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利培酮片|RISPERDAL(Risperidone TABLETS)

2012-10-10 06:46:46  作者:新特药房  来源:中国新特药网天津分站  浏览次数:690  文字大小:【】【】【
简介: 【中文品名】利培酮【药效类别】抗精神病药【通用药名】RISPERIDONE【别  名】【化学名称】 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido ...

部分中文RISPERDAL处方信息(仅供参考)
通用名称:利培酮
英文名称:Risperidone
规格
利培酮口服液:1mg/ml。
利培酮片:0.25mg;0.5mg;1mg;2mg;3mg;4mg。
利培酮口腔崩解片(生产厂家: Janssen-Ortho):0.5mg;1mg;2mg。
药物特点
1.疗效显著,能有效治疗精神分裂症阳性症状和阴性症状患者。
本品对于有幻觉、妄想、思维障碍的精神分裂症阳性症状的患者,疗效尤为显著;对于情感退缩、情感迟钝、言语缺乏的精神分裂症阴性症状的治疗也有较好的效果。
Joseph等关于513例精神分裂症患者用利培酮、氟哌啶醇和安慰剂组治疗疗效的比较研究。
结果显示利培酮和氟哌啶醇组疗效均超过安慰剂组,两者治疗阳性症状效果相当;对阴性症状的患者,用利培酮有显著疗效,而用氟哌啶醇疗效不明显。而且用利培酮治疗的病人,起效时间大多在前2周内,较氟哌啶醇快。
2.适应症广,对其他精神性疾病也有较好效果。
利培酮对5-HT2和D2受体均有较高的亲和力。以前的研究显示利培酮主要用于精神分裂症治疗,但根据它的药理作用和安全性,其治疗范围有可能进一步扩大。最近经多项相关临床试验发现,应用利培酮治疗情感性障碍、少年儿童抽动秽语综合征(Tourette 综合征)、精神发育迟滞的行为紊乱和迟发性运动障碍(TD)有较好疗效。
3.作用维持时间长。
主要代谢物为9- 羟基利培酮,同样具有药理活性。本品及活性代谢物在体内的代谢周期长,t1/2β分别为2.8和24.6小时,因此可以长期发挥作用。
4.副作用小,耐受性好。 利培酮的锥体外系副作用比传统的抗精神病药物氟哌啶醇等要小得多,锥体外系副反应和粒细胞缺乏症少见,耐药性比氟哌啶醇等药物好。其他研究显示,在体重增加、体位性高血压等不良反应均较其他抗精神病药物低。长期使用时,迟发性运动障碍也比经典的神经阻断剂明显降低。
技术优势: 独家的口腔崩解片剂型,服用置于舌上,遇唾液几借助舌与上颚的摩擦可迅速溶解或崩解,不需用水也无需咀嚼,而且溶解吸收迅速服后就无法吐出。因此更适合于幼儿、老年人、卧床不能改变体位者及服药不配合的精神病患者。 
适应症
用于治疗精神分裂症并延缓其复发。
用法用量
用药时将片剂置舌上用水或不饮水(崩解片)让其完全溶解。
本品的用法为一天两次或一天一次。常用剂量:首剂1mg (一片),一天两次,如果能够耐受的话,第二天和第三天以每次1mg ,一天两次的频率增加。第三天达到目标剂量:每次3mg ,一天两次。
有些患者可能需要缓慢加量。每次8mg,每天一次的疗法也是安全和有效的。
调整剂量的时间不应少于一周,每次增减 1-2mg 。
任何疑问,请遵医嘱!


