Generic Name: dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate
Dosage Form: capsule, extended release
DRUG DESCRIPTION

ADDERALL XR is a once daily extended-release, single-entity amphetamine product. ADDERALL XR combines the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d,l-amphetamine aspartate monohydrate. The ADDERALL XR capsule contains two types of drug-containing beads designed to give a double-pulsed delivery of amphetamines, which prolongs the release of amphetamine from ADDERALL XR compared to the conventional ADDERALL (immediate-release) tablet formulation.
INTRODUCTION
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WARNING:
Misuse or abuse of amphetamine may result in serious (possibly fatal) heart and blood pressure problems. Amphetamine-type medications can be habit-forming. Use only as directed. With prolonged use, drug dependence may occur, and withdrawal symptoms may occur after stopping the drug. Consult your doctor or pharmacist for more details.
USES:
This combination medication is used as part of a total treatment program to control attention deficit hyperactivity disorder (ADHD). It may help to increase the ability to pay attention, stay focused, and control behavior problems.
This product is a combination of stimulants (amphetamine and dextroamphetamine). It is thought to work by restoring the balance of certain natural substances (neurotransmitters) in the brain.
OTHER USES:
This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be used to treat certain sleeping disorders (narcolepsy). It should not be used to treat tiredness or to hold off sleep in people who do not have a sleep disorder.
HOW TO USE:
Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking amphetamine/dextroamphetamine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food, usually once daily in the morning or as directed by your doctor. Taking this medication after noon may cause trouble sleeping.
Swallow the capsules whole. Do not crush or chew the capsules. Doing so can destroy the long action of the drug and increase side effects. If you have difficulty swallowing this medication whole, you may sprinkle the entire contents of a capsule on a small amount of applesauce just before taking. Swallow the mixture immediately. Do not chew the mixture, and do not save it for future use. Drink a glass of liquid after each dose.
The dosage is based on your medical condition and response to therapy. Your doctor may adjust your dose to find the dose that is best for you. Follow your doctor's instructions carefully.
Use this medication regularly and exactly as prescribed in order to get the most benefit from it. To help you remember, use it at the same time each day.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time (more than a few weeks) or in high doses. In such cases, withdrawal symptoms (such as severe tiredness, mood changes including depression, and sleep problems) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
Though it is unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit-forming). Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted.
When used for a long period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.
If you are taking this drug for ADHD, your doctor may recommend "drug holidays" when the medication is stopped for a short time to observe any changes in behavior.

药物Adderall XR（硫酸右旋苯丙胺，右旋蔗糖，硫酸，安非他明和安非他明天门冬氨酸）胶囊，缓释
[美国Shire制造公司]

药物Adderall XR®（混合盐的一个单一的实体amphetamine产品）硫酸右旋安非他命，右旋蔗糖，安非他明的天门冬氨酸一水合物，苯丙胺硫酸盐胶囊，CII

美国首次批准：2001

适应症及用法
药物Adderall XR，中枢神经系统兴奋剂，被用于治疗注意缺陷多动障碍（ADHD）。

儿童（6-12岁）：功效是建立在一个为期3周的门诊，对照试验，模拟教室，儿童多动症的对照试验中。
青少年（13-17岁）：功效是建立在一个为期4周的对照试验中与ADHD的青少年。
成人：成人多动症的功效是建立在一个4周的对照试验。
 
【用法用量】
小儿患者（6-17岁）：在早上10毫克，每天一次。 6-12的儿童的最大剂量是30毫克，每天一次。
成人：在早上20毫克，每天一次。
 
剂型和优势
胶囊：5毫克，10毫克，15毫克，20毫克，25毫克，30毫克
 
禁忌
高级动脉硬化
对症心血管疾病
中度，重度高血压
甲状腺功能亢进症
已知的过敏或特异体质的拟交感神经胺
青光眼
激动的状态
药物滥用史
期间或在14天以下的行政单胺氧化酶抑制剂（MAOI）
 
