沙丁胺醇呼吸器解决方案
必须只用于ASTHALIN令舒吸入，通过合适的雾化器口被吸入，不得注射或吞食。
组成
ASTHALIN呼吸器解决方案
每毫升含有：
硫酸沙丁胺醇沙丁胺醇的IP IP相当于........ 5毫克
剂型
为雾化的解决方案。
药
药效
沙丁胺醇是一种选择性的β2受体激动剂，具有起效快，可逆性气道阻塞（5分钟内）提供短效（4-6小时）支气管扩张。在治疗剂量，作用于支气管肌肉的β2-肾上腺素受体。其行动起效快，特别适合哮喘管理和预防攻击。
药代动力学
沙丁胺醇静脉给药的半衰期为4-6小时，部分肾脏和部分无效4`-O型硫酸（酚醛硫酸），这也是尿中排出体外，主要由代谢清除。粪便是次要的排泄途径。最重要的是一个剂量静脉注射，口服，或吸入沙丁胺醇72小时内排出。沙丁胺醇是血浆蛋白结合，以10％的程度。
吸入路线的管理后，10％和20％的剂量达到下呼吸道。其余的被保留在传输系统中，或沉积在口咽部，从那里吞下。沉积在呼吸道的部分被吸收到肺组织和流通，但不是由肺部代谢。在到达全身血液循环，它进入到肝脏代谢，主要在尿液中被排出体外，不变药物和作为酚醛硫酸，。
吸入剂量吞食的部分是从胃肠道吸收和酚醛硫酸经历了相当大的首过代谢。都不变的药物和共轭主要在尿液中排出体外。
适应症
在常规治疗反应迟钝，慢性支气管痉挛的日常管理和使用，在治疗急性重症哮喘表示LASTHALIN呼吸器解决方案。
剂量和用法
ASTHALIN呼吸器的解决方案是使用吸入，被吸入，经口通过一个合适的雾化器，由医生的指示。该解决方案不应该被注入或吞食。 ASTHALIN呼吸器的解决方案可能是间歇性或持续管理。沙丁胺醇`S行动的持续时间为4-6小时，多数患者。
间歇性的管理
成人
ASTHALIN呼吸器溶液0.5毫升，沙丁胺醇（2.5毫克），应稀释至最终体积的2毫升无菌生理盐水。这可能会提高到1毫升（5毫克）沙丁胺醇，稀释到最终体积为2.5毫升。最终的解决方案是从一个适当的驱动雾化吸入直到气溶胶代停止。当使用正确匹配的雾化器和动力之源，这应该需要大约10分钟。
ASTHALIN呼吸器可用于解决为间歇行政稀释。对于这一点，2毫升ASTHALIN呼吸器的解决方案，沙丁胺醇（10毫克）被放置在雾化器和允许病人吸入雾化溶液直到bronchodialation实现。这通常需要3-5分钟。一些成年患者可能需要较高剂量的沙丁胺醇高达10毫克，在这种情况下，可能会继续下去，直到原液雾化气溶胶一代不再。
孩子
间歇性管理模式相同的管理也适用于儿童。最小为12岁以下的儿童开始剂量为0.5毫升，沙丁胺醇（2.5毫克），稀释到2-2.5毫升无菌生理盐水。然而，有些孩子可能需要高达5毫克高剂量的沙丁胺醇。间歇性治疗，可能会重复，每天四次。
连续给药
ASTHALIN呼吸器解决方案包含50-100微克每毫升（1-2毫升溶液与稀释剂100毫升）的沙丁胺醇，用无菌生理盐水稀释。稀释液适当的驱动雾化为气溶胶管理。在平时的管理率是每小时1-2毫克。
在以下18个月的婴儿，沙丁胺醇雾化吸入临床疗效是不确定的。作为可能会出现短暂的低氧血症，吸氧治疗应予以考虑。
禁忌
静脉注射沙丁胺醇，虽然偶尔，沙丁胺醇片用于管理在简单的条件，如前置胎盘，产前出血，妊娠毒血症早产，吸入沙丁胺醇制剂没有适当的管理早产。沙丁胺醇制剂，不应该被用于先兆流产。
ASTHALIN呼吸器的解决方案是在任何组件有过敏史的患者禁忌。
注意事项：
呼吸器解决方案ASTHALIN必须仅用于吸入，通过口通过一个合适的雾化吸入，不得注射或吞食。
支气管扩张不应该是唯一或主要在严重或不稳定哮喘患者的治疗。严重的哮喘，需要正规的医疗评估，包括肺部功能测试，因为患者严重袭击的危险，甚至死亡。医师应考虑使用的最大推荐剂量吸入糖皮质激素和/或口服皮质类固醇治疗在这些患者中。
警告在家中接受治疗的患者，应征求医生的意见，如果治疗与ASTHALIN呼吸器解决方案变得越来越有效。有可能是由于过多的剂量相关的副作用，剂量或用药频率应只增加了医疗咨询。
恶化哮喘
被ASTHALIN呼吸器方案治疗的患者，也可以接收其他剂型短效吸入型支气管扩张剂缓解症状。在一个小时内急性哮喘可能恶化或长期超过数天或更长的时间。如果病人需要比平时更多的ASTHALIN剂量，这可能是哮喘不稳定的标志，并要求病人和治疗方案进行重新评估，并特别考虑到可能需要抗炎治疗，如类固醇。
哮喘严重恶化，必须以正常的方式处理。
