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 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

To evaluate the safety, tolerance, and pharmacokinetics of fluconazole in children with neoplastic diseases, we studied fluconazole in 26 children, aged 5 to 15 years, with normal renal function who were receiving treatment for cancer. The patients received fluconazole, 2, 4, or 8 mg/kg per day for 7 days intravenously for a 2-hour period. Patients had no nausea or vomiting related to fluconazole; three patients had an asymptomatic rise in hepatic aminotransferase values after four to six doses (one patient at 2 mg/kg per day and two patients at 8 mg/kg per day), which returned to normal within 2 weeks after discontinuation of the drug. Fluconazole showed linear first-order kinetics over the dosage range tested and during multiple dosing. After the first dose, mean clearance was 22.8 +/- 2.3 ml/min, volume of distribution 0.87 +/- 0.06 L/kg, and terminal elimination half-life 16.8 +/- 1.1 hours. Similarly, after the last dose, clearance was 19.4 +/- 1.3 ml/min, volume of distribution 0.84 +/- 0.04 L/kg, and terminal elimination half-life 18.1 +/- 1.2 hours. Patients receiving their first fluconazole dose of 8 mg/kg achieved peak serum levels of 9.5 +/- 0.4 microgram/ml and trough levels of 2.7 +/- 0.5 microgram/ml 24 hours later, and an area under the serum concentration-time curve from time zero to infinity of 186 +/- 16 micrograms.hr per milliliter. Renal clearance of fluconazole was 65% +/- 5% of total clearance and demonstrated the predominantly renal excretion of this drug. We suggest that the shorter serum half-life and the higher frequency of aminotransferase elevations in comparison with those of adults warrant careful investigation of fluconazole in controlled clinical trials.
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PMID:Safety and pharmacokinetics of fluconazole in children with neoplastic diseases. 159 62

Fluconazole is a new oral triazole antifungal with good activity against Candida spp. In this study, we investigated the effectiveness and tolerability of a three-day course of treatment with fluconazole compared with clotrimazole vaginal tablets in nonpregnant women with acute Candida vaginitis. Of the 90 evaluable patients who received fluconazole, 76 (84 percent) were asymptomatic seven to ten days after treatment compared with 84 of 95 (88 percent) treated with clotrimazole. An additional ten patients in the fluconazole group (11 percent) and seven in the clotrimazole group (7 percent) had improvement in their signs and symptoms. Only four patients in each group (4 percent) were considered treatment failures. Mycological cures were obtained in 89 and 93 percent of patients treated with fluconazole and clotrimazole, respectively, seven to ten days posttreatment. Clinical cure rates remained high one month posttreatment: 79 percent in the fluconazole group and 83 percent in the clotrimazole group. Both therapies were well tolerated. One patient discontinued treatment after she developed diarrhea while receiving fluconazole. The most common adverse effects associated with fluconazole use were nausea (six percent) and diarrhea (three percent). No clinically significant laboratory abnormalities were observed. In this investigation, oral fluconazole therapy was found to be as safe and effective as clotrimazole vaginal tablets in women with acute vulvovaginal candidiasis.
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PMID:Comparative study of fluconazole and clotrimazole in the treatment of vulvovaginal candidiasis. 187 64

To assess the efficacy and tolerance of fluconazole in the treatment of oesophageal candidiasis, 47 AIDS patients with this infection were enrolled in an open prospective study using fluconazole 100 mg given orally once daily. Clinical cure was obtained in all of 41 evaluable patients, with confirmation of cure in all of 31 patients who underwent post-treatment oesophagoscopy. Forty patients were followed up for at least 30 days; none suffered a relapse of oesophagitis but seven had a recurrence of stomatitis which was effectively treated with fluconazole. Fluconazole was well tolerated. Nausea was noted in three patients one of whom interrupted therapy. Transient mild elevation of ALT/AST was noted in five of 41 patients (12%). Fluconazole appears to be a safe and effective agent for oral therapy of oesophageal candidiasis associated with AIDS.
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PMID:Efficacy of oral fluconazole in the treatment of AIDS associated oesophageal candidiasis. 191 85

