Salbutamol Nebuliser Solution is indicated in adults, adolescents and children aged 4 years and above, see section 4.2.
Salbutamol Nebuliser Solution is indicated for use in the routine management of chronic bronchospasm unresponsive to conventional therapy and the treatment of acute severe asthma.
Salbutamol Nebuliser Solution should be administered by a suitable nebulizer, via a face mask or T piece or via an endotracheal tube.
To open the plastic ampoule, take a strip of ampoules from the foil pack, remove one ampoule, replacing the rest back in the foil pack, and replace the foil pack back in the carton. Hold the ampoule upright and open it by twisting off the top. Squeeze the liquid into the solution holder of the machine.
The usual starting dose is 2.5mg as a single dose. This may be increased to 5mg. Treatment may be repeated up to four times a day.
For the treatment of severe airways, obstruction in adult hospitalized patients, higher doses up to 40mg per day can be given under strict medical supervision.
In domiciliary practice, the benefits of increasing the dosage should be weighed against the risk that a deterioration in the patient’s underlying condition may be masked. In this case, a medical assessment should be considered an alternative therapy instituted where indicated.
Children aged 12 years and over: Dose as per adult population.
Children aged 4 to 11 years: 2.5mg to 5mg up to four times a day.
Other pharmaceutical forms may be more appropriate for administration in children under 4 years old.
Clinical efficacy of nebulized salbutamol in infants under 18 months is uncertain. As transient hypoxemia may occur, supplemental oxygen therapy should be considered.
Salbutamol Nebuliser Solution is designed to be used undiluted. However, if prolonged delivery time is indicated (more than 10 minutes) then dilution with Sodium Chloride Solution (0.9%w/v) for Nebulisation or sterile sodium chloride injection (normal saline) may be required.
Hypersensitivity to the active substance salbutamol or to the excipients (see section 6.1 List of excipients).
Although some forms of salbutamol sulfate have been used in the management of premature labor, Salbutamol Nebuliser Solution should not be used for this purpose. Salbutamol Nebuliser Solution should not be used in threatened abortion.
Salbutamol Nebuliser Solution is for use with a nebulizer under the direction of a physician. The solution must not be injected or administered orally.
In patients with severe or unstable asthma, bronchodilators should not be the only or main treatment. A regular medical assessment is required including lung function testing, as they are at risk of severe attacks and even death. Oral corticosteroid therapy and/or inhaled corticosteroids should be considered. Increasing the use of bronchodilators to relieve symptoms indicates deterioration of asthma control.
In the following cases, salbutamol should only be used with caution and if strictly indicated:
– serious cardiac disorders, in particular, recent myocardial infarction
– coronary heart disease, hypertrophic obstructive cardiomyopathy and tachyarrhythmia (due to the positive ionotropic effect of β2 – agonists)
– severe and untreated hypertension
– diabetes which is difficult to control
Daily self-assessment of asthma control following instructions regarding the use of Salbutamol Nebuliser Solution and any other drugs required for the management of asthma is important in order that the course of the disease can be followed and the success of both bronchodilator and anti-inflammatory therapy monitored. The patient should be instructed in the regular measurement of peak expiratory flow rate (PEFR) using a portable peak flow meter.
Patients receiving treatment with Salbutamol Nebuliser Solution at home should be warned that, if asthma control does not improve satisfactorily or deteriorates, or if the short-acting relief bronchodilator treatment becomes less effective, or more inhalations than usual are required, medical advice must be sought in order that the clinical condition can be re-assessed and therapeutic management revised appropriately. In this situation anti-inflammatory therapy may be required, the dose of anti-inflammatory therapy may need to be increased or a short course of oral glucocorticoids may be needed. Increasing the use of bronchodilators and in particular short-acting inhaled beta2 adrenergic agonists to relieve symptoms indicates deterioration of asthma control.
