部分中文克林霉素处方资料(仅供参考) 药品名称:特丽仙 药品通用名:盐酸克林霉素 适合肤质:油及混合性微乾配方 不留痕跡 用法:每晚睡前洗脸后以适量涂在暗疮,粉刺部分即可。 特麗仙外用暗瘡水,在治療暗瘡的功效上,可媲美外用抗生素,如四環素及紅霉素。與其他外用藥物如Benzoyl peroxide及其它tretinoin比較,療效相同,但副作用如紅腫、脫皮及痕癢等則明顯減少。特麗仙外用暗瘡水透明無色,塗於皮膚上,絕不影響外觀,令你永遠充滿信心。 ----------------------------------------------------------- 英文名:ClindamycinHydrochlorideCapsules 汉语拼音:YansuanKelinmeisuJiaonang 【主要成分】 本品主要成份为:盐酸克林霉素。 【性状】 本品为胶囊剂。 【药理作用】 本品的抗菌谱与林可霉素相同,抗菌活性较林可霉素强4~8倍。本品对需氧革兰阳性球菌有较高抗菌活性,如葡萄球菌属(包括耐青霉素及甲氧西林敏感株)、溶血性链球菌、草绿链球菌、肺炎链球菌等。对厌氧菌亦有良好的抗菌作用,拟杆菌属、梭形杆菌属、放线菌属、消化球菌、消化链球菌等大多均对本品敏感。本品作用于敏感菌核糖体的50S亚基,阻止肽链的延长,从而抑制细菌细胞的蛋白质合成,一般系抑菌剂,但在高浓度时,对某些细菌也具有杀菌作用。 【药代动力学】 本品口服后不被胃酸破坏,在胃肠道内迅速吸收,空腹口服的生物利用度为90%,进食不影响其吸收。口服克林霉素150mg、300mg及600mg后的血药峰浓度(Cmax)分别约为2.5mg/L、4mg/L及8mg/L,达峰时间为0.75~2小时。本品的蛋白结合率高,为92%~94%。除脑脊液外,本品广泛分布于体液及组织中,在骨组织中亦可达较高浓度,在胆汁及尿液中可达高浓度,也能透过胎盘,进入胎儿循环。本品在肝脏代谢,部分代谢物具抗菌活性。约10%给药量以活性成分由尿排出,3.6%以活性成分由粪便排出。血消除半衰期(T1/2b)成人为2.4~3.0小时,儿童为2.5~3.4小时。肾衰竭及严重肝脏损害者T1/2b略有延长(3~5小时)。多次给药未见药物蓄积现象。血透及腹透不能清除克林霉素。 【适应证】 本品适用于由链球菌属、葡萄球菌属及厌氧菌等敏感菌株所致的下述感染:中耳炎、鼻窦炎、化脓性扁桃体炎、肺炎;皮肤软组织感染;在治疗骨和关节感染、腹腔感染、盆腔感染、脓胸、肺脓肿、骨髓炎、败血症等,可根据情况单用或与其他抗菌药联合应用。 【用法用量】 成人,一次0.15~0.3g,一日4次口服,重症感染可增至一次0.45g,一日4次口服。4周或4周以上小儿,一日按体重8~16mg/kg,分3~4次口服。 【不良反应】 (1)胃肠道反应:包括恶心、呕吐、腹痛、腹泻等症状;严重者有腹绞痛、腹部压痛、严重腹泻(水样或脓血样),伴发热、异常口渴和疲乏(假膜性肠炎)。腹泻、肠炎和假膜性肠炎等可出现于治疗中或停药后。 (2)过敏反应:通常以轻到中度的麻疹样皮疹最为多见,其次为水疱样皮疹和荨麻疹,偶见多形红斑,剥脱性皮炎,部分表现为Stevens-Johnson综合征。 (3)可出现肝功能异常、肾功能异常,偶见中性粒细胞减少和嗜酸性粒细胞增多等。 【禁忌】 对克林霉素和林可霉素有过敏史的患者禁用。 【注意事项】 (1)患者对林可霉素过敏时有可能对克林霉素也过敏。 (2)对诊断的干扰:服药后血清丙氨酸氨基转移酶和门冬氨酸氨基转移酶可有增高。 (3)下列情况应慎用: ①肠道疾病或有既往史者,特别如溃疡性结肠炎、局限性肠炎或抗生素相关肠炎; ②肝功能减退; ③肾功能严重减退。 (4)为防止急性风湿热的发生,用克林霉素治疗溶血性链球菌感染时的疗程,至少为10日。 (5)用药期间须密切注意大便次数,如出现排便次数增多,应注意假膜性肠炎的可能,须及时停药并作适当处理。 (6)处理克林霉素所致的假膜性肠炎,轻症单独停药可望有效,中等至重症患者需纠正水、电解质紊乱。如经上述处理,病情无明显好转时,则应给甲硝唑口服250~500mg,一日3次。如复发时可再用甲硝唑口服,仍无效时可改用万古霉素(或去甲万古霉素)口服,成人一日0.5~2.0g,分3~4次服用。 (7)肾功能减退患者(除重度减退者外),本品用量一般无需减少。患者有严重肾功能和(或)肝功能减退,采用本品时需作血清药物浓度监测。 (8)本品偶可引起对本品不敏感的微生物过度增生,特别是真菌,所以应用时需注意二重感染的发生。 【孕妇及哺乳期妇女用药】 动物实验显示本品对胎儿无影响,但在人类孕妇中应用尚缺乏经验,故在孕妇中仍应慎用。本品可分泌至母乳中,哺乳期妇女确实需要用药则须暂停哺乳。 【儿童用药】 小于1个月的小儿不宜应用。 【老人用药】 本品的临床研究没有足够的老年人资料,故不能确定老年人对此药的反应是否与年轻人有异。对于肝功能、肾功能正常的年轻和年老的志愿者,口服或静脉给予克林霉素,药动学方面未显示出具有临床意义的显著差异。有报道在老年人中腹泻和抗生素相关结肠炎更常见且更严重。因此对有腹泻的老年病人应加以严密的监护。 【药物相互作用】 (1)可增强吸入性麻醉药的神经肌肉阻断现象,导致骨骼肌软弱和呼吸抑制或麻痹(呼吸暂停),在手术中或术后同用时应注意。以抗胆碱酯酶药物或钙盐治疗可望有效。 (2)与抗蠕动止泻药、含白陶土止泻药同用:克林霉素在疗程中,甚至在疗程后数周有引起伴严重水样腹泻的伪膜性肠炎可能。因可使结肠内毒素延迟排出,从而导致腹泻延长和加剧,故抗蠕动止泻药不宜同用。含白陶土止泻药和克林霉素同时口服,后者的吸收将显著减少,故两者不宜同时服用,须间隔一定时间(至少2小时) (3)本品具神经肌肉阻断作用,与抗肌无力药合用时将导致后者对骨骼肌的效果减弱。为控制重症肌无力的症状,在合用的疗程中抗肌无力药的剂量应予调整。 (4)氯霉素或红霉素在靶位上均可置换本品,或阻抑后者与细菌核糖体50S亚基的结合,体外试验显示本品与红霉素具拮抗作用,故本品不宜与氯霉素或红霉素合用。 (5)与阿片类镇痛药合用,本品的呼吸抑制作用与阿片类的中枢呼吸抑制作用可因累加现象而有导致呼吸抑制延长或引起呼吸麻痹(呼吸暂停)的可能,故必须对病人进行密切观察或监护。 (6)本品可增强神经肌肉阻断药的作用,两者应避免合用。 【药物过量】 本品无特异性拮抗药,药物过量时主要是对症疗法和支持疗法。 