müller N, Hemphill A. Structure-activity relationships from in vitro efficacies of the thiazolide series against the intracellular apicomplexan protozoan Neospora caninum. Int J Parasitol 2007 Feb; 37 (2): 183-90
12. Müller J, Sterk M, Hemphill A, et al. Characterization of Giardia lamblia WB C6 clones resistant to nitazoxanide and to metronidazole. J Antimicrob Chemother 2007 Aug; 60 (2): 280-7
13. Vdovenko AA, Williams JE. Blastocystis hominis: neutral red supravital staining and its application to in vitro drug sensitivity testing. Parasitol Res 2000 Jul; 86 (7): 573-81
14. Adagu IS, Nolder D, Warhurst DC, et al. In vitro activity of nitazoxanide and related compounds against isolates of Giardia intestinalis, Entamoeba histolytica and Trichomonas vaginalis. J Antimicrob Chemother 2002 Jan; 49 (1): 103-11
15. Cedillo-Rivera R, Chavez B, González-Robles A, et al. In vitro effect of nitazoxanide against Entamoeba histolytica, Giardia intestinalis and Trichomonas vaginalis. J Eukaryot Microbiol 2002; 49 (3): 201-8
16. Bernal-Redondo R, Martínez-Méndez LG, Mendoza-Chavez A, et al. Evaluation of the in vitro effect of albendazole, metronidazole and nitazoxanide on viability and structure of Giardia lamblia cysts. J Submicrosc Cytol Pathol 2004 Jul 31; 36 (3-4): 241-5
17. Giacometti A, Cirioni O, Barchiesi F, et al. Activity of nitazoxanide alone and in combination with azithromycin and rifabutin against Cryptosporidium parvum in cell culture. J Antimicrob Chemother 2000 Apr; 45 (4): 453-6
18. Gargala G, Delaunay A, Li X, et al. Efficacy of nitazoxanide, tizoxanide and tizoxanide glucuronide against Cryptosporidium parvum development in sporozoite-infected HCT-8 enterocytic cells. J Antimicrob Chemother 2000 Jul; 46 (1): 57-60
19. Theodos CM, Griffiths JK, D'Onfro J, et al. Efficacy of nitazoxanide against Cryptosporidium parvum in cell culture and in animal models. Antimicrob Agents Chemother 1998 Aug; 42 (8): 1959-65
20. Müller J, Rühle G, Müller N, et al. In vitro effects of thiazolides on Giardia lamblia WB clone C6 cultured axenically and in coculture with Caco2 cells. Antimicrob Agents Chemother 2006 Jan; 50 (1): 162-70
21. Palomares-Alonso F, Piliado JC, Palencia G, et al. Efficacy of nitazoxanide, tizoxanide and tizoxanide/albendazole sulphoxide combination against Taenia crassiceps cysts. J Antimicrob Chemother 2007 Feb; 59 (2): 212-8
22. McVay CS, Rolfe RD. In vitro and in vivo activities of nitazoxanide against Clostridium difficile. Antimicrob Agents Chemother 2000 Sep; 44 (9): 2254-8
23. Pankuch GA, Appelbaum PC. Activities of tizoxanide and nitazoxanide compared to those of five other thiazolides and three other agents against anaerobic species. Antimicrob Agents Chemother 2006 Mar; 50 (3): 1112-7
24. Dubreuil L, Houcke I, Mouton Y, et al. In vitro evaluation of activities of nitazoxanide and tizoxanide against anaerobes and aerobic organisms. Antimicrob Agents Chemother 1996 Oct; 40 (10): 2266-70
25. Fonseca-Salamanca F, Martínez-Grueiro MM, Martínez- Fernández AR. Nematocidal activity of nitazoxanide in laboratory models. Parasitol Res 2003 Oct; 91 (4): 321-4
26. Musher DM, Logan N, Hamill RJ, et al. Nitazoxanide for the treatment of Clostridium difficile colitis. Clin Infect Dis 2006 Aug 15; 43 (4): 421-7
27. Guttner Y, Windsor HM, Viiala CH, et al. Nitazoxanide in treatment of Helicobacter pylori: a clinical and in vitro study. Antimicrob Agents Chemother 2003 Dec; 47 (12): 3780-3
28. Yamamoto Y, Hakki A, Friedman H, et al. Nitazoxanide, a nitrothiazolide antiparasitic drug, is an anti-Helicobacter pylori agent with anti-vacuolating toxin activity. Chemotherapy 1999 Jul-1999 31; 45 (4): 303-12
29. Mégraud F, Occhialini A, Rossignol JF. Nitazoxanide, a potential drug for eradication of Helicobacter pylori with no cross-resistance to metronidazole. Antimicrob Agents Chemother 1998 Nov; 42 (11): 2836-40
