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使用说明书

 

· 【产品名称】阿巴卡韦双夫定片

· 【商品名/商标】

三协唯

· 【规格】300mg*60片

· 【主要成份】每片三协维含有300mg齐多夫定、150mg拉米夫定和300mg阿巴卡韦。

· 【性状】为蓝绿色胶囊型膜衣片，一面刻有“GXLL1”。

· 【适应症】

用于治疗人类免疫缺陷病毒(HIV)感染的成人。三协唯固定的三种组分(阿巴卡韦、拉米夫定和齐多夫定)用来替代相似剂量的三种单方制剂。建议在治疗初期采用单独阿巴卡韦、拉米夫定和齐多夫定治疗6-8周。选择本固定的复方制剂应主要依据其预计的益处和与三种核苷类似物有关的危险，而不仅仅取决于简单的适用标准。三协唯的疗效可以用首次接受治疗的病人和经过中度抗逆转录病毒治疗的非进展期病人的研究结果来证实。高病毒载量(>100000copies/mL)患者选择治疗需特别考虑.

· 【用法用量】成人(18岁及18岁以上)的参考剂量为每天2次，每1片。不应用于体重不足40公斤的成人和青少年，因为三协唯是剂量固定的片剂不能减少剂量。可与或不与食物同服。若临床显示三协唯其中某一成份需减小剂量或停用时，可以分别使用单剂量的阿巴卡韦拉米夫定和齐多夫定。肾损害：尽管对肾功能不全的病人无须调整阿巴卡韦的剂量，但由于肾脏对药物清除能力下降而使拉米夫定和齐多夫定的血药浓度升高。因此对肾功能减退的病人(肌酐清除率≤(smallerthanorequalto)50mL/分)有必要调整这两种药物的剂量，推荐使用齐多夫定拉米夫定和阿巴卡韦的单方制剂。医生应分别考虑三种药物各自的产品特性，晚期肾病患者不应使用三协唯(参见禁忌症和药理毒理)。肝损害三协唯禁用于肝损害的病人。对血相出现不良反应的患者应调整剂量：如果病人的血红蛋白水平<9g/dL或5.5mmol/L或中性粒细胞计数<1.0x/109L可，能要调整齐多夫定的剂量。由于三协唯是一合剂，单一药物的剂量是无法调整的，故如发生以上情况应使用阿巴卡韦拉米夫定和齐多夫定的单方制剂。医生应分别考虑三种药物各自的特性。

