TERBUTALINE NEBULES 2.5MG/ML
Bricanyl
Pack quantity: 20 X 2ML
USES: Bronchial asthma
2.5MG/ML
Pack quantity: 20 X 2ML
Therapeutic indications
Terbutaline is a selective beta2-adrenergic agonist recommended for the relief of severe bronchospasm in bronchial asthma and in chronic bronchitis and other bronchopulmonary disorders in which bronchospasm is a complicating factor.
Posology and method of administration
In most patients, the use of terbutaline sulphate, 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.
Bricanyl Respules:
Adults: 1 or 2 Respules (5 or 10mg)
Children: (>25kg) 1 Respule (5mg)
Children: (<25kg) use multidose bottles.
Multidose Bottles:
Adults: 0.5 to 1 ml (5 to 10mg) diluted to required nebuliser volume with sterile physiological saline.
Children: 0.2 to 0.5ml (2 to 5mg), see table, diluted to required nebuliser volume with sterile physiological saline.
Table illustrating ml undiluted solution from multidose bottle required for administration to children
Age
Average kg
weight lb
mg terbutaline
ml undiluted solution
<3
10
22
2.0
0.2
3
15
33
3.0
0.3
6
20
44
4.0
0.4
8+
25+
55+
5.0
0.5
Elderly: Dosage as for adults.
Instructions for use and cleaning are provided in the Patient Information Leaflet which can be found in each pack.
Special warnings and precautions for use
Patients should be instructed in proper use and their inhalation technique checked regularly.
If a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should urgently seek further medical advice. 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.
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 Bricanyl. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with beta agonists. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Bricanyl 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.
Due to the hyperglycaemic effects of beta2-agonists, additional blood glucose controls are recommended initially in diabetic patients.
Potentially serious hypokalaemia may result from beta2-agonist therapy. Particular caution is recommended in acute severe asthma as the associated risk may be augmented by hypoxia. The hypokalaemic effect may be potentiated by concomitant treatments (see section 4.5, Interactions). It is recommended that serum potassium levels are monitored in such situations.
Interaction with other medicinal products and other forms of interaction
Beta-blocking agents (including eye drops), especially the non-selective ones such as propranolol, may partially or totally inhibit the effect of beta-stimulants. Therefore, Bricanyl preparations and non-selective beta-blockers should not normally be administered concurrently. Bricanyl should be used with caution in patients receiving other sympathomimetics.
Hypokalaemia may result from beta2-agonist therapy and may be potentiated by concomitant treatment with xanthine derivatives, corticosteroids and diuretics
Pregnancy and lactation
Although no teratogenic effects have been observed in animals or in patients, Bricanyl should only be administered with caution during the first trimester of pregnancy.
Terbutaline is secreted via breast milk, but effect on the infant is unlikely at therapeutic doses.
Undesirable effects
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
