Fenticonazole nitrate for the treatment of vulvovaginitis Review article
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Abstract
Vulvovaginal infections are the most common cause of gynecological problems in women. Knowledge about pharmacological properties of drugs used in the treatment of vulvovaginitis allows for tailoring therapy to each patient. Fenticonazole nitrate is modern and up to date option for treatment of vulvovaginitis. Short- and long-term therapeutic efficacy of fenticonazole nitrate was confirmed in numerous clinical trials. Good tolerance, high effectiveness and high level of patient’s acceptance gives the specialist powerful and efficient tool for management of vaginal and vulvar infections.
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Tomaszewski, J. (2014). Fenticonazole nitrate for the treatment of vulvovaginitis. Medycyna Faktow (J EBM), 7(3(24), 59-65. Retrieved from https://journalsmededu.pl/index.php/jebm/article/view/2355
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References
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2. Tomaszewski J.: Leczenie nawrotowej postaci drożdżakowego zapalenia pochwy i sromu. Zakażenia 2011; 6; 94-99.
3. Fan A.P., Xue F.X.: Clinical characteristics of aerobic vaginitis and its mixed infections. Zhonghua Fu Chan Ke Za Zhi 2010; 45: 904-908.
4. Fan A., Yue Y., Geng N., Zhang H., Wang Y., Xue F.: Aerobic vaginitis and mixed infections: comparison of clinical and laboratory findings. Arch. Gynecol. Obstet. 2013; 287: 329-335.
5. Ventolini G., Baggish M.S.: Reccurent vulvovaginal candidiasis. Clin. Microbiol. Newsletters 2006; 28: 93-95.
6. Sobel J.D.: Vulvovaginal candidosis. Lancet 2007; 369: 1961-1971.
7. Spacek J., Buchta V., Jilek P. et al.: Clinical aspects and luteal phase assesment in patients with recurrent vulvovaginal candidiasis, Eur. J. Obstet. Gynecol. Reprod. Biol. 2007; 131: 198-202.
8. Genital Candidiasis. US DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centres for Disease Control and Prevention (CDC), Division of Bacterial and Mycotic Diseases.
9. Mendling W.: Rezidivierende Vaginalinfektionen: Candidose, Bakterielle Vaginose. Der Gynäkologe 2009; 42: 766-771.
10. Anane S., Kaoech E., Zouari B. et al.: Les candidioses vulvovaginales: facteurs de risque et particularites cliniques et mycologiques. J. Mycol. Med. 2010; 20: 36-41.
11. Sherrard J., Donders G., White D. et al.: European (IUSTI/WHO) guideline on the management of vaginal discharge, 2011. Int. J. STD AIDS 2011; 22: 421-429.
12. Murina F., Graziottin A., Felice R., Di Francesco S., Mantegazza V.: Short-course treatment of vulvovaginal candidiasis: comparative study of fluconazole and intra-vaginal fenticonazole. Minerva Ginecol. 2012; 64: 89-94.
13. Stanowisko zespołu ekspertów Polskiego Towarzystwa Ginekologicznego w sprawie leczenia ostrego i nawrotowego grzybiczego zapalenia pochwy i sromu – stan wiedzy na 2008 r. Ginekol. Pol. 2008; 79: 638-652.
14. Lopez-Martinez R.: Candidosis, a new challenge. Clinics in Dermatology 2010; 28: 178-184.
15. Stanowisko zespołu ekspertów Polskiego Towarzystwa Ginekologicznego dotyczące etiopatogenezy i leczenia nawrotowej postaci drożdżakowego zapalenia pochwy i sromu. Ginekol. Pol. 2011; 82: 869-873.
16. Beggs W.: The effects of antifungal imidazoles on resting cells of Candida parapsilosis. IRCS Med. Sci. Libr. Compend. 1983; 11: 677-678.
