SALBUTAMOL

2. Salbutamol is a selective β2-agonist providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction. Salbutamol Nebuliser is indicated for use in the routine management of chronic bronchospasm unresponsive to conventional therapy and the treatment of acute severe asthma.

2 Posology and method of administration Posology Salamol Steri-Neb is for inhalation use only, to be breathed in through the mouth, under the direction of a physician, using a suitable nebuliser. The solution should not be injected or swallowed.

5 mg given up to three to four times a day by a nebuliser. This may be increased to 5 mg up to three to four times a day if necessary. Up to 40 mg per day can be given under strict medical supervision in hospital. However, in domiciliary practice the benefits of increasing the dose of nebulised salbutamol sulfate should be weighted against the risk that a deterioration in the patients underlying condition may be masked.

In such circumstances a medical assessment should be considered since alternative therapy may be indicated.

Paediatric Population Children aged 12 years and over:

Dose as per adult population. 5 mg to 5 mg up to four times a day. 5 mg up to four times a day. The dose may be increased to 5 mg if necessary, but medical assessment should be considered since alternative therapy may be indicated. 5 mg up to four times a day.

As transient hypoxaemia may occur supplemental oxygen therapy should be considered. Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. Other pharmaceutical forms may be more appropriate for administration in children under 4 years old.

Older People:

The same dosage as for other adults. Delivery of the aerosol may be by face mask or ‘T’ piece. Salamol Steri-Neb should be used undiluted. However, if a delivery time in excess of 10 minutes is required they should be diluted with Sodium Chloride Injection BP.

Private purchase of nebuliser devices for use at home to deliver rescue therapy for the acute treatment of asthma in children and adolescents is not recommended. Only specialists in respiratory medicine should initiate and clinically manage use of nebulisers and associated nebulised medicines at home for acute treatment of asthma in children and adolescents.

Adverse events are listed below by system organ class and frequency.

Frequencies are defined as:

Very common (≥ 1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000) and Very rare (<1/10,000). Very common and Common events were generally determined from clinical trial data. Rare, Very rare and not known events were generally determined from spontaneous data.

Immune system disorders Very rare:

Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse Metabolism and nutrition disorders Rare: Hypokalaemia. 4) Vascular disorders Rare: Peripheral vasodilatation Respiratory, thoracic and mediastinal disorders Very rare: Paradoxical bronchospasm 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 Nebuliser should be discontinued immediately, the patient assessed, and, if necessary, alternative therapy instituted.

Gastrointestinal disorders Uncommon:

Mouth and throat irritation Musculoskeletal and connective tissue disorders Uncommon: Muscle cramps, fine tremor of skeletal muscle * reported spontaneously in post-marketing data therefore frequency regarded as unknown. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Salbutamol Solution is for use with a nebuliser under the direction of a physician. The solution should not be injected or administered orally. Patients who use Salbutamol Nebuliser at home should be warned that if their usual dose is less effective or its duration of action reduced they should not increase either the dose or frequency of treatment but should consult their doctor.

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. , inhaled corticosteroids) should be advised to continue taking their anti-inflammatory medication even when symptoms decrease, and they do not require Salbutamol Nebuliser.

Patients being treated with Salbutamol Nebuliser 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, and patients should be warned to seek medical advice as soon as possible.

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. g. higher doses of inhaled corticosteroid or a course of oral corticosteroid).

Overuse of short-acting beta-agonists may mask the progression of the underlying disease and contribute to deteriorating asthma control, leading to an increased risk of severe asthma exacerbations and mortality. , daytime symptoms, night-time awakening, and activity limitation due to asthma) for proper treatment adjustment as these patients are at risk for overuse of salbutamol.

1. Although some forms of salbutamol sulfate have been used for the management of premature labour, Salbutamol Nebuliser should not be used for this purpose. Salbutamol Nebuliser should not be used in threatened abortion.