A sudden and increasing deterioration of asthma symptoms can be life-threatening. Therefore, medical assistance must be sought immediately.
The administration of salbutamol in patients with acute asthma may cause a further reduction of O2 saturation.
The dose and frequency of inhalation of short-acting beta2 agonists should only be increased following medical advice and if a previously effective dose fails to give the expected relief the patient should be advised to seek medical advice. Exceeding the prescribed dose can be dangerous with resultant cardiac effects, hypokalaemia, taste alteration, nausea, restlessness, sweating, headache, or tremor.
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 ischemia associated with salbutamol. Patients with underlying severe heart disease (e.g. ischemic 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 the assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
Potentially serious hypokalaemia may result from β2-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.
Due to the hyperglycaemic effects of beta2 – stimulants, additional blood glucose measurements are initially recommended when treatment with Salbutamol Nebuliser Solution is started in diabetic patients.
Inhalation of high doses of salbutamol can increase the blood glucose level. Therefore, blood glucose levels in diabetic patients should be monitored closely.
The use of nebulized salbutamol in combination with nebulized anticholinergic agents has been reported to precipitate acute angle-closure glaucoma. This combination should be used with caution, in particular in patients with actual or potential glaucoma. Patients should be warned
Salbutamol Nebuliser Solution should be used with caution in patients receiving other sympathomimetics.
Salbutamol and non-selective β – receptor blocking drugs should not usually be prescribed together. In patients with asthma administration of β – receptor blocking drugs is associated with a risk of severe bronchoconstriction.
Treatment with salbutamol can lead to hypokalaemia (see 4.4 special warnings and precautions for use and 4.8 Undesirable effects). This effect may be potentiated by the concomitant administration of other drugs, in particular, xanthine derivatives, glucocorticoids, diuretics and cardiac glycosides (digoxin). Serum potassium levels should be monitored in these situations.
Tricyclic antidepressants may increase the risk of cardiovascular side effects.
Corticosteroids may increase the risk of hyperglycemia.
A few cases have been reported where the combination of nebulized salbutamol and ipratropium bromide has given rise to acute angle-closure glaucoma.
Based on preclinical studies and long-term clinical experience, salbutamol has not been shown to have any teratogenic effects. If the mother uses salbutamol during pregnancy, the pulse rate of the fetus may increase. Since salbutamol is passively excreted in breast milk, high doses may induce drug effects in the breast-fed infant.
Although salbutamol is considered the first-line treatment to relieve bronchospasm in asthmatic pregnant women, use during pregnancy, especially in the first trimester, and lactation should only be considered once the benefits have been carefully weighed against the risks.
Up to approximately 10% of patients can be expected to experience adverse reactions. These depend upon the dose and individual sensitivity. Most commonly reported are taste alteration (bad, unpleasant and unusual taste) and application site reaction (mouth and throat irritation, burning sensation of the tongue), fine tremor (usually of the hands) nausea, sweating, restlessness, headache, dizziness and muscle cramps. These undesirable effects may subside on continuation of treatment within 1-2 weeks.
As with other inhalation therapies, in rare cases paradoxical bronchospasm may occur, manifested by an immediate increase in wheezing after dosing. Paradoxical bronchospasm should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator. Salbutamol Nebuliser Solution should be discontinued immediately, the patient should be assessed, and if necessary, alternative therapy instituted. Hypersensitivity reactions such as rash, urticaria, dermatitis, pruritus, and erythema have been observed. There have been very rare reports of angioedema (edema of the face, lips, eyes, and throat), bronchospasm, hypotension, and collapse.
Tachycardia, with or without peripheral vasodilation, may occur. In common with other beta2 agonists, cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles), palpitations, angina pectoris, and blood pressure effects have been reported in association with the use of salbutamol, usually in susceptible patients. There are reports about stimulating effects on the central nervous system after inhalation of salbutamol which manifest themselves in hyperexcitability, hyperactive behavior, sleep disturbances, and hallucinations. These observations were predominantly made in children up to 12 years of age.
