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  药店国别: 印度药房
产地国家: 印度
所属类别: 神经系统药物->抗经神病药物
处方药:处方药
包装规格: 100毫克/片 10片/盒
计价单位:
  点击放大  
该药品相关信息网址1:
http://www.rxlist.com/seroquel-drug-center.htm
该药品相关信息网址2:
http://www.drugs.com/monograph/quetiapine-fumarate.html
原产地英文商品名:
ADEQUET 100mg/Tablet 10Tablets/box
原产地英文药品名:
QUETIAPINE FUMARATE
中文参考商品译名:
ADEQUET 100毫克/片 10片/盒
中文参考药品译名:
富马酸喹硫平
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Schizophrenia
英文适应病症2:
Acute manic episodes
临床试验期:
完成
中文适应病症参考翻译1:
精神分裂症
中文适应病症参考翻译2:
急性狂躁发作
药品信息:

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 详细处方信息以本药内容附件PDF文件(2010101018290034.pdf)的“原文Priscribing Information”为准
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部分中文喹硫平处方资料(仅供参考)

【英文名】
Quetiapine fumarate

【药效学特征】
  喹硫平是一种不典型抗精神病药物,对多种神经递质受体有相互作用。在脑中,喹硫平对五羟色胺(5HT2)受体具有高度亲和力,且大于对脑中多巴胺D1和多巴胺D2受体的亲和力。喹硫平对组织胺受体和肾上脉腺素能∝1受体同样有高亲和力,对肾上腺素能∝2受体亲和力低,但对胆碱能毒蕈碱样受体或苯二氮卓受体基本没有亲和力。喹硫平对抗精神病药物活性测定如条件回避反射呈阳性结果。

【不良反应】
  喹硫平短期对照试验中所报告的最常见和最显著的不良事件为:困倦(17.5%),头晕(10%),便秘(9%),体位性低血压(7%),口干(7%),以及肝酶异常(6%)。
  与其它具有α1肾上腺素能阻断作用的抗精神病药物一样,喹硫平片可能导致直立性低血压(伴有头晕),心悸,某些病人会有晕厥;这些事件易发生于开始的剂量增加期。
  偶有报道服用喹硫平片的病人出现癫痫,但其发生率并不高于安慰剂组。
  与其它抗精神病药物一样,用喹硫平片治疗的病人罕见有神经阻滞剂恶性综合征。
  与其它抗精神病药物一样,服用喹硫平片会伴有白细胞计数改变,在临床对照试验中所报告的发生率为1.6%。偶尔有嗜酸性粒细胞增加的报道。
  在服用喹硫平片的某些病人曾观察到出现无症状的血清转氨酶(ALT,AST)或 ψ-GT水平增高。这种增高通常在继续喹硫平片治疗过程中恢复。在喹硫平片治疗过程中曾观察到有非空腹状态下血清甘油三酯和总胆固醇水平轻微升高现象。
  喹硫平片治疗可伴有轻微的与剂量有关的甲状腺激素水平下降,尤其是总T4和游离T4。几乎所有的病人在停用喹硫平后其对总T4和游离T4的影响可以恢复.

【药代学特征】
  喹硫平口服后吸收良好,代谢完全。人类血浆中主要的代谢产物不具有明显的药理学活性。
  进食对喹硫平的生物利用度无明显影响。喹硫平的小分队半衰期大约为7小时。83%的喹硫平与血浆蛋白结合。
  临床试验证实,每日两次给药时喹硫平是有效的。正电子发射断层摄影术(PET)研究资料进一步证实,该药对5HT2和D2受体的占据作用在给药后可持续12小时。喹硫平的药代动力学是线性的,男女无差别。
  老年愉喹硫平的平均清除率较18-65岁成年人低30-50%。严重肾损害(肌酐清除率低于30ml/min/1.73m2)和肝损害(稳定性酒精性肝硬化)的患者,喹硫平的平均血浆清除率可下降约25%,但个体清除率值都在正常人群范围之内。
  喹硫平代谢较完全,服用放射性标记的喹硫平后尿或粪便中原型化合物仅占未改变的药物相关物质的5%以下。大约73%的放射性活性物从尿中排出,21%从粪便中排出。
  离体研究证实喹硫平的主要代谢酶为细胞色素P450酶系统的CYP3A4。
  喹硫平及其几种代谢产物是细胞色素P450酶1A2,2C9,2C19,2D6和3A4的弱抑制剂,但只在高于300-450毫克/日的人类有效剂量范围的10-50倍的深度时才出现。根据这些离体研究结果,喹硫平与其它药物合用时不易导致具有临床意义的与细胞色素P450酶相关的药物抑制作用。

