Penetration activities of ciprofloxacin into female genital tract tissues were studied following a single oral administration of 500 mg and an intravenous injection of 100 mg. Serum and tissue concentrations were within the same order of magnitude 1 and 3 h after oral administration; 3 h after intake of ciprofloxacin, however, tissue concentrations exceeded the corresponding serum levels twofold. Similarly, tissue concentrations following intravenous injection exceeded the corresponding serum levels by 60–190% 0.5 h after injection and were consistently higher throughout the study period of 2 h. These data confirm that ciprofloxacin disposition is characterized by a remarkably pronounced diffusion into the extravascular space, generating tissue levels exceeding the minimal inhibitory concentrations of most pathogens severalfold.
An open, multi-centre study was carried out in 117 pregnant women presenting with vaginal candidosis to assess the effectiveness of econazole in providing mycological control and symptom relief, and in preventing, as far as possible, the risk of contamination of the newborn: nearly 50% of the patients were in the last month of pregnancy. Patients received a single course of econazole given as 1 vaginal pessary (150 mg) on 3 consecutive days. Clinical and mycological assessments were made 1 week after the end of treatment and again at delivery, unless it happened before the first control visit. The infants were investigated at birth and 1 week afterwards. An 80% mycological cure rate was obtained and there was complete or marked relief of symptoms in the majority of patients after treatment. Twenty patients received further antimycotic treatment before delivery either because of failure (13) or relapse (7) after the single course of econazole. The relapse rate was 13.3%. No congenital abnormality was observed in the neonates and only 1 infant, born to a mother who was positive for Candida at the time of delivery, developed oral candidosis. Local tolerance of the vaginal pessaries was good and there were no reports of side-effects.
90 female patients suffering from Candida vaginitis were included in an open, mycologically controlled study, carried out at three gynaecological clinics, to investigate the efficacy and tolerance of one single vaginal tablet containing 500 mg clotrimazole (Canesten® 1). In 40% of the patients the infection was considered to be mild and in 60% severe. In order to confirm the diagnosis and to evaluate the therapeutic effect (before application and 1 as well as 4 weeks after therapy), the following criteria were considered: (1) identification of Candida species on direct microscopic examination (wet film) and also by culture on a Nickerson medium, and (2) influence on the clinical symptoms, such as itching, burning, pathological changes of the vaginal mucosa, thrush. The principle criterion was the cultural mycological finding. In 79 patients (88%) the culture was negative 1 week after therapy and in 81 (90%) 4 weeks after therapy; 9 patients (10%) were treatment failures with positive cultural findings at the last control. The clinical symptoms improved parallel to the mycological findings. At the controls they had disappeared in the majority (up to 90%) of the affected patients. The favourable impression achieved at consideration of the cultural findings could be confirmed at the overall assessment by the clinicians: 88% of the patients were cured 1 week after application and 90% 4 weeks after application. By means of different criteria the state of disease did not have any influence on the therapeutic success. The 500-mg clotri-mazole vaginal tablet was very well tolerated by all patients.
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