阿巴卡韦双夫定　　

【英文名】Compound Abacavir Sulfate,Lamivudine and Zidovudine
【其它名称】三协唯、Trizivir
【 分类】抗微生物药\抗病毒药\抗HIV药\核苷类逆转录酶抑制药
【成分】硫酸阿巴卡韦、拉米夫定、齐多夫定
【临床应用】HIV感染。
【用法用量】1片/次，bid.，p.o.
【禁忌症】 1.对本药任一成分过敏。2.中性粒细胞降低(＜0.75×109/L)。
3.Hb减少(＜75g/L或4.65mmol/L)。4.肝功能损害。5.终末期肾病。6、其它禁忌症：Ccr＜50ml/min。
【特殊人群用药】
儿童 不推荐用。
老人 建议关注＞65岁者的用药情况。
孕妇 不推荐用。美国FDA妊娠分级为：C级。
哺乳妇女 建议服药期间暂停哺乳。美国疾病预防控制中心建议感染HIV妇女不应哺乳。
肝功能不全者 禁用。
肾功能不全/透析者 Ccr＜50ml/min的肾功能减退者应调整拉米夫定和齐多夫定的剂量，不能使用本药。推荐使用齐多夫定、拉米夫定和阿巴卡韦的单成分制剂。终末期肾病患者禁用。
【注意】
1.慎用 (1)骨髓抑制(国外资料)。(2)曾停服阿巴卡韦(国外资料)。(3)曾长期用核苷、起始病毒载量大者、可能对本复方制剂反应差者(国外资料)。(4)合并HBV感染，且HBV可发展为对拉米夫定耐药的变异株，或停用拉米夫定后可致肝炎复发者(国外资料)。
2 . 用药相关检查/ 监测项目 (1)检测血浆HIVRNA(PCR)、CD4细胞计数、肝肾功能、脂/脂蛋白分析、CPK、血糖及血清淀粉酶，适时胸透，长期治疗需定期监测血乳酸盐。(2)监测血常规。对早期HIV感染，可每1～3月监测1次。HIV感染进展期，建议治疗头3月，至少每2周检查1次血常规，以后至少每月检查1次。(3)合并HBV感染者停药后，须定期监测肝功能、HBV复制标志物。
【给药说明】
1.给药条件 (1)不应用于体重＜40kg者。(2)建议治疗初期单独采用阿巴卡韦、拉米夫定和齐多夫定治疗6～8周。(3)单独使用阿巴卡韦、拉米夫定和齐多夫定任一药物疗效充分时，不宜使用固定剂量的三联药物。如临床征象显示本药某一成分需减量或停用，可分别使用阿巴卡韦、拉米夫定和齐多夫定的单成分制剂。(4)对治疗前已有骨髓增生低下或治疗中出现血液不良反应者(如Hb＜90g/L或5.59mmol/L、中性粒细胞计数＜1×109/L)，可能需调整齐多夫定的剂量，应使用阿巴卡韦、拉米夫定和齐多夫定的单成分制剂。
2.减量/停药条件 (1)当过敏反应不能排除，甚至可能是其它诊断时，必须停药。国外资料显示，若患者出现皮疹或以下4项中至少2项症状时，则必须停药：①发热。②恶心、呕吐、腹泻、腹痛。③极度疲倦、全身不适感。④咽喉痛、气短、咳嗽。无论任何原因停药者，重新用药需慎重；若有必要再次用药，须住院治疗。对因发生过敏反应而停药者，不可再用本药或任何含阿巴卡韦的药物。(2)治疗期间，如临床征象或实验检查提示出现胰腺炎，应立即停药。恶心、呕吐和腹痛等也可能提示发生乳酸性酸中毒。氨基转移酶迅速升高、进行性肝肿大或原因不明的代谢性或乳酸性酸中毒者应中断用药。3.其它 间歇治疗可能增加发生阿巴卡韦过敏反应的危险，应告知患者定时服药。必须警告每位患者阿巴卡韦的过敏反应并应密切监测，尤其是在本药治疗的最初2个月内，应每2周会诊1次。治疗初期同时接受本药和其它已知有皮肤毒性药物的患者需特别注意。
【不良反应】
参见阿巴卡韦、拉米夫定和齐多夫定。
【药物过量】
处理意见 尚缺乏过量服用本药的经验。一旦出现服用过量，应进行毒性监测，必要时采用常规支持疗法。此外，拉米夫定可经透析清除；血透和腹透对齐多夫定的清除作用有限，但可促进其葡萄糖醛酸代谢物的生成，从而加速排泄；尚不清楚阿巴卡韦能否经透析清除。
【相互作用】
1.非核苷类逆转录酶抑制药、蛋白酶抑制药：同用的有效性、安全性资料尚不充分。2.乙醇：对HIV感染者的研究中发现，单剂量阿巴卡韦与乙醇合用，阿巴卡韦AUC增加41%，T1/2延长26%，乙醇的代谢未受影响。3.食物：延缓本药吸收，轻度降低Cmax(平均18%～32 %)，延长Tmax约1h，不改变吸收程度。可与食物同服。
【制剂规格】
片剂 300mg(阿巴卡韦)-150mg(拉米夫定)-300mg(齐多夫定)。

【批准文号】 H20020240

注册证号 H20100209
原注册证号 
产品名称（中文） 阿巴卡韦双夫定片
产品名称（英文） Compound Abacavir Sulfate, Lamivudine and Zidovudine Tablets
商品名（中文） 三协唯
商品名（英文） Trizivir
剂型（中文） 片剂
规格（中文） 每片含硫酸阿巴卡韦（按阿巴卡韦计）300mg、拉米夫定150mg和齐多夫定300mg。
注册证号备注 
包装规格（中文） 60片/盒，60片/瓶/盒
生产厂商（中文） 
生产厂商（英文） Glaxo Wellcome Operations
厂商地址（中文） 
厂商地址（英文） Priory Street,Ware,Hertfordshire,SG12 0DJ
厂商国家（中文） 英国
厂商国家（英文） U.K.

