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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗病毒药物->抗艾滋病药物
处方药:处方药
包装规格: 15毫克/胶囊 60胶囊/瓶
计价单位:
  点击放大  
该药品相关信息网址1:
http://www.drugs.com/zerit.html
该药品相关信息网址2:
http://www.rxlist.com/zerit-drug.htm
原产地英文商品名:
STAVUDINE(ZERIT GENERIC)15mg/Capsule 60Capsules/bottle
原产地英文药品名:
STAVUDINE
中文参考商品译名:
司他夫定(赛瑞特仿制药) 15毫克/胶囊 60胶囊/瓶
中文参考药品译名:
司他夫定
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Type Ⅰ HIV infections
临床试验期:
完成
中文适应病症参考翻译1:
Ⅰ型HIV感染
药品信息:

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 详细处方信息以本药内容附件PDF文件(201232718440917.pdf)的“原文Priscribing Information”为准
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部分中文赛瑞特处方资料(仅供参考)

【药物名称】: 赛瑞特

【药物别名】: 司坦夫定

【英文名称】: Zerit

【说 明】: 司坦夫定为白色或类白色的结晶固体,23℃时,本药在水的溶解度约为83 mg/mL,在乙二醇的溶解度约为30 mg/mL。在正辛烷/水的分配系数为0.144。
  本药的胶囊剂除活性成分司坦夫定外,尚含无活性的赋形物:微晶纤维素,乙酸淀粉钠,乳糖,硬脂酸镁。硬胶壳含明胶、二氧化硅、十二烷基硫酸钠、二氧化钛和氧化铁。
  本药的口服粉剂为不含染料的果味粉末。药瓶配有儿童安全瓶盖。所含的非活性成分包括:羟苯甲酸甲酯、对羟苯甲酸丙酯、羧基甲基纤维素钠、蔗糖等。

【功用作用】
  司坦夫定与其它抗病毒药物联合使用,用于治疗Ⅰ型HIV感染 。

【用法用量】
  服用司坦夫定的间隔时间应为12小时,服药时间与进餐无关。
  成人 推荐剂量为:体重>60 kg的患者服用40 mg bid ;体重<60 kg的患者服用30 mg bid。
  儿童 推荐剂量为:体重≥30 kg的患者,按成人推荐剂量服用 ;体重<30 kg的患者服用1 mg/kg/次,bid。
  剂量调整 如在疗程中发生了手足麻木刺,应立即停止司坦夫定的治疗。停止使用本药后,中毒症状可以消退。有些患者停止治疗后,中毒症状可暂时性加重。如症状已完全消退,可给予上述推荐剂量的半量继续治疗。继续给予本药后,若再发生神经病变,需考虑完全停止本药的治疗。
  肾功能损害的病人 推荐剂量如下:
  肌酐清除率>50 mL/分,体重≥60 kg者,给予40 mg bid,体重<60 kg的患者,给予30 mg bid。
  肌酐清除率为26-50 mL/分,体重≥60 kg的患者,给予20 mg bid,体重<60 kg的患者,给予15 mg bid。
  肌酐清除率为10-25 mL/分,体重≥60 kg的患者,给予20 mg qd,体重<60 kg的患者,给予15 mg qd。
  对儿童肾功能损害者,尚无实验数据表明需调整剂量,但可考虑减少剂量或延长用药间隔。
  血液透析的病人 推荐剂量为:体重≥60 kg的患者,每24小时给予20 mg ;体重<60 kg的患者,每24小时给予15mg,于血透完毕后给药。在非透析日,也应在相同时间给药。 成年人曾服用12-24倍的推荐剂量,但未发现急性毒性。长期过量服用本药的并发症包括外周神经病变和肝脏毒性。司坦夫定可通过血液透析排出,其清除率为120±18 mL/分。尚未研究司坦夫定能否通过腹膜透析排出。
  根据司坦夫定口服粉剂药瓶上的说明,在瓶中加入202 mL的纯水,用力摇匀,让药粉完全溶解。配制成200 mL浓度为1 mg/mL的溶液。此溶液稍不透明。每次使用前应将药瓶中的溶液用力摇匀后,再倒入量杯中。然后盖紧瓶盖,放入冰箱内,2-8℃下最多可保存30天。

