【科普】Modafinil与Ritalin 两种神秘的“聪明药”
Armodafinil说明书翻译22
Multi-organ hypersensitivity reactions, including at least one fatality in postmarketing experience, have occurred in close temporal association (median time to detection 13 days: range 4-33) to the initiation of modafinil. A similar risk of multi-organ hypersensitivity reactions with armodafinil cannot be ruled out.
多器官超敏反应，上市后出现至少一例死亡病例。不能排除Armodafinil引起多器官超敏反应的可能性。
Multi-organ hypersensitivity reactions, including at least one fatality in postmarketing experience, have occurred in close temporal association (median time to detection 13 days: range 4-33) to the initiation of modafinil. A similar risk of multi-organ hypersensitivity reactions with armodafinil cannot be ruled out.
多器官超敏反应，上市后出现至少一例死亡病例。不能排除Armodafinil引起多器官超敏反应的可能性。
Armodafinil说明书翻译23
Although there have been a limited number of reports, multi-organ hypersensitivity reactions may result in hospitalization or be lifethreatening. There are no factors that are known to predict the risk of occurrence or the severity of multi-organ hypersensitivity reactions associated with modafinil. Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with other organ system involvement. Other associated manifestations included myocarditis, hepatitis, liver function test abnormalities, hematological abnormalities (e.g., eosinophilia, leukopenia, thrombocytopenia), pruritus, and asthenia. Because multi-organ hypersensitivity is variable in its expression, other organ system symptoms and signs, not noted here, may occur.
尽管报告数量有限，但是多器官超敏反应可能危及生命。
没有已知因素可以预测与Modafinil相关的多器官超敏反应的发生风险和严重程度。
这种疾病的体征和症状是不同的，患者通常（但不唯一）出现与其它器官系统参与有关的发烧和皮疹。
其它症状包括心肌炎、肝炎、肝功能测试异常、血液异常（如嗜酸性粒细胞增多、白细胞减少、血小板减少）、瘙痒和虚弱。
由于多器官超敏反应有多种表现形式，因此可能出现其它器官系统症状和体征，这里没有提到。
Although there have been a limited number of reports, multi-organ hypersensitivity reactions may result in hospitalization or be lifethreatening. There are no factors that are known to predict the risk of occurrence or the severity of multi-organ hypersensitivity reactions associated with modafinil. Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with other organ system involvement. Other associated manifestations included myocarditis, hepatitis, liver function test abnormalities, hematological abnormalities (e.g., eosinophilia, leukopenia, thrombocytopenia), pruritus, and asthenia. Because multi-organ hypersensitivity is variable in its expression, other organ system symptoms and signs, not noted here, may occur.
尽管报告数量有限，但是多器官超敏反应可能危及生命。
没有已知因素可以预测与Modafinil相关的多器官超敏反应的发生风险和严重程度。
这种疾病的体征和症状是不同的，患者通常（但不唯一）出现与其它器官系统参与有关的发烧和皮疹。
其它症状包括心肌炎、肝炎、肝功能测试异常、血液异常（如嗜酸性粒细胞增多、白细胞减少、血小板减少）、瘙痒和虚弱。
由于多器官超敏反应有多种表现形式，因此可能出现其它器官系统症状和体征，这里没有提到。
Armodafinil说明书翻译24
If a multi-organ hypersensitivity reaction is suspected, armodafinil tablets should be discontinued. Although there are no case reports to indicate cross-sensitivity with other drugs that produce this syndrome, the experience with drugs associated with multiorgan hypersensitivity would indicate this to be a possibility.
如果怀疑有多器官超敏反应，应停止服用Armodafinil片。
尽管没有病例报告表明Armodafinil与其它产生这种综合征的药物存在交叉敏感性，但与多器官超敏相关的药物经验表明存在这种可能。
If a multi-organ hypersensitivity reaction is suspected, armodafinil tablets should be discontinued. Although there are no case reports to indicate cross-sensitivity with other drugs that produce this syndrome, the experience with drugs associated with multiorgan hypersensitivity would indicate this to be a possibility.