警告和注意事项
严重的心血管事件：猝死有报道用常规剂量​​的心脏结构异常或其他严重心脏问题的儿童和青少年的中枢神经兴奋剂，常规剂量服用中枢神经兴奋剂在成人猝死，中风和心肌梗死的报道。兴奋剂药物不应使用与已知的心脏结构异常，心肌病，严重的心脏节律异常，冠状动脉疾病，或其他严重心脏问题的患者。
血压升高：在适当的时间间隔监测血压和脉搏。请谨慎使用患者的血压升高可能会出现问题。
精神科不良事件的兴奋剂可能导致在没有事先的历史，或与预先存在的精神病患者的症状加重患者的治疗，出现精神病或躁狂症状。评估之前使用兴奋剂的躁郁症。监测侵略行为。
长期压抑的增长：显示器的身高和体重在适当的时间间隔。
癫痫发作：可能的致惊厥阈值降低。停止发作的存在。
兴奋剂治疗，已报告有视觉障碍：住宿和视力模糊的困难。
抽动可能会加剧抽动。抽动，抽动秽语综合征的兴奋剂管理前的评估。
 
不良反应
儿童（6至12岁）：最常见的不良反应（≥5％，具有较高的发病率比安慰剂组）均录得亏损，食欲不振，失眠，腹痛，情绪不稳，呕吐，精神紧张，恶心和发烧。
青少年（13至17岁）：最常见的不良反应（≥5％，并具有较高的发病率比安慰剂组），食欲不振，失眠，腹痛，消瘦，神经质的损失。
成人：最常见的不良反应≥5％，具有较高的发生率比服用安慰剂的患者口干，食欲不振，失眠，头痛，体重减轻，恶心，焦虑，情绪激动，头晕，心动过速，腹泻，乏力，尿路感染。
报告疑似不良反应，联系美国Shire公司在1-800-828-2088或FDA在1-800-FDA-1088或www.fda.gov / medwatch
 
药物相互作用
禁忌单胺氧化酶抑制剂类抗抑郁药，单胺氧化酶抑制剂安非他明可能的影响。不要管理过程中或后14天内使用单胺氧化酶的药物Adderall XR。
碱化剂（GI抗酸剂和尿液）：这些药物会增加血液中的安非他明。
酸化剂（胃​​肠道和泌尿道）：这些药物降低血液中的安非他明。
肾上腺素能受体阻断剂，抗组织胺药，抗高血压药，苯巴比妥，苯妥英，藜芦生物碱，和安非他明乙琥胺的影响可能会减少。
三环类抗抑郁药，去甲肾上腺素和哌替啶的影响可能会增强安非他明。
 
特殊人群中使用
怀孕：使用只有在潜在利益大于对胎儿的潜在危险。根据动物数据，可能会对胎儿造成伤害。
哺乳期的母亲应避免母乳喂养。
儿童使用：尚未研究在儿童6岁以下的年龄。
老年人使用：没有老年患者进行了研究。

日期：08/2011

每天用药一次的儿童多动症药物Adderall XR

Shire公司Adderall的控释剂型Adderall XR于2001年10月获得了FDA的批准，适应证是儿童的注意力缺乏和多动（ADHD）。此药与其他ADHD药物主要的区别在于用药简单，只须早上顿服一次，药效就可以持续一天。这种用药方式使得患儿不必在学校服药，减轻了心理压力，并且减少了漏服药的可能性。

在学龄儿童中，ADHD是最常见的精神问题。此病的症状包括：注意力不集中、易冲动、多动等，影响患儿正常的学习和生活的行为。

对此药进行的两项临床试验涉及来自50个试验点的600多名患儿。其中一项试验数据显示，与Adderall相比，此药控制ADHD症状的时间较长；在服药后1.5~12h，此药控制症状的效果明显优于安慰剂，且具有统计学意义。

在另一项试验中，500多名经诊断为ADHD的患儿早晨顿服Adderall XR，他们注意力不集中的情况得到了明显的改善，而且4 p.m.时的行为与10 a.m.时没有特别的不同。

此药可能引起的副作用包括：厌食、失眠、腹痛、情绪不稳定和神经紧张等。

Adderall XR是一种苯丙胺制剂，它对中枢神经系统有刺激作用。此药起效的机制与苯丙胺类药物影响儿童精神和行为的机制相同。