【注意事项】
  对司坦夫定和任何其它配方成分有明显过敏的患者禁用。 应告知患者本药可导致外周神经病变,一旦出现手足麻木刺痛,应及时求医,医生可能需要改变司坦夫定的剂量或立即停药。对接受本药治疗的儿童患者,应提醒其监护人注意以上毒性作用,以便及时发现和报告。司坦夫定与其它有相似毒性的药物合用时,其不良反应比单用本药更易发生。
  本药不能治愈HIV病毒感染,患者仍可能患HIV感染引起的疾病,如机会致病菌感染。另外,本药也不能预防HIV通过性接触或血液污染而造成传染。
  长期使用本药的远期效果目前尚不明了。
  致癌、致畸性及对生育能力的影响 一项为期两年的致癌作用研究表明,司坦夫定用在小鼠和大鼠的剂量,分别为临床推荐剂量的39倍和168倍时(此倍数是根据两者总吸收量,即AUC比例折算),均无发现致癌作用。如剂量分别达到临床推荐剂量的250倍和732倍时,小鼠和大鼠均出现良性和恶性肝脏肿瘤,雄性大鼠出现尿路膀胱肿瘤。
  在Ames试验、大肠杆菌反向突变试验和CHO/HGPRT哺乳类细胞前向突变试验,无论有无代谢活化,司坦夫定均无致突变作用。在体外人类淋巴细胞致畸变试验、小鼠成纤维细胞试验和体内小鼠微核试验,司坦夫定均呈阳性。无活化代谢的情况下,司坦夫定浓度在25μg/mL-250μg/mL之间,能增加人类淋巴细胞染色体畸变的发生频率 ;在25μg/mL-2500μg/mL之间,能增加小鼠成纤维细胞转型灶的发生频率。体内微核试验显示,小鼠口服司坦夫定600-2000 mg/kg/日,口服3天后,其骨髓细胞发生突变。
  按临床剂量1 mg/kg/日形成的最高浓度(Cmax)折算,216倍的司坦夫定对大鼠没有造成生育力损害。
  对妊娠及哺乳的影响 司坦夫定属C类药物。按临床剂量1 mg/kg/日形成的最高血药浓度(Cmax)折算,399倍的司坦夫定在家兔生殖实验中无致畸形作用。大鼠实验中发现,216倍剂量的司坦夫定不影响胎鼠的骨骼发育。
  而剂量为399倍时,常见的骨骼变化、胸骨骨化不全和未骨化的发生率均升高。135倍剂量不影响着床后流产率,而216倍剂量时能使其轻度增加。135倍剂量时,大鼠新生幼仔(仔龄4天)的死亡率不受影响,而399倍剂量则增加新生幼仔死亡率。有实验显示,司坦夫定可通过大鼠的胎盘传给胎鼠,药物在胎鼠组织中的浓度约为母鼠血浆浓度的一半。在妊娠妇女中尚无充分的对照性研究。因为动物生殖实验并不能完全预测人类对药物的反应,因此,妊娠期除非确实需要时,才使用本药。
  为监控孕妇服用本药及其它抗病毒药物对胎儿的影响,医生应对服药的患者进行登记。

【哺乳】:大鼠实验发现,司坦夫定经乳汁分泌。虽然目前尚不知道司坦夫定是否在人类的乳汁中分泌,哺乳期服用司坦夫定有潜在的不良反应。因此,使用本药的哺乳妇女应停止哺乳。这与疾病控制中心建议一致,为减少产后HIV传染,HIV感染的母亲不要给新生儿哺乳。
  对儿童的影响 对105例儿童患者给予司坦夫定2 mg/kg/日,平均治疗期6.4个月的临床研究表明,其不良反应发生率和成人的相同。对25例年龄在5周-15岁,体重在2-43 kg,感染HIV的儿童患者给予单剂量和1日2次司坦夫定静脉或口服,并测定药物代谢动力学,结果表明儿童可使用本药.