ASTHALIN呼吸器的解决办法应该是用在已知有收到其他拟交感神经药物的大剂量的患者的护理。
潜在的严重低血钾，可能导致从β2受体激动剂治疗，主要是从注射和雾化吸入给药。这种影响可能被缺氧和伴随治疗与黄嘌呤衍生物，类固醇，利尿剂potentiated特别小心，建议在急性严重哮喘。在这种情况下，应监测血钾水平。
在共同与其他β-肾上腺素受体激动剂，沙丁胺醇可诱发可逆的代谢变化，如增加血糖水平。糖尿病患者可能无法补偿已增加血液中的血糖和酮症酸中毒的发展。皮质类固醇并发管理可以夸大这种影响。
少数的急性闭角型青光眼的情况下结合雾化吸入沙丁胺醇和异丙托溴铵治疗的患者中已有报道。雾化吸入沙丁胺醇雾化吸入抗胆碱能药物的组合，因此，应慎重使用。患者应接受有关正确使用的充分说明，并警告说，不要让解决方案或雾进入眼睛。
沙丁胺醇应给予谨慎，从甲亢患者患。
心血管效应
ASTHALIN，像其他所有β-肾上腺素受体激动剂，可产生显着的心血管效应在测量脉率，血压，和/或症状部分患者临床。虽然这种影响是罕见的推荐剂量ASTHALIN管理后，如果发生，该药物可能需要停止。此外，β-激动剂，已生产心电图（ECG）的变化，如扁平T波，QTc间期延长，ST段压低，。这些研究结果的临床意义是未知的。因此，ASTHALIN，像所有的拟交感神经胺，应谨慎使用，在心血管疾病，尤其是冠状动脉供血不足，心律失常，高血压患者。
心血管的影响可能会看到与拟交感神经药物，包括沙丁胺醇。有一些证据表明，从上市后的数据和出版文学罕见出现心肌缺血与沙丁胺醇。应与潜在的严重的心脏疾病（如缺血性心脏病，心律失常或严重心脏衰竭）的患者正在接受沙丁胺醇警告说，如果他们遇到胸痛或心脏疾病恶化等症状求医。应注意评估症状，如呼吸困难和胸痛，呼吸或心脏的起源，因为他们可能是任。
即时过敏反应
立即过敏反应可能发生硫酸沙丁胺醇吸入气雾剂后的管理，如例荨麻疹，血管性水肿，皮疹，支气管痉挛，过敏反应，和口咽部水肿。
不超过推荐剂量
死亡人数已与哮喘患者吸入拟交感神经药物的过度使用。死亡的确切原因尚不清楚，但怀疑是心脏骤停，严重的急性哮喘危机和随后的缺氧意外发展。 。
药物相互作用
ASTHALIN呼吸器的解决方案通常不应与非选择性β-受体阻断药如普萘洛尔，规定。
怀孕
政府只应考虑药物在怀孕期间，如果母亲是预期收益大于对胎儿的任何可能出现的风险。与大多数药物，很少有发表沙丁胺醇在人类妊娠的早期阶段的安全性的证据，但在动物实验中，有一些在非常高剂量的胎儿的有害影响的证据。
哺乳
沙丁胺醇可能是母乳中分泌，哺乳母亲使用需要慎重考虑。它不知道是否沙丁胺醇对新生儿的有害影响，因此，它的使用应该受到限制的情况下，它被认为预期收益的母亲很可能超过任何潜在危险的新生儿。
不良影响
从β2受体激动剂治疗可能会导致潜在的严重低血钾。与其他吸入疗法一样，可能会出现矛盾的支气管痉挛，立即增加在服药后喘息。这应立即用另一种陈述或不同，速效吸入支气管扩张剂治疗。 ASTHALIN呼吸器解决方案应立即停止，病人评估，并提起，如果必要，替代疗法。
常见的副作用包括震颤，头痛，心动过速，低血钾。
非常罕见的副作用包括外周血管扩张和心律失常，包括房颤，室上性心动过速，期外收缩似是而非的支气管痉挛;，包括荨麻疹，支气管痉挛，低血压和虚脱多动症血管性水肿等过敏反应。
罕见的副作用包括心悸，嘴和喉咙发炎，肌肉痉挛。
心肌缺血（自发地在上市后的数据报告，因此，频率为未知认为）。
过量
TDiscontinue管理ASTHALIN呼吸器解决方案，如果有过量的任何迹象。与沙丁胺醇过量的首选解毒剂是一种心脏选择性β-阻断剂，但应与支气管痉挛病史的患者慎用β-阻断剂。
低血钾，可能会出现与沙丁胺醇过量。应监测血钾水平。
禁
（物理和化学）的药物配伍，疗效，安全ASTHALIN呼吸器解决方案时，在雾化器的其他药物混合尚未建立。
保质期
2年
Asthalin Respirator Solution
Salbutamol Respirator Solution
ASTHALIN Respules must only be used for inhalation, to be inhaled in through the mouth via a suitable nebulizer, and must not be injected or swallowed.
