英文药名:EDURANT Tablets(Rilpivirine Hydrochloride)
中文药名:利匹韦林片
日文药名:エジュラント錠
生产厂家:杨森制药
药品介绍
Edurant(rilpivirine)片既往名TMC278,与其它抗逆转录病毒药物联用治疗HIV-1感染的成人(初治)患者。Edurant(rilpivirine)并不能治愈艾滋病病毒感染。
适应证和用途
EDURANT是一种人类免疫缺陷病毒类型1(HIV-1)特异性,非核苷逆转录酶抑制剂(NNRTI)适用于:在未治疗过成年患者与其他抗病毒药联用为治疗HIV-1 感染。
用EDURANT初始治疗时应考虑以下几点:
(1)在开始治疗时有HIV-1 RNA大于100,000拷贝/mLEDURANT治疗受试者与在开始治疗时有 HIV-1 RNA低于100,000拷贝/mL受试者比较经历更多病毒学失败。
(2)在EDURANT治疗受试者与依法韦仑比较观察病毒学失败率总体治疗耐药性和对NNRTI类交叉耐药性率较高。
(3)与依法韦仑比较用EDURANT治疗受试者发生拉米夫定[lamivudine]/恩曲他滨[emtricitabine]伴耐药性更多。
剂量和给药方法
25mg(25mg一片)每天1次随进餐服用.剂型和规格
25mg片
禁忌证
EDURANT禁忌与可能发生显著降低rilpivirine血浆浓度药物共同给药,这可能导致丧失病毒学反应和可能耐药性和交叉耐药性。
警告和注意事项
(1)EDURANT与可能减低rilpivirine暴露药物应谨慎开处方给药。
(2)EDURANT与一种已知有尖端扭转型室性心动过速[Torsade de Pointes]风险药物开处方应谨慎。
(3)抑郁疾患:曾报道严重抑郁病(心情抑郁,抑郁,烦躁不安,重症抑郁,情绪改变,消极想法,自杀意向,自杀观念)。对严重抑郁病建议立即医学评价。
(4)患者可能发生体脂肪再分布/积蓄(5.3)或免疫重建综合征。
包装规格
25mg*30片/瓶
生产厂商
杨森制药有限公司
EDURANT Tablets 25mg(エジュラント錠25mg)
Brand name : EDURANT Tablets 25mg
Active ingredient: Rilpivirine hydrochloride
Dosage form: white tablet, diameter 6.4 mm, thickness 3.4 mm
Print on wrapping:
Effects of this medicine
This medicine is an antiviral agent that inhibit reverse transcriptase of human immunodeficiency virus type-1 (HIV-1) to slow disease progression.
Usually, used for treatment of HIV-1 infection.
Before using this medicine, be sure to tell your doctor and pharmacist
If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you are pregnant or breastfeeding.
If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
In general, for adults, take 1 tablet (25 mg of rilpivirine) at a time, once daily, definitely with concomitant other anti-HIV agent medication. Take this medicine during a meal or within 30 minutes after a meal because its effect may diminish if taken on an empty stomach. Strictly follow the instructions.
Do not miss any single dose because you lose its effect if you miss a dose. In case you have missed a dose and when you become aware of it, take the missed dose immediately with food if it is within 12 hours after the dose missing, and return to your regular dosing schedule the following day. If you become aware of dose missing after more than 12 hours, then do not take the missed dose and take a dose at your next regular dosing time. You should never take two doses at one time.
If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
This medicine is not intended for radical treatment of HIV infection. The disease may progress even though you are taking it; therefore, inform your doctor of all changes in your physical condition.
Be cautious against ill effects of taking this medicine together with other drugs. Report to your doctor all drugs you are now taking. Consult with your doctor about any drug you are intending to newly start.
Avoid taking this medicine with food or beverage containing Saint. John's wort. Because Saint. John's wort (Hypericum perforatum) may decrease the blood concentration of this medicine and reduce the effect of it.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include headache, nausea, insomnia, dizziness, and abnormal dreams. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
No pertinent entries.
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
Keep out of the reach of children. Store away from light, heat and moisture.
Discard the remainder. Do not store them. If you dispose of unused medicines, seek advice of your pharmacist about proper disposal of drugs.
JANSSEN PHARMACEUTICAL K.K. Internal
Published: 6/2012
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
http://www.kegg.jp/medicus-bin/japic_med?japic_code=00060371