17. Elliott K.: Managing patients with vulvovaginal candidiasis. Nurse Pract. 1998; 23: 44-51.
18. Watson M., Grimshaw J., Bond C. et al.: Oral versus intra-vaginal imidazole and triazole anti-fungal agents for the treatment on uncomplicated vulvovaginal candidiasis (thrush): a systematic review. BJOG. 2002; 109: 85-95.
19. LaFleur M., Kumamoto C.A., Lewis K.: Candida albicans biofilms produce antifungal-tolerant perister cells. Antimicrob. Agents Chemother. 2006; 50: 3839-3846.
20. Ejdys E., Rasztęborska A.N.: Rola biofilmu w przeżywalności i żywotności grzybów rodzaju Candida poza organizmem gospodarza. Mikologia Lekarska 2010; 17: 155-159.
21. Studd J.W., Dooley M.M., Welch C.C. et al.: Comparative clinical trial of fenticonazole ovule (600 mg) versus clotrimazole vaginal tablet (500 mg) in the treatment of symptomatic vaginal candidiasis. Curr. Med. Res. Opin. 1989; 11: 477-84 [a].
22. Studd J.W., Dooley M.M., Welch C.C., Vijayakanthan K., Mowat J.M., Wade A., Newell M.: Comparative clinical trial of fenticonazole ovule (600 mg) versus clotrimazole vaginal tablet (500 mg) in the treatment of symptomatic vaginal candidiasis. Curr. Med. Res. Opin. 1989; 11: 477-484 [b].
23. Angiolella L., De Bernardis F., Bromuro C., Mondello F., Ceddia T., Cassone A.: The effect of antimycotics on secretory acid proteinase of Candida albicans. J. Chemother. 1990; 2: 55-61.
24. Leiste D., Braun W., Fegeler W. et al.: A double-blind clinical trial of fenticonazole (2%) spray versus naftifine (1%) spray in patients with cutaneous mycoses. Curr. Med. Res. Opin. 1989; 11: 567-575.
25. Halbe H.W., Hegg R., Fernandes C.E. et al.: Estudo da eficacia e tolerabilidade do fenticonazol no tratamento da vulvovaginete por candida albicans. Rev. Bras. Med. 2000; 57: 1306-1311.
26. Veraldi S., Milani R.: Topical fenticonazole in dermatology and gynaecology: current role in therapy. Drugs 2008; 68: 2183-2194.
27. Veronese M., Beretoncini A., Monici Preti P.: Evaluation of the skin retention time of imidazole derivatives. Mykosen 1987; 30: 386-390.
28. Gorlero F., Sartani A., Cordaro C.I. et al.: Fenticonazole tissue levels after the application of 3 different dosage forms of vaginal ovules. Int. J. Clin. Pharmacol. Ther. Toxicol 1988; 26: 479-481.
29. De Bernardis F., Cassone A.: Comparison of the effects of fenticonazole a nd econazole on the aspartic proteinase secreted by Candida albicans. Contracept. Fertil. Sex. 1996; 24: 163-165.
30. Wiest W., Ruffmann R.: Short-term treatment of vaginal candidiasis with fenticonazole ovules: a three-dose schedule comparative trial. J. Int. Med. Res. 1987; 15: 319-325.
31. Živaljevic B., Golubovic I., Seratlic J. et al.: Efficiency of fenticonazole for the treatment of vaginal candidiasis. Srp. Arh. Celok. Lek. 2012; 140: 469-474.
32. Balaïsch J.: Evaluation of the time response of a single dose administration of fenticonazole nitrate. Contracept. Fertil. Sex. 1996; 24: 417-422.
33. Kovachev S., Nacheva A., Vacheva-Dobrevska R., Vasilev N.: Combined single-day treatment in acute vulvovaginal candidosis. Akush. Ginekol. 2009; 48: 18-23.
34. Lawrence A.G., Houang E.T., Hiscock E. et al.: Single dose therapy of vaginal candidiasis: a comparative trial of fenticonazole vaginal ovules versus clotrimazole vaginal tablets. Curr. Med. Res. Opin. 1990; 12(2): 114-120.
