英文药名: Kaletra(Lopinavir/Ritonavir Oral Solution)
中文药名: 洛匹那韦利托那韦口服液
品牌药生产厂家: Abbott
药品简介
KALETRA(洛匹那韦和利托那韦)口服使用方案
最初美国批准:2000 最近的重大变化 剂量和给药方法,小儿患者, 警告和注意事项,在早产儿的毒性, 警告和注意事项,免疫重建综合症, 适应症 KALETRA是HIV-1蛋白酶抑制剂与其他抗逆转录病毒药物治疗的HIV-1感染组合表示
剂量和用法 不要使用每日一次Kaletra的管理:
HIV-1感染的病人,三个或多个以下的洛匹那韦耐药相关替换:L10F/I/R/V,K20M/N/R,L24I,L33F,M36I,I47V,G48V,I54L/T/V,V82A / C / F / S / T的,I84V 依非韦伦,奈韦拉平,安普那韦,奈非那韦,卡马西平,苯巴比妥或苯妥英钠组合 小儿患者 片:可采取或没有食物,整颗吞服,不能咀嚼,破碎,粉碎
口服液:必须采取与食品
成年患者
400/100毫克(两个200/50毫克锭剂或5毫升口服液),每日两次或800/200毫克(四200/50毫克片剂或口服液10毫升),每日一次,在不到三年的洛匹那韦耐药相关换人患者。 儿童患者(年龄14天及以上) 每天两次的剂量是根据体重或体表面积。 伴随治疗的成人和儿童患者 Kaletra的剂量可能需要调整时,依非韦伦,奈韦拉平,安普那韦,奈非那韦或共同管理。 KALETRA口服溶液不应给予前42周1月经后的年龄(第一天母亲的最后月经期间出生,加上出生后经过的时间)1至少14天,产后的年龄已经实现新生儿 剂型和优势 薄膜衣片:200毫克洛匹那韦和利托那韦50毫克 薄膜衣片:100毫克洛匹那韦和利托那韦25毫克 口服液:80毫克洛匹那韦和每毫升20毫克利托那韦 禁忌 过敏KALETRA(例如,中毒性表皮坏死松解症,多形性红斑,Stevens-Johnson综合征),或任何其成分,包括利托那韦
共同管理:
药物的高度依赖CYP3A的间隙和血浆水平升高,可能会导致严重的和/或危及生命的事件
强有力的CYP3A的病毒学应答和可能遇到的阻力损失和潜在的交叉耐药性相关的诱导可显着降低洛匹那韦血浆浓度 注意事项: 已发现患者在接受Kaletra以下:
药物相互作用:伴随药物的血浆浓度较高,可能会发生;考虑药物相互作用的潜在严重或危及生命的不良反应,以减少风险 早产儿KALETRA口服液的毒性:不应在早产儿在出生后立即期间使用,因为可能的毒性。尚未建立一个安全和有效剂量的Kaletra的口服液在这个病患族群 胰腺炎:死亡事故时有发生;临床适当的暂停治疗 肝毒性:死亡事故时有发生。前和治疗期间监测肝功能,尤其是在与潜在的肝脏疾病的病人,包括乙型肝炎和丙型肝炎,或明显转氨酶升高 PR间期延长,可能会出现在某些患者。第二和第三度心脏传导阻滞的病例报道。使用预先存在的传导系统疾病,缺血性心脏疾病,心肌病的患者慎用,相关结构性心脏疾病或与其他药物有可能延长管理公关间隔
QT间期延长和尖端扭转de pointes的孤立案件已报告虽然无法建立因果关系。先天性长QT综合征,患者避免使用那些与低血钾,并与其他药物,延长QT间隔
综合征,再分配/体内积聚的脂肪 总胆固醇和甘油三酯的海拔。监测治疗前,并在此后定期
血友病:可能发生自发性出血,和额外的第八因子可能需要 不良反应 最常见的不良反应(> 5%),腹泻,恶心,腹痛,乏力,呕吐,头痛,消化不良
药物相互作用 Kaletra的合作管理,可以改变其他药物和其他药物的血药浓度可能会改变洛匹那韦的血浆浓度。必须考虑潜在的药物相互作用之前和治疗期间 在特殊人群中使用 怀孕:医生鼓励致电1-800-258-4263的患者在抗逆转录病毒的妊娠登记处登记
儿童使用的安全性,有效性和Kaletra的在14天岁以下的儿童患者的药代动力学尚未确定
更新日期:02/2012
规格:80/20mg/ml 300ml
KALETRA ORAL SOLUTION
Generic Name for KALETRA ORAL SOLUTION Lopinavir 80mg, ritonavir 20mg; per mL; cotton candy flavor; alcohol 42.4%.
