ch联系Allerganat 1-800-433-8871或FDA。
药物相互作用
•抗高血压药物：SAPHRIS可能引起低血压。
•帕罗西汀（CYP2D6底物和抑制剂）：与SAPHRIS联合使用时，可逐半减少帕罗西汀。
用于特定人群
•怀孕：在妊娠晚期暴露的新生儿可能引起锥体外系和/或戒断症状。
•儿科用途：未评估10岁以下患者的双相Idisorder治疗的安全性和有效性，以及年龄小于12岁的精神分裂症患者的评估。
包装提供/存储和处理
SAPHRIS（阿塞那平）舌下片剂提供如下：
2.5mg片剂，黑樱桃味
圆形，白色至灰白色舌下片，一侧有六边形。
防儿童包装
盒装60个6个水泡，10片NDC 0456-2402-60
医院单位剂量
盒装100个10个水泡，10片NDC 0456-2402-63
5mg片剂，黑樱桃味
圆形，白色至灰白色舌下片，圆圈内一侧有“5”。
防儿童包装
盒装60个6水泡，10片NDC 0456-2405-60
医院单位剂量
盒装100个10个水泡，10片NDC 0456-2405-63
10毫克片，黑樱桃味
圆形，白色至灰白色的舌下片，圆圈内一侧有“10”。
防儿童包装
盒装60个6水泡，10片NDC 0456-2410-60
医院单位剂量
盒装100个10个水泡，10片NDC 0456-2410-63
存储
储存在20°C至25°C（68°F至77°F）;在15°C和30°C（59°F和86°F）之间允许的偏移[见USP受控室温]。
完整说明资料附件：
https://www.allergan.com/assets/pdf/saphris_pi
SAPHRIS(asenapine)sublingual tablets
IMPORTANT RISK INFORMATION
What is the most important information I should know about SAPHRIS?
Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking antipsychotic drugs are at an increased risk for death. SAPHRIS is not approved for treating people with dementia-related psychosis.
SAPHRIS may cause serious side effects, including:
Stroke (which can be fatal) in elderly people with dementia
Neuroleptic malignant syndrome (NMS): Call your healthcare provider right away if you have high fever; stiff muscles; confusion; changes in pulse, heart rate, or blood pressure; or sweating. These can be symptoms of a rare but potentially fatal side effect called NMS. SAPHRIS should be stopped if you have NMS
Tardive dyskinesia (TD): Tell your healthcare provider if you cannot control the movements of your face, tongue, or other body parts. These could be signs of a serious and sometimes permanent side effect called TD. Risk of developing TD and the chance that it will become permanent are thought to increase the longer a person takes the medicine and the more medicine a person takes over time. TD can develop even after a person has been taking the medicine for a short time at low doses. TD may not go away, even if you stop taking SAPHRIS. TD may also start after you stop taking SAPHRIS
Problems with your metabolism, such as:
High blood sugar and diabetes: If you have diabetes or risk factors for diabetes (eg, being overweight or family history of diabetes), your blood sugar should be tested before you start SAPHRIS and regularly during treatment. Complications of diabetes can be serious and even life threatening. Tell your healthcare provider if you have symptoms such as feeling very thirsty or very hungry, urinating more than usual, or feeling weak
Increased blood cholesterol or triglycerides: Your healthcare provider may decide to check your cholesterol and triglyceride levels during treatment
Weight gain: Weight gain has been reported with SAPHRIS. Your healthcare provider should check your weight before and regularly during treatment
Decreased blood pressure: You may feel lightheaded or faint when you rise too quickly from a sitting or lying position. Ask your healthcare provider about ways to reduce feeling dizzy or lightheaded upon standing, such as sitting on the edge of the bed for several minutes before getting up in the morning or slowly rising after sitting
Falls: SAPHRIS may increase risk of falls, which could cause fractures or other injuri |
