新型慢性阻塞性肺病吸入剂LONHALA MAGNAIR（glycopyrrolate）是第一个在美国批准用于治疗COPD的雾化长效毒蕈碱拮抗剂（LAMA）
批准日期：2018年4月3日 公司：Sunovion Respiratory Development Inc.
LONHALA MAGNAIR（格隆溴铵 glycopyrrolate）吸入溶液，用于口服吸入
初始美国批准：1961年
作用机制
格隆溴铵是一种长效毒蕈碱拮抗剂，通常被称为抗胆碱能药。 它与毒蕈碱受体M1至M5的亚型具有相似的亲和力。 在气道中，它通过抑制平滑肌上的M3受体导致支气管扩张而表现出药理作用。 用人和动物来源受体和分离的器官制剂显示出拮抗作用的竞争性和可逆性。 在临床前体外和体内研究中，预防乙酰甲胆碱和乙酰胆碱诱导的支气管收缩作用是剂量依赖性的并且持续超过24小时。 这些发现的临床相关性尚不清楚。 吸入格隆溴铵后的支气管扩张主要是位点特异性作用。
适应症和用法
LONHALA MAGNAIR是一种抗胆碱能药，适用于慢性阻塞性肺病（COPD）患者气流阻塞的长期维持治疗。
剂量和用量
仅用于口服吸入。不要吞下LONHALA解决方案。只能使用带有MAGNAIR的LONHALA小瓶。
COPD的维持治疗：每天两次LONHALA小瓶的内容物。
剂量形式和强度
LONHALA吸入溶液作为无菌溶液提供，可在一次性使用的低密度聚乙烯（LDPE）小瓶中进行吸入。每个1mL小瓶含有25mcg格隆溴铵。
禁忌症
LONHALA MAGNAIR禁用于对格隆溴铵或任何成分过敏的患者。
警告和注意事项
不要急性恶化COPD或治疗急性症状。
如果出现反常的支气管痉挛，立即停用LONHALA MAGNAIR并进行替代治疗。
可能会出现窄角型青光眼的恶化。对于患有窄角型青光眼的患者慎用，并指导患者在出现症状时立即与医生联系。
可能发生尿潴留恶化。前列腺增生或膀胱颈梗阻患者慎用，并指导患者在出现症状时立即就医。
不良反应
最常见的不良反应（发生率大于或等于2.0％且高于安慰剂）是呼吸困难和尿路感染。
要报告疑似不良反应，请致电1-877-737-7226联系Sunovion制药公司或1-800-FDA-1088或www.fda.gov/medwatch联系FDA。
药物相互作用
抗胆碱能药：可以与伴随使用的抗胆碱能药物相互作用。避免使用含有其他抗胆碱能药物的LONHALA MAGNAIR。
用于特定人群
如果治疗的潜在益处超过风险，应考虑用于严重肾功能不全的患者。
如何提供/存储和处理
如何提供
LONHALA MAGNAIR以1 mL无菌，透明，无色的水溶液形式提供，采用低密度聚乙烯（LDPE）单位剂量小瓶包装。 LONHALA MAGNAIR有一个入门套件，包含60个单位剂量的小瓶，其中包含一个MAGNAIR和FDA批准的患者标签。 LONHALA MAGNAIR还提供一个补充套件，其中包含60个单位剂量的小瓶，其中包含MAGNAIR替换手机和FDA批准的患者标签。
包装配置剂量强度NDC
提供30天的入门套件（30个铝箔袋，每袋2个样品瓶）和完整的MAGNAIR雾化器系统25 mcg NDC：63402-201-00
30天供应的补充套件（30个铝箔袋，每袋2个样品瓶）和MAGNAIR替换手机25 mcg NDC：63402-301-01
存储和处理
将LONHALA吸入溶液储存在20°-25°C（68°-77°F）的保护性铝箔袋中[参见USP Controlled Room Temperature]。
LONHALA样品瓶只能与MAGNAIR一起使用。不要将MAGNAIR与任何其他样品瓶一起使用。
将LONHALA样品瓶存放在保护膜袋中。打开箔袋后，应将未使用的单位剂量小瓶放回并存放在铝箔袋中。打开铝箔袋后，如果在7天内未使用，则丢弃样品瓶。应立即使用打开的单位剂量小瓶。如果溶液不是无色，则丢弃任何单位剂量的小瓶。
始终使用每个LONHALA MAGNAIR笔芯处方随附的MAGNAIR替换手机。
放在儿童接触不到的地方。
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LONHALA MAGNAIR REFILL 25 MCG-ML VL 60 GLYCOPYRROLATE/NEB.ACCESSORIES SUNOVION PHARMACEUTICALS INC 63402030101
LONHALA MAGNAIR STARTER 25 MCG-ML VL 60 GLYCOPYRROL/NEBULIZER/ACCESSOR SUNOVION PHARMACEUTICALS INC 63402020100
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完整资料附件：https://www.lonhalamagnair.com/LonhalaMagnair-Prescribing-Information.pdf
LONHALA MAGNAIR(glycopyrrolate) inhalation solution, for oral inhalation use
LONHALA® MAGNAIR® (glycopyrrolate) is a medicine called an anticholinergic. LONHALA MAGNAIR is used long term, twice each day (morning and evening), for maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Summary of Important Safety Information for LONHALA MAGNAIR
LONHALA® MAGNAIR® [lon-HAH-luh MAGG-nair] (glycopyrrolate) Inhalation Solution
This summary does not include all information about LONHALA MAGNAIR and is not meant to take the place of discussions with your health care provider about your treatment. Please read this important information carefully before you start taking LONHALA MAGNAIR. Discuss any questions about LONHALA MAGNAIR with your healthcare provider.
