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At least 19 recordsLinked to original sources

PubMed2003

Clinical study on the dose-effect relationship of a nifuratel-nystatin combination in the treatment of vulvo-vaginal infections.

OBJECTIVE: The dose-effect relationship of nifuratel (CAS 4936-47-4) + nystatin (CAS 1400-61-9, CAS 34786-70-4) (Macmiror Complex) in topical treatment of vulvo-vaginitis was studied. METHOD: Sixty patients with Trichomoniasis and/or Candidiasis were randomized to: 1) nifuratel 125 mg/nystatin 50000 IU, 2) nifuratel 250 mg/nystatin 100000 IU, 3) nifuratel 500 mg/nystatin 200000 IU. Undistinguishable ovules were intravaginally applied qd for 10 days. The dose-effect relationship was assessed by ANCOVA. RESULT: After 5 days the microbiological cure rate occurred in 10% of patients in the least dose, in 40% in the middle dose and in 85% in the highest dose group (P = 0.000). After 10 days of treatment, the microbiological cure rate increased to 45%, 84%, and 95%, respectively (P = 0.007). Clinical signs and symptoms gradually disappeared in a dose- and time-dependent manner. No relapse has been observed after 10 day-follow up on 46 patients. CONCLUSION: The results confirmed a linear relationship between nifuratel + nystatin dose and effect. The least effective dose was nifuratel 250 mg + nystatin 100,000 IU once daily for 5 days and the best dose in terms of risk/benefit ratio was nifuratel 500 mg + nystatin 200,000 IU once daily for 5 days.

Adolescent↗

PubMed2002

Clinical effects of nifuratel in vulvovaginal infections. A meta-analysis of metronidazole-controlled trials.

Nifuratel (CAS 4936-47-4) displays a strong antiprotozoarian and antibacterial activity and is provided with certain fungicidal effect, but it is not active against the physiologic flora. Its therapeutic effectiveness has been evaluated in more than 12,000 patients. The wide clinical experience with nifuratel confirms that the drug is safe and effective for the treatment of trichomoniasis, bacterial vaginosis, candidosis, and, particularly, in patients suffering from mixed vaginal infection. A meta-analysis of clinical trials comparing nifuratel and metronidazole (CAS 443-48-1) in vulvovaginal infections was performed. All parallel-group metronidazole-controlled trials carried out in patients with vulvovaginal infections have been included, complying with the following criteria: 1) cure assessed both as disappearance of symptoms and signs, and negative microbiological findings; 2) microbiological tests performed with valid methods still used in current practice. Seven clinical trials have been selected, including overall 1767 patients, 832 out of whom were treated with nifuratel and 935 with metronidazole. The results of the meta-analysis confirmed the equivalence between nifuratel and metronidazole: overall proportion of cured patients in the two groups were 88.5% and 90.0%, respectively, in the presence of homogeneity among studies (p = 0.342). In the fixed and random effect analyses, the confidence interval of Odds ratio included 1 and the p values for testing the hypothesis of no difference between treatments were 0.656-1.266, p = 0.582 (fixed effects) and 0.643-1.290, p = 0.599 (random effects), respectively, indicating equivalence. Furthermore, some controlled studies and the wide clinical experience showed that the cure rate of nifuratel in patients with mixed infections due to Trichomonas vaginalis + Candida or Trichomonas vaginalis + bacteria or with bacterial vaginosis and mixed bacterial flora is higher than that of metronidazole, due to the wide spectrum of action of nifuratel.

Antifungal Agents↗

PubMed2005

Helicobacter pylori eradication in childhood after failure of initial treatment: advantage of quadruple therapy with nifuratel to furazolidone.

BACKGROUND: Failures of Helicobacter pylori eradication in children are common. AIM: To evaluate the efficacy of amoxicillin, bismuth subcitrate and omeprazole and nifuratel or furazolidone for H. pylori eradication in children who failed initial treatment with a standard triple therapy. METHODS: Seventy-six consecutive H. pylori-positive paediatric out-patients (aged 12-16 years; mean age 13.7 +/- 1.4) with chronic abdominal complaints who had failed one attempt of eradication of H. pylori using metronidazole-containing triple therapy were enrolled. It was an open prospective study. Patients were randomized to receive a 2-week course of bismuth subcitrate (8 mg/kg/day, q.d.s.), amoxicillin (50 mg/kg/day, q.d.s.), with either nifuratel (15 mg/kg/day, q.d.s.) or furazolidone (10 mg/kg/day, q.d.s.), plus omeprazole (0.5 mg/kg, once daily). RESULTS: There were 37 patients in the nifuratel group and 39 in the furazolidone group. Helicobacter pylori was eradicated in 33 of 37 (89%; 95% CI: 74.5-96.9; intention-to-treat) in nifuratel group and in 34 of 39 (87%; 95% CI: 72.5-95.7) in furazolidone group, respectively. Frequency of severe side-effects was greater with furazolidone (21%) than with nifuratel (3%; P = 0.0289). CONCLUSIONS: Nitrofuran-containing therapies consisting of a proton-pump inhibitor, amoxicillin and bismuth citrate plus either nifuratel or furazolidone produced good cure rates even among those who had failed prior therapy. Nifuratel is preferred because of the lower frequency of side-effects.

