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 详细处方信息以本药内容附件PDF文件（201152220223028.pdf）的“原文Priscribing Information”为准
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部分中文瑞他莫林处方资料（仅供参考）

英文药名: Altabax (Retapamulin Ointment)

中文药名: 瑞他莫林软膏

品牌药生产厂家: Glaxo Smith Kline

药品简介
FDA于2007年4月17日批准史克公司申报的商品名为Altabax的1%瑞他莫林(retapamulin)油膏在美国上市.欧盟在2007年6月1日批准其在欧洲上市,其商品名为(Altargo). 其适应症为9个月以上儿童因金黄色葡萄球菌和化脓性链球菌引起的疱疹病.
葛兰素史克公司的1％瑞他帕林软膏(商品名：Altabax)，用于局部治疗金黄色葡萄球菌或化脓链球菌感染的脓胞病。
瑞他帕林是称为截短侧耳素(pleuromutilins)的新一类抗菌药，与细菌核糖体50S亚基部位结合，通过截短侧耳素类药物独特地与细菌核糖体相互作用来抑制蛋白质合成。体外研究显示，Altabax的活性成分对其它类型抗菌药无交叉耐药性。本品最常见的不良反应是用药部位刺激。
瑞他帕林软膏代表了近20年来美国FDA批准的新一类抗菌药局部处方制剂。Altabax适用于9个月及其以上患者一日2次用药5日的治疗。以往使用的其它局部处方抗菌制剂需一日3次用药长达12日。
美国FDA批准本品是基于瑞他帕林软膏一日2次用药5日与安慰剂软膏对照治疗脓胞病Ⅲ期临床研究的安全性和有效性以及附加的其它临床研究安全性数据。在对210例成人和儿童脓胞病患者进行的多中心随机双盲安慰剂对照研究中，139例局部使用瑞他帕林软膏。经5日治疗后，确定治疗脓胞病的效果是不需再进行抗菌治疗，瑞他帕林软膏组(85.6%)大于安慰剂组(52.1%)。微生物学有效率也是瑞他帕林软膏组(91.2%)大于安慰剂组(50.9%)。患者通常对Altabax耐受性好。

Drug Name: Altabax (retapamulin)
Company: GlaxoSmithKline
Approval Status: Approved April 2007
Treatment Area: impetigo due to Staphylococcus aureus or Streptococcus pyogenes

General Information
Altabax is a bacterial protein synthesis inhibitor belonging to a class of compounds called pleuromutilins. These compounds act by inhibiting the initiation of protein synthesis at the level of bacterial 50S ribosome.

Altabax is specifically indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes.

Altabax is supplied as a gel in 5, 10, and 15 gram tubes for topical administration. The recommended initial dose of the drug is a thin layer over the infected area up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) twice daily for 5 days.

Clinical Results
FDA Approval
FDA approval of Altabax was based on the results of a double-blind, randomized, multi-center, parallel group, comparison trial. This study enrolled 210 adult and pediatric subjects, aged 9 months of age and older, with impetigo up to 100 cm2 in total area (up to 10 lesions) or a total body surface area not exceeding 2%. Subjects were randomized 2:1 to receive Altabax or placebo for five days. Success was defined as the absence of treated lesions, or treated lesions had become dry without crusts with or without erythema compared to baseline, or had improved (defined as a decline in the size of the affected area, number of lesions or both) such that no further antimicrobial therapy was required. The intent-to-treat clinical (ITTC) population consisted of all randomized subjects who took at least 1 dose of Altabax. The clinical per protocol (PPC) population included all ITTC patients who satisfied the inclusion/exclusion criteria and subsequently adhered to the protocol. The intent-to-treat bacteriological (ITTB) population consisted of all randomized patients who took at least one dose of study medication and had a pathogen identified at study entry. The bacteriological per protocol (PPB) population included all ITTB patients who satisfied the inclusion/exclusion criteria and subsequently adhered to the protocol. At the end of therapy, two days after treatment , the success rates in the Altabax group were as follows: PPC (89.5%), ITTC (85.6%), PPB (89.7%), ITTB (88.6%) versus 53.2%, 52.1%, 50.0% and 49.1%, respectively, for placebo. At the treatment follow-up (9 days after therapy) success rates were as follows: PPC (82.4%), ITTC (75.5%), PPB (84.3%) and ITTB (79.8%) versus 43.1%, 39.4%, 37.5% and 33.3%, respectively, for placebo. At the end of therapy, the success rates for the subjects infected with Staphylococcus aureus was 89.8% versus 52.1% for placebo. The success rates for the subjects infected with Streptococcus pyogenes was 90.6% versus 42.9% with placebo. At the 9 day follow-up the success rates for the subjects infected with Staphylococcus aureus was 84.5% versus 43.2% for placebo. The success rates for the subjects infected with Streptococcus pyogenes was 90.6% versus 33.3% for placebo.

Ongoing Study Commitments
GlaxoSmithKline has agreed to a deferred pediatric study under PREA for the treatment of impetigo in pediatric patients ages 2 months to 9 months.
Final Report Submission: December 31, 2007

Side Effects
Adverse events associated with the use of Altabax in adults may include, but are not limited to, the following:
Headache
Application Site Reaction
Diarrhea
Nausea
Nasopharyngitis.

Adverse events associated with the use of Altabax in pediatrics may include, but are not limited to, the following:
Application site pruritus
Diarrhea
Nasopharyngitis
Pruritus
Eczema
Headache
Pyrexia

Mechanism of Action
Altabax is a bacterial protein synthesis inhibitor belonging to a class of compounds called pleuromutilins. These compounds act by inhibiting the initiation of protein synthesis at the level of bacterial 50S ribosome. This binding site involves ribosomal protein L3 and is in the region of the ribosomal P site and peptidyl transferase center. By virtue of binding to this site, pleuromutilins inhibit peptidyl transfer, block P-site interactions, and prevent the normal formation of active 50S ribosomal subunits.

Additional Information
For additional information regarding Altabax or impetigo, please visit the Altabax web page.

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 详细处方信息以本药内容附件PDF文件（201152220223028.pdf）的“原文Priscribing Information”为准
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