Classes
DEA Class; Rx
Common Brand Names; Striverdi Respimat
- Beta2 Agonists
Description
Inhaled long-acting beta-2 agonist (LABA); given once-daily
Used for the maintenance treatment of COPD in adults
Not indicated for the relief of acute bronchospasm or for the treatment of asthma
Indications
Indicated for maintenance bronchodilator treatment in patients with COPD, including chronic bronchitis and/or emphysema who are experiencing airflow obstruction
Contraindications
All LABAs are contraindicated in asthma without an inhaled corticosteroid
Adverse Effects
- Nasopharyngitis (11.3%)
- Upper respiratory tract infection (8.2%)
- Bronchitis (4.7%)
- Cough (4.2%)
- Back pain (3.5%)
- Diarrhea (2.9%)
- Urinary tract infection (2.5%)
- Dizziness (2.3%)
- Rash (2.2%)
- Arthralgia (2.1%)
Warnings
Acute bronchospasm: Not indicated for relief of acute bronchospasm or for the treatment of asthma; data from a large placebo-controlled trial in subjects with asthma showed that LABAs may increase the risk of asthma-related death (see Black Box Warnings)
Acutely deteriorating COPD: Do not initiate in patients with acutely deteriorating COPD, which may be a life-threatening condition; not studied in patients with acutely deteriorating COPD
Cardiovascular disorder: Can produce clinically significant cardiovascular effects, including increased pulse rate or increased systolic or diastolic blood pressure; may also cause ECG changes (eg, flattening of the T wave, prolongation of the QTc interval, and ST segment depression); caution with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy, and hypertension
Do not exceed recommended dose (ie, 2 actuations once daily) or coadminister with other medicines containing a LABA; clinically significant cardiovascular effects and fatalities reported with excessive use of inhaled sympathomimetics
Paradoxical bronchospasm reported; discontinue use and treat immediately with an inhaled, prompt-acting bronchodilator (eg, albuterol)
Beta2-agonists should be used with caution with convulsive disorders, thyrotoxicosis, narrow-angle glaucoma, conditions causing urinary retention, and in individuals who are unusually responsive to sympathomimetic amines
Potential for beta2-agonists to produce significant hypokalemia (possibly through intracellular shunting) and transient hyperglycemia
Use beta2-agonists with extreme caution in patients being treated with MAOIs, TCAs, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents
Immediate hypersensitivity reactions, including angioedema, may occur after administration
Available data do not suggest an increased risk of death with use of LABA in patients with COPD
Pregnancy and Lactation
There are no adequate and well-controlled human studies that have investigated effects of therapy during labor and delivery
There are no available data on presence of drug in human milk, effects on breastfed infant, or on milk production
Maximum Dosage
5 mcg/day olodaterol via oral inhalation (i.e., 2 inhalations/day of Striverdi Respimat).
5 mcg/day olodaterol via oral inhalation (i.e., 2 inhalations/day of Striverdi Respimat).
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
Not indicated.
How supplied
Olodaterol inhaled
metered dose inhalation solution
- 2.5mcg/actuation
- Available in cartridges containing 28 or 60 actuations (after priming)