INFORMATION FOR HEALTH PROFESSIONALS
Home | Consumers | Health Professionals | Regulatory | Other | Hot Topics | Search
Home | Consumers | Health Professionals | Regulatory | Other | Hot Topics | Search
TURBUHALER 250 mcg/dose - white to off-white, rounded granules, which disintegrate to a fine powder upon slight pressure, filled into a specially designed inhaler made of plastic materials. The colour of the turning grip is light blue. Contains 200 actuations. Each actuation releases 250 mcg terbutaline sulphate. On the bottom of the turning grip, a Braille code for identification of terbutaline is embossed.
Terbuatline is an adrenergic agonist which predominantly stimulates beta-2-receptors, thus producing relaxation of bronchial smooth muscle, inhibition of the release of endogenous spasmogens, inhibition of oedema caused by endogenous mediators and increased mucociliary clearance.
The bronchospasmolytic effect (time to onset, time to maximum effect and duration) and the extent of metabolism are dependent on the route of administration of terbutaline. The time to maximum effect is 30-60 minutes following inhalation.
Inhaled terbutaline acts within a few minutes and has a duration of up to 6 hours.
Terbutaline is delivered to the prime site of action in the lungs by TURBUHALER administration.
About 20-30% of the metered dose is deposited in the lungs at a normal inhalation flow rate.
Terbutaline is metabolised mainly by conjugation with sulphuric acid and excreted as the sulphate conjugate.
No active metabolites are formed. Inhaled terbutaline is absorbed unchanged from the respiratory tract.
The presence of the two phenolic hydroxyl groups in the meta-positions confers resistance to metabolism by the enzyme catechol-o-methyl transferase.
In normal adult men and women, the terminal elimination phase has a half-life of around 15 hours.
After administration by inhalation between 2-37% of the delivered terbutaline was recovered in faeces and 3-35% in urine.
Excretion of terbutaline sulphate and its metabolites is essentially complete within 72-96 hours after a single parenteral or oral dose.
As terbutaline is largely excreted in urine, caution should be exercised in patients with renal impairment.
No dosage adjustments are required in the elderly provided hepatic and renal function are normal.
Relief of bronchospasm occurring in bronchial asthma, bronchitis and other bronchopulmonary conditions where bronchospasm is a complicating factor.
Acute prophylaxis in situations known to induce bronchospasm, e.g. exercise-induced asthma.
If long term use of terbutaline is proposed, particularly if the patient is asked to take terbutaline in conjunction with other medications, objective pulmonary function testing (for example, by peak flow meter or spirometer) may be useful as part of assessment of the efficacy of treatment.
BRICANYL TURBUHALER is inspiratory flow driven and hence there is no need to co-ordinate the release of the dose and the inhalation as with a pressurised inhaler. When inhaling, the substance follows the inspired air into the airways. Treatment with BRICANYL TURBUHALER is effective even during an acute asthmatic attack.
The dosage of inhaled terbutaline via BRICANYL TURBUHALER should be individualised. BRICANYL TURBUHALER should be used as required rather than regularly.
Adults and children over 12 years: 250-500 mcg as required. In severe cases the single dose may be increased to 1.5 mg. The total dose should not exceed 6 mg in 24 hours.
Children (3-12 years): 250-500 mcg as required. In severe cases the single dose may be increased to 1.0 mg. The total dose should not exceed 4 mg in 24 hours.
When prescribing BRICANYL TURBUHALER to young children it is necessary to ascertain that they can follow the instructions for use.
Turbuhaler is inspiratory flow-driven which means that, when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.
Note: It is important to instruct the patient
The patient may not taste of feel any medication when using BRICANYL TURBUHALER due to the small amount of medicine dispensed.
Hypersensitivity to sympathomimetic amines.
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 the sign of worsening asthma. Repeated inhalations of β2-agonists must then not delay reassessment of the asthma therapy.