35. Graziani G., Cazzulani P., Barbadoro E.: Toxicological and pharmacological properties of fenticonazole, a new topical antimycotic. Arzneimittelforschung 1981; 31: 2145-2151.
36. Veronese M., Barzaghi D., Bertoncini A., Zadro M.: The Salmonella mutagenicity assay on fenticonazole, a new antifungal imidazole derivative. Arzneimittelforschung 1981; 31: 2140-2142.
37. Novelli A., Periti E., Massi G.B., Masi R., Mazzei T., Periti P.: Systemic absorption of 3H-fenticonazole after vaginal administration of 1 gram in patients. J. Chemother. 1991; 3: 23-27.
38. Fernández-Alba J., Valle-Gay A., Dibildox M., Vargas J.A., González J., García M., López L.H.: Fentimex Mexican Study Group: Fenticonazole nitrate for treatment of vulvovaginitis: efficacy, safety, and tolerability of 1-gram ovules, administered as ultra-short 2-day regimen. J. Chemother. 2004; 16(2): 179-186.
39. Naud P., Matos J., Hammes L. et al.: Efficacy and tolerability of fenticonazol for bacterial vaginosis treatment: double-blind study, randomized, prospective, compared to placebo. Rev. Bras. Med. 2003; 60: 67-70.
40. Munoz Reyes J.R., Villanueva Reynoso C., Ramos C.J. et al.: Efficacy and tolerance of 200 mg of fenticonazole versus 400 mg of miconazole in the intravaginal treatment of mycotic vulvovaginitis. Ginecol. Obstet. Mex. 2002; 70: 59-65.
41. Scalambrino S., Colombo M., Pellegrino A. et al.: Efficacy and tolerability of intravaginal fenticonazole single therapeutic shot in low-recurrent vaginal trichomoniasis and candidiasis. Giorn. Ital. Mal. Inf. 1996; 2: 37-40.
42. Gorlero F., Macchiavello S., Pellegatta L. et al.: Evaluation of the efficacy and tolerability of two different dosages of fenticonazole vaginal ovules (600 mg and 1000 mg) in patients with vaginal trichomoniasis: a controlled, double-blind, randomized clinical trial versus placebo. Curr. Ther. Res. Clin. Exp. 1994; 55: 510-518.
43. Gorlero F., Bosco P., Barbieri M. et al.: Fenticonazole ovules in the treatment of vaginal Trichomonas infections: a double- blind randomized pilot clinical trial. Curr. Ther. Res. Clin. Exp. 1992; 51: 367-376.
44. Bukovsky I., Schneider D., Arieli S. et al.: Fenticonazole in the treatment of vaginal trichomoniasis and vaginal mixed infections. Adv. Ther. 1991; 8: 166-171.
45. Schneider D., Caspi E., Arieli S. et al.: Fenticonazole in the treatment of vaginal candidiasis. Adv. Ther. 1990; 7: 355-361.
46. Wiest W., Azzollini E., Ruffmann R.: Comparison of single administration with an ovule of 600 mg fenticonazole versus a 500 mg clotrimazole vaginal pessary in the treatment of vaginal candidiasis. J. Int. Med. Res .1989; 17: 369-372.
47. De Cecco L., Gorlero F., Marre Brunenghi M.C. et al.: Studio multicentrico sull’efficacia e tollerabilita del fenticonazolo nel trattamento delle vulvovaginiti da candida. Int. J. Drug. Ther. 1988; 5: 296-301.
48. Sartani A., Cordaro C.I., Panconesi E.: A multicenter trial with a new imidazole derivative, fenticonazole, in superficial fungal skin infections. Curr. Ther. Res. Clin. Exp. 1988; 43: 1194-1203.
49. Sartani A., Cordaro C., Adinolfi G. et al.: Short-term treatment of vaginal candidiasis: results of a multi-center study. Riv. Ost. Gin. Perin 1988; 3: 184-189.
