Dosing & Uses
Dosage Forms & Strengths
metered dose inhalation solution
- Available in cartridges containing 28 or 60 actuations (after priming)
Chronic Obstructive Pulmonary Disease
Indicated for maintenance bronchodilator treatment in patients with COPD, including chronic bronchitis and/or emphysema who are experiencing airflow obstruction
5 mcg (2 actuations) inhaled PO qDay at the same time of the day
Not to exceed 2 inhalations every 24 hr
Geriatric patients: No dosage adjustment required
Mild-to-moderate hepatic impairment or renal impairment: No dosage adjustment required
Severe hepatic impairment: Data are not available
Prior to first use, cartridge containing the olodaterol solution is inserted into the Respimat inhaler and the unit is primed
When using the unit for the first time, patients are to actuate the inhaler toward the ground until an aerosol cloud is visible and then repeat the process 3 more times; the unit is then considered primed and ready for use
If not used for >3 days, patients are to actuate the inhaler once to prepare the inhaler for use
If not used for >21 days, patients are to actuate the inhaler until an aerosol cloud is visible and then repeat the process 3 more times to prepare the inhaler for use
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Upper respiratory tract infection (8.2%)
Back pain (3.5%)
Urinary tract infection (2.5%)
Black Box Warnings
Long-acting beta2-adrenergic agonists (LABAs), such as olodaterol, increase the risk for asthma-related death
A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths; this finding is considered a class effect of all LABAs, including olodaterol
Not to be used as a rescue therapy to treat acute bronchospasm; indicated for COPD maintenance therapy
Safety and efficacy not established in patients with asthma; NOT approved for treatment of asthma
All LABAs are contraindicated in asthma without use of a long-term asthma control medication
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
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Probable distribution in human breast milk
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Long-acting beta2 agonist; activates specific β2-adrenergic receptors on the surface of smooth muscle cells, which increases intracellular cAMP and smooth muscle relaxation
Bioavailability: 30% (lung absorption; swallowed portion is negligible)
Peak plasma time: 10-20 minutes
Protein bound: 60%
Vd: 1110 L
Exhibits multicompartmental disposition
Substantially metabolized by direct glucuronidation and by O-demethylation at the methoxy moiety followed by conjugation
Of the 6 metabolites identified, only the unconjugated demethylation product binds to beta2-receptors; this metabolite, however, is not detectable in plasma after long-term inhalation of the recommended therapeutic dose
CYP450 isozymes CYP2C9 and CYP2C8, with negligible contribution of CYP3A4, are involved in the O-demethylation
Uridine diphosphate glycosyl transferase isoforms UGT2B7, UGT1A1, 1A7, and 1A9 were shown to be involved in the formation of olodaterol glucuronides
Half-life, COPD: 7.5 hr (PO inhalation of 5 mcg/day)
Half-life, healthy volunteers: 45 hr (PO inhalation); 22 hr (IV)
Total clearance: 872 mL/min
Renal clearance: 173 mL/min
Excretion: 5-7% urine (PO inhalation)
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
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