Spiriva Special Precautions

Immediate hypersensitivity reactions may occur after administration of SPIRIVA/SPIRIVA RESPIMAT.
Dry mouth, which has been observed with anticholinergic treatment, may in the long term be associated with dental caries.
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.
SPIRIVA/SPIRIVA RESPIMAT should not be used more frequently than once daily (see Overdosage).
Effects on ability to drive or operate machinery: No studies on the effects on the ability to drive and use machines have been performed. The occurrence of dizziness, blurred vision, or headache may influence the ability to drive and use machinery.
Spiriva: 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.
Consistent with its anticholinergic activity, tiotropium bromide should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction (see Adverse Reactions).
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 (see Pharmacology: Pharmacokinetics under Actions).
Patients should be cautioned to avoid getting the drug powder 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.
SPIRIVA capsules contain 5.5 mg lactose monohydrate.
Spiriva Respimat: SPIRIVA RESPIMAT, as a once daily maintenance bronchodilator, should not be used for the 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 a first-line treatment for asthma. Patients with asthma 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.
As with other anticholinergic drugs, SPIRIVA RESPIMAT should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction. In a meta-analysis of placebo-controlled trials, SPIRIVA was associated with a non-significant increase in the risk of urinary retention, and a significant increase in the risk of micturition difficulties.
As with all predominantly renally excreted drugs, SPIRIVA use should be monitored closely in patients with moderate to severe renal impairment (creatinine clearance of ≤ 50 mL/min) (see Pharmacology: Pharmacokinetics under Actions). There is no long term experience in patients with severe renal impairment.
Patients must be instructed in the correct administration of SPIRIVA. Care must be taken not to allow the solution or mist to enter into the eyes. Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop specialist advice should be sought immediately. Miotic eye drops are not considered to be effective treatment.
SPIRIVA cartridges are to be used only with RESPIMAT inhaler (see SPIRIVA RESPIMAT Instructions for Use under Cautions for Usage).
Effects on fertility: Clinical data on fertility are not available for tiotropium. Tiotropium (as bromide) did not affect the fertility of male or female rats when administered by inhalation at doses up to 2 mg/kg (750x the maximum recommended human daily dose of the drug, based on body surface area).
Genotoxicity: Tiotropium (as bromide) did not exhibit any genotoxic effects in assays for gene mutation (bacteria and mammalian cells in vitro and in vivo mouse micronucleus test) or DNA damage (rat hepatocytes in vitro).
Carcinogenicity: Long-term carcinogenicity studies in mice and rats, with tiotropium (as bromide) administered by inhalation, showed no evidence of neoplastic responses. The highest doses studied were approximately 0.8x (male mouse), 38x (female mouse) and 16x (rat) greater than the maximum recommended human daily dose of the drug, based on body surface area.
Hepatic Impairment: There are no data on the use of tiotropium in patients with hepatic impairment. As tiotropium is primarily cleared by renal mechanisms, no dosage adjustment is recommended. However patients should be monitored closely.
Renal Impairment: Renally-impaired patients can use SPIRIVA RESPIMAT at the recommended dose. However, as with all predominantly renally excreted drugs, SPIRIVA RESPIMAT use should be monitored closely in COPD and asthma patients with moderate to severe renal impairment (creatinine clearance ≤ 50 mL/min).
Use in Pregnancy: (Category B1): See Use in Pregnancy & Lactation.
Use in Lactation: See Use in Pregnancy & Lactation.
Use in Children: COPD does not normally occur in children.
In children aged 1-5 years: One 12-week clinical study was conducted in a total of 101 children with asthma on background treatment of at least ICS.
An Aerochamber Plus Flow-Vu valved holding chamber with facemask was used to administer trial medication in 98 patients.
The primary objective of the study was safety; efficacy assessments were exploratory.
There was no difference in the exploratory symptoms score in those treated with tiotropium versus placebo. The number of asthma adverse events was lower for SPIRIVA RESPIMAT compared to placebo.
Tiotropium has not been studied in children less than 1 year.
Use in the Elderly: Elderly patients can use SPIRIVA RESPIMAT at the recommended dose. Renal clearance of tiotropium is likely to be slower in elderly patients (see Renal Impairment as previously mentioned).