如果怀疑有多器官超敏反应，应停止服用Armodafinil片。
尽管没有病例报告表明Armodafinil与其它产生这种综合征的药物存在交叉敏感性，但与多器官超敏相关的药物经验表明存在这种可能。
Armodafinil说明书翻译25
Patients with abnormal levels of sleepiness who take armodafinil tablets should be advised that their level of wakefulness may not return to normal. Patients with excessive sleepiness, including those taking armodafinil tablets, should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity. Prescribers should also be aware that patients may not acknowledge sleepiness or drowsiness until directly questioned about drowsiness or sleepiness during specific activities.
因嗜睡而服用Armodafinil的患者，其服药后清醒程度可能无法完全恢复正常。
患有嗜睡症的患者，应经常对其嗜睡程度进行重新评估，在嗜睡状态下应避免从事驾驶或其它具有潜在危险的活动。
处方者（医生）还应意识到，在直接询问患者嗜睡情况之前，患者可能不会承认嗜睡或困倦。
Patients with abnormal levels of sleepiness who take armodafinil tablets should be advised that their level of wakefulness may not return to normal. Patients with excessive sleepiness, including those taking armodafinil tablets, should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity. Prescribers should also be aware that patients may not acknowledge sleepiness or drowsiness until directly questioned about drowsiness or sleepiness during specific activities.
因嗜睡而服用Armodafinil的患者，其服药后清醒程度可能无法完全恢复正常。
患有嗜睡症的患者，应经常对其嗜睡程度进行重新评估，在嗜睡状态下应避免从事驾驶或其它具有潜在危险的活动。
处方者（医生）还应意识到，在直接询问患者嗜睡情况之前，患者可能不会承认嗜睡或困倦。
Armodafinil说明书翻译26
Psychiatric adverse experiences have been reported in patients treated with modafinil. Modafinil and armodafinil (armodafinil tablets) are very closely related. Therefore, the incidence and type of psychiatric symptoms associated with armodafinil are expected to be similar to the incidence and type of these events with modafinil.
使用Modafinil治疗的患者可能会出现精神类不良反应。
Modafinil与Armodafinil非常相似。
因此，与Armodafinil相关精神类不良反应的发生率和类型与莫达非尼相似。
Psychiatric adverse experiences have been reported in patients treated with modafinil. Modafinil and armodafinil (armodafinil tablets) are very closely related. Therefore, the incidence and type of psychiatric symptoms associated with armodafinil are expected to be similar to the incidence and type of these events with modafinil.
使用Modafinil治疗的患者可能会出现精神类不良反应。
Modafinil与Armodafinil非常相似。
因此，与Armodafinil相关精神类不良反应的发生率和类型与莫达非尼相似。
Armodafinil说明书翻译27
Postmarketing adverse events associated with the use of modafinil have included mania, delusions, hallucinations, suicidal ideation and aggression, some resulting in hospitalization. Many, but not all, patients had a prior psychiatric history. One healthy male volunteer developed ideas of reference, paranoid delusions, and auditory hallucinations in association with multiple daily 600 mg doses of modafinil and sleep deprivation. There was no evidence of psychosis 36 hours after drug discontinuation.
与Modafinil相关的上市后出现的不良反应包括躁狂症、妄想、幻觉、自杀意念和攻击性，有些导致住院治疗。
许多（但不是全部）使用Modafinil的患者有精神病史。
Postmarketing adverse events associated with the use of modafinil have included mania, delusions, hallucinations, suicidal ideation and aggression, some resulting in hospitalization. Many, but not all, patients had a prior psychiatric history. One healthy male volunteer developed ideas of reference, paranoid delusions, and auditory hallucinations in association with multiple daily 600 mg doses of modafinil and sleep deprivation. There was no evidence of psychosis 36 hours after drug discontinuation.
