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Information on Modecate

INDICATIONS
MODECATE is indicated in the management of manifestations of psychotic disorders. It is of particular value in the treatment of chronic schizophrenia. It is not only useful in the hospital milieu, but is useful because of its long duration of action in the long-term maintenance therapy of chronically psychotic patients who are amenable to out-patient therapy.

CONTRA-INDICATIONS
Patients with suspected or established parkinsonism. Phenothiazine compounds should not be used in patients receiving large doses of hypnotics.
In comatose or severely depressed states.
The presence of blood dyscrasia or liver damage precludes the use of phenothiazines.
In patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.
Pregnancy and lactation, as safety has not been established.
Safety and efficacy in children have not been established.
Patients exposed to organophosphate insecticides.

DOSAGE AND DIRECTIONS FOR USE
The usual adequate dosage of fluphenazine decanoate is 25 mg (1 mL) every three to four weeks. If necessary, adjustments in the amount and the dosage interval may be made in accordance with the patient's response.
The optimal amount of the drug and the frequency of administration must be determined for each patient, since dosage requirements have been found to vary with clinical circumstances as well as with individual response to the drug. Although in a large series of patients the optimal dose was usually 25 mg (1 mL) every three to four weeks, the amount required ranged from 12,5 to 100 mg (0,5 to 4 mL). The interval between doses ranged from two weeks to five weeks in most instances, but some patients required doses as often as once every three days for the first few injections, while the response to a single dose was found to last six weeks or longer in a few patients on maintenance therapy.
For patients who have had no previous therapy, it is advisable to initiate treatment with an oral antipsychotic agent or a quick-acting parenteral antipsychotic. When optimal response has been established, fluphenazine decanoate should be administered every three to four weeks. In switching over to fluphenazine decanoate, the quick-acting antipsychotic agent should be administered concurrently for 3 days, and then discontinued.
For patients on short-acting phenothiazine drugs, fluphenazine decanoate at 25 mg (1 mL) every three to four weeks should be adequate. The previous antipsychotic agent should be administered concurrently for 3 days, and then discontinued.
Severely agitated patients may be treated initially with a rapid-acting phenothiazine compound - see package insert accompanying that product for complete information. When acute symptoms have subsided, 25 mg (1 mL) of MODECATE (fluphenazine decanoate) may be administered; subsequent dosage may be adjusted as necessary.
In 'poor risk' patients (those with known hypersensitivity to phenothiazines, or with disorders that predispose to undue reactions) therapy should be initiated cautiously with a quick-acting antipsychotic agent. When optimal response has been established, fluphenazine decanoate should be administered at 25 mg every three weeks. In switching over to fluphenazine decanoate, the quick acting antipsychotic agent should be administered concurrently for 3 days, and then discontinued.
MODECATE may be administered intramuscularly or subcutaneously. A dry needle and syringe should be used. Use of a wet needle or syringe may cause the solution to become cloudy.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
The use of Modecate may impair the mental and physical abilities required for driving a car or operating machinery.
Potentiation of the effects of alcohol may occur with the use of Modecate.
Because of the possibility of cross-sensitivity, fluphenazine decanoate should be used cautiously in patients who have developed cholestatic jaundice, dermatoses or other allergic reactions to other phenothiazine derivatives.
Psychotic patients on large doses of phenothiazine drug who are undergoing surgery should be watched carefully for possible hypotensive phenomena. Moreover, it should be remembered that reduced amounts of anaesthetics or central nervous system depressants may be necessary.
The effects of anticholinergics may be potentiated in some patients receiving fluphenazine because of added anticholinergic effects.
Fluphenazine decanoate administration could be hazardous in patients exposed to extreme heat, since it may impair body temperature regulation.
The preparation should be used with caution in patients with a history of convulsive disorders, since grand mal convulsions have been known to occur.
Use with caution in patients with special medical disorders such as mitral insufficiency or other cardiovascular diseases as well as pheochromocytoma.
Fluphenazine decanoate may elevate prolactin levels, which persists during chronic administration.
The possibility of liver damage, pigmentary retinopathy, lenticular and corneal deposits, and development of irreversible dyskinesia should be remembered when patients are on prolonged therapy.
Central Nervous System: The side effects most frequently reported with phenothiazine compounds are extrapyramidal symptoms including pseudo-parkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonus, and hyperreflexia. Most often these extrapyramidal symptoms are reversible; however, they may be persistent (see following text). With any given phenothiazine derivative, the incidence and severity of such reactions depend more on individual patient sensitivity than on other factors, but dosage level and patient age are also determinants.
Extrapyramidal reactions may be controlled by administration of anticholinergic drugs and by subsequent reduction in dosage.
Other CNS Effects: Occurrences of Neuroleptic Malignant Syndrome (NMS) have been reported in some patients. Leucocytosis, fever, elevated creatinine phosphokinase (CPK), liver function abnormalities and acute renal failure may also occur with NMS.

