英文药名: Prezista(Darunavir Tablets)
中文药名: 地瑞那韦片
生产厂家: Janssen-Ortho
药品简介
地瑞那韦(darunavir ethanolate), 商品名为Prezista, 是由强生公司冰岛分公司Tibotec研发的一种非肽类HIV蛋白酶抑制剂, 2006年6月23日美国FDA批准其上市, 2007年3月在欧盟的27个成员国上市。Prezista为口服片剂, 适用于感染了艾滋病病毒但服用现有抗逆转录病毒药物未见疗效的成年人。该药必须与低剂量的利托那韦或其他抗艾滋病药物结合使用, 以提高药效。
Generic Name for PREZISTA
Darunavir (as ethanolate) 75mg, 300mg, 400mg, 600mg; tabs.
Legal Classification:
Rx
Pharmacological class for PREZISTA
Protease inhibitor.
Manufacturer of PREZISTA
Tibotec, Inc.
Indications for PREZISTA
Treatment of HIV infection in combination with ritonavir and with other antiretroviral agents.
Adult dose for PREZISTA
Take with food. ≥18yrs: Treatment-naive: 800mg once daily with ritonavir 100mg once daily. Treatment-experienced: 600mg twice daily with ritonavir 100mg twice daily. Severe hepatic impairment: not recommended.
Children's dosing for PREZISTA
<6yrs: not recommended. Take with food. Treatment-experienced: ≥6yrs to <18yrs: ≥20kg–<30kg: 375mg twice daily with ritonavir 50mg twice daily; ≥30kg–<40kg: 450mg twice daily with ritonavir 60mg twice daily; ≥40kg: 600mg twice daily with ritonavir 100mg twice daily. Severe hepatic impairment: not recommended.
Contraindications for PREZISTA
Concomitant rifampin, ergots, cisapride, St. John's wort, lovastatin, simvastatin, pimozide, oral midazolam, triazolam.
Precautions for PREZISTA
Children <3yrs old: do not use. Sulfonamide allergy. Hepatic impairment (eg, chronic hepatitis, cirrhosis): monitor liver enzymes; interrupt or discontinue therapy if liver dysfunction occurs or worsens. Severe renal impairment. Diabetes. Hemophilia: monitor for spontaneous bleeding. Fat redistribution. Immune reconstitution syndrome. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions for PREZISTA
See Contraindications. Voriconazole: not recommended. Avoid protease inhibitors other than those studied (lopinavir/ritonavir, saquinavir, indinavir, atazanavir), dexamethasone, fluticasone. Potentiates carbamazepine, risperidone, thioridazine, trazodone, desipramine, IV midazolam, rifabutin, digoxin, atorvastatin, pravastatin, rosuvastatin, sildenafil, vardenafil, tadalafil (reduce their doses). Potentiates, and is potentiated by, indinavir, ketoconazole, itraconazole. Increases efavirenz levels. Antagonizes sertraline, paroxetine (monitor levels), ethinyl estradiol, norethindrone (use backup contraception). Antagonizes and antagonized by other CYP3A4 substrates (eg, carbamazepine, phenobarbital, phenytoin). Antagonized by efavirenz. Monitor antiarrhythmics (eg, bepridil, systemic lidocaine, quinidine, amiodarone, flecainide, propafenone), calcium channel blockers, β-blockers, warfarin, digoxin, immunosuppressants (eg, tacrolimus, sirolimus, cyclosporine), methadone (possible opiate withdrawal syndrome). Reduce concomitant clarithromycin dose in renal impairment. Separate dosing of didanosine. Others.
Adverse Reactions for PREZISTA
GI upset, abdominal pain, headache; rash (discontinue if severe), drug-induced hepatitis, hyperglycemia, others.
How is PREZISTA supplied?
Tabs 75mg—480
300mg—120
400mg, 600mg—60
通用名称PREZISTA
Darunavir(如ethanolate)75毫克,300毫克,400毫克,600毫克;标签。
法律分类:
接收
类药物的PREZISTA
蛋白酶抑制剂。
制造商PREZISTA
Tibotec公司,公司
适应症PREZISTA
治疗艾滋病毒与利托那韦与其他抗逆转录病毒药物组合的感染。
成人剂量PREZISTA
随身携带的食物。 ≥18yrs:治疗初治:800毫克和100毫克,每天一次利托每日一次。治疗经验:两次600毫克,每日两次利托100毫克。严重肝功能不全:不推荐。
儿童剂量为PREZISTA
<6yrs:不推荐。随身携带的食物。治疗经验:≥6yrs到<18yrs:≥二零千克- <三十零公斤:375mg每日两次与利托那韦50毫克,每天两次;≥三〇公斤- <四十零公斤:450mg每日两次与利托那韦60毫克,每天两次;≥四十○千克:600毫克和100毫克,每天两次两次利托每天。严重肝功能不全:不推荐。
禁忌的PREZISTA
伴随利福平,ergots,西沙必利,圣约翰草,洛伐他汀,辛伐他汀,匹莫齐特,口服咪达唑仑,三唑仑。
注意事项PREZISTA
儿童<3岁的时候:不要使用。磺胺类药物过敏。肝功能不全(如慢性肝炎,肝硬化):监测肝酶;中断或终止治疗,如果肝功能障碍的发生或恶化。严重肾功能损害。糖尿病。血友病:监测自发性出血。脂肪的再分配。免疫重建综合征。老人。妊娠(Cat.C)。哺乳母亲:不推荐。
互作PREZISTA
见禁忌。伏立康唑:不推荐。避免比蛋白酶抑制剂研究(洛匹那韦/利托那韦,沙奎那韦,茚地那韦,atazanavir)的人,地塞米松,氟替卡松等。 Potentiates卡马西平,利培酮,甲硫达嗪,唑酮,地昔帕明,四咪唑,利福布丁,地高辛,阿托伐他汀,普伐他汀,瑞舒伐他汀,西地那非,伐地那非,他达拉非(减少剂量)。 Potentiates,是potentiated的,印地那韦,酮康唑,伊曲康唑。提高依法韦仑的水平。拮抗舍曲林,帕罗西汀(显示器水平),炔雌醇,炔诺酮(使用备份避孕)。拮抗和其他CYP3A4的底物(如卡马西平,苯巴比妥,苯妥英)拮抗。拮抗依非韦伦。监视器抗心律失常药(如苄普地尔,全身利多卡因,奎尼丁,胺碘酮,氟卡尼,普罗帕酮),钙通道阻滞剂,β-阻断剂,华法林,地高辛,免疫抑制剂(如他克莫司,西罗莫司,环孢素),美沙酮(可能阿片类戒断综合征)。伴随肾功能损害减少克拉霉素的剂量。单独加药去羟肌苷。其他。
不良反应为PREZISTA
胃肠不适,腹部疼痛,头痛,皮疹(如停止严重),药物性肝炎,高血糖,等等。
如何PREZISTA提供?