Fluconazole, a novel triazole antifungal agent, was given orally or intravenously to 10 patients with pulmonary mycosis (7 patients with primary pulmonary cryptococcosis and 3 with pulmonary aspergillosis). Routes of administration were changed in some patients depending on their condition. Two patients from whom foci was removed by surgical operations were excluded from the efficacy assessment. Clinical efficacies in the remaining 8 patients were good in 2 cases and fair in 3 cases of pulmonary cryptococcosis; excellent in 1 case of pneumonia due to Aspergillus; and fair in 1 case and poor in the other case of pulmonary aspergilloma. Side reactions developed in 9 patients who received intravenous drip infusion were nausea or loss of appetite in 3 patients, fever and/or feverish sensation in 3, vascular pain in 1 and diarrhea and eruption in 1. In the patient who reported fever the drug was discontinued and in the patient who complained of pain at the site of injection, dosing was changed to the oral route but was discontinued due to elevated GOT, GPT, Al-P and gamma-GTP. Seven patients who received the drug orally did not report side effects except 2 patients. None of these side effects reported was serious and from the above results, fluconazole was considered to be a useful agent for the treatment of pulmonary mycosis.
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PMID:[Clinical efficacy of fluconazole in the patient with pulmonary mycosis]. 254 Mar 59

Fluconazole is a novel antifungal agent, available in oral and intravenous forms, which was developed by Pfizer Central Research. It is characterized by its long serum half-life (approximately 30 hours) to allow once-a-day dosing and favorable safety profile. Fluconazole was administered orally or intravenously to 166 patients with deep-seated mycosis and it was possible to evaluate clinical efficacies in 99 patients. Clinical cures were obtained in 41 (87.2%) out of 47 cases of candidiasis, in 10 (66.7%) out of 15 cases of cryptococcosis, in 17 (48.6%) out of 35 cases of aspergillosis and in 1 case each (100%) of mucormycosis and mycosis due to an unspecified yeast. Side effects were observed in 10 cases (rash 2, fever 2, abdominal discomfort 1, nausea 1, edema 1, edema/pleural effusion/oliguria 1, finger stiffness 1, hiccup 1) with incidence rate of 6.0%. Drug administrations were discontinued in 4 cases. In general, however, fluconazole was well tolerated. Abnormal changes in laboratory test values due to the drug were observed in 32 cases and incidence rate was 19.3%. These were, however, slight and temporary changes and most of them were in parameters of liver function. It is not clear if these changes were related to the fluconazole administration, because other drugs were concomitantly administered to these cases. These results indicate that fluconazole is an agent with very good potential for the treatment of the systemic deep-seated mycoses.
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PMID:[Clinical study of fluconazole on deep-seated fungal infections]. 254 Mar 69

In a randomised, double-blind study the efficacy and toxicity of oral fluconazole 50 mg daily and ketoconazole 200 mg daily were compared for the treatment of oropharyngeal candidiasis in patients with acquired immunodeficiency syndrome (AIDS) and AIDS-related complex (ARC). 20 episodes (18 patients) were treated with fluconazole and 20 episodes (19 patients) with ketoconazole. Pretreatment clinical features and laboratory test results were similar in both groups. 17 episodes (85%) in the fluconazole group and 16 (80%) in the ketoconazole group could be evaluated. There was clinical cure at the end of therapy in all fluconazole-treated and 12 of 16 (75%) ketoconazole-treated episodes. Cultures were negative at the end of therapy in 87% of the fluconazole group and 69% of the ketoconazole group. 1 patients stopped taking fluconazole because of severe nausea. 1 of 18 fluconazole-treated and 4 of 19 ketoconazole-treated patients had transient rises in alanine or aspartate aminotransferase. Fluconazole seemed more effective than ketoconazole in the treatment of oral thrush among AIDS and ARC patients.
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PMID:Comparison of fluconazole and ketoconazole for oropharyngeal candidiasis in AIDS. 256 63