· 【不良反应】在治疗HIV感染中，拉米夫定阿巴卡韦和齐多夫定单独或联用的副作用已有报道。三协唯含有阿巴卡韦、拉米夫定和齐多夫定与这些化合物有关的副作用可以预见。 阿巴卡韦的过敏反应：与阿巴卡韦过敏反应有关的征象和症状总结如下： 胃肠道-恶心呕吐腹泻腹痛嘴部溃疡; 神经病学/精神病学-头痛感觉异常; 血液学-淋巴细胞减少; 肝/胰腺-肝功能指标升高; 肌肉和骨胳-肌痛肌溶解关节痛肌酸磷酸酶升高; 呼吸道-呼吸困难喉痛咳嗽流感样综合征; 皮肤-皮疹(通常为斑丘疹和荨麻疹);泌尿科学-肌酸酐升高肾衰; 其它-发热嗜睡不适水肿淋巴节病低血压结膜炎过敏症.临床研究中，接受阿巴卡韦治疗的病人，约有4%发生过敏反应，尽管采取预防措施，部分是危及生命和致死的过敏反应。这种过敏反应的特点是累及多个脏器。几乎所有病人的过敏反应均有发热和/或皮疹(通常为斑丘疹和荨麻疹)成为综合征的一部分，但是也曾出现过无皮疹和发热的过敏反应。一些发生过敏反应的病人，起初会被认为有胃肠道疾病、呼吸道疾病(肺炎支气管炎咽炎)或流感样疾病，这些会延误过敏反应的诊断。阿巴卡韦继续服用或重新使用会导致更为严重的过敏反应和死亡。因此对出现这些疾病症状的病人，应仔细考虑是否诊断为过敏反应。症状通常发生于治疗过程中的6前周内(平均为开始治疗后的第天)也可发生于治疗过程的任何时间，有必要在治疗的最初两个月进行密切的医疗监测，每两周会诊一次。预见引起阿巴卡韦过敏反应发生的严重性的危险因素尚未证实，但是很可能间歇治疗可以增加过敏反应发生的危险，从而产生显著的临床过敏反应，因此应告知病人定时服用三协唯的重要性。发生过敏反应后重新服用三协唯或任何其它含阿巴卡韦的制剂，可在数小时内使症状迅速发生，这种复发的过敏反应通常比初发更严重，而且可能发生危及生命的低血压和死亡。为避免延误诊断和减少危及生命的过敏反应的发生，一旦发生不能排除其它情况的过敏反应，即使可能为其它诊断(呼吸道疾病、流感样疾病、胃肠道疾病或对于其它药物的反应)三协唯必须停用。迅速发生的过敏反应，包括危及生命的反应曾出现在停用阿巴卡韦前仅有一项关键过敏反应症状(皮疹、发热、胃肠道症状、呼吸道症状和如嗜睡和不适)出现后重新服用阿巴卡韦的病人，对于先前没有出现过过敏反应症状而重新开始治疗后出现过敏反应的病人的报道非常罕有，必须在医疗协助具备的情况下作出重新开始接受三协唯治疗的决定。阿巴卡韦的过敏反应必须警告每个病人:已报道的单一成份的不良反应，一旦上述任何症状发生必须注意减少过敏反应发生的可能。乳酸酸中毒：采用核苷类似物进行治疗与乳酸酸中毒有关，有时是致死性的，通常伴发严重肝肿大和肝硬化。与齐多夫定有关的血液学不良反应：贫血、中性粒细胞减少和白细胞减少，这些常见于大剂量(1200-1500mg/天)用药和HIV感染进展期病人(尤其是治疗前骨髓增生不良的病人)，特别是C,4细胞计数<100/mm3的病人，此时可能需要减少剂量或停止治疗，贫血病人可能需进行输血。齐多夫定治疗开始时，中性粒细胞数、血红蛋白水平、血清维生素B12水平低的病人在使用齐多夫定时，中性粒细胞数减少的机率也会增加。

· 【禁忌】三协唯禁用于已知对阿巴卡韦、拉米夫定、齐多夫定或其任何赋形剂过敏者。禁用于晚期肾病肝损害患者。由于其活性成分阿巴卡韦，忌用于严重肝功能受损患者。由于其活性成分齐多夫定，三协唯忌用于中性粒细胞数异常(<.x/L)或血红蛋白水平异常(<.g/dL或.mmol/L)的病人。