与Modafinil相关的上市后出现的不良反应包括躁狂症、妄想、幻觉、自杀意念和攻击性，有些导致住院治疗。
许多（但不是全部）使用Modafinil的患者有精神病史。
Armodafinil说明书翻译28
In the controlled trial armodafinil tablets database, anxiety, agitation, nervousness, and irritability were reasons for treatment discontinuation more often in patients on armodafinil tablets compared to placebo (armodafinil tablets 1.2% and placebo 0.3%). In the armodafinil tablets controlled studies, depression was also a reason for treatment discontinuation more often in patients on armodafinil tablets compared to placebo (armodafinil tablets 0.6% and placebo 0.2%). Two cases of suicide ideation were observed in clinical trials. Caution should be exercised when armodafinil tablets is given to patients with a history of psychosis, depression, or mania. If psychiatric symptoms develop in association with armodafinil tablets administration, consider discontinuing armodafinil tablets.
在对照实验中，焦虑、激动、神经质和烦躁不安，是服用Armodafinil的患者相比安慰剂更常停药的原因（停药率 Armodafinil 1.2% 安慰剂 0.3%）。
在临床试验中观察到两例出现自杀意念的患者。
当Armodafinil给予有精神病、抑郁症或躁狂症病史的患者时，应谨慎。
如果与Armodafinil相关精神症状出现，应考虑停用Armodafinil。
In the controlled trial armodafinil tablets database, anxiety, agitation, nervousness, and irritability were reasons for treatment discontinuation more often in patients on armodafinil tablets compared to placebo (armodafinil tablets 1.2% and placebo 0.3%). In the armodafinil tablets controlled studies, depression was also a reason for treatment discontinuation more often in patients on armodafinil tablets compared to placebo (armodafinil tablets 0.6% and placebo 0.2%). Two cases of suicide ideation were observed in clinical trials. Caution should be exercised when armodafinil tablets is given to patients with a history of psychosis, depression, or mania. If psychiatric symptoms develop in association with armodafinil tablets administration, consider discontinuing armodafinil tablets.
在对照实验中，焦虑、激动、神经质和烦躁不安，是服用Armodafinil的患者相比安慰剂更常停药的原因（停药率 Armodafinil 1.2% 安慰剂 0.3%）。
在临床试验中观察到两例出现自杀意念的患者。
当Armodafinil给予有精神病、抑郁症或躁狂症病史的患者时，应谨慎。
如果与Armodafinil相关精神症状出现，应考虑停用Armodafinil。
Armodafinil说明书翻译29
Armodafinil tablets should be used only in patients who have had a complete evaluation of their excessive sleepiness, and in whom a diagnosis of either narcolepsy, OSAHS, and/or SWSD has been made in accordance with ICSD or DSM diagnostic criteria. Such an evaluation usually consists of a complete history and physical examination, and it may be supplemented with testing in a laboratory setting. Some patients may have more than one sleep disorder contributing to their excessive sleepiness (e.g., OSAHS and SWSD coincident in the same patient).
Armodafinil仅应用于被评估为过度嗜睡的患者。（根据LCSD或DSM诊断标准诊断为发作性睡病，OSAHS或SWSD）
这种评估通常包括完整的病史和体格检查，并可以在实验室环境中进行补充测试。
一些患者可能有一种以上睡眠障碍导致其过度嗜睡（例如，OSAHS和SWSD同时出现）。
Armodafinil tablets should be used only in patients who have had a complete evaluation of their excessive sleepiness, and in whom a diagnosis of either narcolepsy, OSAHS, and/or SWSD has been made in accordance with ICSD or DSM diagnostic criteria. Such an evaluation usually consists of a complete history and physical examination, and it may be supplemented with testing in a laboratory setting. Some patients may have more than one sleep disorder contributing to their excessive sleepiness (e.g., OSAHS and SWSD coincident in the same patient).
