). 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 due to heart failure within the past year.
These patients were excluded from the clinical trials and these conditions may be affected by the anticholinergic mechanism of action. Driving and Operating Machinery 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 . Immune Hypersensitivity Immediate hypersensitivity reactions, including urticaria, angioedema (including swelling of the lips, tongue or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA.
If such a reaction occurs, therapy with SPIRIVA should be stopped at once and alternative treatments should be considered. Given the similar structural formula of atropine to tiotropium, patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to SPIRIVA.
There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of other powder products containing lactose (with probable traces of milk protein); therefore, SPIRIVA should be used with caution in patients with severe milk protein allergy.
Ophthalmologic Worsening of Narrow-Angle Glaucoma (see Anticholinergic Effects). SPIRIVA should be used with caution in patients with narrow-angle glaucoma. 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, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema).
Instruct patients to consult a physi cian Product Monograph SPIRIVA (tiotropium) Page 9 of 42 immediately should any of these signs or symptoms develop. Miotic drops alone are not considered to be effective treatment. Renal As with all predominantly renally excreted drugs, SPIRIVA should be used only if the expected benefit outweighs the potential risk in patients with moderate to severe renal impairment (creatinine clearance ≤ 50 mL/min).
These patients should be monitored closely for potential adverse drug reactions. Worsening of Urinary Retention (see Anticholinergic Effects). SPIRIVA should be used with caution in patients with urinary retention. , difficulty passing urine, painful urination).
Instruct patients to consult a physician immediately should any of these signs or symptoms develop.
Reproductive Health:
Female and Male Potential Fertility Clinical data on fertility are not available for tiotropium. A non-clinical study performed with tiotropium showed no indication of any adverse effect on fertility (see 16 NON-CLINICAL TOXICOLOGY).
Respiratory Paradoxical bronchospasm Inhaled medicines may cause inhalation-induced bronchospasm. If this occurs, treatment with SPIRIVA should be discontinued immediately and other treatment options considered. 1 Pregnant Women Pregnant Women: There is a 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 (see 16 NON-CLINICAL TOXICOLOGY). Because animal reproduction studies are not always predictive of human response, SPIRIVA should be used during pregnancy only if the benefits outweigh any possible risk to the unborn child.
Labour and Delivery:
The safety and effectiveness of SPIRIVA have not been studied during labour and delivery. 9%) is excreted in milk over two days. Clinical data from nursing women exposed to SPIRIVA are not available. SPIRIVA should not be used in nursing women unless the expected benefit outweighs any possible risk to the infant.
3 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics No dose adjustment is required in patients 65 years of age and older.
1 Adverse Reaction Overview Adverse reactions to SPIRIVA are similar in nature to reactions to other anticholinergic bronchodilators. Many of the listed undesirable effects can be assigned to the anticholinergic properties of SPIRIVA.
In controlled clinical studies, the commonly observed undesirable effects were anticholinergic undesirable effects such as dry mouth which occurred in approximately 4% of patients. 2 %). Other undesirable effects consistent with anticholinergic effects include palpitations, supraventricular tachycardia, atrial fibrillation, blurred vision, glaucoma, constipation and intestinal obstruction including ileus paralytic as well as urinary retention.
An increase in anticholinergic effects may occur with increasing age. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of […]