TERBUTALINE SULFATE

g. inhaled corticosteroids, leukotriene receptor antagonists. In most patients, the use of terbutaline sulfate, based on the doses below, given 2-4 times daily will be sufficient to relieve bronchospasm. In acute severe asthma, additional doses may be necessary.

Dosage:

Adults (including the elderly): One or two ampoules (5 or 10mg).

Children (>25kg):

One ampoule (5mg).

Children (<25kg):

Not recommended. Method of administration Instructions for use and cleaning are provided in the Patient Information Leaflet which can be found in each pack. 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. Children should be trained in the correct use of their device to deliver rescue therapy and use should be supervised by a responsible adult.

Urgent medical assistance should be sought if worsening asthma symptoms are not relieved by rescue medicines, even if there is short-term recovery following use of prescribed medication.

Summary of safety profile The frequency of adverse reactions is low at the recommended dose. Terbutaline given by inhalation is unlikely to produce significant systemic effects when given in recommended doses. Most of the adverse reactions are characteristic of sympathomimetic amines.

The majority of these effects have reversed spontaneously within the first 1-2 weeks of treatment. The frequency of side-effects is low at the recommended doses. Tabulated list of adverse reaction 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), very rare (<1/10,000) and not known (cannot be estimated from the available data). g. atrial fibrillation, supraventricular tachycardia and extrasystoles Myocardial ischaemia (see section Vascular disorders Not known^ Peripheral vasodilation Respiratory, thoracic and mediastinal Disorders Not known^ Paradoxical bronchospasm* Gastrointestinal disorders Not known^ Nausea Mouth and throat irritation Skin and subcutaneous tissue disorders Not known^ Urticaria Rash Musculoskeletal and connective tissue disorders# Common Muscle spasms #A few patients feel tense; this is also due to the effects on skeletal muscle and not to direct CNS stimulation.

^ Reported spontaneously in post-marketing data and therefore frequency regarded as unknown. * In rare cases, through unspecified mechanisms, paradoxical bronchospasm may occur, with wheezing immediately after inhalation. This should be immediately treated with a rapid-onset bronchodilator.

Terbutaline Sulfate Nebuliser Solution therapy should be discontinued and, after assessment, an alternative therapy initiated. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Patients should be instructed in proper use and their inhalation technique checked regularly. g. inhaled corticosteroids, leukotriene receptor antagonists. Patients who are prescribed regular anti-inflammatory therapy should be advised to continue taking their anti-inflammatory medication after the introduction of Terbutaline Sulfate Nebuliser Solution, even when symptoms decrease and they do not require Terbutaline Sulfate Nebuliser Solution.

Should symptoms persist, or if a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should seek medical advice as soon as possible, as this could be a sign of worsening of the underlying condition and warrants a reassessment of the therapy.

Consideration should be given to the requirements for additional therapy (including increased dosages of anti-inflammatory medication). Severe exacerbations of asthma should be treated as an emergency in the usual manner. 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.

Patients who take more than twice a week additional “as needed” Terbutaline Sulfate Nebuliser Solution should be re-evaluated for proper treatment adjustment, as these patients are at risk for overuse of Terbutaline Sulfate Nebuliser Solution.

As for all beta2-agonists caution should be observed in patients with thyrotoxicosis. Due to the positive inotropic effect of the beta2-agonists, these drugs should not be used in patients with hypertrophic cardiomyopathy. Cardiovascular effects may be seen with sympathomimetic drugs, including Terbutaline Sulfate Nebuliser Solution.

There is some evidence from post- marketing data and published literature of rare occurrences of myocardial ischaemia associated with beta agonists. g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Terbutaline Sulfate Nebuliser Solution should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease.

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