STRIVERDI RESPIMAT- olodaterol respimat inhalation spray spray, metered
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Patient Information leaflet
(PIL)
05-04-2018
Summary of Product characteristics
(SPC)
23-05-2023
Active ingredient:
OLODATEROL HYDROCHLORIDE (UNII: 65R445W3V9) (OLODATEROL - UNII:VD2YSN1AFD)
Available from:
Boehringer Ingelheim Pharmaceuticals, Inc.
INN (International Name):
Olodaterol hydrochloride
Composition:
Olodaterol 2.5 ug
Administration route:
RESPIRATORY (INHALATION)
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
STRIVERDI RESPIMAT is a long-acting beta2 -agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. STRIVERDI RESPIMAT is not indicated to treat acute deteriorations of COPD [see Warnings and Precautions (5.2) ]. STRIVERDI RESPIMAT is not indicated to treat asthma. The safety and effectiveness of STRIVERDI RESPIMAT in asthma have not been established. Use of a LABA, including STRIVERDI RESPIMAT, without an inhaled corticosteroid is contraindicated in patients with asthma [see Warnings and Precautions (5.1) ]. STRIVERDI RESPIMAT is not indicated for the treatment of asthma. Risk Summary There are no adequate and well-controlled clinical studies with STRIVERDI RESPIMAT in pregnant women to inform of drug-associated risk of adverse pregnancy-related outcomes. There are clinical considerations with the use of STRIVERDI RESPIMAT in pregnant women [see Clinica
Product summary:
STRIVERDI RESPIMAT Inhalation Spray is supplied in a labeled carton containing one STRIVERDI RESPIMAT cartridge and one STRIVERDI RESPIMAT inhaler. The STRIVERDI RESPIMAT cartridge is an aluminum cylinder with a tamper protection seal on the cap. The STRIVERDI RESPIMAT cartridge is only intended for use with the STRIVERDI RESPIMAT inhaler. The STRIVERDI 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 yellow colored cap and the written information on the label of the gray inhaler body indicates that it is labeled for use with the STRIVERDI RESPIMAT cartridge. STRIVERDI RESPIMAT Inhalation Spray is available as: STRIVERDI RESPIMAT Inhalation Spray: 60 metered actuations (NDC 0597-0192-61) The STRIVERDI RESPIMAT cartridge has a net fill weight of at least 4 grams and when used with the STRIVERDI RESPIMAT inhaler, is designed to deliver the labeled number of metered actuations after preparation for use. When the labeled number of metered actuations has been dispensed from the inhaler, the STRIVERDI RESPIMAT locking mechanism will be engaged and no more actuations can be dispensed. After assembly, the STRIVERDI 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.
Authorization status:
New Drug Application
Patient Information leaflet
These highlights do not include all the information
needed to use STRIVERDI RESPIMAT safely and effectively. See
full
prescribing information for STRIVERDI RESPIMAT.
STRIVERDI® RESPIMAT® (olodaterol) Inhalation
SprayFOR ORAL INHALATIONInitial U.S. Approval: 2014
STRIVERDI RESPIMAT-
olodaterol respimat inhalation spray spray,
metered
Boehringer Ingelheim
Pharmaceuticals, Inc.
----------
Medication Guide
STRIVERDI® RESPIMAT® (STRIH ver
deeWhat is the most important information I should know about
STRIVERDI RESPIMAT?s label may have been updated. For current
full prescribing information for STRIVERDI RESPIMAT, go to
www.STRIVERDI.com or to view a video demonstration on how to use
your STRIVERDI RESPIMAT inhaler, scan the code below or visit
www.themist.com. You m
Read the complete document
Summary of Product characteristics
STRIVERDI RESPIMAT- OLODATEROL RESPIMAT INHALATION SPRAY SPRAY,
METERED
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
STRIVERDI RESPIMAT
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR STRIVERDI
RESPIMAT.
STRIVERDI RESPIMAT (OLODATEROL INHALATION SPRAY), FOR ORAL INHALATION USE
INITIAL U.S. APPROVAL: 2014
INDICATIONS AND USAGE
STRIVERDI RESPIMAT Inhalation Spray is a long-acting beta -adrenergic
agonist (LABA) indicated for:
The long-term, once-daily maintenance bronchodilator treatment of
airflow obstruction in patients with
chronic obstructive pulmonary disease (COPD), including chronic
bronchitis and/or emphysema (1.1)
Important limitations:
STRIVERDI RESPIMAT is NOT indicated to treat acute deterioration of
COPD (1.2)
STRIVERDI RESPIMAT is NOT indicated to treat asthma (1.2)
DOSAGE AND ADMINISTRATION
For oral inhalation only
Two inhalations of STRIVERDI 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
olodaterol, equivalent to 2.7 mcg
olodaterol hydrochloride. Two actuations equal one dose. (3)
CONTRAINDICATIONS
Use of a LABA, including STRIVERDI RESPIMAT, without an inhaled
corticosteroid is contraindicated in
patients with asthma. (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 STRIVERDI 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 STRIVERDI
RESPIMAT, or use in conjunction
with other medications containing LABA can result in clinically
significant cardiovascular effects and may
be fatal. (5.3)
Life-threatening paradoxical bronchospasm can occur. Discontinue
STRIVERDI RESPIMAT immediat
Read the complete document
Search alerts related to this product
View documents history