Adolescent↗

PubMed2002

Microbiological and pharmaco-toxicological profile of nifuratel and its favourable risk/benefit ratio for the treatment of vulvo-vaginal infections. A review.

Nifuratel (CAS 4936-47-4) is a furane-derivative provided with a strong trichomonicidal activity equivalent to that of metronidazole (CAS 443-48-1); it has a broad antibacterial spectrum of action, including both Gram-negative and Gram-positive organisms. It is active against Chlamydia trachomatis and Mycoplasma spp. and has also some degree of activity against Candida spp. and mycetes. Its broad spectrum of action, confirmed by in vitro and in vivo studies, covers virtually all the micro-organisms responsible for the infections of the genito-urinary tract. Nifuratel has a very safe toxicological profile. It is practically non-toxic in acute tests in mice and rats and is also well tolerated after repeated oral and intravaginal administrations. Nifuratel is devoid of teratogenic effects. The comparison among past and recent clinical studies confirms that, in contrast to metronidazole, no resistance phenomena to the treatment with nifuratel are reported. The drug can be used during pregnancy due to the absence of teratogenic effects. In conclusion, nifuratel shows a very favourable risk/benefit ratio for the treatment of patients with vulvo-vaginal infections.

Animals↗

PubMed1970

Nifuratel compared with metronidazole in the treatment of trichomonal vaginitis.

Nifuratel (Magmilor) was compared with metronidazole (Flagyl) in the treatment of trichomonal vaginitis by a randomized double-blind trial. Only 18 out of 47 patients (38%) treated with nifuratel were found to be cured, whereas 42 out of 49 patients (85%) treated with metronidazole were cured. Severe reactions, necessitating withdrawal of treatment, occurred in three patients treated with nifuratel. There were no serious side-effects with metronidazole. The results of this trial indicate that nifuratel is not a satisfactory substitute for metronidazole in the treatment of trichomoniasis.

Adolescent↗

PubMed1976

Treatment of candidal urinary tract infection with nifuratel.

Three patients with candidal urinary tract infections were successfully treated with oral nifuratel, a nitrofuran antimicrobial agent active against yeast and Trichomonas as well as urinary bacterial pathogens. The recommended dose is 400 mg thrice daily for a week. No side effects that could be attributed to the treatment were noted. Minimum ibhibitory concentration determinations for nifuratel against Candida strains of five species showed that 48 out of 59 organisms were inhibited by 50 mg/1 or less, the three strains of Candida species eliminated from our treated patients having MICs of nifuratel in the range of 10-50 mg/1.

Administration, Oral↗

PubMed2005

["Mixed" and "miscellaneous" vulvovaginitis: diagnostics and therapy of vaginal administration of nystatin and nifuratel].

AIM OF THE STUDY: The evaluation of combined and miscellaneous vulvovaginal infections incidence and their treatment with combined vaginal products containing nifuratel and nystatin. DESIGN: Prospective study. SETTING: Gynecologic outpatient department LEVRET, Prague; Laboratories of Microbiology AescuLab, Prague. METHODS: 70 consecutive patients were examined with complaint of vaginal fluor and/or pruritus. We established macroscopic features of fluor, pH, amine test and mounts stained with Giemsa and Gram. We qualified the cases with more diagnostic criteria (mycosis, lactobacillosis, anaerobic vaginosis, aerobic vaginitis) as combined infection, those with no diagnostic criteria as miscellaneous. We treated all patients with vaginal tablets nystatin + nifuratel (Macmiror complex). We prescribed clotrimazol cream, if pruritus was present. We evaluated withdrawals of symptoms and relapses during 3 months after treatment. RESULTS: Combined infection was found in 21 patients from 70 (30%). The most frequent combination was that of mycosis and aerobic vaginitis (13/70, 18.6%) or mycosis and anaerobic vaginosis (4/70, 5.7%); 11 patients fulfilled criteria of no diagnosis. We concluded them as "miscelaneous". The treatment was successful in all cases, 10 women relapsed in 3 months. CONCLUSIONS: Combined vaginal infection findings are present very often (30%), likewise miscellaneous ones (15%) occur. The treatment of these women in successful with vaginal tablets with nystatin + nifuratel.

