SPIRIVA- tiotropium bromide monohydrate capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

TIOTROPIUM BROMIDE MONOHYDRATE (UNII: L64SXO195N) (TIOTROPIUM - UNII:0EB439235F)

Tilgjengelig fra:

Physicians Total Care, Inc.

INN (International Name):

TIOTROPIUM BROMIDE MONOHYDRATE

Sammensetning:

TIOTROPIUM BROMIDE MONOHYDRATE 18 ug

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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. SPIRIVA HandiHaler is indicated to reduce exacerbations in COPD patients. SPIRIVA HandiHaler is contraindicated in patients with a hypersensitivity to ipratropium or tiotropium.  In clinical trials and postmarketing experience with SPIRIVA HandiHaler, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported. Teratogenic Effects, Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women.  SPIRIVA HandiHaler should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. No evidence of structural alterations was observed in rats and rabbits at inhalation tiotropium doses of up to approximately 660 and 6

Produkt oppsummering:

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: Storage Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature]. The SPIRIVA capsules should not be exposed to extreme temperature or moisture. Do not store SPIRIVA capsules in the HandiHaler device.

Autorisasjon status:

New Drug Application

Preparatomtale

SPIRIVA - TIOTROPIUM BROMIDE MONOHYDRATE CAPSULE
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SPIRIVA HANDIHALER SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR SPIRIVA HANDIHALER.
SPIRIVA HANDIHALER (TIOTROPIUM BROMIDE INHALATION POWDER)
CAPSULES FOR RESPIRATORY INHALATION
DO NOT SWALLOW SPIRIVA CAPSULES
FOR ORAL INHALATION ONLY WITH THE HANDIHALER DEVICE
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Indications and Usage (1)
12/2009
Dosage and Administration (2)
12/2009
Contraindications (4)
12/2009
Warnings and Precautions,
Immediate Hypersensitivity Reactions (5.2)
12/2009
Worsening of Narrow-Angle Glaucoma (5.4)
12/2009
Worsening of Urinary Retention (5.5)
12/2009
Renal Impairment (5.6)
12/2009
INDICATIONS AND USAGE
SPIRIVA HandiHaler is an anticholinergic indicated for the long-term,
once-daily, maintenance treatment of bronchospasm
associated with chronic obstructive pulmonary disease (COPD), and for
reducing COPD exacerbations (1)
DOSAGE AND ADMINISTRATION
DO NOT swallow SPIRIVA capsules (2)
For Use with the HandiHaler Device ONLY (2)
For Oral Inhalation ONLY (2)
Two inhalations of the powder contents of a single SPIRIVA capsule (18
mcg) once daily (2)
DOSAGE FORMS AND STRENGTHS
SPIRIVA capsules for oral inhalation: 18 mcg tiotropium powder, for
use with HandiHaler device (3)
CONTRAINDICATIONS
Hypersensitivity to ipratropium or tiotropium (4)
WARNINGS AND PRECAUTIONS
Not for acute use: Not for use as a rescue medication (5.1)
Immediate hypersensitivity reactions: Discontinue SPIRIVA HandiHaler
at once and consider alternatives if immediate
hypersensitivity reactions, including angioedema, occur. Use with
caution in patients with severe hypersensitivity to
milk proteins. (5.2)
Paradoxical bronchospasm: Discontinue SPIRIVA HandiHaler and consider
other treatments if paradoxical
bronchospasm occurs (5.3)
Worsening of narrow-angle glaucoma may occur. Use with caution in
patients with narrow-angle