英文药名:Stribild Combination Tab(Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate )
中文药名:埃替格韦+替诺福韦酯+恩曲他滨+Cobicistat配合片
生产厂家:Torii Pharmaceutical Co., Ltd. 给药说明: 商標名 Stribild Combination Tab. 一般名 エルビテグラビル Elvitegravir 化学名 6-[(3-Chloro-2-fluorophenyl)methyl]-1-[(2S)-1-hydroxy-3-methylbutan-2-yl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 分子式 C23H23ClFNO5 分子量 447.88 化学構造式
性 状 它是一种白色的粉末至淡黄色,易溶于二甲亚砜,N,或四氢呋喃N - 二甲基甲酰胺,和微溶于乙醇,乙腈或甲醇中(95),微溶于2 - 丙醇,和几乎不溶于水。 熔点 约163℃ 分配系数 LogD=4.5(pH6.8的) 一般名 コビシスタット Cobicistat 化学名 1,3-Thiazol-5-ylmethyl {(2R,5R)-5-[(2S)-2-(3-methyl-3-{[2-(1-methylethyl)-1,3-thiazol-4-yl]methyl}ureido)-4-(morpholin-4-yl)butanamido]-1,6-diphenylhexan-2-yl}carbamate 分子式 C40H53N7O5S2 分子量 776.02 化学構造式
性 状 它是一种固体白色至淡黄色,易溶于甲醇,乙腈,二氯甲烷,或二甲亚砜,并在庚烷或几乎不溶于水。 熔点 35℃的玻璃化转变温度,约200℃(分解) 分配系数 (1 - 辛醇/pH8.5磷酸盐缓冲溶液)4.3 一般名 エムトリシタビン Emtricitabine 化学名 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2(1H)-one 分子式 C8H10FN3O3S 分子量 247.25 化学構造式
性 状 它是白色至淡黄色的粉末,并易溶于水和甲醇,微溶于乙腈中,极微溶于乙酸异丙酯。 熔点 约155℃ 分配系数 -0.43(辛醇/水) 一般名 テノホビル ジソプロキシルフマル酸塩 Tenofovir Disoproxil Fumarate 化学名 Bis(isopropoxycarbonyloxymethyl) {[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl} phosphonate monofumarate 分子式 C19H30N5O10P・C4H4O4 分子量 635.51 化学構造式
性 状 它是一种白色至黄白色结晶粉末,易溶微微甲醇,乙醇(95),和微溶于丙酮,水,和在乙醚中几乎不溶。 熔点 114〜118℃ 分配系数 (1 - 辛醇/pH6.5磷酸盐缓冲溶液)1.25 审批条件 1. 在使用这种药物,使其充分地描述,例如,事实上正在收集持续的疗效和安全性进一步的数据相对于该药物用于患者,以获得知情同意,有可能请求医生。 2. 对于计划的临床试验或正在进行海外,应结束后尽快提交分析结果和试验结果越好 3. 在复试阶段,直到最后,进行的国内原则上所有病例治疗后的市场调查,结合使用时,对实际使用这种药物(患者的背景,疗效和安全性(其他代理信息它可以通过收集数据等)和药物相互作用),包括疗效和安全性,在应用调查结果时需提交的申请附件复检定期报告。 适应证 成人HIV-1感染的治疗。 剂量与用法 成人口服,一天一次(含300毫克的富马酸替诺福韦酯200毫克和150毫克,为恩曲他滨150毫克,为Kobishi统计为Erubitegurabiru),一次一粒。
包装规格:30片/瓶
生产厂家 鸟居药业有限公司(提携技术:GILEAD 吉利德公司) 注:治疗以原处方为准:http://www.kegg.jp/medicus-bin/japic_med?japic_code=00061353 Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate WARNING: Stribild can cause serious, life-threatening side effects. These include lactic acidosis (buildup of lactic acid in the blood) and liver problems. Contact your health care provider right away if you have any of the following symptoms that may signal lactic acidosis: Weakness or tiredness. Unusual (not normal) muscle pain. Trouble breathing. Stomach pain with nausea and vomiting. Feeling cold, especially in your arms and legs. Dizziness or lightheadedness. Fast or irregular heartbeat. Contact your health care provider right away if you have any of the following symptoms that may signal liver problems: Yellowing of your skin or the whites of your eyes (jaundice). Dark-colored urine. Light-colored bowel movements. Loss of appetite for several days or longer. Feeling sick to your stomach (nausea). Pain in the stomach area (abdominal pain). Stribild is not approved for the treatment of hepatitis B virus (HBV) infection. If you have both HIV and HBV infection and take Stribild, your HBV infection may get worse (flare up) if you stop taking Stribild. The HBV drug adefovir dipivoxil (brand name: Hepsera) should not be taken with Stribild. While taking Stribild, it is important to keep all of your appointments with your health care provider. What is Stribild? Stribild is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults who have never taken HIV medicines before. Stribild is a complete regimen for the treatment of HIV infection and should not be used with other HIV medicines. Stribild contains the following four different medicines combined in one pill: Elvitegravir - an HIV medicine called an integrase inhibitor. Cobicistat – a medicine called a pharmacokinetic enhancer, used to increase the effectiveness of elvitegravir. Emtricitabine – an HIV medicine called a nucleoside reverse transcriptase inhibitor (NRTI). Tenofovir disoproxil fumarate – another HIV medicine (also an NRTI). Integrase inhibitors block an HIV enzyme called integrase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) NRTIs block an HIV enzyme called reverse transcriptase. By blocking integrase and reverse transcriptase, the drugs in combination prevent HIV from multiplying and can reduce the amount of HIV in the body. Stribild does not cure HIV/AIDS. People with HIV should stay on continuous HIV treatment as directed by their health care provider and should take steps to avoid passing HIV to others (for example, using a condom during sex). What should I tell my health care provider before taking Stribild?Before taking Stribild, tell your health care provider: If you are allergic to any of the HIV medicines in Stribild (elvitegravir, cobicistat, emtricitabine, or tenofovir disproxil fumarate) or any other medicines. If you have liver problems, including HBV infection. If you have kidney problems. If you have bone problems. If you have any other medical conditions. If you are pregnant or plan to become pregnant. Whether Stribild can harm an unborn baby is unknown. If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking Stribild. About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Stribild may affect the way other medicines or products work, and other medicines or products may affect how Stribild works. Taking Stribild together with certain medicines or products may cause serious and/or life-threatening side effects. How should I take Stribild?Stribild comes in tablet form. Each tablet contains: 150 mg elvitegravir. 150 mg cobicistat. 200 mg emtricitabine (brand name: Emtriva). 300 mg tenofovir disproxil fumarate (brand name: Viread). Take Stribild according to your health care provider’s instructions. Take Stribild with food. Do not take Stribild with other HIV medicines. If you take too much Stribild, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room. For more information on how to take Stribild, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.) What should I do if I forget a dose?Take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose. What side effects can Stribild cause? Stribild can cause serious, life-threatening side effects. These include lactic acidosis (buildup of lactic acid in the blood) and liver problems. (See the WARNING above). Other possible side effects of Stribild include: New or worsening kidney problems, including kidney failure. Bone problems (bone pain, softening, or thinning [osteopenia]). Changes in body fat (lipodystrophy). Changes in the immune system (immune reconstitution inflammatory syndrome [IRIS]). Tell your health care provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Stribild. Ask your health care provider or pharmacist for more information on side effects of Stribild. You may also want to read this fact sheet about HIV medicines and side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088). How should Stribild be stored? Store Stribild at room temperature, 68°F to 77°F (20°C to 25°C). Keep Stribild in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture. Do not use Stribild if the original seal over the bottle opening is broken or missing. Safely throw away Stribild that is no longer needed or expired (out of date). Keep Stribild and all medicines out of reach of children. Where can I find more information about Stribild? The Stribild drug label, from DailyMed. The Patient Counseling Information section of the label includes information for people taking Stribild. Stribild-related research studies, from the AIDSinfo database of ClinicalTrials.gov study summaries. A list of FDA-approved HIV medicines, from FDA.
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