As for all β2-agonists caution should be observed in patients with thyrotoxicosis and in patients with severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.
Due to the hyperglycaemic effects of β2-agonists, additional blood glucose controls are recommended initially in diabetic patients.
Potentially serious hypokalaemia may result from β2-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 Interactions). It is recommended that serum potassium levels are monitored in such situations.
BRICANYL should be used with caution if susceptibility to sympathomimetic amines is likely to be increased, for instance in patients with hyperthyroidism not yet under adequate control.
BRICANYL TURBUHALER does not affect the ability to drive or use machines.
No teratogenic effects have been observed in patients or in animals. However, caution is recommended during the first trimester of pregnancy.
Although terbutaline is secreted into breast milk, and milk concentrations are approximately those in maternal plasma, two individual case studies indicate that the infant is likely to receive 0.2 - 0.7% of the maternal dose (0.4 and 0.7 mcg/kg/day respectively), depending (for example) on the time of feeding in relation to administration of the medicine. In the 4 infant studies this did not result in any signs of beta-adrenoceptor stimulation.
Transient hypoglycaemia has been reported in newborn preterm infants after maternal β2-agonist treatment.
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 because pharmacologically active concentrations of the drug are not achieved in the systemic circulation.
Commonly observed side effects include tremor, headache, tonic muscle cramps, nervousness, increases in heart rate and palpitations. The majority of these effects reverse spontaneously within the first 1-2 weeks of treatment.
Cardiovascular: Ectopic beats.
Gastrointestinal: Nausea, vomiting, bad taste, diarrhoea.
General: Sweating.
Musculo-skeletal: Muscle twitching.
Nervous system: Drowsiness, dizziness, sleep disturbances and behavioural disturbances such as agitation, hyperactivity and restlessness.
Dermatological; Urticaria and exanthema may occur.
Other: In rare cases, through unspecified mechanisms, medicines for inhalation may cause bronchospasm.
As for all β-agonists, cardiac arrhythmias, eg. atrial fibrillation, supraventricular tachycardia and extrasystoles have been rarely reported.
Beta-receptor blocking agents (including eye-drops), especially those which are non-selective, may partly or totally inhibit the effect of beta-agonists.
Hypokalaemia may result from β2-agonist therapy and may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics (see Warnings and Precautions).
Possible symptoms and signs: headache, anxiety, tremor, nausea, insomnia, tonic muscle cramps, palpitations, tachycardia and cardiac arrhythmias. A fall in blood pressure sometimes occurs.
Laboratory findings: Hyperglycaemia and lactacidosis sometimes occur. Beta-2-agonists may cause hypokalaemia as a result of redistribution of potassium.
Usually no treatment is required. If it is suspected that significant amounts of terbutaline sulphate have been swallowed, the following measures should be considered:
Gastric lavage, activated charcoal. Determine acid-base balance, blood glucose and electrolytes. Monitor heart rate and rhythm and blood pressure. The preferred antidote for overdosage with BRICANYL is a cardioselective beta-receptor blocking agent, but beta-receptor blocking medicines should be used with caution in patients with a history of bronchospasm. If the β2-mediated reduction in peripheral vascular resistance significantly contributes to the fall in blood pressure, a volume expander should be given.
BRICANYL TURBUHALER should be stored a temperatures not exceeding 30°C, with the cover on.
24 months.
BRICANYL TURBUHALER is a multidose, inspiratory flow-driven, metered dose powder inhaler. The device is made of plastic parts.
Prescription Medicine
250 mcg/dose, 200 doses
Chemical name: 1-(3,5-Dihydroxyphenyl)-2-t-butylaminoethanol sulphate.
BRICANYL TURBUHALER contains only the active substance terbutaline sulphate and is free from propellants, lubricants, preservatives, carrier substances or other additives.
AstraZeneca Limited
303 Manukau Road, Epsom,
P O Box 1301
Auckland
Telephone: (09) 623-6300
27 June 2002
CDS 280102