Long-term maintenance treatment of airflow obstruction due to COPD.
- Olodaterol– A long-acting beta2 -adrenergic agonist (LABA) that stimulates adenyl cyclase, resulting in accumulation of cyclic adenosine monophosphate (cAMP) at beta2 –adrenergic receptors resulting in bronchodilation.
- tiotropium– Acts as anticholinergic by selectively and reversibly inhibiting M3 receptors in smooth muscle of airways.
Bronchodilation with decreased airflow obstruction and decreased incidence and severity of bronchospasm.
Absorption: 30% absorbed following oral inhalation (from lung surface); swallowed drug in minimally absorbed.
Distribution: Extensive tissue distribution; probably enters breast milk
Metabolism and Excretion: Extensively metabolized (some by CYP 3A4), only one metabolite binds to B2 adrenergic receptors. Following inhalation, 5–7% excreted unchanged in urine, remainder in feces as drug and metabolites (84%).
Half-life: 45 hr (following inhalation).
Absorption: 19% absorbed following inhalation.
Distribution: Extensive tissue distribution; due to route of administration ↑ concentrations occur in lung.
Metabolism and Excretion: 74% excreted unchanged in urine; 25% of absorbed drug is metabolized.
Half-life: 5–6 days.
TIME/ACTION PROFILE (improvement in FEV1)
|olodaterol/tiotropium (inhaln)||within minutes||2 hr||24 hr|
- Severe/acute/deteriorating symptoms of airflow obstruction due to COPD
- Treatment of asthma
- Hypersensitivity to any components.
Use Cautiously in:
- History of seizures
- Thyrotoxicosis; History of cardiovascular disorders (coronary insufficiency, arrhythmias, hypertension)
- Sensitivity to sympathomimetics (adrenergics)
- Narrow-angle glaucoma
- History of bladder-neck obstruction or prostatic hypertrophy
- Mild to moderate renal impairment (CCr<60 mL/min) ↑ risk of anticholinergic side effects
- Severe hepatic impairment
- OB: Use during pregnancy only if potential benefit justifies potential risk to the fetus; Lactation:Use cautiously if breastfeeding (olodaterl probably enters breast milk);
- Pedi: Safe and effective use in children has not been established.
Exercise Extreme Caution in:
Concurrent use with MAOIs, tricyclic antidepressants or drugs that prolong QTc (↑ risk of adverse cardiovascular reactions).
Adverse Reactions/Side Effects
EENT: blurred vision, glaucoma
Resp: PARADOXICAL BRONCHOSPASM, cough, nasopharyngitis
GU: urinary retention
F and E: hypokalemia
MS: back pain
Misc: hypersensitivity reactions including anaphylaxis
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
- Concurrent use with MAOIs , tricyclic antidepressants or drugs that prolong QTc ↑ risk of adverse cardiovascular reactions (use with extreme caution).
- Concurrent use of other adrenergics ↑ risk of adverse adrenergic adverse reactions (tachycardia, ↑ BP).
- Concurrent use with corticosteroids , non-potassium sparing diuretics or xanthine derivatives (including theophylline; may ↑ risk of hypokalemia and adverse cardiovascular reactions; use cautiously).
- Concurrent use with beta blockers may ↓ effectiveness and cause severe bronchospasm (use cautiously).
- Should not be used concurrently with any other long-acting beta2 -adrenergic blockers (LABAs)
- Blood levels may be ↑ by ketoconazole.
- Should not be used concurrently with ipratropium or other anticholinergics due to ↑ anticholinergic effects.
PO: (Adults) Two inhalations once daily.
Inhalation spray : olodateril 2.5 mg/tiotropium 2.5 mcg per actuation in 60 metered actuation cartridge and 28 actuation cartridge (institutional pack) as part of Respimat system
- Assess respiratory status (rate, breath sounds, degree of dyspnea, pulse) before administration. Olodaterol/tiotropium is not to be used for acute symptoms or asthma. Short-acting bronchodilator should also be prescribed. If paradoxical bronchospasm (wheezing) occurs, discontinue olodaterol/tiotropium immediately and use short-acting bronchodilator.
- Monitor for signs and symptoms of hypersensitivity reactions (urticaria, angioedema, swelling of lips, tongue or throat, rash, bronchospasm, anaphylaxis, itching). Discontinue inhaler and provide supportive care if symptoms occur.
Lab Test Considerations:
May cause hypokalemia and hyperglycemia.
- Ineffective airway clearance (Indications)
- Inhaln: Administer 1 inhalation once daily at the same time each day. When using unit for first time or if not used in 3 days, prime inhaler by actuating inhaler toward ground until an aerosol cloud is visible, then repeat process 3 more times. Follow instructions in Medication Guide for use of inhaler. See medication administration techniques for administration of inhalation medications.
- Instruct patient in how to use inhaler, to use it once daily at the same time each day and not to stop taking medication without consulting health care professional. Advise patient to rinse mouth without swallowing to reduce risk of oropharyngeal candidiasis. Instruct patient to read Medication Guide prior to use of inhaler and with each Rx refill in case of changes.
- Instruct patient in need for and use of rescue inhaler. Caution patient to notify health care professional if symptoms get worse, need more inhalations than usual from rescue inhaler, decrease in lung function as described by health care professional. Increased use of short-acting agent may signal disease deterioration.
- May cause dizziness and blurred vision. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
- Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
- Advise female patient to notify health care professional if pregnancy is planned or suspected, or if breastfeeding.
Improved airflow and ↓ exacerbations in COPD.
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