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马来酸氯氧平Saphris

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马来酸氯氧平Saphris
药品名称:马来酸氯氧平Saphris
药品别名:Saphris
英 文 名:
药品价格:$ 美国市场售价 633.14 美元
研发公司:
适 用 症:适用于精神分裂症的治疗,以及作为用或锂或丙戊酸盐辅助治疗为伴随双极障碍I型躁狂或混合发作的急性治疗。
型号规格:本品为片剂,每片含有效成份5mg/10mg两种规格,每瓶60片装。
药品详情:

【马来酸氯氧平Saphris 简述】
 
    SAPHRIS是一种舌下片。

马来酸氯氧平Saphris_香港济民药业

 
 
【马来酸氯氧平Saphris 适应症】
 
    SAPHRIS适用于精神分裂症的治疗,以及作为用或锂或丙戊酸盐辅助治疗为伴随双极障碍I型躁狂或混合发作的急性治疗。
 
【马来酸氯氧平Saphris 规格】
 
    本品为片剂,每片含有效成份5mg/10mg两种规格,每瓶60片装。
 
【马来酸氯氧平Saphris 服用方法】
 
    本品为含片,不建议患者直接吞食、咀嚼或压碎,建议患者在给药后10分钟内不要进食。
 
    推荐起始用量为每天2次,每次5mg。具体用药量请咨询您的主治医师。
 
【马来酸氯氧平Saphris 注意事项】
 
    精神分裂症患者中用SAPHRIS维持试验证实疗效。在此研究中起始剂量是5 mg每天2次1周后根据耐受性增加至10 mg每天2次[见临床试验(14.1)]。虽然目前没有证据可以回答精神分裂患者应保持用SAPHRIS如何长时间的问题,应定期再次评估患者以确定维持治疗的需要。
 
【马来酸氯氧平Saphris 不良反应】
 
    在安慰剂对照的临床治疗高血压或心绞痛的试验中,最常见的副作用是头痛,水肿,疲劳,嗜睡,恶心,腹痛,潮红,心悸和眩晕。在这些临床试验中未发现有与本品相关的临床检验指标异常。
 
  观察到较少的副作用有秃头症,大便习惯改变。关节痛,衰弱,背痛,消化不良,呼吸困难,牙龈增生,男子乳房女性化,高血糖症,阳痿,尿频,白血球减少症,全身不适,情绪变化,口干,盗汗,痉挛,肌痛,周围神经病变,胰腺炎,出汗增加,晕厥,血小板减少症,血管炎和视觉障碍,在多数情况下,上述改变与本品的因果关系尚未确定。
 
  过敏反应罕见,包括:搔痒,皮疹,血管性水肿和多型红斑。
 
  曾有极罕见的肝炎,黄疸,肝酶升高的报道(通常与胆汁淤积相一致,某些因病情较重住院的病例据报道与使用氨氯地平相关。在许多情况下,其因果关系不能确定)
 
  与其他的钙拮抗剂相似,以下的不良事件也有少数报道,但事件难以与基础疾病的自然病程相区分,如:心肌梗死,心律失常(包括室性心动过速和房颤)以及胸痛。

 
Saphris(Asenapine)

 
Asenapine, sold under the trade names Saphris and Sycrest among others, is an atypical antipsychotic medication used to treat schizophrenia and acute mania associated with bipolar disorder.
 
It was chemically derived via altering the chemical structure of the tetracyclic (atypical) antidepressant, mianserin.[5]
 
Medical uses
 
Asenapine has been approved by the FDA for the acute treatment of adults with schizophrenia and acute treatment of manic or mixed episodes associated with bipolar Idisorder with or without psychotic features in adults.[6] In Australia asenapine's approved (and also listed on the PBS) indications include the following:[7]
 
§  Schizophrenia
§  Treatment, for up to 6 months, of an episode of acute mania or mixed episodes associated with bipolar I disorder
§  Maintenance treatment, as monotherapy, of bipolar I disorder
In the European Union and the UK asenapine is only licensed for use as a treatment for acute mania in bipolar I disorder.[3][4]
Absorbed readily if administered sublingually, asenapine is poorly absorbed when swallowed.[8]
 
Schizophrenia
 
There is only weak evidence supporting the use of Asenapine for treating schizophrenia, making it hard to recommend.[9]
 
Acute mania
 
As for its efficacy in the treatment of acute mania, a recent meta-analysis showed that it produces comparatively small improvements in manic symptoms in patients with acute mania and mixed episodes than most other antipsychotic drugs (with the exception of ziprasidone) such as risperidone and olanzapine. Drop-out rates (in clinical trials) were also unusually high with asenapine.[10] According to a post-hoc analysis of two 3-week clinical trials it may possess some antidepressant effects in patients with acute mania or mixed episodes.[11]
 