COMPOSITION
ASTHALIN Respirator Solution
Each ml contains:
Salbutamol Sulphate IP equivalent to Salbutamol IP…….. 5 mg
DOSAGE FORM
Solution for nebulization.
PHARMACOLOGY
Pharmacodynamics
Salbutamol is a selective beta 2 -agonist providing short-acting (4-6 hours) bronchodilatation with a fast onset (within 5 minutes) in reversible airways obstruction. At therapeutic doses, it acts on the beta 2 -adrenoceptors of bronchial muscle. With its fast onset of action, it is particularly suitable for the management and prevention of attack in asthma.
Pharmacokinetics
Salbutamol administered intravenously has a half-life of 4-6 hours and is cleared partly renally and partly by metabolism to the inactive 4`-O-sulphate (phenolic sulphate), which is also excreted primarily in the urine. The faeces are a minor route of excretion. Most of a dose of salbutamol given intravenously, orally, or by inhalation is excreted within 72 hours. Salbutamol is bound to plasma proteins to the extent of 10%.
After administration by the inhaled route, between 10% and 20% of the dose reaches the lower airways. The remainder is retained in the delivery system or is deposited in the oropharynx from where it is swallowed. The fraction deposited in the airways is absorbed into the pulmonary tissues and circulation, but is not metabolized by the lungs. On reaching the systemic circulation, it becomes accessible to hepatic metabolism and is excreted, primarily in the urine, as unchanged drug and as phenolic sulphate.
The swallowed portion of an inhaled dose is absorbed from the gastrointestinal tract and undergoes considerable first-pass metabolism to phenolic sulphate. Both unchanged drug and conjugate are excreted primarily in the urine.
INDICATIONS
LASTHALIN Respirator Solution is indicated for use in the routine management of chronic bronchospasm unresponsive to conventional therapy, and in the treatment of acute severe asthma.
DOSAGE AND ADMINISTRATION
ASTHALIN Respirator Solution is for inhalation use only, to be inhaled in through the mouth via a suitable nebulizer, as instructed by a physician. The solution should not be injected or swallowed. ASTHALIN Respirator Solution may be administered intermittently or continuously. Salbutamol`s duration of action is 4-6 hours in most patients.
Intermittent Administration
Adults
ASTHALIN Respirator Solution 0.5 ml (2.5 mg of salbutamol) should be diluted to a final volume of 2 ml with sterile normal saline. This may be increased to 1 ml (5 mg of salbutamol), diluted to a final volume of 2.5 ml. The resulting solution is inhaled from a suitably driven nebulizer until aerosol generation ceases. When using a correctly matched nebulizer and driving source, this should take about 10 minutes.
ASTHALIN Respirator Solution may be used undiluted for intermittent administration. For this, 2 ml of ASTHALIN Respirator Solution (10 mg of salbutamol) is placed in the nebulizer and the patient allowed to inhale the nebulized solution until bronchodialation is achieved. This usually takes 3-5 minutes. Some adult patients may require higher doses of salbutamol up to 10 mg, in which case, nebulization of the undiluted solution may continue until aerosol generation ceases.
Children
The same mode of administration for intermittent administration is also applicable to children. The minimum starting dosage for children below the age of 12 years is 0.5 ml (2.5 mg of salbutamol), diluted to 2-2.5 ml with sterile normal saline. Some children may, however, require higher doses of salbutamol up to 5 mg. Intermittent treatment may be repeated up to four times daily.
Continuous Administration
ASTHALIN Respirator Solution is diluted with sterile normal saline to contain 50-100 mcg of salbutamol per ml (1-2 ml solution made up to 100 ml with diluents). The diluted solution is administered as an aerosol by a suitably driven nebulizer. The usual rate of administration is 1-2 mg per hour.
