Spiriva

/ Boehringer Ingelheim

The medicinal product is intended for inhalation use only. The recommended dosage of tiotropium bromide is inhalation of the contents of one capsule once daily with the HandiHaler device at the same time of day. The recommended dose should not be exceeded. Tiotropium bromide capsules are only for inhalation and not for oral intake. Tiotropium bromide capsules must not be swallowed. Tiotropium bromide should only be inhaled with the HandiHaler device.
Special Populations: Geriatric patients can use tiotropium bromide at the recommended dose. Renally impaired patients can use tiotropium bromide at the recommended dose. For patients with moderate to severe impairment (creatinine clearance ≤ 50 ml/min). Hepatically impaired patients can use tiotropium bromide at the recommended dose. Paediatric population.
COPD: There is no relevant use in the paediatric population (below 18 years).
Cystic fibrosis: The safety and efficacy of Spiriva 18 microgram in children and adolescents has not been established. No data are available.
Method of administration:To ensure proper administration of the medicinal product the patient should be trained how to use the inhaler by the physician or by other healthcare professionals.
Instructions for handling and use: See prescribing information for full details.
See prescribing information for full details.

Tiotropium is a bronchodilator for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

Tiotropium bromide inhalation powder is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to the excipient lactose monohydrate which contains milk protein.   

Tiotropium bromide, as a once daily maintenance bronchodilator, should not be used for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy. Immediate hypersensitivity reactions may occur after administration of tiotropium bromide inhalation powder. Consistent with its anticholinergic activity, tiotropium bromide should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction. Inhaled medicines may cause inhalation-induced bronchospasm. Tiotropium should be used with caution in patients with recent myocardial infarction < 6 months; any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy in the past year; hospitalisation of heart failure (NYHA Class III or IV) within the past year. These patients were excluded from the clinical trials and these conditions may be affected by the anticholinergic mechanism of action.

Dry mouth.
See prescribing information for full details.

Although no formal drug interaction studies have been performed, tiotropium bromide inhalation powder has been used concomitantly with other drugs without clinical evidence of drug interactions. These include sympathomimetic bronchodilators, methylxanthines, oral and inhaled steroids, commonly used in the treatment of COPD. 

Pregnancy: There is a very limited amount of data from the use of tiotropium.
Lactation: It is unknown whether tiotropium bromide is excreted in human breast milk.
See prescribing information for full details.

High doses of tiotropium bromide may lead to anticholinergic signs and symptoms. However, there were no systemic anticholinergic adverse effects following a single inhaled dose of up to 340 microgram tiotropium bromide in healthy volunteers. Additionally, no relevant adverse effects, beyond dry mouth, were observed following 7 day dosing of up to 170 microgram tiotropium bromide in healthy volunteers. In a multiple dose study in COPD patients with a maximum daily dose of 43 microgram tiotropium bromide over four weeks no significant undesirable effects have been observed. Acute intoxication by inadvertent oral ingestion of tiotropium bromide capsules is unlikely due to low oral bioavailability.
See prescribing information for full details.

Lactose: Contains lactose.
Storage: Do not store above 25°C, do not freeze. Do not store in direct sunlight or heat.