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Priftin(rifapentine,利福喷丁)片剂
2015-01-12 23:50:09 来源: 作者: 【 】 浏览:333次 评论:0

Generic Name and Formulations:
Rifapentine 150mg; tabs.

Company:
Sanofi Aventis
Indications for PRIFTIN:
Susceptible pulmonary tuberculosis.

Adult:
Take with food. Initial Phase: 600mg twice weekly for 2 months, with an interval of no less than 3 consecutive days (72hrs) between doses, in combination with other antituberculosis drugs (eg, ethambutol, pyrazinamide, streptomycin). Continuation Phase: Following Initial Phase, 600mg once weekly for 4 months in combination with isoniazid or an appropriate antituberculosis agent.

Children:
Not recommended.

Pharmacological Class:
Rifamycin.

Warnings/Precautions:
Not for use as monotherapy. HIV seropositive patients: Initial Phase treatment regimen has not been studied, also do not use once weekly Continuation Phase regimen in combination with isoniazid; higher rate of failure and/or relapse with presence of rifampin-resistant organisms. Porphyria: not recommended. Cavitary pulmonary lesions and/or positive sputum cultures after initial phase of treatment, bilateral pulmonary disease, poor compliance, HIV positive patients: higher rates of relapse. Hepatic impairment: monitor liver tests prior to and every 2–4 weeks during therapy; discontinue if liver disease occurs or worsens. May discolor body tissue/fluids, contacts and dentures may become permanently stained. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:
May antagonize protease inhibitors, reverse transcriptase inhibitors (significant decrease in plasma concentrations and loss of therapeutic effect), antiarrhythmics (disopyramide, mexiletine, quinidine, tocainide), antibiotics (chloramphenicol, clarithromycin, dapsone, doxycycline, fluoroquinolones), oral anticoagulants (eg, warfarin), anticonvulsants (eg, phenytoin), antimalarials (eg, quinine), azole antifungals (eg, fluconazole, itraconazole, ketoconazole), antipsychotics (eg, haloperidol), barbiturates (eg, phenobarbital), benzodiazepines (eg, diazepam), β-blockers (eg, propranolol), calcium channel blockers (eg, diltiazem, nifedipine, verapamil), cardiac glycoside preparations (eg, digoxin), corticosteroids (eg, prednisone), fibrates (eg, clofibrate), oral hypoglycemics (eg, sulfonylureas), hormonal contraceptives (eg, ethinyl estradiol, levonorgestrel), immunosuppressants (eg, cyclosporine, tacrolimus), theophylline, methadone, PDE-5 inhibitors (eg, sildenafil), levothyroxine, tricyclic antidepressants (eg, amitriptyline, nortriptyline). May inhibit standard assays for serum folate and Vit. B12; use alternative method.

Adverse Reactions:
Hyperuricemia, pyuria, hematuria, UTI, proteinuria, lymphopenia, neutropenia, anemia, hypoglycemia; hepatotoxicity, hyperbilirubinemia, C. difficile-associated diarrhea.

How Supplied:
Tabs—32
FDA批准赛诺菲结核病药物Priftin联合异烟肼用于潜伏性结核感染治疗
赛诺菲(Sanofi)近日宣布,经过优先审查之后,FDA已批准Priftin(rifapentine,利福喷丁)片剂联合异烟肼(isoniazid,INH)用于2岁及以上伴有发展为结核病(TB)高风险的潜伏性结核感染(latent tuberculosis infection,LTBI)的治疗。Priftin于1998年在美国上市,该药是一种抗分支杆菌药物,联合一种或多种抗结核药物用于活动性肺结核的治疗。
赛诺菲是极少数继续投资于结核病(TB)管理的药企之一。自1950年,该公司一直致力于研究和开发治疗、诊断和预防结核病(TB)的方法。
Priftin LTBI新适应症的获批,部分基于由美国疾病预防与控制中心(CDC)与结核病试验联盟(TBTC)联合开展的关键III期PREVENT TB研究的数据。该研究将12周每周一次Priftin+INH(3RPT/INH)方案作为直接观察疗法,与9个月自我管理每日一次INH(9INH)方案进行了比较。数据表明,3RPT/INH组(n=3074)有5例发展为结核病(TB),9INH组(n=3074)有10例发展为结核病(TB)。此外,3RPT/INH治疗组有81.2%的患者完成治疗,9INH组仅68.3%完成治疗。相关研究结果已于2011年发表于《新英格兰医学杂志》。
根据试验结果,CDC更新了潜伏性结核感染(LTBI)的治疗指南,推荐12周每周一次Priftin-INH方案作为9个月每日一次INH方案的等效替代方案。此外,在2014年10月,有关潜伏性结核感染(LTBI)管理的WHO指南,也已推荐将12周Priftin-INH方案作为一种治疗选择。
根据世界卫生组织(WHO),结核病(TB)是仅次于艾滋病(HIV/AIDS)由单一感染源导致的全球第二大杀手。在2013年,全球结核病患者总数达到900万例,死亡病例150万。目前,Priftin仅在美国上市,赛诺菲正积极努力使Priftin尽快在世界其他国家批 

 

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