【适应症】
  用于治疗精神分裂症。

【服用方法】
  应每日两次给药,饭前饭后均可。
  成人 :前4天治疗期的日总剂量为50毫克(第一日),100毫克(第二日),200毫克(第三日)和300毫克(第四日)。从第四日以后,将近剂量逐渐增加到有效剂量范围,一般为300-450毫克/日。可根据病人的临床反应和耐受性将剂量在150-750毫克/日之间调整。
  肾脏和肝脏损害 :口服喹硫平后的清除率在肾脏和肝脏损伤的病人中下降约25%。喹硫平在脏用词不当中代谢广泛,因此就在慎用于肝脏损害的患者。有肾脏或肝脏损害的病人,喹硫平的开始剂量应为25毫克/日。随后每日增加剂量,幅度为25-50毫克,直到有效剂量。

【禁忌症】
  禁用于对该产品的任何成分过敏的病人。

【注意事项】
心血管疾病
  可能会导致直立性低血压,尤其是在最初的加药期;在老年患者中上述现象较年轻患者多见。在临床试验中,使用喹硫平不伴发持久性QTc间期的延长。但与其它抗精神病药一样,如果效喹硫平与其它已知会延长QTc间期的药物合用时就在当谨慎,尤其是用于老年人时。
  应慎用于已知有心血管疾病、脑血管疾病或其它有低血压倾向的病人。
抽搐
  在临床对照试验中,服用此药的病人的抽搐发生率与服用安慰剂的病人无区别。与其它抗精神病药物一样,当用于治疗有抽搐病史的患者时应予以注意。
神经阻滞剂恶性综合征
  抗精神病药物治疗会伴发神经阻滞剂恶性综合征。临床表现包手高热、精神状态改变、肌肉强直、植物神经功能紊乱以及肌酸磷酸激酶活性增加。若出现此种情况,应停用“思瑞康”并给予适当的治疗。
迟发性运动障碍
  与其它抗精神病药物一样,长期服用此药治疗也有导致迟发性运动障碍的可能性。如果出现迟发性运动障碍的体征和症状,应考虑减少喹硫平剂量或停用。
  由于此药可能会导致困倦。因此对操纵危险机器包括开车的病人应予提醒。

【孕妇及哺乳】
妇女用药
  此药用于人类妊娠时的疗效和安全性尚未肯定(对动物的生殖毒性资料见临床前案例性资料一节的生殖研究部分)。因此,只有在获益大于潜在危险的情况下喹硫平才能用于妊娠中的患者。
  喹硫平在人类乳汁中的排泄情况尚不清楚。哺乳妇女若服用喹硫平应劝其在服药期间中断哺乳。
儿童用药
  喹硫平用于儿童和青少年的安全性和有效性尚未进行评价。
老年患者用药
  与其它抗精神病药物一样,喹硫平用于老年人也应慎彼一时,尤其在开始用药时。老年人的起始剂量应为25毫克/日。每日增加剂量,幅度为25-50毫克,直到有效剂量。有效剂量可能较一般年轻病人低。