Armodafinil仅应用于被评估为过度嗜睡的患者。（根据LCSD或DSM诊断标准诊断为发作性睡病，OSAHS或SWSD）
这种评估通常包括完整的病史和体格检查，并可以在实验室环境中进行补充测试。
一些患者可能有一种以上睡眠障碍导致其过度嗜睡（例如，OSAHS和SWSD同时出现）。
Armodafinil说明书翻译30
In OSAHS, armodafinil tablets is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets. If armodafinil tablets is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary. There was a slight trend for reduced CPAP use over time (mean reduction of 18 minutes for patients treated with armodafinil tablets and a 6 minute reduction for placebo treated patients from a mean baseline use of 6.9 hours per night) in armodafinil tablets trials.
在OSAHS中，Armodafinil是潜在阻塞标准治疗的辅助手段。如果持续气道正压通气（CPAP）是患者的首选治疗方法，应在开始使用Armodafinil之前，完成CPAP治疗。如果将Armodafinil与CPAP辅助使用，则必须定期评估CPAP安全性。 在Armodafinil试验中，随着时间的推移，CPAP使用减少的趋势略有下降（使用Armodafinil治疗的患者平均减少18分钟，安慰剂治疗患者平均减少6分钟，平均每人使用6.9小时）。
In OSAHS, armodafinil tablets is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets. If armodafinil tablets is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary. There was a slight trend for reduced CPAP use over time (mean reduction of 18 minutes for patients treated with armodafinil tablets and a 6 minute reduction for placebo treated patients from a mean baseline use of 6.9 hours per night) in armodafinil tablets trials.
在OSAHS中，Armodafinil是潜在阻塞标准治疗的辅助手段。如果持续气道正压通气（CPAP）是患者的首选治疗方法，应在开始使用Armodafinil之前，完成CPAP治疗。如果将Armodafinil与CPAP辅助使用，则必须定期评估CPAP安全性。 在Armodafinil试验中，随着时间的推移，CPAP使用减少的趋势略有下降（使用Armodafinil治疗的患者平均减少18分钟，安慰剂治疗患者平均减少6分钟，平均每人使用6.9小时）。
Armodafinil说明书翻译31
Although armodafinil tablets has not been shown to produce function impairment, any drug affecting the CNS may alter judgment, thinking or motor skills. Patients should be cautioned about operating an automobile or other hazardous machinery until they are reasonably certain that armodafinil tablets therapy will not adversely affect their ability to engage in such activities.
尽管在实验中，患者服用Armodafinil后未表现出功能障碍，但任何影响CNS的药物都有可能改变判断力、思维和运动技能。
在确定Armodafinil不会对此类活动产生不利影响之前，应告知患者避免驾驶和操作机械。
Although armodafinil tablets has not been shown to produce function impairment, any drug affecting the CNS may alter judgment, thinking or motor skills. Patients should be cautioned about operating an automobile or other hazardous machinery until they are reasonably certain that armodafinil tablets therapy will not adversely affect their ability to engage in such activities.
尽管在实验中，患者服用Armodafinil后未表现出功能障碍，但任何影响CNS的药物都有可能改变判断力、思维和运动技能。
在确定Armodafinil不会对此类活动产生不利影响之前，应告知患者避免驾驶和操作机械。
Armodafinil说明书翻译32
Armodafinil tablets has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable angina, and such patients should be treated with caution.
对有心肌梗死或不稳定型心绞痛病史的患者，Armodafinil的安全性尚未确定，应谨慎使用此药物。
Armodafinil tablets has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable angina, and such patients should be treated with caution.
对有心肌梗死或不稳定型心绞痛病史的患者，Armodafinil的安全性尚未确定，应谨慎使用此药物。
Armodafinil说明书翻译33
In clinical studies of modafinil, signs and symptoms including chest pain, palpitations, dyspnea and transient ischemic T-wave changes on ECG were observed in three subjects in association with mitral valve prolapse or left ventricular hypertrophy. It is recommended that armodafinil tablets not be used in patients with a history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced the mitral valve prolapse syndrome when previously receiving CNS stimulants. Signs of mitral valve prolapse syndrome include but are not limited to ischemic ECG changes, chest pain, or arrhythmia. If new onset of any of these symptoms occurs, consider cardiac evaluation.