Zerit (stavudine, d4T)
What is Zerit?
•Zerit is an HIV medication. It is in a category of HIV medications called nucleoside reverse transcriptase inhibitors (NRTIs). Zerit prevents HIV from altering the genetic material of healthy CD4 cells. This prevents the cells from producing new virus and decreases the amount of virus in the body.
•Zerit, manufactured by Bristol-Myers Squibb, was approved by the U.S. Food and Drug Administration for the treatment of HIV in 1994.
•Three generic versions of stavudine have been approved for marketing in the United States. They were approved by the FDA in December 2008.
•Zerit must be used in combination with at least two other HIV drugs.

What is known about Zerit?
•One Zerit capsule must be taken twice a day. The standard dose approved by the U.S. Food and Drug Administration is one 40 mg capsule twice a day. However, the dose can be adjusted according to body weight. If you weigh 132 pounds or more, the approved dose is 40mg twice-daily; if you weigh less than 132 pounds, the correct dose is 30mg twice a day. In fact, the World Health Organization (WHO) recommends one 30 mg capsule twice daily for all HIV-positive people using Zerit or its generic equivalent, regardless of body weight, to reduce the risk or severity of stavudine side effects. Studies also suggest that for HIV-positive adults who have kidney problems or are experiencing peripheral neuropathy as a result of Zerit, the dose can be dropped to 15 or 20mg twice a day.
•Children can also take Zerit. The dose for a child depends on their weight. If you are caring for a child who is HIV-positive and has been prescribed Zerit, be sure that you understand the correct dose to give the child. As a child grows, the dose of Zerit will need to be increased. To learn about treatment options for children, click here.
•Zerit can be taken either with or without food.
•Numerous studies have demonstrated that Zerit is effective for the treatment of HIV when combined with other HIV drugs, usually at least one other nucleoside reverse transcriptase inhibitor (NRTI) and either a protease inhibitor or non-nucleoside reverse transcriptase inhibitor (NNRTI). Zerit should not be taken alone (as monotherapy) or with just one other HIV drug.
•Because of its potential side effects, Zerit is no longer a recommended NRTI for HIV-positive adults beginning anti-HIV drug therapy for the first time, according to treatment guidelines issued by the United States Department of Health and Human Services. Tenofovir and emtricitabine, used together as Truvada or as a part of Atripla (efavirenz, tenofovir and emtricitabine), is listed as the "preferred" dual-NRTI option. To learn more about these recommendations and options, click here.
• The DHHS recommends against using Zerit and Videx EC (didanosine) together in the same drug combination. The risk of side effects, which are similar for Zerit and Videx EC, are increased when these drugs are used at the same time.
•Therapy with Zerit can cause certain changes (mutations) in HIV's structure to occur. Some mutations will prevent Zerit from working against HIV. Many of these mutations will also prevent Retrovir (zidovudine) from working against HIV. Some mutations can also prevent all of the NRTIs from working against HIV. If your viral load does not go undetectable or becomes detectable (and increases) while you are taking an HIV drug regimen that contains Zerit, your doctor can order a drug-resistance test to determine if your HIV has mutations that are causing resistance to Zerit and to help you figure out which NRTIs your HIV is still sensitive to.

What about drug interactions?
• Zerit should not be combined with Retrovir. They are "antagonistic," which means that they do not work well together and can cause additional side effects.
• Zerit should not be combined with ribavirin (Rebetol; Copegus). Ribavirin is an oral medication used to treat hepatitis C. Ribavirin can affect the way Zerit is broken down by the body into its active form. This can make Zerit less effective against HIV.
•Methadone, a painkiller used to treat heroin addiction, can decrease Zerit levels in the bloodstream. Drug levels of methadone are not changed when combined with Zerit. There is no need to change the dose of either drug if they are used together.
• Combining Zerit with Videx EC, another NRTI, may increase the risk of developing lactic acidosis and other side effects. This is especially true in HIV-positive pregnant women who take both of these drugs together. In turn, the U.S. Food and Drug Administration (FDA) has recommended that HIV-positive women not take these two drugs together while they are pregnant. The Department of Health and Human Services (DHHS) recommends that all HIV-infected adults and children avoid using these drugs together.
• Combining Zerit with Videx EC may increase the risk of developing peripheral neuropathy, a side effect caused by both drugs. The Department of Health and Human Services (DHHS) recommends that all HIV-infected adults and children avoid using these drugs together.