30. Sisson G, Goodwin A, Raudonikiene A, et al. Enzymes associated with reductive activation and action of nitazoxanide, nitrofurans, and metronidazole in Helicobacter pylori. Antimicrob Agents Chemother 2002 Jul; 46 (7): 2116-23
31. Rossignol J-F, Abu-Zekry M, Hussein A, et al. Effect of nitazoxanide for treatment of severe rotavirus diarrhoea: randomised double-blind placebo-controlled trial. Lancet 2006 Jul 8; 368 (9530): 124-9
32. Esposito M, Stettler R, Moores SL, et al. In vitro efficacies of nitazoxanide and other thiazolides against Neospora caninum tachyzoites reveal antiparasitic activity independent of the nitro group. Antimicrob Agents Chemother 2005 Sep; 49 (9): 3715-23
33. Reuter S, Manfras B, Merkle M, et al. In vitro activities of itraconazole, methiazole, and nitazoxanide versus Echinococcus multilocularis larvae. Antimicrob Agents Chemother 2006 Sep; 50 (9): 2966-70
34. Walker M, Rossignol JF, Torgerson P, et al. In vitro effects of nitazoxanide on Echinococcus granulosus protoscoleces and metacestodes. J Antimicrob Chemother 2004 Sep; 54 (3): 609-16
35. Baishanbo A, Gargala G, Duclos C, et al. Efficacy of nitazoxanide and paromomycin in biliary tract cryptosporidiosis in an immunosuppressed gerbil model. J Antimicrob Chemother 2006 Feb; 57 (2): 353-5
36. Blagburn BL, Drain KL, Land TM, et al. Comparative efficacy evaluation of dicationic carbazole compounds, nitazoxanide, and paromomycin against Cryptosporidium parvum infections in a neonatal mouse model. Antimicrob Agents Chemother 1998 Nov; 42 (11): 2877-82
37. Li X, Brasseur P, Agnamey P, et al. Long-lasting anticryptosporidial activity of nitazoxanide in an immunosuppressed rat model. Folia Parasitol (Praha) 2003 Mar; 50 (1): 19-22
38. Marion R, Baishanbo A, Gargala G, et al. Transient neonatal Cryptosporidium parvum infection triggers long-term jejunal hypersensitivity to distension in immunocompetent rats. Infect Immun 2006 Jul; 74 (7): 4387-9
39. Broekhuysen J, Stockis A, Lins RL, et al. Nitazoxanide: pharmacokinetics and metabolism in man. Int J Clin Pharmacol Ther 2000 Aug; 38 (8): 387-94
40. Stockis A, Allemon AM, De Bruyn S, et al. Nitazoxanide pharmacokinetics and tolerability in man using single ascending oral doses. Int J Clin Pharmacol Ther 2002 May; 40 (5): 213-20
41. Stockis A, Deroubaix X, Lins R, et al. Pharmacokinetics of nitazoxanide after single oral dose administration in 6 healthy volunteers. Int J Clin Pharmacol Ther 1996 Aug; 34 (8): 349-51
42. Stockis A, De Bruyn S, Gengler C, et al. Nitazoxanide pharmacokinetics and tolerability in man during 7 days dosing with 0.5 g and 1 g b.i.d. Int J Clin Pharmacol Ther 2002 May; 40 (5): 221-7
43. Romark Laboratories. Romark advances development of Alinia in treating Clostridium difficile-associated disease [media release]. 2005 Dec 8
44. Rossignol J-F, Kabil SM, Said M, et al. Effect of nitazoxanide in persistent diarrhea and enteritis associated with Blastocystis hominis. Clin Gastroenterol Hepatol 2005 Oct; 3 (10): 987-91
45. Rossignol J-FA, Ayoub A, Ayers MS. Treatment of diarrhea caused by Giardia intestinalis and Entamoeba histolytica or E. dispar: a randomized, double-blind, placebo-controlled study of nitazoxanide. J Infect Dis 2001 Aug 1; 184 (3): 381-4
46. Rossignol J-FA, Ayoub A, Ayers MS. Treatment of diarrhea caused by Cryptosporidium parvum: a prospective randomized, double-blind, placebo-controlled study of nitazoxanide. J Infect Dis 2001 Jul 1; 184 (1): 103-6
47. Amadi B, Mwiya M, Musuku J, et al. Effect of nitazoxanide on morbidity and mortality in Zambian children with cryptosporidiosis: a randomised controlled trial. Lancet 2002 Nov; 360 (9343): 1375-80