50. Scienza G., Bulgheroni C., Confalonieri C.: Vaginiti recidivanti efficacia e tollerabilita della terapia locale con fenticonazolo. G. Ital. Ost. Gin. 1987; 9: 758-760.
51. Brewster E., Preti P.M., Ruffmann R., Studd J.: Effect of fenticonazole in vaginal candidiasis: a double-blind clinical trial versus clotrimazole. J. Int. Med. Res. 1986; 14: 306-310.
2. Tomaszewski J.: Leczenie nawrotowej postaci drożdżakowego zapalenia pochwy i sromu. Zakażenia 2011; 6; 94-99.
3. Fan A.P., Xue F.X.: Clinical characteristics of aerobic vaginitis and its mixed infections. Zhonghua Fu Chan Ke Za Zhi 2010; 45: 904-908.
4. Fan A., Yue Y., Geng N., Zhang H., Wang Y., Xue F.: Aerobic vaginitis and mixed infections: comparison of clinical and laboratory findings. Arch. Gynecol. Obstet. 2013; 287: 329-335.
5. Ventolini G., Baggish M.S.: Reccurent vulvovaginal candidiasis. Clin. Microbiol. Newsletters 2006; 28: 93-95.
6. Sobel J.D.: Vulvovaginal candidosis. Lancet 2007; 369: 1961-1971.
7. Spacek J., Buchta V., Jilek P. et al.: Clinical aspects and luteal phase assesment in patients with recurrent vulvovaginal candidiasis, Eur. J. Obstet. Gynecol. Reprod. Biol. 2007; 131: 198-202.
8. Genital Candidiasis. US DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centres for Disease Control and Prevention (CDC), Division of Bacterial and Mycotic Diseases.
9. Mendling W.: Rezidivierende Vaginalinfektionen: Candidose, Bakterielle Vaginose. Der Gynäkologe 2009; 42: 766-771.
10. Anane S., Kaoech E., Zouari B. et al.: Les candidioses vulvovaginales: facteurs de risque et particularites cliniques et mycologiques. J. Mycol. Med. 2010; 20: 36-41.
11. Sherrard J., Donders G., White D. et al.: European (IUSTI/WHO) guideline on the management of vaginal discharge, 2011. Int. J. STD AIDS 2011; 22: 421-429.
12. Murina F., Graziottin A., Felice R., Di Francesco S., Mantegazza V.: Short-course treatment of vulvovaginal candidiasis: comparative study of fluconazole and intra-vaginal fenticonazole. Minerva Ginecol. 2012; 64: 89-94.
13. Stanowisko zespołu ekspertów Polskiego Towarzystwa Ginekologicznego w sprawie leczenia ostrego i nawrotowego grzybiczego zapalenia pochwy i sromu – stan wiedzy na 2008 r. Ginekol. Pol. 2008; 79: 638-652.
14. Lopez-Martinez R.: Candidosis, a new challenge. Clinics in Dermatology 2010; 28: 178-184.
15. Stanowisko zespołu ekspertów Polskiego Towarzystwa Ginekologicznego dotyczące etiopatogenezy i leczenia nawrotowej postaci drożdżakowego zapalenia pochwy i sromu. Ginekol. Pol. 2011; 82: 869-873.
16. Beggs W.: The effects of antifungal imidazoles on resting cells of Candida parapsilosis. IRCS Med. Sci. Libr. Compend. 1983; 11: 677-678.
17. Elliott K.: Managing patients with vulvovaginal candidiasis. Nurse Pract. 1998; 23: 44-51.
18. Watson M., Grimshaw J., Bond C. et al.: Oral versus intra-vaginal imidazole and triazole anti-fungal agents for the treatment on uncomplicated vulvovaginal candidiasis (thrush): a systematic review. BJOG. 2002; 109: 85-95.
19. LaFleur M., Kumamoto C.A., Lewis K.: Candida albicans biofilms produce antifungal-tolerant perister cells. Antimicrob. Agents Chemother. 2006; 50: 3839-3846.
