SPIRIVA RESPIMAT- tiotropium bromide inhalation spray spray, metered

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

TIOTROPIUM BROMIDE ANHYDROUS (UNII: XX112XZP0J) (TIOTROPIUM - UNII:0EB439235F)

Tilgjengelig fra:

Boehringer Ingelheim Pharmaceuticals, Inc.

INN (International Name):

TIOTROPIUM BROMIDE

Sammensetning:

TIOTROPIUM BROMIDE 1.562 ug

Administreringsrute:

RESPIRATORY (INHALATION)

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

SPIRIVA RESPIMAT (tiotropium bromide) 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 RESPIMAT is indicated to reduce exacerbations in COPD patients. Important Limitation of Use: SPIRIVA RESPIMAT is NOT indicated for the relief of acute bronchospasm. SPIRIVA RESPIMAT is a bronchodilator indicated for the long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older. Important Limitation of Use: SPIRIVA RESPIMAT is NOT indicated for the relief of acute bronchospasm. SPIRIVA RESPIMAT is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, or any component of this product [see Warnings and Precautions (5.2)] . In clinical trials with SPIRIVA RESPIMAT, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported [see Warning

Produkt oppsummering:

SPIRIVA RESPIMAT Inhalation Spray is supplied in a carton containing one SPIRIVA RESPIMAT cartridge and one SPIRIVA RESPIMAT inhaler. The SPIRIVA RESPIMAT cartridge is provided as an aluminum cylinder with a tamper protection seal on the cap. The SPIRIVA RESPIMAT cartridge is only intended for use with the SPIRIVA RESPIMAT inhaler and should not be interchanged with any other RESPIMAT device delivered product. The SPIRIVA RESPIMAT inhaler is a cylindrical shaped plastic inhalation device with a gray colored body and a clear base. The clear base is removed to insert the cartridge. The inhaler contains a dose indicator. The written information on the label of the gray inhaler body indicates that it is labeled for use with the SPIRIVA RESPIMAT cartridge. SPIRIVA RESPIMAT Inhalation Spray is available in two dosage strengths, identified by dose delivered per actuation and by the color of the cap and associated container label: aqua represents 2.5 mcg per actuation; blue represents 1.25 mcg per actuation. To deliver the recommended dosage for COPD: To deliver the recommended dosage for asthma: The SPIRIVA RESPIMAT cartridge for each strength has a net fill weight of 4 grams and when used with the SPIRIVA RESPIMAT inhaler, is designed to deliver the labeled number of metered actuations after preparation for use. Each actuation from the SPIRIVA RESPIMAT inhaler delivers 1.25 or 2.5 mcg of tiotropium (equivalent to 1.562 or 3.124 mcg, respectively, of tiotropium bromide monohydrate) from the mouthpiece. When the labeled number of actuations has been dispensed from the inhaler, the RESPIMAT locking mechanism will be engaged and no more actuations can be dispensed. After assembly, the SPIRIVA RESPIMAT inhaler should be discarded at the latest 3 months after first use or when the locking mechanism is engaged, whichever comes first. Keep out of reach of children. Do not spray into eyes. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Avoid freezing.

Autorisasjon status:

New Drug Application

Preparatomtale

SPIRIVA RESPIMAT- TIOTROPIUM BROMIDE INHALATION SPRAY SPRAY, METERED
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SPIRIVA RESPIMAT SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SPIRIVA
RESPIMAT.
SPIRIVA® RESPIMAT® (TIOTROPIUM BROMIDE INHALATION SPRAY), FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
SPIRIVA RESPIMAT 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 (1.1)
The long-term, once-daily, maintenance treatment of asthma in patients
6 years of age and older (1.2)
Limitation of Use:
Not indicated for relief of acute bronchospasm (1.1, 1.2, 5.1)
DOSAGE AND ADMINISTRATION
For oral inhalation only
To receive the full dose of medication, SPIRIVA RESPIMAT must be
administered as two inhalations once-
daily.
Treatment of COPD: 2 inhalations of SPIRIVA RESPIMAT 2.5 mcg
once-daily (2)
Treatment of asthma patients 6 years and older: 2 inhalations of
SPIRIVA RESPIMAT 1.25 mcg once-
daily (2)
DOSAGE FORMS AND STRENGTHS
Inhalation spray: 1.25 mcg or 2.5 mcg tiotropium per actuation with
the SPIRIVA RESPIMAT inhaler. Two
actuations equal one dose (2.5 mcg or 5 mcg). (3)
CONTRAINDICATIONS
Hypersensitivity to tiotropium, ipratropium, or any component of this
product (4)
WARNINGS AND PRECAUTIONS
Not for acute use, i.e., not a rescue medication (5.1)
Immediate hypersensitivity reactions: Discontinue SPIRIVA RESPIMAT at
once and consider alternatives
if immediate hypersensitivity reactions, including angioedema,
urticaria, rash, bronchospasm, or
anaphylaxis, occur. (5.2)
Paradoxical bronchospasm: Discontinue SPIRIVA RESPIMAT 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
glaucoma and instruct patients to con