药品信息:
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--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(20098320354126.pdf)的“原文Priscribing Information”为准 ---------------------------------------------------------------
部分中文硝酸布康唑处方资料(仅供参考)
本品为具有抗真菌活性的咪唑衍生物,其商品名为GYNAZOLE-1®,制剂为2%硝酸布康唑乳膏,主要用于治疗阴道炎。
英文名:butoconazole nitrate化学名:(±)-1-[4-(对-氯苯基)-2[-2,6-二氯苯基)硫基] ]丁基]咪唑]硝酸盐,CAS RN:64872-77-1
理化性状:本品为白色至类白色结晶性粉末,微溶于甲醇,微溶于氯仿,二氯甲烷,丙酮,乙醇,极微溶于乙酸乙酯,几乎不溶于水。熔点约159°(分解)。
适应症:2%硝酸布康唑乳膏主要用于由念珠菌感染的外阴阴道念珠菌病。该病的诊断应作KOH 涂片镜检法确诊。该药对非妊娠妇女是安全有效的,但对妊娠妇女的安全和有效性尚未被确定。
剂量与给药:每支5g,(含硝酸布康唑100ng)阴道内给药。
副作用:在一下临床试验中,314名使用该药的患者中,18例患者(5.7%)主诉外阴阴道有灼感,搔痒,疼痛和肿胀,骨盆或腹部疼痛或痉挛,或有2个或多个该类症状。3例患者(1%)的这些主诉被认为是与治疗有关。18例患者中有5人报告有不良反应,为此而中止该项研究。
注意事项:1.该乳膏剂含有矿物油,可对乳胶或橡胶产品如避孕套或阴道避孕隔膜产生影响,因此,在用该乳膏剂治疗的72小时内,不要使用上述避孕产品。2.如果临床症状不改变的话,应重作检查,排除其它病原体,以确定原来的诊断。排除其它可造成患者阴道真菌感染的病因。3.儿童使用的安全性和有效性尚未被确定。
禁忌症:禁用于对硝酸布康唑乳膏中任一成分有过敏反应的患者。
Indications and Usage Gynazole·1® (butoconazole nitrate) vaginal cream, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections cause by Candida). The diagnosis should be confirmed by KOH smears and/or cultures. Gynazole·1 is safe and effective in nonpregnant women; however, the safety and effectiveness of this product in pregnant women has not been established. (For further information, please see our product insert sheet, PRECAUTIONS: Pregnancy.) Gynazole·1 may weaken latex or rubber products such as condoms and contraceptive diaphragms. Usage within 72 hours of treatment is not recommended. If clinical symptoms persist after treatment, tests should be repeated to rule out other pathogens, to confirm the original diagnosis, and to rule out other conditions that may predispose a patient to recurrent vaginal yeast infections. Recurrent vaginal yeast infections, especially those that are difficult to eradicate, can be an early sign of infection with the human immunodeficiency virus (HIV) in women who are considered at risk for HIV infection.
2011-3-22更新 |