What is LONHALA MAGNAIR?
LONHALA MAGNAIR is a prescription, anticholinergic medicine, used long term and twice each day (morning and evening) to improve symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults with COPD. COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both.
Anticholinergic medicines such as LONHALA MAGNAIR help the muscles around the airways in your lungs stay relaxed to help control COPD symptoms such as wheezing, coughing, chest tightness, and shortness of breath.
Who should not use LONHALA MAGNAIR?
Do not use LONHALA MAGNAIR if you:
have sudden symptoms of COPD. LONHALA MAGNAIR should not be used as rescue therapy. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed.
are allergic to glycopyrrolate, or any of the ingredients in LONHALA MAGNAIR (see below). Ask your healthcare provider if you are not sure.
Active ingredient: glycopyrrolate
Inactive ingredients: citric acid monohydrate, sodium chloride, sodium hydroxide and water for injection
LONHALA MAGNAIR should not be used by children. It is not known if LONHALA MAGNAIR is safe and effective for children.
What warnings should I know about LONHALA MAGNAIR?
LONHALA MAGNAIR can cause serious side effects, including:
sudden shortness of breath immediately after use. Sudden shortness of breath may be life-threatening. If you have sudden breathing problems immediately after inhaling your medicine, stop using LONHALA MAGNAIR. Call your healthcare provider or go to the nearest hospital emergency room right away.
life-threatening paradoxical bronchospasm, which means your airway passages may narrow and breathing may become difficult. Stop using LONHALA MAGNAIR immediately.
serious allergic reactions. Stop using LONHALA MAGNAIR if you get any of the following symptoms:
rash
hives
swelling of the tongue, lips, and face
difficulty breathing or swallowing
new or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms may include:
eye pain or discomfort
red eyes
blurred vision
nausea or vomiting
seeing halos or bright colors around lights
new or worsened problems emptying your bladder (urinary retention). People who use LONHALA MAGNAIR may develop new or worsened urinary retention. Urinary retention can be caused by a blockage in your bladder or it can develop in men with a larger than normal prostate. Symptoms may include:
difficulty urinating
painful urination
urinating frequently
urination in a weak stream or drips
If you have any of these side effects, stop using LONHALA MAGNAIR and call your healthcare provider or get emergency medical treatment right away before taking another dose.
Do not exceed the recommended dose. Excessive use of LONHALA MAGNAIR, or use with other anticholinergic medications, can result in undesirable increase in anticholinergic activity.
If your COPD symptoms worsen over time, do not increase your dose of LONHALA MAGNAIR. Call your healthcare provider.
What should I tell my healthcare provider before using LONHALA MAGNAIR?
Before using LONHALA MAGNAIR, tell your healthcare provider about all of your medical conditions, including if you:
have kidney problems.
have eye problems such as glaucoma. LONHALA MAGNAIR may make glaucoma worse.
have prostate or bladder problems, or problems passing urine. LONHALA MAGNAIR may make these problems worse.
are pregnant or plan to become pregnant. It is not known if LONHALA MAGNAIR can harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if the medicine in LONHALA MAGNAIR passes into your breast milk or if it can harm your baby.
are allergic to LONHALA MAGNAIR or any of its ingredients or any other medicines.
Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements. LONHALA MAGNAIR may affect the way other medicines work, and other medicines can affect how LONHALA MAGNAIR works. This may cause serious side effects.
Especially tell your healthcare provider if you take other anticholinergics (including umeclidinium, tiotropium, ipratropium, aclidinium, glycopyrrolate).
Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I use LONHALA MAGNAIR?
Read the step-by-step instructions for using LONHALA MAGNAIR found in the Prescribing Information and the Manufacturer's Instruction for Use booklet.
Only use LONHALA vials with the MAGNAIR device.
Do not use LONHALA MAGNAIR unless your healthcare provider has taught you how to use the device and you understand how to use it correctly.
Use LONHALA MAGNAIR exactly as your healthcare provider tells you to use it.
Do not use LONHALA MAGNAIR:
more often than prescribed.
at higher dose than prescribed.
with other anticholinergic medicines.
Inhale the medicine in 1 LONHALA vial through the MAGNAIR device twice each day (1 vial in the morning and 1 vial in the evening).
Do not inject or swallow the LONHALA medicine.
If you miss a dose of LONHALA MAGNAIR, just skip that dose. Take the next dose at your usual time. Do not use 2 vials at 1 time. Do not use more than 2 vials in a day.
Do not stop using LONHALA MAGNAIR or other medicines to control or treat your COPD unless told to do so by your healthcare provider. Your symptoms might get worse. Your healthcare provider will change your medicines as needed.
What are the possible side effects with LONHALA MAGNAIR?
See "What warnings should I know about LONHALA MAGNAIR?"
Common side effects of LONHALA MAGNAIR include: shortness of breath and urinary tract infections.
These are not all the side effects of LONHALA MAGNAIR. Tell your healthcare provider about any side effect that bothers you or that does not go away. Ask your healthcare provider or pharmacist for more information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.