20. Ejdys E., Rasztęborska A.N.: Rola biofilmu w przeżywalności i żywotności grzybów rodzaju Candida poza organizmem gospodarza. Mikologia Lekarska 2010; 17: 155-159.
21. Studd J.W., Dooley M.M., Welch C.C. et al.: Comparative clinical trial of fenticonazole ovule (600 mg) versus clotrimazole vaginal tablet (500 mg) in the treatment of symptomatic vaginal candidiasis. Curr. Med. Res. Opin. 1989; 11: 477-84 [a].
22. Studd J.W., Dooley M.M., Welch C.C., Vijayakanthan K., Mowat J.M., Wade A., Newell M.: Comparative clinical trial of fenticonazole ovule (600 mg) versus clotrimazole vaginal tablet (500 mg) in the treatment of symptomatic vaginal candidiasis. Curr. Med. Res. Opin. 1989; 11: 477-484 [b].
23. Angiolella L., De Bernardis F., Bromuro C., Mondello F., Ceddia T., Cassone A.: The effect of antimycotics on secretory acid proteinase of Candida albicans. J. Chemother. 1990; 2: 55-61.
24. Leiste D., Braun W., Fegeler W. et al.: A double-blind clinical trial of fenticonazole (2%) spray versus naftifine (1%) spray in patients with cutaneous mycoses. Curr. Med. Res. Opin. 1989; 11: 567-575.
25. Halbe H.W., Hegg R., Fernandes C.E. et al.: Estudo da eficacia e tolerabilidade do fenticonazol no tratamento da vulvovaginete por candida albicans. Rev. Bras. Med. 2000; 57: 1306-1311.
26. Veraldi S., Milani R.: Topical fenticonazole in dermatology and gynaecology: current role in therapy. Drugs 2008; 68: 2183-2194.
27. Veronese M., Beretoncini A., Monici Preti P.: Evaluation of the skin retention time of imidazole derivatives. Mykosen 1987; 30: 386-390.
28. Gorlero F., Sartani A., Cordaro C.I. et al.: Fenticonazole tissue levels after the application of 3 different dosage forms of vaginal ovules. Int. J. Clin. Pharmacol. Ther. Toxicol 1988; 26: 479-481.
29. De Bernardis F., Cassone A.: Comparison of the effects of fenticonazole a nd econazole on the aspartic proteinase secreted by Candida albicans. Contracept. Fertil. Sex. 1996; 24: 163-165.
30. Wiest W., Ruffmann R.: Short-term treatment of vaginal candidiasis with fenticonazole ovules: a three-dose schedule comparative trial. J. Int. Med. Res. 1987; 15: 319-325.
31. Živaljevic B., Golubovic I., Seratlic J. et al.: Efficiency of fenticonazole for the treatment of vaginal candidiasis. Srp. Arh. Celok. Lek. 2012; 140: 469-474.
32. Balaïsch J.: Evaluation of the time response of a single dose administration of fenticonazole nitrate. Contracept. Fertil. Sex. 1996; 24: 417-422.
33. Kovachev S., Nacheva A., Vacheva-Dobrevska R., Vasilev N.: Combined single-day treatment in acute vulvovaginal candidosis. Akush. Ginekol. 2009; 48: 18-23.
34. Lawrence A.G., Houang E.T., Hiscock E. et al.: Single dose therapy of vaginal candidiasis: a comparative trial of fenticonazole vaginal ovules versus clotrimazole vaginal tablets. Curr. Med. Res. Opin. 1990; 12(2): 114-120.
35. Graziani G., Cazzulani P., Barbadoro E.: Toxicological and pharmacological properties of fenticonazole, a new topical antimycotic. Arzneimittelforschung 1981; 31: 2145-2151.
36. Veronese M., Barzaghi D., Bertoncini A., Zadro M.: The Salmonella mutagenicity assay on fenticonazole, a new antifungal imidazole derivative. Arzneimittelforschung 1981; 31: 2140-2142.
