近日，美国FDA批准AUVI-Q（EPINEPHRINE 中文译名：肾上腺素）自动注射器，用于婴儿和幼儿的威胁生命的过敏反应.
首次使用肾上腺素自动注射器（EAI），其针头长度和剂量专为16.5至33磅（7.5至15公斤）的婴儿和儿童设计。
儿童过敏反应和食物过敏增加; 以前没有EAI批准治疗体重16.5至33磅（7.5至15公斤）的婴儿和儿童。
批准日期：2018年8月29日 公司：KALEO INC
AUVI-Q（肾上腺素[epinephrine]注射液，USP）0.3mg，0.15mg，0.mg，自动注射器，用于肌内或皮下使用
最初的美国批准：1939年
最近的重大变化
剂量和用量：11/2017
作用机制
肾上腺素作用于α和β-肾上腺素能受体。
适应症和用法
AUVI-Q含有肾上腺素，一种非选择性α和β-肾上腺素能受体激动剂，适用于过敏反应（I型）的急诊治疗，包括过敏反应。
剂量和给药
患者大于或等于30公斤（66磅）：AUVI-Q 0.3mg。
患者15至30千克（33至66磅）：AUVI-Q 0.15毫克。
患者7.5至15千克（16.5至33磅）：AUVI-Q 0.1mg。
如有必要，通过衣服将AUVI-Q肌内或皮下注射到大腿的前外侧。每个设备都是一次性注射。
剂量形式和强度
注射剂，0.3mg：0.3mg/0.3mL肾上腺素注射液，USP，预填充自动注射器
注射剂，0.15mg：0.15mg/0.15mL肾上腺素注射液，USP，预填充自动注射器
注射液，0.1mg：0.1mg/0.1mL肾上腺素注射液，USP，预填充自动注射器。
禁忌症
没有。
警告和注意事项
与使用相结合，立即寻求医疗或住院治疗。
不要静脉注射，注入臀部，或注入数字，手或脚。
为了尽量减少注射相关伤害的风险，指导护理人员将孩子的腿牢固地固定到位，并在给予幼儿或婴儿时注射前和注射期间限制运动。
肾上腺素注射后报告了罕见的严重皮肤和软组织感染病例。如果患者在肾上腺素注射部位出现感染迹象或症状，建议患者寻求医疗护理。
本产品中存在亚硫酸盐不应妨碍使用。
心脏病患者慎用;可能加重心绞痛或产生室性心律失常。
不良反应
对肾上腺素的不良反应包括焦虑，忧虑，烦躁不安，震颤，虚弱，头晕，出汗，心悸，苍白，恶心和呕吐，头痛和/或呼吸困难。
要报告疑似不良反应，请致电1-844-828-8472联系kaleo，Inc。或致电1-800-FDA-1088或www.fda.gov/medwatch联系FDA。
药物相互作用
心脏糖苷或利尿剂：观察心律失常的发展。
三环类抗抑郁药，单胺氧化酶抑制剂，左旋甲状腺素钠和某些抗组胺药：增强肾上腺素的作用。
β-肾上腺素能阻断药物：拮抗肾上腺素的心脏刺激和支气管扩张作用。
α-肾上腺素能阻滞药：拮抗肾上腺素的血管收缩和高血压作用。
麦角生物碱：可逆转肾上腺素的升压作用。
用于特定人群
老年患者可能更容易发生不良反应。
包装提供/存储和处理
提供
纸箱包含两个AUVI-Q（肾上腺素注射液，USP）0.3mg自动注射器和一个AUVI-Q训练器-NDC 60842-023-01
纸箱包含两个AUVI-Q（肾上腺素注射液，USP）0.15mg自动注射器和一个AUVI-Q训练器-NDC 60842-022-01
纸箱包含两个AUVI-Q（肾上腺素注射液，USP）0.1mg自动注射器和一个AUVI-Q训练器-NDC 60842-021-01
仅限Rx
存储和处理
肾上腺素是光敏感的，应存放在外壳中以保护其免受光照。 储存在20°至25°C（68°至77°F）; 允许偏移15°至30°C（59°至86°F）[见USP受控室温]。 不要冷藏。 使用前，请检查以确保自动进样器中的溶液是清澈无色的。 如果溶液变色，混浊或含有颗粒，请更换自动进样器。
完整说明附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6180fb40-7fca-4602-b3da-ce62b8cd2470
Auvi-Q(epinephrine injection, USP) 0.3mg, 0.15mg
Indication
AUVI-Q(epinephrine injection, USP) is a prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions.
Important Safety Information
AUVI-Q is for immediate self(or caregiver)administration and does not take the place of emergency medical care. Seek immediate medical treatment after using AUVI-Q. Each AUVI-Q contains a single dose of epinephrine. AUVI-Q should only be injected into your outer thigh, through clothing if necessary. If you inject a young child or infant with AUVI-Q, hold their leg firmly in place before and during the injection to prevent injuries. Do not inject AUVI-Q into any other part of your body, such as into veins, buttocks, fingers, toes, hands, or feet.
If this occurs, seek immediate medical treatment and make sure to inform the healthcare provider of the location of the accidental injection. Only a healthcare provider should give additional doses of epinephrine if more than two doses are necessary for a single allergic emergency.
Rarely, patients who use AUVI-Q may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following symptoms at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.
If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use AUVI-Q. Be sure to tell your healthcare provider about all the medicines you take, especially medicines for asthma. Also tell your healthcare provider about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, heart problems or high blood pressure, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.
Common side effects include fast, irregular or ‘pounding’ heartbeat, sweating, shakiness, headache, paleness, feelings of over excitement, nervousness, or anxiety, weakness, dizziness, nausea and vomiting, or breathing problems. These side effects usually go away quickly, especially if you rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.