Oranair

A clear colorless, odourless solution.
Each 2.5 mL of the solution contains: Salbutamol (as sulfate) BP 2.5 mg.

Pharmacotherapeutic group: Adrenergics, inhalants. Selective beta-2-adrenoreceptor agonists.
Pharmacology: Pharmacodynamics: Salbutamol is a selective β2-agonist providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction. At therapeutic doses it acts on the β2-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 is readily absorbed from the gastrointestinal tract. When given by inhalation, 10 to 20% of the dose reaches the lower airways. The remainder is retained in the delivery system or is swallowed and absorbed from the gut.
Salbutamol is subject to first-pass metabolism in the liver and possibly in the gut wall but does not appear to be metabolised in the lung; the main metabolite is the inactive sulfate conjugate.
Salbutamol is rapidly excreted, mainly in the urine, as metabolites and unchanged drug, a smaller proportion is excreted in the feces. The plasma half-life of salbutamol has been estimated to range from 4 to 6 hours.

Salbutamol is used as bronchodilators in the management of reversible airways obstruction, as in asthma and in some patients with chronic obstructive pulmonary disease.

Adults: The usual starting dose is 2.5 mg as a single dose. This may be increased to 5 mg.
Treatment may be repeated up to 4 times a day.
Paediatric Population: Children aged 12 years and over: Dose as per adult population.
Children aged 4 to 11 years: 2.5 mg to 5 mg up to four times a day.
Or as prescribed by the physician.

The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events, including tachycardia, tremor, hyperactivity and metabolic effects including hypokalaemia and lactic acidosis.
Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored. Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose.

Hypersensitivity to the active substance salbutamol or to the excipients.
Although some forms of salbutamol sulfate have been used in the management of premature labour, Salbutamol Solution for Inhalation should not be used for this purpose. It should not be used in threatened abortion.

Salbutamol Solution for Inhalation must only be used by inhalation, to be breathed in through the mouth, 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 seek medical advice if treatment with Salbutamol Solution for Inhalation becomes less effective. The dosage or frequency of administration should only be increased on medical advice.
Patients being treated with Salbutamol Solution for Inhalation may also be receiving other dosage forms of short-acting inhaled bronchodilators to relieve symptoms. Increasing use of bronchodilators, in particular short-acting inhaled β2-agonists to relieve symptoms, indicates deterioration of asthma control. The patient should be instructed to seek medical advice if short-acting relief bronchodilator treatment becomes less effective or more inhalations than usual are required. In this situation patients should be assessed and consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of inhaled corticosteroid or a course of oral corticosteroid).
Severe exacerbations of asthma must be treated in the normal way.
Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis.
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.
Salbutamol Nebules should be used with care in patients known to have received large doses of other sympathomimetic drugs.
Potentially serious hypokalaemia may result from β2-agonist therapy, mainly from parenteral and nebulised 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 β-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.
Lactic acidosis has been reported in association with high therapeutic doses of intravenous and nebulised short-acting beta-agonist therapy, mainly in patients being treated for an acute asthma exacerbation. Increase in lactate levels may lead to dyspnoea and compensatory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short-acting beta-agonist treatment. It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting.
A small number of cases of acute angle-closure glaucoma have been reported in patients treated with a combination of nebulised salbutamol and ipratropium bromide. A combination of nebulised salbutamol with nebulised anticholinergics should therefore be used cautiously. Patients should receive adequate instruction in correct administration and be warned not to let the solution or mist enter the eye.
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. Salbutamol Nebules should be discontinued, and if necessary a different fast-acting bronchodilator instituted for on-going use.

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 fetus. 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 fetus 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.

Salbutamol has mainly beta-agonist effects and, like other beta agonists, may cause fine tremor of skeletal muscle (particularly the hands), palpitations, tachycardia, nervous tension, headaches, peripheral vasodilatation, and rarely muscle cramps. Inhalation causes fewer adverse effects than systemic dosage, and the more selective beta-2 agonists cause fewer adverse effects than less selective beta agonists. Potentially serious hypokalaemia has been reported after large doses. Myocardial ischaemia has also been reported. Hypersensitivity reactions have occurred, including paradoxical bronchospasm, angioedema, urticaria, hypotension, and collapse. The high doses of salbutamol used intravenously to delay premature labour have additionally been associated with nausea and vomiting, and with severe adverse cardiac and metabolic effects and pulmonary oedema.

Use of salbutamol and other beta-2 agonists with corticosteroids, diuretics, or xanthines increases the risk of hypokalaemia, and monitoring of potassium concentrations is recommended in severe asthma, where such combination therapy is common.

Store at temperatures not exceeding 30°C.

Antiasthmatic & COPD Preparations

R03AC02 - salbutamol ; Belongs to the class of adrenergic inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.

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