【药物相互作用】
  由于喹硫平主要具有中枢神经系统作用,喹硫平在与其它作用于中枢的药物或酒精合用时应当谨慎。
  喹硫平与锂合用不会影响锂的药代动力学。
  喹硫平不会诱导与安替比林代谢有关的肝脏酶系统。喹硫平和苯妥英(一种微粒体酶诱导剂)合用可增加喹硫平的清除率。如果效喹硫平与苯妥英或其它肝酶诱导剂(如卡马西平、巴比妥类、利福平)合用,为保持抗精神病症状的效果,应增加喹硫平的剂量。如果停用苯妥曲并换用一种非诱导剂(如丙戊酸钠),则喹硫平的剂量需要减少。合用抗精神病药物利培酮或氟哌啶醇不会显著改变喹硫平的药代动力学。但喹硫平与硫利达嗪合用时会增加喹硫平的清除率。
  与抗抑郁药丙米嗪(一种已知的CYP2D6抑制剂)或氟西汀(一种已知的CYP3A4和CYP2D6抑制剂)合用不会显著改变喹硫平的药代动力学。
  在细胞色素酶P450中,介导喹硫平代谢的主要酶类为CYP3A4。与西咪替丁(CIMETIDINE)或氟西汀(两种药物都是已知的P450酶抑制剂)合用不会改变喹硫平的药代动力学。但是喹硫平与CYP3A4的强抑制剂[如全身应用的酮康只唑(KETOCONAZOLE)或红霉素]合用需谨慎。

【药物过量】
  在临床试验中,对于喹硫平过量的经验不多。有人曾服用过10克喹硫平,未致死,而且病人完全恢复,无后遗症。
  一般情况下,所报告的症状和体征是该药的已知药理学作用的增加,即困倦和镇静,心悸和低血压。
  喹硫平无特异性解毒剂。遇到严重中毒的病人,应考虑多种药物介入的可能性,并建议采取积极的监护措施,包括开辟良好的气道,保证适当的氧气供应和呼吸,并且监测和维持心血管系统功能。
  应采取严密的医疗监护和监测,直到病人恢复。

【储藏】
  应贮存于30℃以下

Quetiapine
Quetiapine ( /kwɨˈtaɪ.əpiːn/ kwi-TY-ə-peen) (branded as Seroquel, Ketipinor), is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder and as an add-on to treat depression.

Annual sales are approximately $5.7 billion worldwide, and $2.9 billion in the United States.The U.S. patent,which was set to expire in 2011, received a pediatric exclusivity extension which pushed its expiration to March 26, 2012.The patent has already expired in Canada. There are now several generic versions of quetiapine, such as Quepin.

Medical uses
Quetiapine (Seroquel) 25 mg tablets, next to US one-cent coin for comparison.Quetiapine fumarate is used to treat either schizophrenia or bipolar disorder.

Schizophrenia
It is debatable whether, as a class, typical or atypical antipsychotics are better. Both have equal drop-out and symptom relapse rates when typicals are used at low to moderate dosages.

Bipolar disorder
In those with bipolar disorder, it is used for depressive episodes, acute manic episodes associated with bipolar I disorder (as either monotherapy or adjunct therapy to lithium, valproate or lamotrigine), and maintenance treatment of bipolar I disorder (as adjunct therapy to lithium or divalproex).

Alzheimer's
Quetiapine is ineffective in reducing agitation among people with Alzheimer's, whose usage of the drug once constituted 29% of sales. Quetiapine worsens cognitive functioning in the elderly with dementia and therefore is not recommended.

Other
It is sometimes used off-label, often as an augmentation agent, to treat conditions such as obsessive-compulsive disorder, post-traumatic stress disorder, autism, alcoholism, borderline personality disorder, depression,Tourette syndrome, and has been used by physicians as a sedative for those with sleep disorders or anxiety disorders.

Adverse effects
The most common side-effect of quetiapine is somnolence. Other common side-effects include: sluggishness, fatigue, dry mouth, sore throat, dizziness, abdominal pain, constipation, upset stomach, orthostatic hypotension, inflammation or swelling of the sinuses or pharynx, increased appetite, and weight gain.