· 【注意事项】应用三协唯治疗时需有治疗HIV感染经验的内科医生的指导下进行。过敏反应：接受阿巴卡韦治疗的病人中，约有4%发生过敏反应，部分为致死性的，尽管引起注意但仍有死亡病例出现。过敏反应的描述：这种过敏反应的特点是出现累及多个脏器的症状，几乎所有过敏反应会出现发热和/或皮疹等症状。过敏反应的其它症状还包括：呼吸系统症状如呼吸困难、咽喉痛和咳嗽；胃肠道症状如恶心、呕吐、腹泻和腹痛。上述情况可导致将过敏反应误诊为呼吸系统疾病(肺炎支气管炎咽炎)和胃肠道疾病，其它常见的过敏反应征象包括嗜睡、不适和肌肉骨胳症状(肌痛罕有肌溶解和关节痛)。继续接受治疗会使过敏反应有关的症状恶化并可危及生命，通常停用阿巴卡韦后上述症状可以缓解。过敏反应的处理：过敏反应通常发生于阿巴卡韦治疗过程中的前周内，尽管这些反应可以于治疗过程的任何时间发生，应密切监测病人特别是在三协唯治疗的最初个月内，应每两周进行会诊。在治疗过程中若病人确诊有过敏反应必须立即停止服用三协唯。因发生过敏反应而停止治疗的病人，今后决不可再用三协唯或任何含阿巴卡韦的药物，出现过敏反应后再次使用阿巴卡韦，会在数小时内使症状迅速发生且复发的过敏反应通常较初发更为严重，包括危及生命的低血压和死亡。为避免延误诊断和减少危及生命的过敏反应发生的危险，当过敏反应不能排除甚至可能是其它诊断时(呼吸疾病流感样疾病胃肠炎和对其它药物的反应)，必须停止使用三协唯，如有必要重新接受三协唯治疗，必须在医院里进行。治疗初期同时接受三协唯和其它已知导致皮肤毒性(如非核苷类逆转录酶抑制剂)药品的病人，需特别注意，因为很难区分皮疹是由阿巴卡韦引起的过敏反应还是由其它药物引起的。中断三协唯治疗后的处理：无论任何原因停止三协唯的治疗其重新用药需慎重考虑在停止用药前需确认中断治疗的原因是否与出现过敏反应症状有关。迅速发生的过敏反应，包括危及生命的反应曾出现在停用阿巴卡韦前仅有一项关键过敏反应症状(皮疹、发热、胃肠道症状、呼吸道症状和全身症状如嗜睡和不适)出现后重新服用阿巴卡韦的病人。对于先前没有出现过过敏反应症状而重新开始治疗后出现过敏反应的病人的报道非常罕有。必须在医疗协助具备的情况下作出重新开始三协唯治疗的决定。

· 【孕妇及哺乳期妇女用药】妊娠期：三协唯对于人类妊娠的安全性尚未建立。动物的生殖试验发现与阿巴卡韦、拉米夫定、齐多夫定有关的结果(参见药理毒理)，因此仅在对母亲的益处大于对胎儿可能的危害时才考虑妊娠期用药。哺乳期：拉米夫定和齐多夫定都能分泌到人乳中，而且浓度与血清中的浓度相似，虽未经证实。预测阿巴卡韦也可分泌到乳汁中，因此建议服用三协唯的母亲不要母乳喂养。为了避免将HIV传播给婴儿，建议可能被HIV感染了的妇女不要进行母乳喂养。

· 【贮藏】置于30℃以下保存。

· 【生产厂家】英国Glaxo Wellcome Operations

· 【生产地址】Priory Street,Ware,Hertfordshire,SG12 0DJ

Trizivir

Generic Name: abacavir, lamivudine, and zidovudine (a BACK a veer, la MIV yoo deen, zye DOE vyoo deen)
Brand Names: Trizivir

What is Trizivir?

Trizivir contains a combination of abacavir, lamivudine, and zidovudine. Abacavir, lamivudine, and zidovudine areantiviral medications that prevent human immunodeficiency virus (HIV) from multiplying in your body.

Trizivir is used to treatHIV, which can cause the acquired immunodeficiency syndrome (AIDS).

Trizivir is not a cure for HIV or AIDS.

Important information

Stop using Trizivir and call your doctor at once if you have any of these signs of an allergic reaction: fever; rash; nausea, vomiting, diarrhea, stomach pain; general ill feeling, extreme tiredness, body aches; shortness of breath, cough, sore throat.Once you have had an allergic reaction to this medicine, you must never use it again.

 

Trizivir can weaken your immune system. Your blood may need to be tested often.

Trizivir may also cause a serious condition calledlactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

If you have ever had hepatitis B, this condition may come back or get worse after you stop taking Trizivir.

Do not allow your medicine to run out completely before you get your prescription refilled. It is important that you not stop taking Trizivir once you have started. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking the medication again. If you stop taking this medicine for any reason, talk to your doctor before you start taking it again.

