Skip to main content

1. Indications | Spiriva Respimat

Commonly requested product information

Select Another Category

Select another category
 

1. Indications

SPIRIVA® Respimat® Therapeutic Indications

The below content contains references to information available within the Summary of Product Characteristics.

Click here for Summary of Product Characteristics
Click here for Prescribing Information

Licensed Indication

SPIRIVA® Respimat® is indicated as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥800μg budesonide/day or equivalent) and long-acting β2 agonists and who experienced one or more severe exacerbations in the previous year.[1]

Contraindications
The use of SPIRIVA® Respimat® is contraindicated in patients with hypersensitivity to tiotropium, atropine or its derivatives (for example, ipratropium or oxitropium) or to any of the excipients[2] which are listed below:[3]

  • benzalkonium chloride
  • disodium edetate
  • water (purified)
  • hydrochloric acid 3.6%

SPIRIVA® Respimat® should not be used for the relief of acute symptoms of asthma or for the initial treatment of patients with acute episodes of bronchospasm. It should not be used as first-line monotherapy for patients with asthma. Once a patient starts using SPIRIVA® Respimat®, clinicians should advise them to continue taking their current anti-inflammatory therapy (e.g. inhaled corticosteroids), unchanged, even if they experience an improvement in their symptoms.[4]

SPIRIVA® Respimat® is not recommended for the treatment of patients with cystic fibrosis (CF) because it may increase the signs and symptoms of CF (for example, patients may experience serious adverse events, an increase in pulmonary exacerbations and respiratory tract infections).[4]

Special populations
Geriatric patients can use tiotropium at the recommended dose.
Patients with impairment of hepatic function can also use tiotropium at the recommended dose.[5]

Patients with moderate to severe renal impairment
Patients with renal impairment can use tiotropium at the recommended dose. However, in patients with moderate to severe renal impairment (creatinine clearance <50ml/min), clinicians should weigh the expected benefits of using tiotropium against the potential risks. In these patients, the impairment in renal function is associated with an increase in the plasma concentration of tiotropium. There is no long-term experience of the use of tiotropium in patients with severe renal impairment.[4]

Cautions
Patients may experience type I hypersensitivity reactions and inhalation-induced bronchospasm after taking inhaled tiotropium.[4]

Caution is also necessary when considering the use of tiotropium in patients with:[4]

  • narrow-angle glaucoma
  • prostatic hyperplasia
  • obstruction of the bladder neck
  • a history of myocardial infarction within the last six months
  • cardiac arrhythmias that are unstable or life-threatening
  • cardiac arrhythmias for which they have needed an intervention or a change in drug treatment within the past year
  • admission to hospital for heart failure (New York Heart Association (NYHA) Class III or IV) within the past year.

Pregnancy and breast-feeding
There is little data about the use of tiotropium in pregnant women and, as a precaution, clinicians should avoid prescribing SPIRIVA® Respimat® for pregnant women. It is not known whether tiotropium is excreted in human breast milk and the use of SPIRIVA® Respimat® is not recommended in women who are breast-feeding.[6]

Clinicians should advise patients who are using SPIRIVA® Respimat® to avoid getting the spray in their eyes because this could cause:[4]

  • eye pain or discomfort
  • temporary blurring of vision
  • narrow-angle glaucoma or worsening of pre-existing narrow-angle glaucoma[1] (please see contraindications above)
  • visual halos or coloured images
  • conjunctival congestion; and
  • corneal oedema.

If a patient develops any of these eye symptoms they should stop using tiotropium and seek medical advice immediately.

Dry mouth, which has been observed with anticholinergic treatment, may be associated with dental caries in the long-term.[4]

References

1. Summary of Product Characteristics. SPIRIVA® Respimat®. March 2016. Paragraph 4.1 Therapeutic indications.

2. Summary of Product Characteristics. SPIRIVA® Respimat®. March 2016. Paragraph 4.3 Contraindications.

3. Summary of Product Characteristics. SPIRIVA® Respimat®. March 2016. Paragraph 6.1. List of excipients.

4. Summary of Product Characteristics. SPIRIVA® Respimat®. March 2016. Paragraph 4.4. Special warnings and precautions for use.

5. Summary of Product Characteristics. SPIRIVA® Respimat®. March 2016. Paragraph 4.2. Posology and method of administration.

6. Summary of Product Characteristics. SPIRIVA® Respimat®. March 2016. Paragraph 4.6. Fertility, pregnancy and lactation.