What about side effects?
• Lactic acidosis, which can be fatal, and severe liver problems (fatty liver) have been reported in people taking NRTIs. Studies have demonstrated that Zerit is more likely than other NRTIs to cause lactic acidosis, though it is still considered to be a rare side effect. The risk of lactic acidosis increases if Zerit is taken in combination with Videx/Videx EC (ddI), another NRTI, or in combination with ribavirin (Rebetol; Copegus), an antiviral drug commonly used to treat hepatitis C. Contact your doctor immediately if you experience nausea, vomiting, or unusual or unexpected stomach discomfort; weakness and tiredness; shortness of breath; weakness in the arms and legs; yellowing of the skin or eyes; or pain in the upper stomach area.
• Fatal and nonfatal pancreatitis (inflammation of the pancreas) has occurred with Zerit when taken in combination with Videx and other HIV drugs. Symptoms of pancreatitis include stomach pain, nausea, or vomiting. If you notice these symptoms, stop taking Zerit, and call your doctor right away.
• A common side effect of Zerit is peripheral neuropathy, which can result in pain, tingling, numbness, or burning in the hands and/or feet. Stopping Zerit and starting another nucleoside reverse transcriptase inhibitor (NRTI) that does not usually cause peripheral neuropathy—for example, Retrovir or Ziagen (abacavir)—is often the best way to stop peripheral neuropathy.
•Less common side effects include allergic reactions, loss of appetite, bone pain (arthralgia), stomach upset, headache, problems sleeping, muscle pain (myalgia), diarrhea, nausea, vomiting, anemia, and pancreatitis. These side effects improve within a few months/weeks of starting Zerit.
•There has been some concern that Zerit might cause, or at least contribute to, changes in body fat (lipodystrophy), most notably a loss of fat in the arms, legs, and face (lipoatrophy). A number of studies have demonstrated that Zerit is more likely to cause this problem than other NRTIs, particularly when it is used in combination with a protease inhibitor (protease inhibitors are also believed to cause changes in body fat). If you notice that the layer of fat beneath your skin in your arms, legs, or face appears to be becoming thinner—sunken cheeks and veiny arms and legs are common symptoms—you should discuss this with your doctor. If you and your doctor suspect that Zerit might be to blame, one option might be to stop therapy with Zerit and switch to another nucleoside reverse transcriptase inhibitor (NRTI).

Can pregnant women take Zerit?
•Zerit is classified by the FDA as a pregnancy category C drug. Pregnancy category C means that animal studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. HIV-positive women who become pregnant should discuss the benefits and possible side effects of HIV treatment to help protect their babies from HIV (see our lesson called Family Planning, Pregnancy & HIV).
• It is not known whether Zerit passes into breast milk and what effects it may have on a nursing baby. However, to prevent HIV transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed.

Who should not take Zerit?
• Before taking this medication, tell your doctor if you have: kidney disease; liver disease; a history of pancreatitis; a history of anemia; a history of lactic acidosis or elevated lactate levels; a history of peripheral neuropathy. You may not be able to take Zerit, or you may require lower doses or special monitoring during treatment, if you have any of these conditions.

Where can I learn more about clinical trials that are using Zerit?
•If you would like to find out if you are eligible for any clinical trials that include Zerit, there is an interactive web site run by ACRIA, the AIDS Community Research Initiative of America.
•Another useful service for finding clinical trials is AIDSinfo.nih.gov, a site run by the U.S. National Institutes of Health. They have "health information specialists" you can talk to at their toll-free number at 1-800-HIV-0440 (1-800-448-0440).

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 详细处方信息以本药内容附件PDF文件(201232718440917.pdf)的“原文Priscribing Information”为准
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更新日期: 2012-3-28
附件:


201232718440917.PDF    

 
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