FDA批准高剂量盐酸纳洛酮鼻喷剂

（健康日） - 美国食品和药物管理局经批准使用较高剂量的盐酸纳洛酮鼻喷雾治疗阿片类药物过量，周五宣布。

新批准的8mg剂量为2mg和4mg已经批准使用的剂量提供另外的选择。

FDA在一份声明中表示，这一决定是继该机构为改善纳洛酮产品供应而采取的其他步骤之后做出的，包括要求所有阿片类止痛药和治疗阿片类使用障碍药物的药品制造商在处方信息中添加纳洛酮建议，以及将纳洛酮鼻喷剂的保质期从2年延长到3年。

纳洛酮可能导致阿片类药物戒断阿片类药物依赖的患者。戒断症状包括身体疼痛、腹泻、心动过速、发烧、流鼻涕、打喷嚏、勃起、出汗、打哈欠、恶心或呕吐、紧张、不安或烦躁、颤抖或颤抖、腹部痉挛、虚弱和血压升高。

“通过批准更高剂量的盐酸纳洛酮鼻喷雾产品来治疗阿片类药物过量, the FDA is making sure the overdose-reversing drug is potent enough to counteract the increasingly lethal and illicitly manufactured fentanyl and fentanyl analogs," Patrice Harris, M.D., chair of the American Medical Association Opioid Task Force, said in a statement. "Now, we must make sure that the new version of naloxone is placed on the lowest cost-sharing tier with low or no cost-sharing and also available in pharmacies. Communities are looking for tools to respond to the epidemic of drug overdoses, and the FDA action today adds a powerful one."

Hikma Pharmaceuticals通过505(b)(2)批准途径获得了联邦食品、药品和化妆品法案的批准。

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