There is an emerging controversy regarding quetiapine fatalities. The deaths of at least six U.S. military veterans who were given drug cocktails including quetiapine [15] have been attributed to its inclusion by military doctors to treat PTSD. Approximately 10,000  lawsuits against AstraZeneca for problems ranging from slurred speech and chronic insomnia to death have been experienced by individuals from civilian populations.

It is marketed as one of the most sedating of all anti-psychotics, although those claims are contested.Beginning users may feel extremely tired and 'out of it' for the first few days, and sometimes longer. Quetiapine's newest indication, for bipolar depression, usually specifically calls for the entire dose to be taken before bedtime due to its sedative effects. The sedative effects may disappear after some time on the drug, or with a change of dosage, and with possibly different, non-sedative side-effects emerging.

Both typical and atypical antipsychotics can cause tardive dyskinesia. According to one study, rates are lower with the atypicals at 3.9% as opposed to the typicals at 5.5%. Although Quetiapine and Clozapine are atypical antipsychotics, switching to these atypicals is an option to minimize symptoms of tardive dyskinesia caused by other atypicals.

Weight gain can be a problem for some patients. Quetiapine has been found to cause more weight gain than fluphenazine, haloperidol, loxapine, molindone, olanzapine, pimozide, risperidone, thioridazine, thiothixene, trifluoperazine, and ziprasidone, but less than chlorpromazine, clozapine, perphenazine, and sertindole when calculated according to a fixed effects model.

Studies conducted on beagles have resulted in the formation of cataracts. While there are reports of cataracts occurring in humans, controlled studies including thousands of patients have not demonstrated a clear causal association between quetiapine therapy and this side-effect.[citation needed] However, the Seroquel website
still recommends users have eye examinations every six months.

As with some other anti-psychotics, quetiapine may lower the seizure threshold, and should be taken with caution in combination with drugs such as bupropion.

A recent comparative study of anti-psychotics drugs has found that quetiapine mono treatment was associated with increased risk of death relative to the other analyzed treatments (but still better than no anti-psychotics drug treatment at all).

Discontinuation
Quetiapine should be discontinued gradually, with careful consideration from the prescribing doctor, to avoid withdrawal symptoms or relapse.

The British National Formulary recommends a gradual withdrawal when discontinuing anti-psychotic treatment to avoid acute withdrawal syndrome or rapid relapse. Due to compensatory changes at dopamine, serotonin, adrenergic and histamine receptor sites in the central nervous system, withdrawal symptoms can occur during abrupt or over-rapid reduction in dosage. However, despite increasing demand for safe and effective antipsychotic withdrawal protocols or dose-reduction schedules, no specific guidelines with proven safety and efficacy are currently available.

Withdrawal symptoms reported to occur after discontinuation of antipsychotics include nausea, emesis, lightheadedness, diaphoresis, dyskinesia, orthostasis, tachycardia, nervousness, dizziness, headache, excessive non-stop crying, and anxiety. These withdrawal symptoms may be caused by irregularities in oxytocin levels. Some have argued that additional somatic and psychiatric symptoms associated with dopaminergic super-sensitivity, including dyskinesia and acute psychosis, are common features of withdrawal in individuals treated with neuroleptics. This has led some to suggest that the withdrawal process might itself be schizo-mimetic, producing schizophrenia-like symptoms even in previously healthy patients, indicating a possible pharmacological origin of mental illness in a yet unknown percentage of patients currently and previously treated with antipsychotics. This question is unresolved, and remains a highly controversial issue among professionals in the medical and mental health communities, as well the public.

Overdosage
Most instances of acute overdosage result only in sedation, hypotension and tachycardia, but cardiac arrythmia, coma and death have occurred in adults. Serum or plasma quetiapine concentrations are usually in the 1–10 mg/L range in overdose survivors, while postmortem blood levels of 10–25 mg/L are generally observed in fatal cases.

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 详细处方信息以本药内容附件PDF文件(2010101018290034.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

 

更新日期: 2012-5-29
附件:


2010101018290034.pdf    

 
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