Safety and Tolerability

The recommended dosage of SPIRIVA is the inhalation of the contents of one SPIRIVA capsule, once daily, every day. SPIRIVA capsules are for inhalation only and must not be swallowed.² See the full Prescribing Information and Patient's Instructions for Use.

Click here to watch a patient training video on the SPIRIVA patient site. You can direct your patients to this video by having them visit www.Spiriva.com and click on “Taking SPIRIVA.”

SPIRIVA capsules contain 18 mcg tiotropium bromide and are light green in color. They come packaged in an aluminum blister card with perforated cut lines between each blister.

Three SPIRIVA packages are available, each with a new HandiHaler inhalation device:

• 5 SPIRIVA capsules and HandiHaler inhalation device
• 30 SPIRIVA capsules and HandiHaler inhalation device
• 90 SPIRIVA capsules and HandiHaler inhalation device

• It may take several weeks to feel the full effects of SPIRIVA; however, lung function improvements may occur after the first dose.
• Patients should take SPIRIVA every day as directed, even on days when they feel they are breathing better.
• The SPIRIVA capsule should not be swallowed.
• As with any COPD maintenance therapy, patients should carry a rescue inhaler, such as albuterol.

In a clinical trial, SPIRIVA reduced the use of rescue medication by 23% vs placebo.⁹
Similar results were observed in another 1-year study and in one of two 6-month studies. ²

SPIRIVA capsules are intended for oral inhalation only and are to be used only with the HandiHaler inhalation device. The HandiHaler device should not be used for administering other medications.

SPIRIVA capsules should always be stored in the sealed blisters, and only removed immediately before use, or else its effectiveness may be reduced.
Please refer to the Patient’s Instructions for Use for additional information on the use of the SPIRIVA HandiHaler.

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IMPORTANT PRODUCT INFORMATION

SPIRIVA HandiHaler is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

SPIRIVA HandiHaler is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, ie, ipratropium, or to any component of this product.

SPIRIVA HandiHaler is not indicated for the initial treatment of acute episodes of bronchospasm, ie, rescue therapy.

Immediate hypersensitivity reactions, including angioedema, may occur after administration of SPIRIVA. Additionally, inhaled medicines, including SPIRIVA, may cause paradoxical bronchospasm. If either of these occurs, treatment with SPIRIVA should be stopped and other treatments considered.

As an anticholinergic drug, SPIRIVA may potentially worsen symptoms and signs associated with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction, and should be used with caution in patients with any of these conditions.

As SPIRIVA is a predominantly renally excreted drug, SPIRIVA use should be monitored closely in patients with moderate to severe renal impairment (creatinine clearance of ≤50 mL/min).

SPIRIVA has been used concomitantly with other drugs commonly used in COPD (these include sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids) without increases in adverse drug reactions. However, the co-administration of SPIRIVA with other anticholinergic-containing drugs (eg, ipratropium) has not been studied and is therefore not recommended.

The most commonly reported adverse drug reaction with SPIRIVA was dry mouth, which was usually mild and often resolved during continued treatment. Other reactions reported in individual patients and consistent with possible anticholinergic effects included constipation, increased heart rate, blurred vision, glaucoma, urinary difficulty and urinary retention.

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