Adverse effects
 
Adverse effect incidence[1][2][3][4]
Note: The discussion below these lists provides some more context into the frequency and severity of these adverse effects.
Very common (>10% incidence) adverse effects include:
§  Somnolence
Common (1-10% incidence) adverse effects include:
§  Weight gain
§  Increased appetite
§  Extrapyramidal side effects (EPS; such as dystonia, akathisia, dyskinesia, muscle rigidity, parkinsonism)
§  Sedation
§  Dizziness
§  Dysgeusia
§  Oral hypoaesthesia
§  Increased alanine aminotransferase
§  Fatigue
Uncommon (0.1-1% incidence) adverse effects include:
§  Hyperglycaemia — elevated blood glucose (sugar)
§  Syncope
§  Seizure
§  Dysarthria
§  Sinus bradycardia
§  Bundle branch block
§  QTc interval prolongation (has a relatively low risk for causing QTc interval prolongation.[13][14])
§  Sinus tachycardia
§  Orthostatic hypotension
§  Hypotension
§  Swollen tongue
§  Dysphagia (difficulty swallowing)
§  Glossodynia
§  Oral paraesthesia
Rare (0.01-0.1% incidence) adverse effects include:
§  Neuroleptic malignant syndrome (Combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness, and sudden change in blood pressure and heart rate)
§  Tardive dyskinesia
§  Speech disturbance
§  Rhabdomyolysis
§  Angioedema
§  Blood dyscrasias such as agranulocytosis, leukopenia and neutropenia
§  Accommodation disorder[clarification needed]
§  Pulmonary embolism
§  Gynaecomastia
§  Galactorrhoea
Unknown incidence adverse effects
§  Allergic reaction
§  Restless legs syndrome
§  Nausea
§  Oral mucosal lesions (ulcerations, blistering and inflammation)
§  Salivary hypersecretion
§  Hyperprolactinaemia
 
Asenapine seems to have a relatively low weight gain liability for an atypical antipsychotic (which are notorious for their metabolic side effects) and according to a recent meta-analysis it produces significantly less weight gain (SMD [standard mean difference in weight gained in those on placebo vs. active drug]: 0.23; 95% CI: 0.07-0.39) than, paliperidone (SMD: 0.38; 95% CI: 0.27-0.48), risperidone (SMD: 0.42; 95% CI: 0.33-0.50), quetiapine (SMD: 0.43; 95% CI: 0.34-0.53), sertindole (SMD: 0.53; 95% CI: 0.38-0.68), chlorpromazine (SMD: 0.55; 95% CI: 0.34-0.76), iloperidone (SMD: 0.62; 95% CI: 0.49-0.74), clozapine (SMD: 0.65; 95% CI: 0.31-0.99), zotepine (SMD: 0.71; 95% CI: 0.47-0.96) and olanzapine (SMD: 0.74; 95% CI: 0.67-0.81) and approximately (that is, no statistically significant difference at the p=0.05 level) as much as weight gain as aripiprazole (SMD: 0.17; 95% CI: 0.05-0.28), lurasidone (SMD: 0.10; 95% CI: –0.02-0.21), amisulpride (SMD: 0.20; 95% CI: 0.05-0.35), haloperidol (SMD: 0.09; 95% CI: 0.00-0.17) and ziprasidone (SMD: 0.10; 95% CI: –0.02-0.22).[15] Its potential for elevating plasma prolactin levels seems relatively limited too according to this meta-analysis.[15] This meta-analysis also found that asenapine has approximately the same odds ratio (3.28; 95% CI: 1.37-6.69) for causing sedation [compared to placebo-treated patients] as olanzapine (3.34; 95% CI: 2.46-4.50]) and haloperidol (2.76; 95% CI: 2.04-3.66) and a higher odds ratio (although not significantly) for sedation than aripiprazole (1.84; 95% CI: 1.05-3.05), paliperidone (1.40; 95% CI: 0.85-2.19) and amisulpride (1.42; 95% CI: 0.72 to 2.51) to name a few and is hence a mild-moderately sedating antipsychotic.[15] Being a second-generation (atypical) antipsychotic its liability for causing extrapyramidal side effect is comparatively low compared to first-generation antipsychotics such as haloperidol as is supported by the aforementioned meta-analysis (although this meta-analysis did reveal it had a relatively high EPS liability for an atypical antipsychotic drug).[15]
 
 




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