Before taking this medicine

Do not take Trizivir if you have ever had an allergic reaction to it or any medicine that contains abacavir, lamivudine, or zidovudine, including: Combivir, Epivir, Epzicom, Retrovir, or Ziagen.Once you have had an allergic reaction to abacavir, you must never use it again.

Some people taking Trizivir develop a serious condition calledlactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

Trizivir can also cause severe or life-threatening effects on your liver, especially if you have hepatitis B or C.

To make sure Trizivir is safe for you, tell your doctor if you have:

· bone marrow suppression;

· kidney disease;

· liver disease (especially if you also use ribavirin or interferon alfa);

· heart disease or high blood pressure; or

· a risk factor for heart disease such as smoking, diabetes, or high cholesterol.

You may need a blood test before you start taking this medicine for the first time, or if you are restarting the medication after stopping for reasons not related to an allergic reaction.

It is not known whether Trizivir will harm an unborn baby. But HIV can be passed to your baby if you are not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant. Take all of your HIV medicines as directed to control your infection.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Trizivir should not be used to treat HIV in adolescents weighing less than 90 pounds.

How should I take Trizivir?

Take Trizivir exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Trizivir with or without food.

Trizivir comes with a Medication Guide and a Warning Card that lists the symptoms of an allergic reaction. Read this information carefully and carry the Warning Card with you at all times so you will know what symptoms to watch for.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

If you have ever had hepatitis B, this condition may come back or get worse after you stop taking Trizivir. You may need frequent blood tests to check your liver function for several months after you stop using this medicine.

Store at room temperature away from moisture and heat.

Trizivir dosing information

Usual Adult Dose for HIV Infection:

1 tablet orally twice a day

Use: In combination with other antiretroviral agents or alone, for the treatment of HIV-1 infection

Usual Adult Dose for Nonoccupational Exposure:

US CDC recommendations: 1 tablet orally twice a day
Duration of therapy: 28 days

Comments:
-Recommended as an alternative regimen for nonoccupational postexposure prophylaxis of HIV infection; this triple NRTI regimen is recommended only when a NNRTI-based or a protease inhibitor-based regimen cannot or should not be used.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Occupational Exposure:

US Public Health Service working group recommendations: 1 tablet orally twice a day
Duration of therapy: 28 days, if tolerated

Comments:
-Only with expert consultation, as an alternative regimen for use as HIV postexposure prophylaxis
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection:

At least 40 kg: 1 tablet orally twice a day

Comments: Use of the individual components is recommended for patients less than 40 kg; the manufacturer product information for Trizivir should be consulted.

Use: In combination with other antiretroviral agents or alone, for the treatment of HIV-1 infection

Dosage Information (comprehensive)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Do not allow your medicine to run out completely before you get your prescription refilled. It is important that you not stop taking the medicine once you have started. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking Trizivir again.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Trizivir?

Avoid drinking alcohol. It may increase your risk of liver damage.

Taking Trizivir will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Trizivir side effects

Stop using Trizivir and call your doctor at once if you have symptoms of an allergic reaction from two or more of these specific side effect groups:

· Group 1 - fever;

· Group 2 - rash;

· Group 3 - nausea, vomiting, diarrhea, stomach pain;

· Group 4 - general ill feeling, extreme tiredness, body aches;

· Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to Trizivir, you must never use it again. If you stop taking this medicine for any reason, talk to your doctor before you start taking it again.

Trizivir can cause other serious side effects that may not be signs of an allergic reaction. Call your doctor at once if you have:

· the first sign of any skin rash, no matter how mild;

· low white blood cells - fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

· low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, trouble concentrating; or

· liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Earlysymptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Trizivir may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start your treatment. Tell your doctor if you have:

· signs of a new infection - fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

· chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

· cold sores, sores on your genital or anal area;

· rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

· trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

· swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common Trizivir side effects may include:

· headache;

· weakness or tiredness;

· nausea, vomiting; or

· changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).