RISPERDAL TABLETS Rx
BOXED WARNING
Elderly patients w/ dementia-related psychosis treated w/ antipsychotic drugs are at an increased risk of death. Not approved for the treatment of patients w/ dementia-related psychosis.
Mood disorders 
Psychosis  Only 4 drugs may be compared at once
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Generic Name and Formulations:
Risperidone 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg.
Company:
Janssen Pharmaceuticals, Inc.
Select therapeutic use: Mood disorders
Psychosis
Indications for RISPERDAL TABLETS:
Monotherapy in adults and children/adolescents (10–17yrs old) for short-term treatment of acute manic or mixed episodes associated with bipolar I disorder, or in combination with lithium or valproate in adults. Irritability associated with autistic disorder in children/adolescents (5–17yrs old).
Adult:
Initially 2–3mg once daily; may adjust at intervals of at least 24hrs by 1mg/day. Usual range: 1–6mg/day; max 6mg/day. Elderly, debilitated, hypotensive, severe renal or hepatic impairment: 0.5mg twice daily; adjust in increments of up to 0.5mg twice daily; titrate at intervals of at least 1 week if exceeding 1.5mg twice daily; may switch to once-daily dosing after titration. For all: re-evaluate periodically; withdraw gradually. Oral soln: do not give with cola, tea. M-Tabs: dissolve on tongue; swallow with or without liquid.
Children:
Bipolar mania: <10yrs: not established. ≥10yrs: Initially 0.5mg once daily (AM or PM); may adjust at intervals of at least 24hrs by 0.5mg–1mg/day to target doses of 1–2.5mg/day. Usual range: 1–6mg/day; max 6mg/day. If somnolence occurs: give ½ daily dose twice daily. Irritability w. autism: <5yrs: not recommended. ≥5yrs: Give as a single daily dose or ½ total daily dose twice daily. <20kg: initially 0.25mg/day; may increase to 0.5mg/day after ≥4 days. Maintain dose for ≥14 days; if no response, may increase at ≥2 week intervals in increments of 0.25mg/day. ≥20kg: initially 0.5mg/day; may increase to 1mg/day after ≥4 days. Maintain dose for ≥14 days; if no response, may increase at ≥2 week intervals in increments of 0.5mg/day. Usual range: 0.5–3mg/day. If somnolence occurs, give once daily dose at bedtime, or ½ daily dose twice daily, or reduce dose. <15kg: use cautiously. For all: re-evaluate periodically.
Contraindications:
Hypersensitivity to paliperidone.
Warnings/Precautions:
Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Discontinue if neuroleptic malignant syndrome (NMS) occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease; increased risk with metabolic changes (eg, hyperglycemia, dyslipidemia, weight gain); monitor. Diabetes risk factors (obtain baseline and periodic fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia: monitor CBCs during 1st few months of therapy; discontinue if WBCs decline. Orthostatic hypotension. History of seizures. Risk of aspiration pneumonia. Exposure to extreme temperatures. Parkinson's disease. Dementia with Lewy bodies. Renal or hepatic dysfunction. Phenylketonuria (M-Tabs). Write ℞ for smallest practical amount. Reevaluate periodically. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions:
Caution with alcohol, or other CNS drugs. May potentiate antihypertensives. May antagonize levodopa, dopamine agonists. Clearance may be decreased by clozapine; may be increased by carbamazepine, other enzyme inducers (eg, phenytoin, rifampin, phenobarbital); adjust risperidone dose. May be affected by fluoxetine or paroxetine (max risperidone dose: 8mg/day), or others that affect CYP isoenzymes. Monitor valproate.
See Also:
RISPERDAL M-TABS
RISPERDAL ORAL SOLUTION
Pharmacological Class:
Atypical antipsychotic (benzisoxazole deriv.).
Adverse Reactions:
Parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, abdominal pain, dyspepsia, diarrhea, increased saliva, constipation, dry mouth, increased appetite or weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, pharyngolaryngeal pain; orthostatic hypotension, tardive dyskinesia, NMS, hyperprolactinemia, priapism, leukopenia/neutropenia, agranulocytosis.
How Supplied:
Tabs 0.25mg, 0.5mg, 1mg, 2mg, 3mg—60, 500; 4mg—60; Oral soln—30mL (w. pipette); M-Tabs—28
Indications for RISPERDAL TABLETS:
Schizophrenia.
Adult:
Give once daily or in 2 divided doses. Initially 2mg/day; may adjust at intervals of at least 24hrs by 1–2mg/day to target dose of 4–8mg/day. Usual range: 4–16mg/day; max 16mg/day. Elderly, debilitated, hypotensive, severe renal or hepatic impairment: 0.5mg twice daily; adjust in increments of up to 0.5mg twice daily; titrate at intervals of at least 1 week if exceeding 1.5mg twice daily; may switch to once-daily dosing after titration. For all: reassess periodically; withdraw gradually. Oral soln: do not give with cola, tea. M-Tabs: dissolve on tongue; swallow with or without liquid.
Children:
<13yrs: not established. ≥13yrs: initially 0.5mg once daily (AM or PM); may adjust at intervals of at least 24hrs by 0.5mg–1mg/day to target dose of 3mg/day. Usual range: 1–6mg/day; max 6mg/day. If somnolence occurs: give ½ daily dose twice daily.
Contraindications:
Hypersensitivity to paliperidone.
Warnings/Precautions:
Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Discontinue if neuroleptic malignant syndrome (NMS) occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease; increased risk with metabolic changes (eg, hyperglycemia, dyslipidemia, weight gain); monitor. Diabetes risk factors (obtain baseline and periodic fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia: monitor CBCs during 1st few months of therapy; discontinue if WBCs decline. Orthostatic hypotension. History of seizures. Risk of aspiration pneumonia. Exposure to extreme temperatures. Parkinson's disease. Dementia with Lewy bodies. Renal or hepatic dysfunction. Phenylketonuria (M-Tabs). Write ℞ for smallest practical amount. Reevaluate periodically. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions:
Caution with alcohol, or other CNS drugs. May potentiate antihypertensives. May antagonize levodopa, dopamine agonists. Clearance may be decreased by clozapine; may be increased by carbamazepine, other enzyme inducers (eg, phenytoin, rifampin, phenobarbital); adjust risperidone dose. May be affected by fluoxetine or paroxetine (max risperidone dose: 8mg/day), or others that affect CYP isoenzymes. Monitor valproate.
See Also:
RISPERDAL M-TABS
RISPERDAL ORAL SOLUTION
Pharmacological Class:
Atypical antipsychotic (benzisoxazole deriv.).
Adverse Reactions:
Parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, abdominal pain, dyspepsia, diarrhea, increased saliva, constipation, dry mouth, increased appetite or weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, pharyngolaryngeal pain; orthostatic hypotension, tardive dyskinesia, NMS, hyperprolactinemia, priapism, leukopenia/neutropenia, agranulocytosis.
How Supplied:
Tabs 0.25mg, 0.5mg, 1mg, 2mg, 3mg—60, 500; 4mg—60; Oral soln—30mL (w. pipette); M-Tabs—28
STORAGE
20-25°C (68-77°F). Risperdal/Risperdal M-Tab: 15-25°C (59-77°F). Oral Sol: Protect from light and freezing. Tab: Protect from light and moisture.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f2e8b588-fae5-476a-b7c5-f27e72db56e3

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