Product Dossier
BRICANYL
Product Dossier for BRICANYL (terbutaline sulfate, AstraZeneca). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: AstraZeneca
- Active ingredient: terbutaline sulfate
- Therapeutic area: Respiratory
- Same area: NUCALA
- Same area: VENTOLIN
What it is
Bricanyl Injection is a clear, colourless solution for injection containing 0.5 mg/mL of terbutaline sulfate. Terbutaline sulfate is a sympathomimetic bronchodilator with selective β2-stimulant activity on the respiratory system. Bricanyl Injection is for subcutaneous use only.
Approved indications
— Relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease. — Acute prophylaxis against exercise-induced asthma or in other situations known to induce bronchospasm.
Dosing overview
For adults and children over 12 years, the dose is 0.5 mL, repeated as required up to every 6 hours. Bricanyl injection solution is recommended for acute use only.
Key safety warnings
Caution is advised when terbutaline is administered to patients with thyrotoxicosis, hypertension, coronary artery disease, arrhythmias and tachyarrhythmia, as cardiovascular effects may be seen with sympathomimetic drugs. There is some evidence of rare occurrences of myocardial ischaemia associated with beta agonists. Patients with underlying severe heart disease who are receiving Bricanyl should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Potentially serious hypokalaemia may result from β2-agonist therapy, with particular caution recommended in acute severe asthma as the associated risk may be augmented by hypoxia. It is recommended that serum potassium levels are monitored in such situations. Lactic acidosis has been reported in association with high therapeutic doses of parenteral short-acting β-agonist therapy, mainly in patients being treated for an acute asthma exacerbation. In patients not adequately responding to acute therapy with Bricanyl Injection, consideration should be given to the presence of lactic acidosis as a possible contributing factor to ongoing respiratory symptoms. Due to the blood-glucose increasing effects of β2-stimulants, extra blood glucose controls are initially recommended when diabetic patients are commenced on terbutaline.
Contraindications
Bricanyl is contraindicated in patients with hypersensitivity to sympathomimetic amines or any other ingredient in the medicine.
PBS listing
Bricanyl Injection containing terbutaline sulfate 500 micrograms in 1 mL is listed on the PBS as one item with unrestricted access at an ex-manufacturer price of A$12.35.
Regulatory history
Bricanyl Injection was first approved on 11 July 1991. In July 2020, the PBAC recommended a new listing of a new form for bronchospasm.