SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder) Dosage and Administration

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Prescribing Information

SPIRIVA^® HandiHaler^® (tiotropium bromide inhalation powder)
Dosage and Administration


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DO NOT SWALLOW SPIRIVA CAPSULES
FOR USE WITH HANDIHALER DEVICE ONLY

FOR ORAL INHALATION ONLY

SPIRIVA capsules must not be swallowed as the intended effects on the lungs will not be obtained. The contents of the SPIRIVA capsules are only for oral inhalation and should only be used with the HandiHaler device [see Overdosage].

The recommended dose of SPIRIVA HandiHaler is two inhalations of the powder contents of one SPIRIVA capsule, once-daily, with the HandiHaler device [see Patient Counseling Information].

For administration of SPIRIVA HandiHaler, a SPIRIVA capsule is placed into the center chamber of the HandiHaler device. The SPIRIVA capsule is pierced by pressing and releasing the green piercing button on the side of the HandiHaler device. The tiotropium formulation is dispersed into the air stream when the patient inhales through the mouthpiece [see Patient Counseling Information].

No dosage adjustment is required for geriatric, hepatically-impaired, or renally-impaired patients. However, patients with moderate to severe renal impairment given SPIRIVA HandiHaler should be monitored closely for anticholinergic effects [see Warnings and Precautions, Use in Specific Populations, and Clinical Pharmacology].

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SPIRIVA Safety Information

IMPORTANT PRODUCT INFORMATION

SPIRIVA Handihaler is contraindicated in patients with a history of hypersensitivity to ipratropium or tiotropium (atropine derivatives).

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

Immediate hypersensitivity reactions, including angioedema (swelling of lips, tongue or throat), itching, and rash, may occur after administration of SPIRIVA. Additionally, inhaled medicines, including SPIRIVA, may cause paradoxical bronchospasm. If any of these occurs, treatment with SPIRIVA should be stopped and other treatments considered.

Patients with a history of hypersensitivity reactions to atropine should be closely monitored for similar hypersensitivity reactions to SPIRIVA.

Use with caution in patients with severe hypersensitivity to milk proteins.

SPIRIVA HandiHaler should be used with caution in patients with narrow-angle glaucoma or urinary retention. Prescribers should instruct patients to consult a physician immediately should any signs or symptoms of narrow-angle glaucoma, or prostatic hyperplasia or bladder-neck obstruction occur.

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 HandiHaler has been used concomitantly with short-acting and long-acting sympathomimetic (beta-agonists) bronchodilators, methylxanthines, and oral and inhaled steroids without increases in adverse drug reactions. The co-administration of SPIRIVA HandiHaler with other anticholinergic-containing drugs (e.g., ipratropium) has not been studied and is therefore not recommended.

The most common adverse reactions in the 1-year placebo-controlled trials were dry mouth, upper respiratory tract infection, sinusitis, pharyngitis, non-specific chest pain, and urinary tract infection. In addition, the most commonly reported adverse reactions from the 4-year trial not included above were headache, constipation, depression, insomnia and arthralgia.

Please see full prescribing information.

SPIRIVA ^® HandiHaler^® (tiotropium bromide inhalation powder)

spiriva_safety_information.htm

Full Prescribing Information