STORAGE INSTRUCTIONS
Store at room temperature not exceeding 25°C. Avoid excessive heat. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

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部分中文 Modecate 处方信息（仅供参考）

【商品名称】 保利神 
【药理作用】 本药为长效吩噻嗪类抗精神病药，能阻滞脑内多巴胺能受体，具有强大的中枢安定作用。 
动力学 肌肉注射后，药物从组织缓慢释放，一般于42-72 hr发挥作用，48-96 hr效果最明显，一次注射可有效控制精神分裂症状达4-6周。 
【适应症】 精神病的长期治疗(例如 ：慢性精神分裂症)。
【用法用量】 本药可作肌肉或皮下注射。精神失常 成人 严重躁动的患者最初应给速效复方吩噻嗪类药物，如盐酸氟奋乃嗪注射剂。当急性症状缓解后，给予本药25 mg，随后根据需要调整剂量。对于多数患者，开始治疗时可给予12.5-25 mg。随后的注射次数和剂量间隔应根据患者的反应而定。维持治疗时剂量不应超过100 mg。如认为剂量超过50 mg是必须的，下一个剂量或随后的剂量的增加应谨慎，每次递增量为12.5 mg。老年患者 应给予较低剂量(如上述剂量的1/4-1/3)。没有服用吩噻嗪类药物史的患者，在给本药前应使用短效的氟奋乃嗪(盐酸氟奋乃嗪制剂)，来确定病人对氟奋乃嗪的反应和确定合适的剂量。每日10 mg盐酸氟奋乃嗪相当于每3周12.5 mg的氟奋乃嗪癸烷酸。对吩噻嗪类药物高度敏感，或倾向于过度不协调反应的患者，治疗开始时应小心使用盐酸氟奋乃嗪。当药理作用和恰当剂量已为明了时，可以使用相对应的本药剂量。随后根据患者的反应调整剂量。 
【不良反应】 锥体外系症状包括拟帕金森氏综合征，肌张力障碍，运动障碍，静坐不能，眼球震颤危象，退行步态和反射亢进。这些锥体外系症状大多数是可逆的，并可通过给予抗胆碱药物或抗帕金森氏药物而得到控制(如 ：苯托品)，继而减少剂量得到缓解。迟发性运动障碍综合征，出现不随意手足徐动，舌、面部、嘴或下腭及躯干和肢端的异常活动。为尽早发现此综合征，如果临床情况允许，应定期减量并观察病人运动失调的体征。其它中枢神经系统副作用包括恶性精神抑制性综合征(NMS)，白细胞增多，磷酸肌酸激酶升高，肝功能异常，急性肾衰，嗜睡和昏睡也会发生。一些病人出现不安静、兴奋或怪梦。肌电图或脑脊液蛋白均可发生改变。伴有嗜铬细胞瘤，脑血管或肾功能不全，心储备功能严重不足(如二尖瓣关闭不全)的患者，特别容易发生低血压反应。自主神经反应包括恶心、食欲丧失、流涎、出汗、口干、头痛、便秘，一些病人出现视觉模糊，青光眼，膀胱麻痹，粪便滞留，麻痹性肠梗阻，心动过速及鼻塞。