STIOLTO RESPIMAT- tiotropium bromide and olodaterol spray, metered

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

TIOTROPIUM BROMIDE MONOHYDRATE (UNII: L64SXO195N) (TIOTROPIUM - UNII:0EB439235F), OLODATEROL HYDROCHLORIDE (UNII: 65R445W3V9) (OLODATEROL - UNII:VD2YSN1AFD)

थमां उपलब्ध:

Boehringer Ingelheim Pharmaceuticals Inc.

INN (इंटरनेशनल नाम):

TIOTROPIUM BROMIDE MONOHYDRATE

रचना:

TIOTROPIUM 3.124 ug

प्रशासन का मार्ग:

RESPIRATORY (INHALATION)

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

STIOLTO RESPIMAT is a combination of tiotropium and olodaterol indicated for long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Important Limitations of Use - STIOLTO RESPIMAT is not indicated to treat acute deteriorations of COPD [see Warnings and Precautions (5.2)]. - STIOLTO RESPIMAT is not indicated to treat asthma. The safety and effectiveness of STIOLTO RESPIMAT in asthma have not been established. Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid is contraindicated in patients with asthma [see Warnings and Precautions (5.1)] . STIOLTO RESPIMAT is not indicated for the treatment of asthma. STIOLTO RESPIMAT is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, olodaterol, or any component of this product [see Warnings and Precautions (5.4)] . In clinical trials and postmarketing experience with tiotropium, immediate hypersensitivity reactions, inc

उत्पाद समीक्षा:

STIOLTO RESPIMAT Inhalation Spray is supplied in a labeled carton containing one STIOLTO RESPIMAT cartridge and one STIOLTO RESPIMAT inhaler. The STIOLTO RESPIMAT cartridge is provided as an aluminum cylinder with a tamper protection seal on the cap. The STIOLTO RESPIMAT cartridge is only intended for use with the STIOLTO RESPIMAT inhaler and should not be interchanged with any other RESPIMAT device delivered product. The STIOLTO 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 light green-colored cap and the written information on the label of the gray inhaler body indicate that it is labeled for use with the STIOLTO RESPIMAT cartridge. STIOLTO RESPIMAT Inhalation Spray is available as: The STIOLTO RESPIMAT cartridge has a net fill weight of at least 4 grams and when used with the STIOLTO RESPIMAT inhaler, is designed to deliver the labeled number of metered actuations after preparation for use. 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 STIOLTO 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.

प्राधिकरण का दर्जा:

New Drug Application

सूचना पत्रक

Boehringer Ingelheim Pharmaceuticals Inc.
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MEDICATION GUIDE
STIOLTO® RESPIMAT® (sti-OL-to– RES peh mat)
(tiotropium bromide and olodaterol)
inhalation spray, for oral inhalation use
Read the Medication Guide that comes with STIOLTO RESPIMAT before you
start using it and each
time you get a refill. There may be new information. This Medication
Guide does not take the place of
talking to your healthcare provider about your medical condition or
treatment.
What is the most important information I should know about STIOLTO
RESPIMAT?
STIOLTO RESPIMAT has been approved for chronic obstructive pulmonary
disease (COPD) only.
STIOLTO RESPIMAT is not to be used in asthma.
STIOLTO RESPIMAT can cause serious side effects, including:
•
People with asthma who take long-acting beta2-adrenergic agonist
(LABA) medicines, such as
olodaterol (one of the medicines in STIOLTO RESPIMAT), have an
increased risk of death from
asthma problems.
•
It is not known if LABA medicines, such as olodaterol (one of the
medicines in STIOLTO
RESPIMAT), increase the risk of death in people with COPD.
•
Get emergency medical care if:
•
breathing problems worsen quickly
•
you use your rescue inhaler medicine, but it does not relieve your
breathing problems
What is STIOLTO RESPIMAT?
STIOLTO RESPIMAT contains the anticholinergic tiotropium, and the
long-acting beta2-adrenergic
agonist (LABA), olodaterol.
STIOLTO RESPIMAT is used long term, 2 puffs once each day, in
controlling symptoms of COPD in
adults with COPD).
Anticholinergic and LABA medicines help the muscles around the airways
in your lungs stay relaxed to
prevent symptoms, such as wheezing, cough, chest tightness, and
shortness of breath.
STIOLTO RESPIMAT is not for use to treat sudden symptoms of COPD.
Always have a rescue
medicine with you to treat sudden symptoms. If you do not have a
rescue inhaler, contact your healthcare
provider to have one prescribed for you.
It is not known if STIOLTO RESPIMAT is safe and effective in people
with asthma.
STIOLTO RESPIMAT should n

उत्पाद विशेषताएं

STIOLTO RESPIMAT- TIOTROPIUM BROMIDE AND OLODATEROL 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
STIOLTO RESPIMAT SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR STIOLTO
RESPIMAT.
STIOLTO RESPIMAT (TIOTROPIUM BROMIDE AND OLODATEROL INHALATION SPRAY),
FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
STIOLTO RESPIMAT is a combination of tiotropium, an anticholinergic
and olodaterol, a long-acting beta -
adrenergic agonist (LABA) indicated for the long-term, once-daily
maintenance treatment of patients with
chronic obstructive pulmonary disease (COPD). (1.1)
Important limitations:
STIOLTO RESPIMAT is NOT indicated to treat acute deterioration of
COPD. (1.1)
STIOLTO RESPIMAT is NOT indicated to treat asthma. (1.1)
DOSAGE AND ADMINISTRATION
For oral inhalation only.
Two inhalations of STIOLTO RESPIMAT once-daily at the same time of
day. (2)
DOSAGE FORMS AND STRENGTHS
Inhalation spray: Each actuation from the mouthpiece delivers 2.5 mcg
tiotropium (equivalent to 3.124
mcg tiotropium bromide monohydrate), and 2.5 mcg olodaterol
(equivalent to 2.736 mcg olodaterol
hydrochloride). Two actuations equal one dose. (3)
CONTRAINDICATIONS
Use of a LABA, including STIOLTO RESPIMAT, without an inhaled
corticosteroid is contraindicated in
patients with asthma. (4)
Hypersensitivity to tiotropium, ipratropium, olodaterol, or any
component of this product. (4)
WARNINGS AND PRECAUTIONS
LABA as monotherapy (without an inhaled corticosteroid) for asthma
increases the risk of serious
asthma-related events. (5.1)
Do not initiate STIOLTO RESPIMAT in acutely deteriorating COPD
patients. (5.2)
Do not use for relief of acute symptoms. Concomitant short-acting beta
-agonists can be used as
needed for acute relief. (5.2)
Do not exceed the recommended dose. Excessive use of STIOLTO RESPIMAT,
or use in conjunction with
other medications containing LABA can result in clinically signifi