英文药名：COMPLERA Combination Tablets (Rilpivirine Hydrochloride/Tenofovir Disoproxil Fumarate/Emtricitabine)

中文药名：利匹韦林/恩曲他滨/替诺福韦酯三联组合片

生产厂家：杨森制药
治疗类别名称
抗病毒化疗药物
批准上市：2014年11月25日
商品名称：COMPLERA Combination Tablets
通用名称：盐酸Rirupibirin/富马酸替诺福韦酯/恩曲他滨片组合片剂
剂型：片剂
主治：HIV-1感染
用法与用量：正常口服，对于（含富马酸乐200毫克至300毫克和恩曲他滨盐25毫克Rirupibirin，替诺福韦）期间，每日一次吃饭成人一次1片或进食后立即到。
包装规格：
联合片剂：30片（瓶）
生产厂商：日本杨森制药有限公司
完整处方资料附件：http://www.120ty.net/bencandy.php?fid=141&aid=30623
Complera (Emtricitabine / Rilpivirine Hydrochloride / Tenofovir Disoproxil Fumarate) - Indications and Dosage
INDICATIONS AND USAGE
COMPLERA (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is indicated for use as a complete regimen for the treatment of HIV-1 infection in antiretroviral treatment-naive adults.
This indication is based on Week 48 safety and efficacy analyses from 2 randomized, double-blind, active controlled, Phase 3 trials in treatment-naive subjects comparing rilpivirine to efavirenz [See Clinical Studies].
The following points should be considered when initiating therapy with COMPLERA:
More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure compared to subjects with HIV-1 RNA less than 100,000 copies/mL at the start of therapy [See Clinical Studies].
The observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz [See Microbiology].
More subjects treated with rilpivirine developed lamivudine/emtricitabine associated resistance compared to efavirenz [See Microbiology].
COMPLERA is not recommended for patients less than 18 years of age [See Use in Specific Populations].
DOSAGE AND ADMINISTRATION
Adults: The recommended dose of COMPLERA is one tablet taken orally once daily with a meal [See Clinical Pharmacology].
Renal Impairment: Because COMPLERA is a fixed-dose combination, it should not be prescribed for patients requiring dose adjustment such as those with moderate or severe renal impairment (creatinine clearance below 50 mL per minute).
DOSAGE FORMS AND STRENGTHS
COMPLERA is available as tablets. Each tablet contains 200 mg of emtricitabine (FTC), 27.5 mg of rilpivirine hydrochloride (equivalent to 25 mg of rilpivirine) and 300 mg of tenofovir disoproxil fumarate (tenofovir DF or TDF, equivalent to 245 mg of tenofovir disoproxil).
The tablets are purplish-pink, capsule-shaped, film-coated, debossed with "GSI" on one side and plain-faced on the other side.
HOW SUPPLIED/STORAGE AND HANDLING
COMPLERA tablets are purplish-pink, capsule-shaped, film-coated, debossed with "GSI" on one side and plain-faced on the other side. Each bottle contains 30 tablets (NDC 61958-1101-1), a silica gel desiccant, polyester fiber coil, and is closed with a child-resistant closure.
Store at 25 °C (77 °F), excursions permitted to 15—30 °C (59—86 °F) (see USP Controlled Room Temperature).