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简介：本品（立思丁) 通过抑制细菌的蛋白质合成而产生杀菌作用。立思丁对一系列革兰氏阳性细菌有强大的抗菌作用。葡萄球菌，包括对青霉素，甲氧西林和其它抗菌素耐药的菌株，均对本品高度敏感。立思丁与临床使用的其它抗菌药物之间无交 耐药性。本品有极好的组织渗透能力，在机体内分布广泛。临床上尤为重要的是，本品不但在血液供应丰富的组织中有高浓度，即使在血管分布较少的组织中也同样具有高浓度。已知在脓液、痰液、软组织、心脏、骨组织、滑液、死骨片、烧伤痂、脑脓肿和眼内，立思丁的浓度均超过其对葡萄球菌的最小抑菌浓度（0.03-0.16微克/毫升）。 产品说明书 立思丁Ò 抗葡萄球菌抗菌素 商品名 立思丁Ò 通用名 夫西地酸 活性成份 片剂 夫西地酸钠 250mg/片 口服混悬液 夫西地酸钠 50mg/毫升 静脉注射剂 夫西地酸钠 500 mg/瓶
药理作用 立思丁通过抑制细菌的蛋白质合成而产生杀菌作用。立思丁对一系列革兰氏阳性细菌有强大的抗菌作用。葡萄球菌，包括对青霉素，甲氧西林和其它抗菌素耐药的菌株，均对本品高度敏感。立思丁与临床使用的其它抗菌药物之间无交 耐药性。本品有极好的组织渗透能力，在机体内分布广泛。临床上尤为重要的是，本品不但在血液供应丰富的组织中有高浓度，即使在血管分布较少的组织中也同样具有高浓度。已知在脓液、痰液、软组织、心脏、骨组织、滑液、死骨片、烧伤痂、脑脓肿和眼内，立思丁的浓度均超过其对葡萄球菌的最小抑菌浓度（0.03-0.16微克/毫升）。 立思丁在肝脏代谢，主要由胆汁排出，几乎不经肾脏排泄。 立思丁毒性极低，与临床使用的其它抗菌药物之间无交叉？过敏性，因此本品可用于治疗对其它抗菌素禁忌的病人，如对青霉素或其它抗菌素过敏者，对因严重或深部感染而需长时间用药时，建议立思丁与其它抗葡萄球菌药物联用以减少耐药性的产生。立思丁可与耐青霉素类、头孢菌素类、红霉素、氨基糖甙类，林可霉素、利福平或万古霉素联合使用并可获得相加或协同作用的效果。 适应症 立思丁主治由各种敏感细菌，尤其是葡萄球菌引起的各种感染，如骨髓炎、败血症、心内膜炎，反复感染的囊性纤维化、肺炎、皮肤及软组织感染，外科及创伤性感染等。 副作用 口服立思丁可能导致胃肠不适（消化不良、恶心、呕吐），但餐后服药可避免。静脉注射立思丁可能会导致血栓性静脉炎和静脉痉挛。每天用药1.5-3克时有可逆性转氯酶增高的报道。曾有报道个别病人用药后出现可逆行黄疸，这主要见于大剂量静脉给药，尤其是严重的金黄色葡萄球菌性菌血症的病人。在这种情况下，改用口服给药较大为有利。若黄疸持续不退，需停用立思丁，则血清胆红素会回复正常。过敏反应的报道十分罕见。 注意事项 由于立思丁的代谢和排泄特性，当长期大剂量用药或立思丁联合其它排出途径相似的药物（如林可霉素或利福平）时，对肝功能不全和胆道异常的病人应定期检查肝功能。 在体外实验中，立思丁可在白蛋白结合位点上取代胆红素。这种取代作用的临床意义尚不清楚，新生儿使用立思丁后亦未发现核黄疸。但早产儿，黄疸，酸中毒及严重病弱的新生儿使用本品时需留意这一因素。 禁忌症 对夫西地酸过敏者不能使用本品。 妊娠及哺乳 动物实验及多年的临床经验表明立思丁完全没有致畸作用。由于立思丁可通过胎盘，理论上又有导致核黄疸的危险，因此妊娠的后三个月应避免使用本品。母乳中的立思丁浓度低至可忽略不计，因此哺乳母亲可使用本品。 用法与用量 片剂： 成人及12岁以上儿童：500毫克（2片），每天3次。 皮肤及软组织感染患者：250毫克（1片），每天2次。严重患者剂量可增加 一倍。 口服混悬液： 成人： 15毫升，每天3次。 婴幼儿： 1毫升（50毫克）/公斤体重/天，分3至4次口服。 1- 5岁儿童：5毫升，每天3次。 5-12岁儿童：10毫升，每天3次
静脉注射剂： 静脉注射剂适用于不宜口服给药或胃肠道吸收不良的病人。 成人： 500毫克（1瓶），每天3次。 儿童及婴儿： 20毫克/公斤体重/天，分3次给药。
取立思丁注射剂1瓶（500毫克）溶于10毫升所附的缓冲液中，然后用生理盐水或5%葡萄糖溶液稀释到250-500毫升静脉输注。若葡萄糖液酸度过高，溶液会呈乳状，出现此种情况即不能使用。每瓶的输注时间不应少于2-4小时。本品应输入血流良好，直径较大的静脉，或中心静脉插管输入，以减少发生静脉痉挛及血栓性静脉炎的危险。成人每日总量不得超过2克。静脉输注液配好后应在24小时之内用完。 未经稀释的立思丁溶液不得直接静脉注射。为避免局部组织损伤，本品亦不得肌肉注射或皮下注射。 根据立思丁代谢和排泄特点，肾功能不全及血液透析病人使用本品无需调整剂量，而本品的透析清除量也不高。 配伍禁忌 立思丁静脉注射剂不能与卡那霉素、庆大霉素、万古霉素、头孢噻啶或羟苄青霉素混合。本品亦不可与全血、氨基酸溶液或含钙溶液混合。当溶液的pH低于7.4时，本品会沉淀。 药物相互作用 偶有报道立思丁可增加香豆素类药物的抗凝血作用。 贮存 室温保存（15℃-25℃）
丹麦利奥制药有限公司 出品
FucidinÒ Antistaphylococcal Antibiotic Brand name: Fucidin INN name: Fusidic acid Active ingredients and strength: Tablets: Sodium fusidate 250mg Oral suspension: Fusidic acid 50mg/ml Intravenous infusion: Sodium fusidate 500mg/vial Therapeutic properties: Properties: Fucidin is an antibiotic which mode of action is as inhibitor of the bacterial protein synthesis resulting in a bactericidal effect. Fucidin has a powerful antibacterial activity against a number of gram-positive microorganisms. Staphylococci, including the strains resistant to penicillin, methicillin or other antibiotics, are particularly susceptible to Fucidin. Fucidin shows no cross-resistance to any other antibiotic agent used in clinical practice. Fucidin has an unusually good ability to penetrate tissue and is widely distributed in the organism. It is of great clinical importance that Fucidin provides high concentrations not only in areas well supplied with blood, but also in relatively avascular tissue. Concentrations exceeding the M.I.C. for Staphylococcus aureus (0.03-0.16 mcg/ml) have been found in pus, sputum, soft tissue, heart tissue, bone tissue, synovial fluid, sequestra, brun crusts, brain abscesses, and intraocularly. Fucidin is metabolized in the liver and mainly excreted through the bile, little or none being excreted throgh the bile, little or none being excreted through