A generic tiotropium capsule has recently been added to the Pharmaceutical Benefits Scheme (PBS). Braltus® capsules are considered equivalent to Spiriva® capsules for the purposes of brand substitution on the PBS. However, some important differences should be noted to avoid confusion.
Braltus® capsules for inhalation contain 13 micrograms of tiotropium, while Spiriva® contains 18 micrograms per capsule. However, the dose delivered from the mouthpiece of the inhaler device is 10 micrograms per capsule for each brand. Braltus® is able to provide the same delivered dose from a smaller formulated dose due to the enhanced aerosolisation properties of the formulation.
Braltus® capsules should only be administered using the Zonda® inhaler device included in each pack. While the Zonda® device is operationally similar to the Spiriva® HandiHaler® device, the devices are not interchangeable. Patients should be educated on proper inhaler technique for each device they use.
A comparison of the two brands of tiotropium capsules is shown below.
|Active ingredient||Tiotropium (as bromide)||Tiotropium (as bromide monohydrate)|
|Tiotropium per capsule||13mcg||18mcg|
|Tiotropium delivered dose per capsule||10mcg|
|Recommended dose||1 capsule inhaled daily|
|Indications||Long-term maintenance treatment of bronchospasm and dyspnoea associated with COPD; prevention of COPD exacerbations|
|Device maintenance||Discard device after 30 uses. New device supplied with each pack.||Device can be washed and re-used|
|Presentation||Bottle, clear capsules||Blister pack, green capsules|
- Algorta J, Andrade L, Medina M, Kirkov V, Arsova S, Li F, et al. Pharmacokinetic bioequivalence of two inhaled tiotropium bromide formulations in healthy volunteers. Clin Drug Investig. 2016; 36(9): 753-62.
- Braltus® (Tiotropium) Australian approved product information. Macquarie Park: Teva Pharma. Approved October 2018.
- Therapeutic Goods Administration. Australian Public Assessment Report for Tiotropium: Braltus®. Woden: TGA; 2019.