 

TRIZIVIR® (abacavir sulfate, lamivudine, and zidovudine)

See the full Prescribing Information for TRIZIVIR

Indication and Usage

TRIZIVIR treats HIV infection in combination with other HIV medicines or alone. HIV medicines do not cure HIV infection/AIDS or prevent passing HIV to others.

• TRIZIVIR is used in combination with other HIV medicines, or alone, for the treatment of HIV infection. TRIZIVIR is a combination of three medicines: ZIAGEN^® (abacavir sulfate), EPIVIR^® (lamivudine or 3TC), and RETROVIR^® (zidovudine, or ZDV). If you weigh less than 90 pounds, you should not take TRIZIVIR because it may be too much medicine for your body to handle
• TRIZIVIR is one of several medicines containing abacavir. Before you start taking TRIZIVIR, review your medical history with your healthcare professional to make sure you have not had a severe allergic reaction to abacavir in the past
• There is limited information on the use of this triple-combination therapy in patients with viral loads >100,000 c/mL. Talk to your healthcare professional about whether TRIZIVIR might be right for you

Important Safety Information

TRIZIVIR contains abacavir. Patients taking abacavir may have a serious allergic reaction (hypersensitivity reaction) that can cause death.

If you get a symptom from two or more of the following groups while taking abacavir, stop taking abacavir and call your healthcare professional right away.

Symptom(s) Group 1 Fever Group 2 Rash Group 3 Nausea, vomiting, diarrhea, or abdominal (stomach area) pain Group 4 Generally ill feeling, extreme tiredness, or achiness Group 5 Shortness of breath, cough, or sore throat

Read the list of problems that can happen on the Warning Card that your pharmacist gives you. Carry this Warning Card with you.

If you stop TRIZIVIR because you have an allergic reaction to abacavir, NEVER take TRIZIVIR or another abacavir-containing medicine again. If you take TRIZIVIR or another abacavir-containing medicine again after you have had an allergic reaction, WITHIN HOURS you may get life-threatening symptoms that may include very low blood pressure or death.

If you stop abacavir, for any other reason, even for a few days, and you are not allergic to abacavir, talk with your doctor before taking it again. Taking abacavir again can cause a serious or life-threatening reaction, even if you never had an allergic reaction to it before. If your doctor tells you that you can take abacavir again, start taking it when you are around medical help or people who can call a doctor if you need one.

Other Important Safety Information

• TRIZIVIR, like other HIV medicines, can cause a condition called lactic acidosis and severe liver problems. Lactic acidosis occurs when acid builds up in the blood, which can affect how the body functions. In some cases, lactic acidosis can cause death. Nausea and tiredness that don't get better may be symptoms of lactic acidosis. Women are more likely than men to get this serious side effect.
• Make sure to see your doctor regularly because other serious side effects can occur, such as muscle damage and a decrease in red and/or white blood cells, especially in patients with advanced HIV disease or AIDS
• If you have a serious liver problem and your liver does not function properly, you should not take TRIZIVIR
• If you have less serious liver problems (including hepatitis B), or kidney problems, talk to your doctor about whether or not you should take TRIZIVIR
• Patients with hepatitis B virus (HBV) infection who take lamivudine, an active ingredient in TRIZIVIR, and then stop taking it, may get "flare-ups" of their hepatitis. A flare-up is when the disease suddenly returns in a worse way than before. If you have HBV infection, your doctor should closely monitor your liver function for several months after stopping lamivudine. You may need to take anti-HBV medicines
• Worsening of liver disease (sometimes resulting in death) has occurred in patients infected with both HIV and hepatitis C virus who are taking anti-HIV medicines and are also being treated for hepatitis C with interferon with or without ribavirin. If you are taking TRIZIVIR as well as interferon with or without ribavirin, and you experience side effects, be sure to tell your doctor
• When you start taking HIV medicines, your immune system may get stronger and may begin to fight infections that have been hidden in your body, such as pneumonia, herpes virus, or tuberculosis. If you have new symptoms after starting your HIV medicines, be sure to tell your doctor
• Changes in body fat may occur in some patients taking anti-HIV medicines. These changes may include an increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the trunk. Loss of fat from the legs, arms, and face may also occur. The cause and long-term health effects of these conditions are not known at this time
• The most common side effects of at least moderate intensity associated with the use of TRIZIVIR include nausea, headache, weakness or tiredness, vomiting, hypersensitivity reaction, diarrhea, fever and/or chills, depression, muscle and joint pain, skin rashes, ear/nose/throat infections, cold symptoms, and nervousness
• These are not all the side effects you could have when taking TRIZIVIR. Your healthcare professional can talk to you about these and other side effects with TRIZIVIR
• Tell your doctor promptly about any side effects or other unusual symptoms you may experience

  See the full Prescribing Information for TRIZIVIR

  Visit the Web site for TRIZIVIR