the urine. Fucidin is generally atoxic and shows no cross-hypersensitivity to other antibiotics in clinical use which is why Fucidin also can be used in many cases where other antibiotics are contraindicated, e.g. in patients allergic to penicillin or other antibiotics. In severe or deep-seated infections and when prolonged therapy is required, systemic Fucidin should generally be given concurrently with other antistaphylococcal antibiotic therapy to minimize the risk of resistance development. Fucidin may be combined with penicillinase-stable penicillins, cephalosporins, erythromycin, aminoglycosides, lincomycin, rifampicin or vancomycin, and thus an additive or synergistic effect is obtained. Indications: Fucidin is indicated for the treatment of infections caused by susceptible organisms, especially staphylococci, e.g. osteomyelitis, septicaemia, endocarditis, superinfected cystic fibrosis, pneumonia, skin and soft tissue infections, surgical and traumatic wound infection.
Adverse effects: Fucidin given orally may cause gastrointestinal disturbances (dyspepsia, nausea, vomiting) which can normally be avoided by giving Fucidin with meals. Thrombophlebitis and venospasm may be seen when using Fucidin for intravenous infusion. Reversible increase of transaminases is reported at daily dosages of 1.5-3g of Fucidin. Reversible jaundice has been reported in some patients after administration of Fucidin, most frequently in patients receiving intravenous Fucidin in high dosage and especially in serous Staph. Aureus bacteremia. In some cases, instituting oral therapy may be beneficial. If the jaundice persistes, Fucidin should be withdrawn, after which the serum bilirubin will return to normal. Allergic reactions are reported in very few cases. Precautions: Due to the metabolism and excretion of Fucidin, periodic liver function tests should be carried out in patients with liver dysfunction, abnormalities in the biliary pathway, when Fucidin is given in high doses for prolonged periods, or when it is given in combination with other antibiotics which have similar excretion pathways, e.g. lincomycin and rifampicin . In vitro, Fucidin displaces bilirubin from its albumin binding site. The clincial significance of this finding is uncertain and kernicterus has not been observed in neonates receiving Fucidin. However, this observation should be borne in mind when the drug is given to preterm, jaundiced, acidotic or seriously ill neonates. Contraindications: Hypersensitivity to fucidic acid. Pregnancy and lactation: Animal studies and many years of clinical experience suggest that Fucidin is devoid of teratogenic effects. Fucidin passes the placenta and should be avoided during third trimester due to the theoretical risk of kernicterus. Concentrations of Fucidin found in breast milk are negligible and its use is not contraindicated in nursing mothers. Dosage: Tabletes: Adults and children over 12 years: 500mg (2 tablets) threee times daily. Recommended dosage in skin and soft tissue infections: 250 mg sodium fusidate (1 tablet) twice daily. Dosage may be doubled in severe cases. Suspension: Adults: 15ml of suspension 3 times daily. Children and infants: 1ml of suspension (50mg) per kg body weigh daily in 3-4 equal doses. 1-5 years: 5ml 3 times daily 5-12 years: 10ml 3 times daily Intravenous infusion : Fucidin may be given as intravenous infusion whenever oral therapy is inappropriate, including cases where absorption from the gastrointesinal tract is unpredicatble.
