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 详细处方信息以本药内容附件PDF文件（20111620473211.pdf）的“原文Priscribing Information”为准
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部分中文美乐力处方资料（仅供参考）

Monurol
药品商品名：美乐力

英文通用名：FOSFOMYCIN TROMETHAMINE

中文通用名：磷霉素氨丁三醇

产品分类：西药产品-抗感染药\抗生素\其它抗生素

药理作用：本药对革兰氏阳性及革兰氏阴性菌，包括耐青霉素菌株及经常引起尿路感染的菌属(如大肠杆菌、变形杆菌、克雷白杆菌、肠杆菌、假单胞菌、葡萄球菌属等)具有高效广谱的抗菌作用。本药具有以下特性： 完全溶于水 ；口服后迅速有效地吸收 ；血药、组织浓度高 ；原形药物主要通过肾脏排泄 ；口服单治疗剂量后，迅速达到杀菌浓度(2-4小时)，并至少维持36-48小时 ；与其他抗菌素不存在交叉耐药性 ；可在不同pH尿液中保持抗菌活性 ；一般毒性及较低的胎儿毒性；与多数抗菌素合用可能有协同作用。 鉴于以上特性，本药在短期内(1-2个剂量)即能有效预防及治疗急性单纯性下尿路感染。 本药治疗下尿路感染具有以下优点 ：治疗简便并且与长期治疗方法具有同等疗效。具有很好的耐受性。在长期治疗单纯性尿路感染中，经常会出现由于病人自觉临床症状消失而过早停药的情况，使用本药则不易产生因过早停药而引起的不良后果。本药在感染区达到的高浓度确保它对大多数尿路感染原的杀菌作用，因此降低了出现新耐药菌株的危险。 本药为磷霉素氨丁三醇(2-氨基-2-羟甲基-1，3-丙二醇)(2R-顺式)-(3-甲基环氧乙基)单磷酸盐，是一种具有抗菌作用的独特分子，从磷酸衍生而得。 

适应症：用于敏感菌引起的急性膀胱炎、慢性膀胱炎急性发作、急性尿道膀胱综合征、非特异性尿道炎 ；无症状的菌尿症(孕期) ；手术后的尿路感染 ；预防外科手术中尿路感染及经尿路诊断手法引起的感染。

用法用量：本药应在胃排空后口服，最好在睡前排尿后服用。成人 ：单剂量治疗，每疗程1包(3 g活性成分)。儿童 ：单剂量治疗，每疗程1包(2 g活性成分)，临床症状通常在治疗后2-3天消失。 急性下尿路感染(膀胱炎、非淋球菌尿道炎) ，单剂量(儿童2 g活性成分，成人3 g活性成分)即可痊愈。如治疗后，局部症状仍存在，并不能说明治疗失败，通常是既往炎症引起的。 在较多的疑难病例中(老年人、卧床患者、反复感染者)，或由微生物引起的感染通常对最高的抗菌剂量敏感(假单胞菌、肠杆菌、吲哚阳性变形杆菌)，上述剂量加倍，可间隔24小时服用。预防外科手术及经尿路诊疗所致的尿路感染(假单胞菌、肠杆菌、吲哚阳性变形杆菌)，通常用2倍的剂量，初始剂量在术前3小时口服，第二个剂量在初始剂量后24小时口服。 

不良反应：偶有胃肠道反应(恶心、胃灼热、腹泻)和皮疹发生，无需特别的对应治疗可自行迅速消失。

禁忌：对本品过敏者禁用。 

注意事项：每包加水(50-70 mL)或其它无酒精饮料，溶解后即服。 孕期、哺乳期患者及婴儿慎用。用餐会影响本药的活性化合物的吸收，使血药、尿药浓度稍有降低。因此，本药须餐前1小时或餐后2小时，胃排空后服用。

MONUROL (fosfomycin tromethamine) sachet contains fosfomycin tromethamine, a synthetic, broad-spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange flavor, saccharin, and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1 R ,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is C3 H7 O4 P·C4 H11 NO3 , and its chemical structure is as follows:
Monurol Indications And Usage
MONUROL is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. MONUROL is not indicated for the treatment of pyelonephritis or perinephric abscess.
If persistence or reappearance of bacteriuria occurs after treatment with MONUROL, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES section.)
Monurol Contraindications
MONUROL is contraindicated in patients with known hypersensitivity to the drug.
Monurol Side Effects
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including MONUROL, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
Monurol Precautions
General
Do not use more than one single dose of MONUROL to treat a single episode of acute cystitis. Repeated daily doses of MONUROL did not improve the clinical success or microbiological eradication rates compared to single dose therapy, but did increase the incidenUrine specimens for culture and susceptibility testing should be obtained before and after completion of therapy.
Information For Patients
Patients should be informed:
That MONUROL (fosfomycin tromethamine) can be taken with or without food.
That their symptoms should improve in two to three days after taking MONUROL; if not improved, the patient should contact her health care provider.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Drug Interactions
Metoclopramide: When coadministered with MONUROL, metoclopramide, a drug which increases gastrointestinal motility, lowers the serum concentration and urinary excretion of fosfomycin. Other drugs that increase gastrointestinal motility may produce similar effects.
Cimetidine: Cimetidine does not affect the pharmacokinetics of fosfomycin when coadministered with MONUROL.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long term carcinogenicity studies in rodents have not been conducted because MONUROL is intended for single dose treatment in humans. MONUROL was not mutagenic or genotoxic in the in vitro Ames' bacterial reversion test, in cultured human lymphocytes, in Chinese hamster V79 cells, and the in vivo mouse micronucleus assay. MONUROL did not affect fertility or reproductive performance in male and female rats.
Pregnancy: Teratogenic Effects
Pregnancy Category B
When administered intramuscularly as the sodium salt at a dose of 1 gm to pregnant women, fosfomycin crosses the placental barrier. MONUROL crosses the placental barrier of rats; it does not produce teratogenic effects in pregnant rats at dosages as high as 1000 mg/kg/day (approximately 9 and 1.4 times the human dose based on body weight and mg/m2 , respectively). When administered to pregnant female rabbits at dosages as high as 1000 mg/kg/day (approximately 9 and 2.7 times the human dose based on body weight and mg/m2 , respectively), fetotoxicities were observed. However, these toxicities were seen at maternally toxic doses and were considered to be due to the sensitivity of the rabbit to changes in the intestinal microflora resulting from the antibiotic administration. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
It is not known whether fosfomycin tromethamine is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from MONUROL, a decision should be made whether to discontinue nursing or to not administer the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in children age 12 years and under have not been established in adequate and well-controlled studies.
Geriatric Use: Clinical studies of Monurol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Monurol Overdosage
In acute toxicology studies, oral administration of high doses of MONUROL up to 5 gm/kg were well-tolerated in mice and rats, produced transient and minor incidences of watery stool in rabbits, and produced diarrhea with anorexia in dogs occurring 2-3 days after single dose administration. These doses represent 50-125 times the human therapeutic dose.
The following events have been observed in patients who have taken Monurol in overdose: vestibular loss, impaired hearing, metallic taste, and general decline in taste perception. In the event of overdosage, treatment should be symptomatic and supportive.
Monurol Information For Patients
Patients should be informed:
That MONUROL (fosfomycin tromethamine) can be taken with or without food.
That their symptoms should improve in two to three days after taking MONUROL; if not improved, the patient should contact her health care provider.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

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 详细处方信息以本药内容附件PDF文件（20111620473211.pdf）的“原文Priscribing Information”为准
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2011年1月7日更新