The table below presents a possible adverse drug reaction in system organ class order and sorted by frequency.
|Organ System||Frequency||Adverse drug reaction|
|Immune system disorders||Very rare (including isolated cases) (<1/10,000)||Hypersensitivity reaction|
|Metabolism||Rare ( >1/10,000, <1/1,000)||Hypokalaemia, hyperglycemia|
|Psychiatric disorders||Common (>1/100, <1/10)||Restlessness|
|Nervous system disorders||Common (>1/100, <1/10)||Fine tremor, dizziness|
|Rare ( >1/10,000, <1/1,000)||Hyperactive behaviour|
|Very rare (including isolated cases) (<1/10,000)||Hyperexcitability, sleeping disturbances, hallucinations|
|Cardiac disorders||Rare ( >1/10,000, <1/1,000)||Tachycardia, cardiac arrhythmia (atrial fibrillation, supraventricular tachycardia, extrasystoles), palpitations, angina pectoris, blood pressure effects (lowering or increase)|
|Vascular disorders||Rare ( >1/10,000, <1/1,000)||Peripheral vasodilation|
|Very rare (including isolated cases) (<1/10,000)||Collapse|
|Respiratory, thoracic and mediastinal disorders||Rare ( >1/10,000, <1/1,000)||Paradoxical bronchospasm|
|Gastrointestinal disorders||Common (>1/100, <1/10)||Nausea, taste alteration|
|Skin and subcutaneous tissue disorders||Common (>1/100, <1/10)||Pruritus, rash, erythema, urticaria, angioedema|
|Very rare (including isolated cases) (<1/10,000)|
|Musculoskeletal disorders||Rare ( >1/10,000, <1/1,000)||Muscle cramps|
|General disorders and administration site condition||Common (>1/100, <1/10)||Headache, application site reaction (mouth and throat irritation, burning sensation of the tongue)|
*Reported spontaneously in post-marketing data, therefore, frequency regarded as unknown
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
The risk of overdose with Salbutamol Nebuliser Solution is rather unlikely if used according to the instructions.
Symptoms of an overdose
In the case of an overdose, the above-mentioned undesirable effects (see 4.8, Undesirable effects) occur very quickly and with increased severity. Typical symptoms are tachycardia, palpitations, arrhythmia, restlessness, sleep disturbances, chest pain, and vigorous tremor, especially on hands but also on the whole body. Nausea, dizziness, increased systolic blood pressure and decreased diastolic blood pressure may also be observed.
Occasionally, psychotic reactions were observed after excessive doses of salbutamol.
In the case of a salbutamol overdose, there can increasingly be a shift of potassium into the intracellular space resulting in hypokalaemia, as well as hyperglycemia, hyperlipidemia, and hyperketonaemia.
Increased serum lactate levels and rarely, lactic acidosis, have been reported following therapy with salbutamol, particularly after high dose administration. Symptoms include deep, rapid breathing, cold and blue colored fingers and toes, inability to concentrate and general malaise.
Management of an overdose
Treatment after an overdose of a β-sympathomimetic is mainly symptomatic. The following measures may be considered, depending upon the individual circumstances:
o If large amounts of the drug are swallowed, the irrigation of the stomach should be considered. Activated charcoal and laxatives can have favorable effects on the undesired absorption of the β-sympathomimetic.
o For the cardiac symptoms of overdosage with salbutamol, a cardioselective beta-blocking agent may be considered, but beta-blocking drugs should only be used with caution and be avoided as far as possible in patients with a history of bronchospasm. ECG monitoring is indicated in such patients.
o In the case of a fairly pronounced lowering of the blood pressure, volume substitution (e.g. plasma expanders) is recommended.
o If hypokalaemia develops, electrolyte balance should be monitored and, if appropriate, electrolytes may need to be administered.