Administration, Intravaginal↗

PubMed1975

Ampicillin, carbenicillin indanyl ester, and nifuratel in the treatment of urinary infection in domiciliary practice.

A total of 120 patients, including 53 pregnant women with significant bacteriuria, received 163 7-day courses of oral antimicrobial agents allocated in a randomised manner. The cure rates after 6 weeks' follow-up ranged from 73% to 86%, and there was no statistical difference between preparations of ampicillin, carbenicillin indanyl easter, and 2 different formulations of nifuratel. Side-effects occurred in 30% to 40% of the courses of penicillin drugs, but in under 15% of the course of nifuratel. It is concluded that the new oral preparation of carbenicillin is a useful addition to the list of antimicrobial agents which are effective in the treatment of urinary infections in domiciliary patients. Furthermore, nifuratel has been confirmed as a highly active non-toxic drug which is valuable in the treatment of urinary infections.

Administration, Oral↗

PubMed1976

Sensitivity of Trichomonas vaginalis to metronidazole, tinidazole, and nifuratel in vitro.

Prompted by the sensitivity of trichomonads to metronidazole and nifuratel in clinical practice, a study was conducted in 1971-1972 of 63 consecutive strains of Trichomonas vaginalis isolated from women with clinically refractory vaginal discharge. Their susceptibility to metronidazole, tinidazole, and nifuratel was tested, using a serial tube dilution technique. The minimum concentrations which in 48 hrs caused immobilization and lysis of trichomonads cultured in Diamond's medium was assessed. No differences in drug potency could be determined. The median trichomonistatic and trichomonicidal concentrations were 0-1 and 0-6 mug/ml. respectively when using an inoculum of 10,000 organisms per ml. An inoculum of 100,000 per ml. resulted in inhibitory concentrations of 1-0 and killing concentrations of 3-3 mug./ml. These levels are readily attained in blood and vaginal tissue after oral ingestion of the two imidazole derivatives. Thus, metronidazole has maintained its efficacy since it was first introduced more than a decade ago. The few therapeutic failures with metronidazole and tinidazole are considered to have been caused by pharmacokinetic deficiencies in the patients, or by re-infection.

Drug Resistance, Microbial↗

PubMed1972

Antibacterial activity of nifuratel in urine and serum.

The minimum inhibitory concentrations of nifuratel for 205 randomly selected isolates from urinary tract infections were tested by tube dilution. Of these, 177 (86.3%) were resistant to more than 6 mug/ml and 140 of 141 (99.3%) strains of Escherichia coli were resistant to more than 3 mug/ml. Urine levels of nifuratel were examined in two groups: one group had 400 mg given once and the other group had 2 g given over 24 hours. In both groups samples of urine were collected every hour for seven hours after the last dose. After one 400-mg dose the maximum urine level achieved by any subject was 2.0 mug/ml and the mean maximum level was 0.75 mug/ml. With the 2 g total dose, the maximum level noted was 4 mug/ml and the mean maximum level was 1.8 mug/ml. No measurable inhibition was noted in any of the blood samples removed at one and a half to two hours after the last dose.

Bacteria↗

PubMed2005

Determination of nifuratel in human plasma by HPLC and study on its pharmacokinetics.

A simple and sensitive reversed-phase high-performance liquid chromatography method using UV detection is established for the determination of nifuratel in human plasma and applied to a study of its pharmacokinetics. Plasma samples are extracted with ethyl acetate. A C(18) column and a mobile phase of 0.01 M (pH 7) phosphate buffer (KH(2)PO(4)) and acetonitrile (61:39, v/v) are used. Analysis is run at a flow rate of 1.0 mL/min with the detector operated at a wavelength of 367 nm. The calibration curve is linear over a concentration range of 0.2-40 ng/mL with a correlation coefficient of 0.9996. The limit of detection is 0.1 ng/mL. The mean absolute recovery value is greater than 80%. The intraday precision (relative standard deviation) ranges from 1.89% to 7.32%, and the interday precision ranges from 1.71% to 7.83%. The results show that the area under the plasma concentration-time curve, time to maximum observed plasma concentration, maximum concentration reached in the concentration profile, and elimination half-life between the testing tablets and reference tablets have no significant difference (P > 0.05). Relative bioavailability is 104.0% +/- 16.5%.

Chromatography, High Pressure Liquid↗

PubMed1983