药品信息:
通用名:硫酸沙丁胺醇
其他名称:舒布托, 全乐宁, 全特宁, 硫酸舒喘灵, 硫酸阿布叔醇, 萨姆, 爱纳灵, 全宁碟, 喘宁碟, 沙博特, 达芬科闯, 律克, 硫酸沙丁胺醇粉雾剂, 硫酸沙丁胺醇缓释片, 硫酸沙丁胺醇胶囊, 硫酸沙丁胺醇片, 硫酸沙丁胺醇注射液, 硫酸沙丁胺醇控释片, 惠百适, 硫酸沙丁胺醇缓释胶囊, 硫酸沙丁胺醇控释胶囊
英文其他名称:Volmax, Ventolin, Salbutamol Sulphate, Etinoline, Albuterol Sulfate, Ventodisks, Salbutamol Sulfate Controlled Release Capsules, Salbutamol Sulfate Controlled Release Tablets, Salbutamol Sulfate Nebules Inhalation Solution, Salbutamol Sulfate Sustained Release Capsules, Salbutamol Sulfate Sustained Release Tablets, Salbutamol Sulfate Capsules, Salbutamol Sulfate Injection, Salbutamol Sulfate Orally Disintegrating Tablets, Salbutamol Sulfate Powder for Inhalation, Salbutamol Sulfate Powder for Inhalation(Capsuliform), Salbutamol Sulfate Respirator Solution, Salbutamol Sulfate Solution for Inhalation, Salbutamol Sulfate Sustained Release Pellets, Salbutamol Sulfate Tablets, Ventolin Rotacaps
功能/功效: 1.用于防治支气管哮喘、哮喘性支气管炎和肺气肿患者的支气管痉挛。 2.本药雾化吸入溶液还可用于运动性支气管痉挛及常规疗法无效的慢性支气管痉挛。 3.还用于改善充血性心力衰竭。 4.亦用于预防高危妊娠早产
注意事项: 1.交叉过敏 对其它肾上腺素受体激动药过敏者也可能对本药过敏。 2.禁忌症 对本药或其它肾上腺素受体激动药过敏者。 3.慎用 (1)高血压患者。(2)青光眼患者(国外资料)。(3)糖尿病患者。(4)嗜铬细胞瘤患者 不良反应: 1.较常见的不良反应有:震颤、恶心、心悸、头痛、失眠、心率增快或心搏异常强烈。 2.较少见的不良反应:头晕、目眩、口咽发干。 3.罕见肌肉痉挛,过敏反应(表现为异常支气管痉挛、血管神经性水肿、荨麻疹、
给药说明: 1.通常预防用药时口服给药,控制发作时用气雾或粉雾吸入。 2.本药缓释及控释制剂应整片吞服,不得咀嚼。 3.对氟利昂过敏的患者禁用本药气雾剂,惊厥患者慎用本药雾化吸入溶液。
用法与用量: 成人 ·常规剂量 ·口服给药 一次2-4mg,一日3次。缓释及控释制剂,一次8mg,一日2次,早、晚服用。 ·气雾吸入 每4-6小时200-500μg,1次或分2次吸入,2次吸入时间隔1分钟。
制剂与规格: 硫酸沙丁胺醇片 2mg。 贮法:避光,密封保存。 硫酸沙丁胺醇缓释片 (1)4mg。(2)8mg。 贮法:避光,密封保存。 硫酸沙丁胺醇控释片 (1)4mg。(2)8mg。 贮法:避光,密封,在阴凉处保存。
禁忌:对本药或其它肾上腺素受体激动药过敏者。
Ventolin HFA (albuterol sulfate inhalation aerosol) Company: GlaxoSmithKline Approval Status: Approved April 2001 Treatment for: Asthma Areas: Pulmonary/Respiratory Diseases
General Information Ventolin HFA has been approved for the treatment or prevention of bronchospasm in adults and children four years of age and older with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm in patients four years of age and older. Ventolin HFA is a new version of the Ventolin metered-dose inhaler (MDI) currently marketed by GlaxoSmithKline. However unlike the current version, the new inhaler does not use chlorofluorocarbons (CFCs) to propel the medication. Ventolin HFA uses an alternative propellant called HFA or hydrofluoroalkane.
CFCs have been implicated in the depletion of the ozone layer, and as a result, the use of CFC-aerosol products in the United States has been sharply curtailed over the last few decades. While CFC production and importation have been banned for all commercial purposes in the United States since 1996, an exception is made for medical products that are considered essential with no suitable alternatives. While no action to remove the albuterol CFC MDIs from the market is planned at this time, the approval of Ventolin HFA provides an additional albuterol HFA MDI option to patients and physicians.
Clinical Results A 12-week, randomized, double-blind trial compared Ventolin HFA to CFC 11/12-propelled albuterol and an HFA-134a placebo inhaler. The trial included adolescent and adult subjects (12-76 years of age) with mild to moderate asthma. Serial forced expiratory volume in one second (FEV1) measurements showed that two inhalations of Ventolin HFA produced a significantly greater improvement in FEV1 over the pretreatment value than placebo.
A second 12-week, randomized, double-blind trial evaluated the effectiveness of switching subjects from CFC 11/12-propelled albuterol to Ventolin HFA. In an initial run-in phase, all subjects received CFC 11/12-propelled albuterol. During the double-blind treatment phase, Ventolin HFA was compared to CFC 11/12-propelled albuterol and an HFA-134a placebo inhaler in adolescent and adult subjects with mild to moderate asthma. Serial FEV1 measurements showed that two inhalations of Ventolin HFA produced significantly greater improvement in pulmonary function than placebo. The switching from CFC 11/12-propelled albuterol inhaler to Ventolin HFA did not reveal any clinically significant changes in the efficacy profile.
Additionally, a two-week, randomized, double-blind trial was conducted to compare Ventolin HFA, CFC 11/12-propelled albuterol, and an HFA-134a placebo inhaler in 135 pediatric subjects (4-11 years old) with mild to moderate asthma. Serial pulmonary function measurements showed that two inhalations of Ventolin HFA produced significantly greater improvement in pulmonary function than placebo, and that there were no significant differences between the groups treated with Ventolin HFA and CFC 11/12-propelled albuterol.
A controlled trial in adult subjects with asthma showed that two inhalations of Ventolin HFA taken approximately 30 minutes prior to exercise significantly prevented exercise-induced bronchospasm compared to an HFA-134a placebo inhaler. In addition, Ventolin HFA was shown to be clinically comparable to a CFC 11/12-propelled albuterol inhaler for this indication. (from Ventolin HFA Product Information)
Side Effects Adverse events reported from clinical trials include (but are not limited to) the following: Throat irritation Upper respiratory inflammation Viral respiratory infections Cough Musculoskeletal pain Overall, the adverse events were similar between Ventolin HFA and a CFC 11/12-propelled albuterol inhaler. Additionally, according to the results of a two-week pediatric trial, the pediatric adverse event profile was generally similar to that of the adult.
Mechanism of Action In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta2-adrenergic receptors compared to isoproterenol. Activation of beta2-adrenergic receptors on airway smooth muscle leads to the activation of adenylcyclase, and to an increase in the intracellular concentration of cyclic-3',5'-adenosine monophosphate (cyclic AMP). This increase of cyclic AMP leads to the activation of protein kinase A, which inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in relaxation. Albuterol relaxes the smooth muscles of all airways, from the trachea to the terminal bonchioles. Albuterol acts as a functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor challenges. (from Ventolin HFA Product Information)
Additional Information Please visit the company web site for additional information on GlaxoSmithKline products.
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