SPIRIVA 18MCG CAPSULE FOR INHALATION
Spiriva: Each capsule for inhalation contains tiotropium as bromide monohydrate 18 mcg.
Spiriva Respimat: Tiotropium 2.5 mcg/puff (2 puffs/dose) is equivalent to tiotropium bromide monohydrate 3.124 mcg. It also contains the following excipients: Benzalkonium chloride, disodium edetate, purified water and hydrochloric acid for pH adjustment.
Indications / Uses :
Maintenance treatment of patients with COPD (including chronic bronchitis and emphysema), the maintenance treatment of associated dyspnea.
Spiriva: Maintenance treatment of patients with COPD (including chronic bronchitis and emphysema). Maintenance treatment of associated dyspnea, improvement of COPD compromised quality of life and reduction of exacerbations.
Spiriva Respimat: Maintenance treatment of patients with COPD (including chronic bronchitis and emphysema). Maintenance treatment of associated dyspnea, improvement of COPD compromised quality of life and reduction of exacerbations. As add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (budesonide =800 mcg/day or equivalent) and long-acting B2-agonists and who experienced =1 severe exacerbations in the previous year.
Patients with a history of hypersensitivity to atropine or its derivatives eg, ipratropium or oxitropium, or to any component of Spiriva/Spiriva Respimat.
Special Precautions :
Spiriva/Spiriva Respimat, as a once-daily maintenance bronchodilator, should not be used for the initial treatment of acute episodes of bronchospasm ie, rescue therapy.
Immediate hypersensitivity reactions may occur after administration of tiotropium inhalation powder or tiotropium bromide solution for inhalation.
As with other anticholinergic drugs, Spiriva/Spiriva Respimat should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction.
Inhaled medicines may cause inhalation-induced bronchospasm.
As with all predominantly renally excreted drugs, Spiriva use should be monitored closely in patients with moderate to severe renal impairment (CrCl of =50 mL/min).
Patients must be instructed in the correct administration of Spiriva capsules or Spiriva Respimat. Care must be taken not to allow the powder or the solution or mist to enter into the eyes. Eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, specialist’s advice should be sought immediately.
Miotic eye drops alone are not considered to be effective treatment.
Spiriva/Spiriva Respimat should not be used more frequently than once daily.
Spiriva capsules are to be used only with the HandiHaler device.
Spiriva Respimat cartridges are to be used only with Respimat inhaler.
Effects on the Ability to Drive or Operate Machinery: Spiriva Respimat: No studies on the effects on the ability to drive and use machines have been performed. The occurrence of dizziness or blurred vision may influence the ability to drive and use machinery.