Sixty-five patients with Candida albicans fungaemia, admitted to intensive care units, were treated intravenously with fluconazole. All patients had at least one blood culture which was positive for C. albicans. The first group of 34 consecutive patients received fluconazole at a dose of 5 mg/kg bodyweight/day and the subsequent 31 patients received 10 mg/kg/day. Thirty patients in each group were evaluated. The clinical response rate was 60% in the 5 mg/kg once daily group and 83% in the group which received 10 mg/kg/day. Eradication of C. albicans from the blood was achieved in all but two patients in the 5 mg/kg group and in all patients in the 10 mg/kg group. As regards other sites of infection, eradication was achieved in only nine of 25 cases from the 5 mg/kg group and in 11 of 23 cases from the 10 mg/kg group. Death related to fungal infection occurred in eight patients receiving 5 mg/kg/day and in one patient receiving 10 mg/kg/day. Fluconazole was reasonably well tolerated. Raised concentrations of liver enzymes were observed in 14 patients. Other adverse effects were fatigue, nausea, gastric pain, sleepiness and epileptic seizure. In conclusion, fluconazole at a dose of 10 mg/kg/day would seem to be an effective and safe drug for the management of C. albicans fungaemia.
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PMID:Treatment of Candida albicans fungaemia with fluconazole. 847 60

A multiple center clinical trial was conducted to evaluate the efficacy and safety of domestic fluconazole in treating 913 cases of deep-seated fungal infections. Fluconazole was given 100-200 mg daily for 3 days to 8 months. The results showed that the cure rate and the total efficacy rate were 69.26% and 94.29% respectively. The fungal clearance rate was 93.83%. The main side-effects were nausea, vomiting, diarrhea and abdominal pain, but most of the patients could endure. The side-effect rate was 9.20%. This clinical trial indicated that domestic fluconazole was effective and safe in treating deep-seated fungal infections.
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PMID:[A multiple center clinical trial on fluconazole for deep-seated fungal infections]. 873 61

Clinical efficacy of fluconazole was evaluated against fungal infections complicated with hematological diseases. Fluconazole 200 approximately 400 mg was administered intravenously to 20 suspected fungal infections occurring in patients with hematological diseases (acute leukemia 6, malignant lymphoma 11, adult T cell leukemia 2, chronic myelogenous leukemia blastic crisis 1). These mycoses included 8 cases of suspected pulmonary fungal infection, 10 cases suspected fungemia, and two cases of suspected hepatic fungal abscess. The clinical response rate was 60.0%. Side effects were observed in two cases, one with transient liver function test abnormality and the other with nausea. Fluconazole is considered to be a potent, safe antifungal agent for the treatment of suspected fungal infections associated with hematological diseases.
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PMID:[Clinical efficacy of fluconazole against fungal infections in hematological diseases]. 878 30

We conducted an open label, randomised clinical trial to compare amphotericin B colloidal dispersion (ABCD, Amphocil) 2 mg/kg/day intravenously with fluconazole 200 mg/day orally, for the prevention of fungal disease in neutropenic patients with haematological malignancies. In the event of unresolved fever after 4 days of empirical antibacterial therapy, patients in both treatment groups were to receive ABCD, 4 mg/kg/day. However, the study had to be stopped in an early phase, due to severe side-effects of ABCD. A total of 24 patients were enrolled, 12 patients were randomly assigned to receive prophylactic ABCD, which was administered for a mean of 13.9 days. Fluconazole prophylaxis was given to 12 patients for a mean of 21.2 days. Therapeutic ABCD, 4 mg/kg, was initiated in four patients because of suspected fungal infection, all of whom had initially received fluconazole. A high rate of infusion-related toxicity of ABCD was observed. Chills occurred in 15/16 ABCD recipients (94%), accompanied by a temperature rise of >/=2 degrees C in 4/16 patients and of >/=1 degrees C but <2 degrees C in 10/16 patients. Other ABCD-related adverse events were hypotension (4/16), nausea with vomiting (5/16), tachycardia (7/16), headache (3/16) and dyspnoea (3/16). For premedication patients received: antihistamines (12/16), hydrocortisone (9/16) and/or morphine (6/16). ABCD was discontinued in 8/16 patients (50%) due to side-effects, which ultimately dictated early termination of the study. We conclude that ABCD is not suitable for antifungal prophylaxis in neutropenic patients due to severe infusion-related side-effects. Subject numbers were too low for conclusions on variables of antifungal efficacy.
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PMID:Amphotericin B colloidal dispersion (Amphocil) vs fluconazole for the prevention of fungal infections in neutropenic patients: data of a prematurely stopped clinical trial. 1080 10


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