Adults: 500 mg (1 vial) 3 times daily Children and infants: 20 mg/kg/day divided into 3 equal doses. Dissolve I vial of Sodium fusidate (500 mg) in the 10ml of buffer solution provided. Dilute to 250-500ml with Sodium Chloride injection or 5% Dextrose injection BP. Opalescence may be encountered with more acidic samples of dextrose, and the solution should then be discarded. The infusion period should not be less than 2-4 hours. Fucidin infusion should be made into a wide-bore vein with good blood flow or through a central venous catheter to minimize the risk of venospasms and thrombophlebitis. For adults a total daily dose of 2 g should not be exceeded. The infusion solution should be used within 24hours.
The soulution of Fucidin in the buffer must never be injected undiluted. Due to local tissue injurey Fucidin must not be given intramuscularly or subcutaneously. Accouding to the metabolism and excretion of Fucidin, no dosage adujustment is needed in renal impairment or in patients undergoing hemodialysis as Fucidin is not signiificantly dialysed. Incompatibilites: Infusion solutions containing Fucidin are incompatible with kanamycin, gentamicin, vancomycin, cephaloridine, carbenicillin, whole blood, amino-acid solutions and calcium-containing solutions. Precipitation of fucidic acid may occur in infusion solutions with pH values below 7.4. Drug interaction: Fucidin has in few cases been reported to potentiate the anticoagulant efficacy of coumarin derivatives.
Storage condition: Store at controlled room temperature (15℃-25℃).
LEO PHARMACEUTICAL PRODUCTS BALLERUP-DENMARK Contents: 1vial of 500mg Sodium fusidate B.P. 1 vial of 10ml Sterile buffer solution
Direction for use: See enclosed leaflet. Store at controlled room Temperature(15℃-25℃). Protect from heat and direct sunlight.
LEO PHARMACEUTICAL PRODUCTS BALLERUP-DENMARK
FucidinÒ Only for intravenous infusion.
The concentrated Fucidin buffer solution should be diluted further before use.
取立思丁注射1瓶（500毫克）溶于10毫升所附的缓冲液中，然后用生理盐水或5%葡萄糖溶液稀释到250-500毫升静脉输注。 每瓶的输注时间不应少于2-4小时。 静脉输注液配好后应在24小时之内用完。 为避免局部组织损伤，本品亦不得肌肉注射或皮下注射。
主要成份： 夫西地酸钠500毫克/瓶 缓冲液10毫升/瓶
缓冲液必须经稀释后方可使用
用法详见说明书
室温避光保存（15℃-25℃）
立思丁Ò 静脉注射液 夫西地酸钠
进口注册证号：X19990382 丹麦利奥制药有限公司出品 广东康力医药有限公司总经销
LEO PHARMACEUTICAL PRODUCTS BALLERUP-DENMARK
立思丁Ò 夫西地酸钠B.P. 500毫克
静脉注射剂 必须将缓冲液稀释方可使用。
请在医生指导下使用 室温避光保存（15℃-25℃） Fucicin vial label
Sterile Buffer Solution (only for use in the hloonstitution of Fucidin for intravenous infasion) Each ml contains: Disodium edetate Ph. Eur 0.5mg Disodium hydrogen phosphate Fh. Eur 19.6mg Citric acid Ph. Eur 1.0mg Water for injection Ph. Eur to 1.0ml Store at controlled room temperature (15℃-25℃).
消菌缓冲液 （只用于溶配立思丁进行静脉输注） 每毫升含： 二钠依地酸盐Ph.Eur 0.5毫克 二钠依地酸盐Ph.Eur 19.6毫克 柠檬酸 1.0毫克 用以注射之水份Ph.Eur 1.0毫克 室温避光保存（15℃-25℃）
Buffer shlution label
LφVENS KEMISKE PRODUCTS LEO PHARMACEUTICAL PRODUCTS BALLERUP-DENMARK LEO LABORATORIES LIMITED PRINCESRISBOROUGH, BUCKS, UK AND DUBLIN 12 IRELAND
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