Presentation and Status in Health Basket
Solution for Inhalation
(in a Respimat inhaler): 60 actuations (30 med, doses)
The medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat inhaler.
Two puffs from the Respimat inhaler comprise one medicinal dose.
The recommended dose for adults is 5 microgram tiotropium given as two puffs from the Respimat inhaler once daily, at the same time of the day.
The recommended dose should not be exceeded.
In the treatment of asthma the full benefit will be apparent after several doses of the medicinal product. In adult patients with severe asthma, tiotropium should be used in addition to inhaled corticosteroids (≥ 800 μg budesonide/day or equivalent) and at least one controller.
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.
Asthma: The recommended dose for patients 6 to 17 years of age is 5 microgram tiotropium given as two puffs from the Respimat inhaler once daily, at the same time of the day.
In adolescents (12 – 17 years) with severe asthma, tiotropium should be used in addition to inhaled corticosteroids (> 800 – 1600 μg budesonide/day or equivalent) and one controller or in addition to inhaled corticosteroids (400 – 800 μg budesonide/day or equivalent) with two controllers.
For children (6 – 11 years) with severe asthma, tiotropium should be used in addition to inhaled corticosteroids (> 400 μg budesonide/day or equivalent) and one controller or in addition to inhaled corticosteroids (200 – 400 μg budesonide/day or equivalent) with two controllers.
The safety and efficacy of Spiriva Respimat in children aged 6 – 17 years with moderate asthma has not been established.The safety and efficacy of Spiriva Respimat in children below 6 years of age has not been established.
COPD: There is no relevant use of Spiriva Respimat in children and adolescents below 18 years.
Cystic fibrosis: The efficacy and safety of Spiriva Respimat has not been established.
Method of administration: To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler by a physician or other health professionals.
COPD: Tiotropium is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).
Asthma: Spiriva Respimat is indicated as add-on maintenance bronchodilator treatment in patients aged 6 years and older with severe asthma who experienced one or more severe asthma exacerbations in the preceding year.
Spiriva Respimat is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients.
Excipients: Benzalkonium chloride may cause wheezing and breathing difficulties. Patients with asthma are at an increased risk for these adverse events.
Tiotropium bromide, as a once daily maintenance bronchodilator, should not be used for the initial treatment of acute episodes of bronchospasm, or for the relief of acute symptoms. In the event of an acute attack a rapid-acting beta-2-agonist should be used. Spiriva Respimat should not be used as monotherapy for asthma. Asthma patients must be advised to continue taking anti-inflammatory therapy, i.e. inhaled corticosteroids, unchanged after the introduction of Spiriva Respimat, even when their symptoms improve. Immediate hypersensitivity reactions may occur after administration of tiotropium bromide inhalation solution. 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. As plasma concentration increases with decreased renal function in patients with moderate to severe renal impairment (creatinine clearance ≤ 50 ml/min) tiotropium bromide should be used only if the expected benefit outweighs the potential risk. There is no long term experience in patients with severe renal impairment. Patients should be cautioned to avoid getting the spray into their eyes. They should be advised that this may result in precipitation or worsening of narrow-angle glaucoma, eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema. Should any combination of these eye symptoms develop, patients should stop using tiotropium bromide and consult a specialist immediately. Dry mouth, which has been observed with anti-cholinergic treatment, may in the long term be associated with dental caries. Tiotropium bromide should not be used more frequently than once daily. Spiriva Respimat is not recommended in cystic fibrosis (CF). If used in patients with CF, Spiriva Respimat may increase the signs and symptoms of CF (e.g. serious adverse events, pulmonary exacerbations, respiratory tract infections).
Common: Dry Mouth.
See prescribing information for full details.
Although no formal drug interaction studies have been performed, tiotropium bromide has been used concomitantly with other drugs commonly used in the treatment of COPD and asthma, including sympathomimetic bronchodilators, methylxanthines, oral and inhaled steroids, antihistamines, mucolytics, leukotriene modifiers, cromones, anti-IgE treatment without clinical evidence of drug interactions.
Use of LABA or ICS was not found to alter the exposure to tiotropium.
The co-administration of tiotropium bromide with other anticholinergic containing drugs has not been studied and therefore is not recommended.
Pregnancy and Lactation
Pregnancy: There is a very limited amount of data from the use of tiotropium in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses. As a precautionary measure, it is preferable to avoid the use of Spiriva Respimat during pregnancy.
Lactation: It is unknown whether tiotropium bromide is excreted in human breast milk. Despite studies in rodents which have demonstrated that excretion of tiotropium bromide in breast milk occurs only in small amounts, use of Spiriva Respimat is not recommended during breast-feeding. Tiotropium bromide is a long-acting compound. A decision on whether to continue/discontinue breast-feeding or to continues/discontinue therapy with Spiriva Respimat should be made taking into account the benefit of breast-feeding to the child and the benefit of Spiriva Respimat therapy to the woman.
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/throat and dry nasal mucosa, were observed following 14-day dosing of up to 40 microgram tiotropium inhalation solution in healthy volunteers with the exception of pronounced reduction in salivary flow from day 7 onwards.
In-use shelf life: 3 months.
Storage: Do not freeze.