Legal Classification: Rx
Pharmacological Class for KALETRA ORAL SOLUTION Protease inhibitor.
Manufacturer of KALETRA ORAL SOLUTION Abbott Laboratories
Indications for KALETRA ORAL SOLUTION HIV infection.
Adult dose for KALETRA ORAL SOLUTION Swallow tabs whole; take oral soln with food. Converting from caps to tabs or oral soln: Treatment-naive: Lopinavir/ritonavir 400mg/100mg (2 tabs or 5mL) twice daily or lopinavir/ritonavir 800mg/200mg (4 tabs or 10mL) once daily. Treatment-experienced: Lopinavir/ritonavir 400mg/100mg (2 tabs or 5mL) twice daily. Concomitant efavirenz, nevirapine, fosamprenavir (without ritonavir) or nelfinavir in treatment-experienced patients when reduced susceptibility to lopinavir is suspected: 600mg/150mg (3 tabs) twice daily. Concomitant efavirenz, nevirapine, amprenavir or nelfinavir: 533mg/133mg (6.5mL) twice daily.
Children's dosing for KALETRA ORAL SOLUTION May use tabs if able to swallow whole and ≥15kg. Take twice daily with food. <6months: not recommended. ≥6months: 7 to <15kg: lopinavir/ritonavir 12mg/3mg per kg; 15–40kg: 10mg/2.5mg per kg; >40kg: max 400mg/100mg twice daily. Concomitant efavirenz, nevirapine or (fos)amprenavir: ≥6months: 7 to <15kg: 13mg/3.25mg per kg; 15–45kg: 11mg/2.75mg per kg; >45kg: max oral soln: 533mg/133mg twice daily; or max tabs: 400mg/100mg or 600mg/150mg twice daily. See literature.
Also: KALETRA 100mg/25mg KALETRA 200mg/50mg
Contraindications for KALETRA ORAL SOLUTION Loss of virologic response or resistance with rifampin, St. John's wort. Drugs metabolized by CYP3A that may cause serious events if blood levels are elevated (eg, cisapride, ergots, pimozide, midazolam, triazolam).
Warnings/Precautions for KALETRA ORAL SOLUTION Suspend if pancreatitis occurs. History of, or risk factors for, pancreatitis (eg, elevated triglycerides). Hepatic impairment. Hepatitis. Diabetes. Monitor: lipids at baseline then periodically, ALT/AST in liver disease, for hyperglycemia or fat redistribution, hemophiliacs (for spontaneous bleed). Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions for KALETRA ORAL SOLUTION See Contraindications. Lovastatin, simvastatin, St. John's wort, rifampin, voriconazole: not recommended. Potentiates sildenafil, vardenafil, tadalafil (reduce dose of these), statins metabolized by CYP3A (eg, atorvastatin), fluticasone (avoid). Avoid oral soln with metronidazole, disulfiram. Monitor other antiretrovirals, warfarin. Increases levels of antiarrhythmics, dihydropyridine, calcium channel blockers, immunosuppressants (monitor); ketoconazole, itraconazole (avoid high doses); rifabutin (reduce rifabutin dose and monitor); clarithromycin (reduce clarithromycin dose in renal dysfunction), trazodone (reduce trazodone dose). Give didanosine 1 hour before or 2 hours after. Decreases levels of atovaquone, methadone, estrogen-containing oral contraceptives (use other or back-up contraception). Lopinavir levels decreased by anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin), dexamethasone, efavirenz, nevirapine. Lopinavir levels may be increased by delavirdine, CYP3A inhibitors. May decrease zidovudine or abacavir levels. See literature.
Adverse Reactions for KALETRA ORAL SOLUTION Diarrhea, GI upset, asthenia, headache, abdominal pain, rash, insomnia, pancreatitis, fat redistribution, hyperlipidemia, increased triglycerides.
How is KALETRA ORAL SOLUTION supplied? 200mg/50mg—120; 100mg/25mg—60; Soln—160mL (w. dose cup)
|