孟鲁司特钠口溶膜)
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国家药监局修订孟鲁司特制剂说明书:患者用药不良反应中个别涉及抑郁和自杀倾向
Cai Jing Wang· 2025-12-25 11:11
Core Viewpoint - The National Medical Products Administration (NMPA) has announced a unified revision of the instructions for Montelukast formulations to enhance public medication safety, highlighting the potential neuropsychiatric adverse reactions associated with the drug [1] Group 1: Regulatory Changes - The NMPA's decision is based on the evaluation of adverse drug reactions, aiming to ensure safer medication use among the public [1] - The revised warning will include reports of neuropsychiatric adverse reactions across all age groups, including severe reactions such as depression and suicidal tendencies [1] Group 2: Patient Guidance - The new instructions recommend that if neuropsychiatric symptoms occur during treatment with Montelukast, the medication should be discontinued and medical attention sought [1] - Patients and caregivers are advised to be vigilant for neuropsychiatric adverse reactions and to inform healthcare providers if related symptoms arise during the medication period [1]
国家药监局修订孟鲁司特制剂说明书 警示语应包含精神副作用
Bei Jing Shang Bao· 2025-12-23 04:54
Core Viewpoint - The National Medical Products Administration (NMPA) has announced a unified revision of the instructions for Montelukast formulations, highlighting the potential neuropsychiatric adverse reactions associated with the drug [1] Group 1: Regulatory Changes - The NMPA's announcement includes a warning that neuropsychiatric adverse reactions have been reported in patients of all ages taking Montelukast, including severe reactions such as depression and suicidal tendencies [1] - It is advised that if neuropsychiatric symptoms occur during treatment, the medication should be discontinued and medical attention sought [1] - The revision also mandates the addition of stuttering as a reported adverse reaction based on post-marketing experience [1] Group 2: Expert Opinions - Ji Lianmei, founder of "Ask the Pharmacist," stated that Montelukast is not the first-line treatment for allergic rhinitis and asthma [1] - The incidence of psychiatric side effects, such as irritability and attention abnormalities, is reportedly higher in children [1] - It is emphasized that both adults and children should discontinue the medication and seek medical help if any neuropsychiatric symptoms arise, and a thorough assessment of benefits versus risks should be conducted before use [1]
国家药监局修订孟鲁司特制剂说明书,警示语应包含精神副作用
Bei Jing Shang Bao· 2025-12-23 04:43
Core Viewpoint - The National Medical Products Administration (NMPA) has announced a unified revision of the instructions for Montelukast formulations, highlighting the potential neuropsychiatric adverse reactions associated with the drug [1] Group 1: Regulatory Changes - The NMPA's announcement includes a warning that neuropsychiatric adverse reactions have been reported in patients of all ages taking Montelukast, including severe reactions such as depression and suicidal tendencies [1] - It is advised that if neuropsychiatric symptoms occur during treatment, the medication should be discontinued and medical attention sought [1] Group 2: Expert Opinions - Ji Lianmei, founder of "Ask the Pharmacist," stated that Montelukast sodium is not the first-choice medication for allergic rhinitis or asthma treatment [1] - The incidence of psychiatric side effects, such as irritability and attention abnormalities, is reportedly higher in children [1] - A thorough assessment of benefits versus risks is recommended before using the medication, and immediate discontinuation and medical consultation are advised if neuropsychiatric symptoms arise during treatment [1]