Spiriva (Tiotropium Bromide Monohydrate Inhalation) - Indications and Dosage

INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

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 section).

The recommended dosage of SPIRIVA HandiHaler (tiotropium bromide inhalation powder) is the inhalation of the contents of one SPIRIVA capsule, once-daily, with the HandiHaler device (see " Patient Information " and " Patient’s Instructions for Use ").

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 (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and PRECAUTIONS).

HOW SUPPLIED

SPIRIVA HandiHaler consists of SPIRIVA capsules and the HandiHaler device. SPIRIVA capsules contain 18 mcg of tiotropium and are light green, with the Boehringer Ingelheim company logo on the SPIRIVA capsule cap and TI 01 on the SPIRIVA capsule body, or vice versa.

The HandiHaler device is gray colored with a green piercing button. It is imprinted with SPIRIVA HandiHaler (tiotropium bromide inhalation powder), the Boehringer Ingelheim company logo, and the Pfizer company logo. It is also imprinted to indicate that SPIRIVA capsules should not be stored in the HandiHaler device and that the HandiHaler device is only to be used with SPIRIVA capsules.

SPIRIVA capsules are packaged in an aluminum/aluminum blister card and joined along a perforated-cut line. SPIRIVA capsules should always be stored in the blister and only removed immediately before use. The drug should be used immediately after the packaging over an individual SPIRIVA capsule is opened.

The following packages are available:

• carton containing 5 SPIRIVA capsules (1 unit-dose blister card) and 1 HandiHaler device (NDC 0597-0075-75)
• carton containing 30 SPIRIVA capsules (3 unit-dose blister cards) and 1 HandiHaler device (NDC 0597-0075-41)
• carton containing 90 SPIRIVA capsules (9 unit-dose blister cards) and 1 HandiHaler device (NDC 0597-0075-47)