在Modafinil的临床研究中，三名受试者出现与二尖瓣脱垂或左心室肥大相关的症状，包括胸痛，心悸，呼吸困难和心电图短暂性缺血性T波改变。 建议Armodafinil禁用于有左心室肥大病史的患者或二尖瓣脱垂患者。部分患者在接受CNS兴奋剂时曾出现过二尖瓣脱垂综合征， 二尖瓣脱垂综合征的症状包括但不限于缺血性ECG改变，胸痛或心律失常。 如果出现这些症状，请进行心脏检查。
In clinical studies of modafinil, signs and symptoms including chest pain, palpitations, dyspnea and transient ischemic T-wave changes on ECG were observed in three subjects in association with mitral valve prolapse or left ventricular hypertrophy. It is recommended that armodafinil tablets not be used in patients with a history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced the mitral valve prolapse syndrome when previously receiving CNS stimulants. Signs of mitral valve prolapse syndrome include but are not limited to ischemic ECG changes, chest pain, or arrhythmia. If new onset of any of these symptoms occurs, consider cardiac evaluation.
在Modafinil的临床研究中，三名受试者出现与二尖瓣脱垂或左心室肥大相关的症状，包括胸痛，心悸，呼吸困难和心电图短暂性缺血性T波改变。 建议Armodafinil禁用于有左心室肥大病史的患者或二尖瓣脱垂患者。部分患者在接受CNS兴奋剂时曾出现过二尖瓣脱垂综合征， 二尖瓣脱垂综合征的症状包括但不限于缺血性ECG改变，胸痛或心律失常。 如果出现这些症状，请进行心脏检查。
Armodafinil说明书翻译34
Blood pressure monitoring in short term (<=3 months) controlled trials showed only small average increases in mean systolic and diastolic blood pressure in patients receiving armodafinil tablets as compared to placebo (1.2 to 4.3 mmHg in the various experimental groups). There was also a slightly greater proportion of patients on armodafinil tablets requiring new or increased use of antihypertensive medications (2.9%) compared to patients on placebo (1.8%). Increased monitoring of blood pressure may be appropriate in patients on armodafinil tablets.
短期（<= 3个月）对照试验的血压监测显示，与安慰剂相比，接受Armodafinil的患者的平均收缩压和舒张压仅有较小的平均增加（各实验组为1.2至4.3 mmHg）。 与安慰剂组（1.8％）患者相比，Armodafinil组需要新增或增加使用抗高血压药物（2.9％）的患者比例略高。 对于使用Armodafinil的患者，可能需要进行血压监测。
Blood pressure monitoring in short term (<=3 months) controlled trials showed only small average increases in mean systolic and diastolic blood pressure in patients receiving armodafinil tablets as compared to placebo (1.2 to 4.3 mmHg in the various experimental groups). There was also a slightly greater proportion of patients on armodafinil tablets requiring new or increased use of antihypertensive medications (2.9%) compared to patients on placebo (1.8%). Increased monitoring of blood pressure may be appropriate in patients on armodafinil tablets.
短期（<= 3个月）对照试验的血压监测显示，与安慰剂相比，接受Armodafinil的患者的平均收缩压和舒张压仅有较小的平均增加（各实验组为1.2至4.3 mmHg）。 与安慰剂组（1.8％）患者相比，Armodafinil组需要新增或增加使用抗高血压药物（2.9％）的患者比例略高。 对于使用Armodafinil的患者，可能需要进行血压监测。
Armodafinil说明书翻译35
The effectiveness of steroidal contraceptives may be reduced when used with armodafinil tablets and for one month after discontinuation of therapy. Alternative or concomitant methods of contraception are recommended for patients treated with armodafinil tablets and for one month after discontinuation of armodafinil tablets treatment.