48. Ortiz JJ, Ayoub A, Gargala G, et al. Randomized clinical study of nitazoxanide compared to metronidazole in the treatment of symptomatic giardiasis in children from Northern Peru. Aliment Pharmacol Ther 2001 Sep; 15 (9): 1409-15
49. Rossignol J-F, Kabil SM, el-Gohary Y, et al. Effect of nitazoxanide in diarrhea and enteritis caused by Cryptosporidium species. Clin Gastroenterol Hepatol 2006 Mar; 4 (3): 320-4
50. Favennec L, Jave Ortiz J, Gargala G, et al. Double-blind, randomized, placebo-controlled study of nitazoxanide in the treatment of fascioliasis in adults and children from northern Peru. Aliment Pharmacol Ther 2003 Jan; 17 (2): 265-70
51. Ortiz JJ, Lopez Chegne N, Gargala G, et al. Comparative clinical studies of nitazoxanide, albendazole and praziquantel in the treatment of ascariasis, trichuriasis and hymenolepiasis in children from Peru. Trans R Soc Trop Med Hyg 2002 Mar-Apr 30; 96 (2): 193-6
52. Kabil SM, El Ashry E, Ashraf NK. An open-label clinical study of nitazoxanide in the treatment of human fascioliasis. Curr Ther Res Clin Exp 2000 Jun; 61 (6): 339-45
53. Rossignol JF, Maisonneuve H. Nitazoxanide in the treatment of Taenia saginata and Hymenolepis nana infections. Am J Trop Med Hyg 1984 May; 33 (3): 511-2
54. Rossignol J-F, Abaza H, Friedman H. Successful treatment of human fascioliasis with nitazoxanide. Trans R Soc Trop Med Hyg 1998 Jan-1998 28; 92 (1): 103-4
55. Belkind-Valdovinos U, Belkind-Gerson J, Sánchez-Francia D, et al. Nitazoxanide vs albendazole against intestinal parasites in a single dose and for three days [in Spanish]. Salud Publica Mex 2004; 46 (3): 333-40
56. Davila-Gutierrez CE, Vasquez C, Trujillo-Hernandez B, et al. Nitazoxanide compared with quinfamide and mebendazole in the treatment of helminthic infections and intestinal protozoa in children. Am J Trop Med Hyg 2002 Mar; 66 (3): 251-4
57. Cabello RR, Guerrero LR, del Rocio Muñoz García M, et al. Nitazoxanide for the treatment of intestinal protozoan and helminthic infections in Mexico. Trans R Soc Trop Med Hyg 1997 Nov 31; 91: 701-3
58. Abaza H, El-Zayadi AR, Kabil SM, et al. Nitazoxanide in the treatment of patients with intestinal protozoan and helminthic infections: a report on 546 patients in Egypt. Curr Ther Res Clin Exp 1998 Feb; 59 (2): 116-21
59. Rossignol JF, El-Gohary M. Nitazoxanide in the treatment of viral gastroenteritis: a randomized double-blind placebo-controlled clinical trial. Aliment Pharmacol Ther 2006 Nov; 24 (10): 1423-30
60. Musher DM, Logan N, Mehendiratta V, et al. Clostridium difficile colitis that fails conventional metronidazole therapy: response to nitazoxanide. J Antimicrob Chemother 2007 Apr; 59 (4): 705-10
61. Rossignol J-F, Hidalgo H, Feregrino M, et al. A double-'blind' placebo-controlled study of nitazoxanide in the treatment of cryptosporidial diarrhoea in AIDS patients in Mexico. Trans R Soc Trop Med Hyg 1998 Nov 31; 92 (6): 663-6
62. Zulu I, Kelly P, Njobvu L, et al. Nitazoxanide for persistent diarrhoea in Zambian acquired immune deficiency syndrome patients: a randomized-controlled trial. Aliment Pharmacol Ther 2005 Mar 15; 21 (6): 757-63
63. Rossignol JF. Nitazoxanide in the treatment of acquired immune deficiency syndrome-related cryptosporidiosis: results of the United States compassionate use program in 365 patients. Aliment Pharmacol Ther 2006 Sep 1; 24 (5): 887-94
64. American Society of Health-System Pharmacists®. Anthelmintics. In: McEvoy GK, editor. AHFS Drug Information® 2007. Bethesda (MD): American Society of Health-System Pharmacists, Inc., 2007: 45-60
65. Annita® (nitazoxanida): Brazilian prescribing information. Brazil: Farmoquímica, 2006
66. Kidonax® (nitazoxanida suspension, tabletas, tabletas dispersables): Mexican prescribing information. Veracruz: Unipharm, 2006
67. Paramix® (nitazoxanida grageas, suspension, tabletas dispersables): Mexican prescribing information. Cuajimalpa: Liomont, 2006
