About SPIRIVA

SPIRIVA HandiHaler inhalation device SPIRIVA is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both.²

SPIRIVA:

Is the only long-acting anticholinergic bronchodilator^{6, 7}
Helps open narrowed airways for 24 hours with one daily dose²
Has an established safety profile²

Clinical Evidence

To review key findings from clinical trials for SPIRIVA, just click on the tabs below.
Click "Read Abstract" to read more about the study.

Vincken W, van Noord JA, Greenhorst APM, et al, on behalf of the Dutch/Belgian Tiotropium Study Group. Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium. Eur Respir J. 2002;19:209-216.

SPIRIVA delivers superior and sustained predose FEV₁ improvement vs ipratropium.⁵

Chart from Vincken W, et al study, showing patients treated with SPIRIVA had a 180 mL difference in FEV1 versus those treated with ipratropium from days 8 through 364 of a 1-year study.

Study compared SPIRIVA (n=153) 18 μg once daily and ipratropium 40 μg qid (n=72) in patients with COPD. Means were adjusted for center, treatment, and baseline effect. Common baseline mean FEV₁ was 1.19 L.^{1, 5}

Albuterol prn, short-acting theophylline, inhaled corticosteroids, and minimal doses of oral corticosteroids were allowed if doses were stabilized for at least 6 weeks prior to treatment period.^{1, 5}

Read Abstract

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Click here for full Prescribing Information and Patient's Instructions for Use

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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