当甾体避孕药与Armodafinil一起使用时，以及在停止治疗后一个月内，甾体避孕药的有效性可能会降低。 对于使用Armodafinil治疗的患者（以及停用Armodafinil治疗后1个月内的患者），建议采用其它避孕方法。
The effectiveness of steroidal contraceptives may be reduced when used with armodafinil tablets and for one month after discontinuation of therapy. Alternative or concomitant methods of contraception are recommended for patients treated with armodafinil tablets and for one month after discontinuation of armodafinil tablets treatment.
当甾体避孕药与Armodafinil一起使用时，以及在停止治疗后一个月内，甾体避孕药的有效性可能会降低。 对于使用Armodafinil治疗的患者（以及停用Armodafinil治疗后1个月内的患者），建议采用其它避孕方法。
Armodafinil说明书翻译36
he blood levels of cyclosporine may be reduced when used with armodafinil tablets. Monitoring of circulating cyclosporine concentrations and appropriate dosage adjustment for cyclosporine should be considered when these drugs are used concomitantly.
当环孢素与Armodafinil一起使用时，可降低环孢素的血药浓度。 当同时使用这些药物时，应考虑监测环孢素血药浓度，适当调整环孢素用量。
he blood levels of cyclosporine may be reduced when used with armodafinil tablets. Monitoring of circulating cyclosporine concentrations and appropriate dosage adjustment for cyclosporine should be considered when these drugs are used concomitantly.
当环孢素与Armodafinil一起使用时，可降低环孢素的血药浓度。 当同时使用这些药物时，应考虑监测环孢素血药浓度，适当调整环孢素用量。
Armodafinil说明书翻译37
In patients with severe hepatic impairment, with or without cirrhosis, armodafinil tablets should be administered at a reduced dose.
对于严重肝功能不全的患者，应减量使用Armodafinil。
In patients with severe hepatic impairment, with or without cirrhosis, armodafinil tablets should be administered at a reduced dose.
对于严重肝功能不全的患者，应减量使用Armodafinil。
Armodafinil说明书翻译38
There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment.
没有足够的信息来确定Armodafinil对严重肾功能不全患者的安全性和有效性。
There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment.
没有足够的信息来确定Armodafinil对严重肾功能不全患者的安全性和有效性。
Armodafinil说明书翻译39
In elderly patients, elimination of armodafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population.
在老年患者中，由于衰老，会减少Armodafinil及其代谢物的清除速率。 因此，应考虑在该类人群中使用较低剂量。
In elderly patients, elimination of armodafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population.
在老年患者中，由于衰老，会减少Armodafinil及其代谢物的清除速率。 因此，应考虑在该类人群中使用较低剂量。
Armodafinil说明书翻译40
Patients should be informed that it may be critical that they continue to take their previously prescribed treatments (e.g., patients with OSAHS receiving CPAP should continue to do so).
应告知患者，按照处方按时服药非常重要（例如，接受CPAP的OSAHS患者应继续按时服用药物）。
Patients should be informed that it may be critical that they continue to take their previously prescribed treatments (e.g., patients with OSAHS receiving CPAP should continue to do so).
应告知患者，按照处方按时服药非常重要（例如，接受CPAP的OSAHS患者应继续按时服用药物）。
Armodafinil说明书翻译41
atients should be advised to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, because of the potential for interactions between armodafinil and other drugs.
如果患者正在服用其它药物，应告知医生，因为Armodafinil与其它药物之间可能存在相互作用。
Patients should be advised that the use of armodafinil tablet in combination with alcohol has not been studied. Patients should be advised that it is prudent to avoid alcohol while taking armodafinil tablets.
禁止Armodafinil与酒精联合使用。患者服用Armodafinil时应避免饮酒。
Patients should be advised to stop taking armodafinil tablets and to notify their physician if they develop a rash, hives, mouth sores, blisters, peeling skin, trouble swallowing or breathing or a related allergic phenomenon.