In infants below 18 months of age, the clinical efficacy of nebulized salbutamol is uncertain. As transient hypoxaemia may occur, supplemental oxygen therapy should be considered.
CONTRAINDICATIONS
Although intravenous salbutamol and, occasionally, salbutamol tablets are used in the management of premature labour uncomplicated by conditions such as placenta praevia, antepartum haemorrhage, or toxaemia of pregnancy, inhaled salbutamol preparations are not appropriate for managing premature labour. Salbutamol preparations should not be used for threatened abortion.
ASTHALIN Respirator Solution is contraindicated in patients with a history of hypersensitivity to any of the components.
WARNINGS AND PRECAUTIONS
ASTHALIN Respirator Solution must only be used for inhalation, to be inhaled in through the mouth via a suitable nebulizer, and must not be injected or swallowed.
Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment, including lung-function testing, as patients are at risk of severe attacks and, even, death. Physicians should consider using the maximum recommended dose of inhaled corticosteroid and/or oral corticosteroid therapy in these patients.
Patients receiving treatment at home should be warned to seek medical advice if treatment with ASTHALIN Respirator Solution becomes less effective. As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.
Deterioration of Asthma
Patients being treated with ASTHALIN Respirator Solution may also be receiving other dosage forms of short-acting inhaled bronchodilators to relieve symptoms. Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of ASTHALIN than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen, with special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
Severe exacerbations of asthma must be treated in the normal way.
ASTHALIN Respirator Solution should be used with care in patients who are known to have received large doses of other sympathomimetic drugs.
Potentially serious hypokalaemia may result from beta 2 -agonist therapy, mainly from parenteral and nebulized administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids, and diuretics. Serum potassium levels should be monitored in such situations.
In common with other beta-adrenoceptor agonists, salbutamol can induce reversible metabolic changes such as increased blood glucose levels. Diabetic patients may be unable to compensate for the increase in blood glucose and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.
A small number of cases of acute angle-closure glaucoma have been reported in patients treated with a combination of nebulized salbutamol and ipratropium bromide. A combination of nebulized salbutamol with nebulized anticholinergics should, therefore, be used cautiously. Patients should receive adequate instructions about correct usage and be warned not to let the solution or mist enter the eyes.
Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis.
Cardiovascular Effects
ASTHALIN , like all other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of ASTHALIN at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, ASTHALIN , like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
Immediate Hypersensitivity Reactions
Immediate hypersensitivity reactions may occur after administration of salbutamol sulphate inhalation aerosol, as demonstrated by cases of urticaria, angio-oedema, rash, bronchospasm, anaphylaxis, and oropharyngeal oedema.
Do Not Exceed Recommended Dose
Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected. .
Drug Interactions
ASTHALIN Respirator Solution should not normally be prescribed with non-selective beta-blocking drugs, such as propranolol.
Pregnancy
Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. As with the majority of drugs, there is little published evidence of the safety of salbutamol in the early stages of human pregnancy, but in animal studies, there was evidence of some harmful effects on the foetus at very high dose levels.
Lactation
As salbutamol is probably secreted in breast milk, its use in nursing mothers requires careful consideration. It is not known whether salbutamol has a harmful effect on the neonate and, so, its use should be restricted to situations where it is felt that the expected benefit to the mother is likely to outweigh any potential risk to the neonate.
UNDESIRABLE EFFECTS
Potentially serious hypokalaemia may result from beta 2 -agonist therapy. As with other inhalation therapy, paradoxical bronchospasm may occur, with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different, fast-acting inhaled bronchodilator. ASTHALIN Respirator Solution should be discontinued immediately, the patient assessed, and, if necessary, alternative therapy instituted.
Common side effects include tremor, headache, tachycardia, and hypokalaemia.
Very rare side effects include peripheral vasodilatation; hypersensitivity reactions, including angio-oedema, urticaria, bronchospasm, hypotension and collapse hyperactivity; and cardiac arrhythmias, including atrial fibrillation, supraventricular tachycardia, and extrasystoles paradoxical bronchospasm.
Uncommon side effects include palpitations, mouth and throat irritation, and muscle cramps.
Myocardial ischaemia (reported spontaneously in postmarketing data; therefore, frequency regarded as unknown).
OVERDOSAGE
TDiscontinue administration of ASTHALIN Respirator Solution if there are any signs of overdosage. The preferred antidote for overdosage with salbutamol is a cardioselective beta-blocking agent, but beta -blocking drugs should be used with caution in patients with a history of bronchospasm.
Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.
INCOMPATIBILITY
Drug compatibility (physical and chemical), efficacy, and safety of ASTHALIN Respirator Solution when mixed with other drugs in a nebulizer have not been established.
SHELF-LIFE
2 years
PACKAGING INFORMATION
ASTHALIN Respirator Solution ………….Bottle of 15 ml