How does it work? Dalacin C capsules contain the active ingredient clindamycin hydrochloride, which is an antibiotic medicine. Clindamycin treats bacterial infections by killing the bacteria causing the infection. It does this by preventing the bacteria from forming normal cell walls. The cell walls of bacteria protect the bacterial cells and are essential for their survival. When these cell walls are not formed correctly it causes them to disintegrate and the bacteria therefore die. This inhibits the ability of the bacteria to grow and therefore stops the spread of the infection. Clindamycin kills a wide variety of bacteria that are known collectively as anaerobic bacteria. This means that they do not need oxygen to grow and multiply. Anaerobic bacteria can cause infections in areas of the body such as the bones, gut, pelvic cavity and gums. Clindamycin is used to treat these types of infections, as well as leg ulcers and pressure sores that are infected with anaerobic bacteria. Clindamycin also has a similar range of antibacterial activity to the penicillins and is useful as an alternative antibiotic in those people who are allergic to penicillins or for infections caused by bacteria called staphylococci that have become resistant to penicillin. However, it is not a widely used antibiotic because the risk of developing antibiotic-associated colitis (inflammation of the colon) is greater with clindamycin compared to other antibiotics. This usually results in severe diarrhoea and clindamycin should be stoppped immediately if this occurs. Dalacin C capsules are usually used for serious infections after treatment with other antibiotics, such as penicillin or metronidazole has not been effective. What is it used for? Bacterial infections of the skin and soft tissue, such as infected ulcers, mouth abscesses, cellulitis. Bacterial infections of bone (osteomyelitis). Bacterial infections of joints. Bacterial infections of the intestine (enteritis). Preventing infection of the heart (bacterial endocarditis) during medical or dental procedures in people with heart valve defects or artificial heart valves. Warning! Unless your doctor tells you otherwise, it is important that you finish the prescribed course of this antibiotic medicine, even if you feel better or it seems the infection has cleared up. Stopping the course early increases the chance that the infection will come back and that the bacteria will grow resistant to the antibiotic. This medicine can sometimes cause inflammation of the bowel (colitis). For this reason, if you get diarrhoea either during or after taking this medicine, particularly if it becomes severe or persistent, or contains blood or mucus, you should consult your doctor immediately. If you are having long-term treatment with this medicine your doctor may want you to