BRICANYL TURBOHALER Inhalation powder Ref.[7932] Active ingredients: Terbutaline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: AstraZeneca UK Limited, 1 Francis Crick Avenue, Cambridge, CB2 0AA, UK

Therapeutic indications

Terbutaline is a selective beta2-adrenergic agonist recommended for the relief and prevention of bronchospasm in bronchial asthma and other bronchopulmonary disorders in which bronchospasm or reversible airways obstruction is a complicating factor.

Posology and method of administration

Posology

Adults and Children

One inhalation (0.5 mg) as required. Not more than 4 inhalations should be required in any 24-hour period.

The duration of action of a single dose is up to 6 hours.

Elderly

Dosage as for adults.

Method of administration

Instructions for use and cleaning are provided in the Patient Information Leaflet, which can be found in each pack.

Overdose

There is a potential for progressive accumulation of dry powder in the mouthpiece of the Bricanyl Turbuhaler that could be released if dropped (for example, from a table) towards the end of inhaler life. To minimize unnecessary systemic exposure to terbutaline, the patients should be advised to, when possible, rinse their mouth after each use.

i) Possible symptoms and signs

Headache, anxiety, tremor, nausea, tonic cramp, palpitations, tachycardia and arrhythmia. A fall in blood pressure sometimes occurs.

Laboratory findings: Hypokalaemia, hyperglycaemia and metabolic acidosis sometimes occur.

ii) Treatment

Mild and moderate cases: Reduce the dose.

Severe cases: Gastric lavage, administration of activated charcoal (where suspected that significant amounts have been swallowed). Determination of acid-base balance, blood sugar and electrolytes, particularly serum potassium levels. Monitoring of heart rate and rhythm and blood pressure. Metabolic changes should be corrected. A cardioselective beta-blocker (e.g. metoprolol) is recommended for the treatment of arrhythmias causing haemodynamic deterioration. The beta-blocker should be used with care because of the possibility of inducing bronchoconstriction: use with caution in patients with a history of bronchospasm. If the beta2-mediated reduction in peripheral vascular resistance significantly contributes to the fall in blood pressure, a volume expander should be given.

Shelf life

3 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

Bricanyl Turbohaler consists of a number of assembled plastic details, the main parts being the dosing mechanism, the drug substance store, the desiccant store and the mouthpiece. The inhaler is protected by an outer tubular cover screwed onto a bottom plate.

Each inhaler contains 120 doses.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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