罗替戈汀24小时透皮贴片说明书(Rotigotine)- Neupro 3mg/24h

产地国家：美国

处 方 药：是

所属类别：3毫克/张 24小时 30贴/张

包装规格：3毫克/张 24小时 30贴/张

计价单位：盒

生产厂家中文参考译名:

UCB INC

生产厂家英文名:

UCB INC

原产地英文商品名:

Neupro 3mg/24hours 30Patches/box

原产地英文药品名:

Rotigotine

中文参考商品译名:

Neupro 3毫克/张 24小时 30贴/盒

中文参考药品译名:

罗替戈汀

简介：

近日，美国食品药品管理局(FDA)已批准Neupro(rotigotine transdermal system)透皮系统贴剂，用于治疗进展期特发性帕金森病(PD)的症状和体征，以及治疗中至重度原发性不宁腿综合征(RLS)。Neupro是一种多巴胺激动剂的透皮贴剂，据称可持续释放药物。

作为一种PD治疗药物，Neupro的作用机制与其对尾壳核内多巴胺受体的刺激作用有关，大脑尾壳核区域具有调节运动的功能。与此相似，对于RLS，Neupro可能也通过刺激多巴胺受体而发挥作用。但该药对PD和RLS的确切治疗机制尚不明确。

Neupro对PD症状和体征的疗效在5项平行分组、随机双盲、安慰剂对照试验中得到了确认。依据试验设计，患者服用Neupro的剂量每24 h增加2mg，在1周内滴定至随机剂量或最佳剂量。

批准日期：2012年4月3日

公司：UCB, Inc

NEUPRO(罗替戈汀[rotigotine])透皮系统，局部外贴剂

美国最初批准：2007年

作用机制

罗替戈汀是一种非麦角灵多巴胺激动剂。 罗替戈汀作为治疗帕金森病的确切作用机制尚不清楚，尽管它被认为与其刺激大脑尾壳核内多巴胺受体的能力有关。 罗替戈汀作为治疗不安腿综合征的确切作用机制尚不清楚，但被认为与其刺激多巴胺受体的能力有关。

适应症和用法

NEUPRO是一种多巴胺激动剂，适用于治疗：

帕金森病

中度至重度原发性不安腿综合征

剂量和给药

帕金森病：最初为早期疾病2毫克/24小时或晚期疾病4毫克/ 24小时。剂量可以根据需要每周增加2mg/24小时，对于早期疾病可以增加至6mg/24小时，对于晚期疾病可以增加至8mg/24小时。

不安腿综合征：最初，1毫克/24小时，每周一次增加1毫克/24小时，最多3毫克/24小时。

每天一次涂抹于皮肤;牢牢按压30秒。不要将NEUPRO放在油性，刺激性或受损的皮肤上，或用紧身衣擦拭的地方。不要每14天使用同一个网站多次。可以使用单个或多个贴片实现规定剂量。