代谢和内分泌方面的副作用有体重增加，外周水肿，男性乳房发育、阳痿，女性性欲改变、月经紊乱。各种皮肤过敏性病变，如瘙痒、荨麻疹、脂溢性皮炎、光过敏、湿疹，但哮喘，喉水肿，血管神经性水肿则罕见。本药可引起血液恶液质，包括白细胞减少，粒细胞缺乏，血小板减少，非血小板减少性紫癜，嗜酸性细胞减少和全血细胞减少。少见的反应包括猝死，系统性红斑狼疮样综合征和EKG改变，长期使用时可出现皮肤色素沉着，晶状体及角膜混浊，色素沉着性视网膜病。
【禁忌】 对本药有过敏史的患者。怀疑或已有皮质下脑损伤和接受大剂量中枢抑制剂的患者，如酒精、巴比妥类、麻醉剂、催眠剂等，处于昏迷或严重的抑郁状态者。血恶液质及肝损伤患者，12岁以下儿童。 警告：本药可引起迟发性运动障碍综合征，而且随着治疗时间的延长，精神安定剂的总累积剂量增加，可能使此综合征进一步发展和变为不可逆的机率增高。长期应用精神安定剂，一般应仅限于下列慢性疾病的患者，如 ：已知对精神安定剂有效者 ；可用于那些疗效相同，而潜在的危害较小，可替代药物缺乏或不合适的患者。对确实需要长期治疗的患者，应选用最小的剂量和最短的疗程，而足以产生满意疗效的治疗方案。用精神安定剂治疗的患者，一旦出现迟发性运动障碍综合征的症状或体征，则应考虑停药。本药也可能引起精神安定剂恶性综合征(NMS)，即高热和自主神经功能失调，表现为肌肉僵硬，精神变态，不规则的脉搏或波动的血压，心动过速，出汗及心律失常。如出现此恶性综合征，应立即停药并给予对症治疗和医疗监护。对于曾出现NMS的患者，即使恢复后，亦应慎用本药。本药可影响驾驶汽车或操作重型机械的能力。 
【注意事项】 应使用干燥注射器和21号以上的针头，用湿的注射器或针头会使溶液混浊。 由于同类药有交叉过敏的可能性，对吩噻嗪类衍生物有过敏反应病史的患者慎用本药。大剂量本药治疗的患者，在手术时需密切观察可能出现的低血压。此外，应减少麻醉剂和中枢神经系统抑制剂的用量。由于能增加抗胆碱作用，对于接受本药治疗的某些患者，阿托品的作用可能增强。下列患者应慎用本药 ：暴露于高热或含磷杀虫剂，有惊厥病史，二尖瓣关闭不全或其它心血管疾病或嗜铬细胞瘤。本药还可提高泌乳素的水平，并在长期给药中一直维持高水平。对妊娠和哺乳的影响 孕妇用药的安全性尚未确立。尚不知本药是否存在于乳汁中，哺乳妇女用药时应停止哺乳。 
【相互作用】 加强酒精、催眠剂、镇静剂或强镇痛剂引起的中枢抑制作用。拮抗肾上腺素和其它拟交感神经药物的作用，逆转胍乙啶与可乐宁等肾上腺素能阻断剂的降压作用。消弱左旋多巴的抗帕金森氏病的作用，影响抗惊厥药的作用、三环类抗抑郁药的代谢及糖尿病的控制。增强抗凝作用。能和锂剂发生相互作用。
【制剂】 注射液：25 mg/mL X 1 mL x 10 安瓿 
【储藏】 15-30℃避光保存。
【生产厂家】 百时美施贵宝公司

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更新于2010年1月11日