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 详细处方信息以本药内容附件PDF文件（201071401454417.pdf）的“原文Priscribing Information”为准
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部分中文Invega处方资料（仅供参考）

    FDA批准首个口服缓释片Invega治疗精神分裂症

    FDA近日已批准精神分裂症治疗药Invega（帕潘立酮缓释片，paliperidone），该药是一种新型分子实体类药物，是利哌酮（抗精神失常药）的主要活性代谢物，每日口服一次。一项遍及23个国家、大约1665名患者参与的安慰剂控制临床实验表明，Invega不但可以显著改进精神分裂症的症状，而且可以改善个人及社会行为水平（PSP Scale），与安慰剂对照组相比较，使用Invega治疗的受试组疗效更佳。推荐剂量为每天3～12ng。Invega最常见的不良反应是坐立不安、锥体外系症状（运动失调）、心动过速以及嗜睡。Invega属于非典型性抗精神病药物，这种药物与安慰剂组相比，更容易导致患有伴痴呆精神病的老年患者死亡。

NVEGA® (paliperidone) extended-release tablets are used for the treatment of schizophrenia.

IMPORTANT SAFETY INFORMATION FOR INVEGA

Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. INVEGA (paliperidone) is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with INVEGA and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.

One risk of INVEGA is that it may change your heart rhythm. This effect is potentially serious, and you should talk to your doctor about any current or past heart problems. Some medications interact with INVEGA. Please inform your healthcare professional of any medications or supplements that you are taking.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with INVEGA and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.

High blood sugar and diabetes have been reported with INVEGA and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with INVEGA. Complications of diabetes can be serious and even life threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.

INVEGA and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection. The connection between prolactin levels and side effects is unknown.

People with narrowing or blockage of the gastrointestinal tract (esophagus, stomach or small or large intestine) should talk to their healthcare professional before taking INVEGA.

Some people taking INVEGA may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional's dosing instructions, this side effect may be reduced or it may go away over time.

INVEGA may affect your driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional. Avoid alcohol while on INVEGA.

INVEGA should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.

Inform your healthcare professional if you are pregnant or if you are planning to get pregnant while taking INVEGA. Caution should be exercised when INVEGA is administered to a nursing woman.

INVEGA may affect alertness and motor skills; use caution until the effect of INVEGA is known.

INVEGA may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm. INVEGA should be swallowed whole. Tablets should not be chewed, divided, or crushed. Do not be worried if you see something that looks like a tablet in your stool. This is what is left of the tablet after all the medicine has been released.

The most common side effects that occurred with INVEGA were restlessness and extrapyramidal disorder (for example, involuntary movements, tremors and muscle stiffness).

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 详细处方信息以本药内容附件PDF文件（201071401454417.pdf）的“原文Priscribing Information”为准
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2010年7月14更新