停止治疗，逐渐减少剂量直至NEUPRO完全停药。

剂量形式和强度

透皮系统：1mg/24小时，2mg/24小时，3mg/24小时，4mg/24小时，6mg/24小时和8mg/24小时的罗替戈汀。

禁忌症

对罗替戈汀或透皮贴剂组分过敏的历史。

警告和注意事项

含有偏亚硫酸氢钠，可能会导致亚硫酸盐敏感的过敏反应。

在日常生活活动中睡着，包括机动车的操作，并且可能发生嗜睡。

可能会出现幻觉/精神病和运动障碍。

可出现症状性体位性低血压和晕厥，尤其是在剂量递增期间。

如果患者出现强迫行为，可考虑减少剂量或停止NEUPRO。

可能发生血压升高和心率升高。

应用现场反应可能发生并且可能很严重。

突然停药或减少剂量可能会导致高热和混乱。

不良反应

帕金森病：最常见的不良反应(比安慰剂至少高5%)是恶心，呕吐，嗜睡，应用部位反应，头晕，厌食，开始和维持睡眠的干扰，多汗症，视觉障碍，外周性水肿和运动障碍。

不安腿综合征：最常见的不良反应(比安慰剂至少高5%)是应用部位反应，恶心，开始和保持睡眠，嗜睡和头痛的干扰。

用于特定人群

怀孕：根据动物数据，可能会造成胎儿伤害。

包装提供/存储和处理

每个透皮系统都包装在一个单独的小袋中。

每种强度都可以在30个透皮系统的纸箱中获得。

储存在20° - 25°C(68°-77°F); 允许的偏差在15°- 30°C(59°- 86°F)之间。[见USP受控室温]

NEUPRO应存放在原始小袋中。 不要存放在袋子外面。

从袋中取出后立即涂抹透皮系统。 在家庭垃圾中丢弃使用过的系统，以防止儿童，宠物或其他人意外使用或摄入。

英文说明书

NEUPRO (rotigotine transdermal system)

INDICATION

NEUPRO is a prescription medicine used to treat Parkinson's disease.

IMPORTANT SAFETY INFORMATION

NEUPRO contains a sulfite called sodium metabisulfite. Sulfites can cause severe allergic reactions that are life threatening to some people who are sensitive to sulfites. People with asthma are more sensitive to sulfites. Remove the patch right away and call your doctor if you have swelling of the lips or tongue, chest pain, or trouble breathing or swallowing.

NEUPRO may make you fall asleep suddenly or without warning while doing normal activities, such as driving, which may result in accidents. Tell your doctor right away if this happens. Drinking alcohol or taking other medicines that cause drowsiness may increase your chances of becoming sleepy while using NEUPRO. Do not drive, use hazardous machinery, or do other dangerous activities until you know how NEUPRO affects you.

NEUPRO can cause or worsen psychotic symptoms including hallucinations (seeing or hearing things that are not real), confusion, excessive suspicion, aggressive behavior, agitation, delusional beliefs (believing things that are not real), and disorganized thinking. The chances of having hallucinations or these other psychotic-like changes are higher in people with Parkinson's disease who are elderly, taking NEUPRO, or taking higher doses of NEUPRO. If you have any of these problems, talk to your doctor.

NEUPRO can cause decreases in blood pressure, especially when you start or increase your dose. Increases in blood pressure and heart rate, fainting, weight gain, and fluid retention also can occur. If you faint or feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down, or have an unusually fast increase in weight, swelling, or fluid retention, especially in the ankles or legs, tell your doctor.

Some patients using NEUPRO get urges to behave in a way that is unusual for them, such as unusual urges to gamble, strong urges to spend money, binge eating, or increased sexual urges and behaviors. If you or your family notices you are developing any unusual behaviors, talk to your doctor.

NEUPRO may cause uncontrolled, sudden movements or make such movements you already have worse or more frequent if you have Parkinson's disease, which may mean that your anti-Parkinson's medicine needs to be changed.

Skin reactions may occur at the site where you apply NEUPRO. Tell your doctor if you get a rash, redness, swelling, or itching that will not go away. Some people with Parkinson's disease may have an increased chance of getting a skin cancer called melanoma. You should have your skin checked by a doctor regularly.

Avoid exposing the NEUPRO patch you are wearing to heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, and direct sunlight. Too much medicine could be absorbed into your body. Also, do not wear NEUPRO during medical procedures called magnetic resonance imaging (MRI) or cardioversion because this could cause skin burns.

Tell your doctor if you have breathing problems, a sleep disorder, mental problems, high or low blood pressure, or heart problems; are pregnant or plan to become pregnant; or are breastfeeding or plan to breastfeed. NEUPRO may not be right for you.

The most common side effects in people taking NEUPRO for Parkinson's disease are nausea, vomiting, sleepiness, application site reactions, dizziness, loss of appetite, difficulty falling asleep and staying asleep, increased sweating, vision problems, leg swelling, and uncontrolled, sudden movements of the arms or legs.