have regular blood tests to monitor your kidney and liver function. Dalacin capsules contain lactose and are not suitable for people with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption. Not to be used in Allergy to the antibiotic lincomycin. People with a history of inflammatory bowel disease such as Crohn's disease or ulcerative colitis. History of inflammation of the large intestine due to antibioitc treatment (antibiotic-associated colitis). This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately. Pregnancy and breastfeeding Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine. The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor. Seek medical advice from your doctor. This medicine passes into breast milk in small amounts. The effect of this on the breastfed baby is unknown, therefore this medicine should be used with caution in breastfeeding mothers. Seek medical advice from your doctor. Label warnings Take at regular intervals. Complete the prescribed course unless otherwise directed. This medication should be taken with plenty of water. Side effects Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect. Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting, indigestion or abdominal pain. Inflammation of the large intestine (colitis). Yellowing of the skin and eyes (jaundice). Inflammation of the vagina (vaginitis). Decrease in the number of white blood cells, red blood cells or platelets in the blood. Skin reactions, such as rash, hives, redness of skin. The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist. How can this medicine affect other medicines? It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start taking this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to ensure that the combination is safe. If you are prescribed this medicine whilst taking oral contraceptives, there is a very low risk that the clindamycin may make your pill less effective at preventing pregnancy. Although the risk of this is very low, it is recommended that you use an extra method of contraception (eg condoms) while you are taking this medicine and for seven days after finishing the course. If these seven days run beyond the end of a pill packet, a new packet should be started without a break. Other medicines containing the same active ingredient Dalacin cream Dalacin T Zindaclin gel Clindamycin capsules are also available without a brand name, ie as the generic medicine. 附件: 201151823461240.pdf
-------------------------------------------------------------- 产地国家: 欧洲共同体国家 原产地英文商品名: DALACIN 2% VAGINAL CREAM 7 APLICAD 40g/tube 原产地英文药品名: CLINDAMYCIN 中文参考商品译名: 特丽仙2%阴道用软膏7 APLICAD 40克/管 中文参考药品译名: 克林霉素 生产厂家中文参考译名: 辉瑞 生产厂家英文名: PFIZER
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