37. Novelli A., Periti E., Massi G.B., Masi R., Mazzei T., Periti P.: Systemic absorption of 3H-fenticonazole after vaginal administration of 1 gram in patients. J. Chemother. 1991; 3: 23-27.
38. Fernández-Alba J., Valle-Gay A., Dibildox M., Vargas J.A., González J., García M., López L.H.: Fentimex Mexican Study Group: Fenticonazole nitrate for treatment of vulvovaginitis: efficacy, safety, and tolerability of 1-gram ovules, administered as ultra-short 2-day regimen. J. Chemother. 2004; 16(2): 179-186.
39. Naud P., Matos J., Hammes L. et al.: Efficacy and tolerability of fenticonazol for bacterial vaginosis treatment: double-blind study, randomized, prospective, compared to placebo. Rev. Bras. Med. 2003; 60: 67-70.
40. Munoz Reyes J.R., Villanueva Reynoso C., Ramos C.J. et al.: Efficacy and tolerance of 200 mg of fenticonazole versus 400 mg of miconazole in the intravaginal treatment of mycotic vulvovaginitis. Ginecol. Obstet. Mex. 2002; 70: 59-65.
41. Scalambrino S., Colombo M., Pellegrino A. et al.: Efficacy and tolerability of intravaginal fenticonazole single therapeutic shot in low-recurrent vaginal trichomoniasis and candidiasis. Giorn. Ital. Mal. Inf. 1996; 2: 37-40.
42. Gorlero F., Macchiavello S., Pellegatta L. et al.: Evaluation of the efficacy and tolerability of two different dosages of fenticonazole vaginal ovules (600 mg and 1000 mg) in patients with vaginal trichomoniasis: a controlled, double-blind, randomized clinical trial versus placebo. Curr. Ther. Res. Clin. Exp. 1994; 55: 510-518.
43. Gorlero F., Bosco P., Barbieri M. et al.: Fenticonazole ovules in the treatment of vaginal Trichomonas infections: a double- blind randomized pilot clinical trial. Curr. Ther. Res. Clin. Exp. 1992; 51: 367-376.
44. Bukovsky I., Schneider D., Arieli S. et al.: Fenticonazole in the treatment of vaginal trichomoniasis and vaginal mixed infections. Adv. Ther. 1991; 8: 166-171.
45. Schneider D., Caspi E., Arieli S. et al.: Fenticonazole in the treatment of vaginal candidiasis. Adv. Ther. 1990; 7: 355-361.
46. Wiest W., Azzollini E., Ruffmann R.: Comparison of single administration with an ovule of 600 mg fenticonazole versus a 500 mg clotrimazole vaginal pessary in the treatment of vaginal candidiasis. J. Int. Med. Res .1989; 17: 369-372.
47. De Cecco L., Gorlero F., Marre Brunenghi M.C. et al.: Studio multicentrico sull’efficacia e tollerabilita del fenticonazolo nel trattamento delle vulvovaginiti da candida. Int. J. Drug. Ther. 1988; 5: 296-301.
48. Sartani A., Cordaro C.I., Panconesi E.: A multicenter trial with a new imidazole derivative, fenticonazole, in superficial fungal skin infections. Curr. Ther. Res. Clin. Exp. 1988; 43: 1194-1203.
49. Sartani A., Cordaro C., Adinolfi G. et al.: Short-term treatment of vaginal candidiasis: results of a multi-center study. Riv. Ost. Gin. Perin 1988; 3: 184-189.
50. Scienza G., Bulgheroni C., Confalonieri C.: Vaginiti recidivanti efficacia e tollerabilita della terapia locale con fenticonazolo. G. Ital. Ost. Gin. 1987; 9: 758-760.
51. Brewster E., Preti P.M., Ruffmann R., Studd J.: Effect of fenticonazole in vaginal candidiasis: a double-blind clinical trial versus clotrimazole. J. Int. Med. Res. 1986; 14: 306-310.