出现皮疹、荨麻疹、口腔溃疡、水疱、皮肤脱落、吞咽困难、呼吸困难或其它过敏症状时，应立即停止服用Armodafinil，并通知医生。
Clinical chemistry, hematology, and urinalysis parameters were monitored in the studies. Mean plasma levels of gamma glutamyltransferase (GGT) and alkaline phosphatase (AP) were found to be higher following administration of armodafinil tablets, but not placebo. Few subjects, however, had GGT or AP elevations outside of the normal range. No differences were apparent in alanine aminotransferase, aspartate aminotransferase, total protein, albumin, or total bilirubin, although there were rare cases of isolated elevations of AST and/or ALT. A single case of mild pancytopenia was observed after 35-days of treatment and resolved with drug discontinuation. A small mean decrease from baseline in serum uric acid compared to placebo was seem in clinical trials. The clinical significance of this finding is unknown.
在临床研究中监测化学，血液学和尿分析参数。 在给予Armodafinil后，发现受试者γ谷氨酰转移酶（GGT）和碱性磷酸酶（AP）的平均血浆水平更高（和安慰剂组相比）。 然而，很少有受试者的GGT或AP升高超出正常范围。 丙氨酸氨基转移酶，天冬氨酸氨基转移酶，总蛋白，白蛋白和总胆红素没有明显差异，尽管存在罕见的AST或ALT升高的病例。 治疗35天后观察到一例轻度全血细胞减少症，并停药后恢复正常。 在临床试验中，与安慰剂相比，受试者血清尿酸略有下降。 这一发现的临床意义尚不清楚。
No pattern of ECG abnormalities could be attributed to armodafinil administration in placebo controlled clinical trials.
在临床对照实验中，没有证据证明Armodafinil会导致心电图异常。
atients should be advised to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, because of the potential for interactions between armodafinil and other drugs.
如果患者正在服用其它药物，应告知医生，因为Armodafinil与其它药物之间可能存在相互作用。
Patients should be advised that the use of armodafinil tablet in combination with alcohol has not been studied. Patients should be advised that it is prudent to avoid alcohol while taking armodafinil tablets.
禁止Armodafinil与酒精联合使用。患者服用Armodafinil时应避免饮酒。
Patients should be advised to stop taking armodafinil tablets and to notify their physician if they develop a rash, hives, mouth sores, blisters, peeling skin, trouble swallowing or breathing or a related allergic phenomenon.
出现皮疹、荨麻疹、口腔溃疡、水疱、皮肤脱落、吞咽困难、呼吸困难或其它过敏症状时，应立即停止服用Armodafinil，并通知医生。
Clinical chemistry, hematology, and urinalysis parameters were monitored in the studies. Mean plasma levels of gamma glutamyltransferase (GGT) and alkaline phosphatase (AP) were found to be higher following administration of armodafinil tablets, but not placebo. Few subjects, however, had GGT or AP elevations outside of the normal range. No differences were apparent in alanine aminotransferase, aspartate aminotransferase, total protein, albumin, or total bilirubin, although there were rare cases of isolated elevations of AST and/or ALT. A single case of mild pancytopenia was observed after 35-days of treatment and resolved with drug discontinuation. A small mean decrease from baseline in serum uric acid compared to placebo was seem in clinical trials. The clinical significance of this finding is unknown.
在临床研究中监测化学，血液学和尿分析参数。 在给予Armodafinil后，发现受试者γ谷氨酰转移酶（GGT）和碱性磷酸酶（AP）的平均血浆水平更高（和安慰剂组相比）。 然而，很少有受试者的GGT或AP升高超出正常范围。 丙氨酸氨基转移酶，天冬氨酸氨基转移酶，总蛋白，白蛋白和总胆红素没有明显差异，尽管存在罕见的AST或ALT升高的病例。 治疗35天后观察到一例轻度全血细胞减少症，并停药后恢复正常。 在临床试验中，与安慰剂相比，受试者血清尿酸略有下降。 这一发现的临床意义尚不清楚。
No pattern of ECG abnormalities could be attributed to armodafinil administration in placebo controlled clinical trials.
在临床对照实验中，没有证据证明Armodafinil会导致心电图异常。