68. Dexidex® (nitazoxanida suspension oral, tabletas): Mexican prescribing information. Benito Juarez: Serral, 2006
69. Daxon® (nitazoxanida suspension, tabletas, tabletas dispersables): Mexican prescribing information. Cuajimalpa: Siegfried Rhein, 2006
70. República de Colombia Ministerio de la Protección Social. El suscrito secretario ejecutivo de la sala especializada de medicamentos y productos biologicos de la comision revisora (natizoxanida grageas y suspension): Colombian prescribing information [online]. Available from URL: http://www.invima.gov.co/version1/consultas_publicos/archivos/actas%201999/ ACTA28.pdf [Accessed 2007 Jan 17]
71. Montresor A, Crompton DWT, Hall A, et al. Guidelines for the evaluation of soil-transmitted helminthiasis and schistosomiasis at community level [online]. Available from URL: http://whqlibdoc.who.int/hq/1998/WHO_CTD_SIP_98.1. pdf [Accessed 2007 Jan 24]
72. Moon TD, Oberhelman RA. Antiparasitic therapy in children. Pediatr Clin North Am 2005; 52 (3): 917-48
73. Bethony J, Brooker S, Albonico M, et al. Soil-transmitted helminth infections: ascariasis, trichuriasis, and hookworm. Lancet 2006; 367 (9521): 1521-32
74. Farthing MJ. Treatment options for the eradication of intestinal protozoa. Nat Clin Pract Gastroenterol Hepatol 2006 Aug; 3 (8): 436-45
75. White Jr AC. Nitazoxanide: an important advance in antiparasitic therapy. Am J Trop Med Hyg 2003 Apr; 68 (4): 382-3
76. Stevens DM, Adam HM. Giardiasis and cryptosporidiosis. Pediatr Rev 2004 Jul; 25 (7): 258-9
77. Fraser D, Bilenko N, Deckelbaum RJ, et al. Giardia lamblia carriage in Israeli Bedouin infants: risk factors and consequences. Clin Infect Dis 2000 Mar; 30 (3): 419-24
78. Huang DB, Chappell C, Okhuysen PC. Cryptosporidiosis in children. Semin Pediatr Infect Dis 2004 Oct; 15 (4): 253-9
79. Forrest G. Gastrointestinal infections in immunocompromised hosts. Curr Opin Gastroenterol 2004; 20 (1): 16-21
80. Alam NH, Ashraf H. Treatment of infectious diarrhea in children. Pediatr Drugs 2003; 5 (3): 151-65
81. American Gastroenterological Association medical position statement: guidelines for the evaluation and management of chronic diarrhea. Gastroenterology 1999 Jun; 116 (6): 1461-3
82. Bhatnagar S, Bhandari N, Mouli UC, et al. Consensus statement of IAP National Task Force: status report on management of acute diarrhea. Indian Pediatr 2004 Apr; 41 (4): 335-47
83. White Jr AC. The disappearing arsenal of antiparasitic drugs [letter]. N Engl J Med 2000 Oct 26; 343 (17): 1273-4
84. Flagyl® (metronidazole tablets): US prescribing information. Chicago (IL): Pharmacia, 2003 Aug
85. Tindamax™ (tinidazole tablets): US prescribing information. Arlington Heights (IL): Presutti Laboratories Inc., 2004 May 14
86. Stromectol® (ivermectin tablets): US prescribing information. Whitehouse Station (NJ): Merck & Co., Inc., 2005 Sep
87. Biltricide® (praziquantel tablets): US prescribing information. Westhaven (CT): Bayer Health Care, 2004
88. American Society of Health-System Pharmacists®. Antiprotozoals. In: McEvoy GK, editor. AHFS Drug Information® 2007. Bethesda (MD): American Society of Health-System Pharmacists, Inc., 2007: 833-88
89. Raether W, Hänel H. Nitroheterocyclic drugs with broad spectrum activity. Parasitol Res 2003 Jun; 90 Suppl. 1: S19-39
90. Drugs for parasitic infections. Med Lett Drugs Ther 2004 Aug; 46 (1189): e1-12
91. Abubakar I, Aliyu SH, Arumugam C, et al. Prevention and treatment of cryptosporidiosis in immunocompromised patients. Cochrane Database Syst Rev 2007; (1): CD004932
92. Bartlett JG. Narrative review: the new epidemic of Clostridium difficile-associated enteric disease. Ann Intern Med 2006 Nov; 145 (10): 758-64
93. Keating GM. Rotavirus vaccine (RotaTeq®). Pediatric Drugs 2006; 8 (3): 197-202