Olodaterol


Concise Prescribing Info
Indications/Uses
Maintenance therapy in COPD.
Dosage/Direction for Use
Adult : Inhalation As metered-dose aerosol inhaler (2.5 mcg/actuation): 2 inhalations once daily.
Dosage Details
Inhalation/Respiratory
Maintenance therapy in chronic obstructive pulmonary disease
Adult: As metered-dose aerosol inhaler (2.5 mcg/actuation): 2 inhalations once daily.
Contraindications
Monotherapy in the treatment of asthma. As primary treatment of asthma, acute episodes of bronchospasm, and acutely deteriorating COPD.
Special Precautions
Patient with CV disease (e.g. arrhythmia, coronary insufficiency, hypertension, heart failure), diabetes mellitus, hyperthyroidism, hypokalaemia, seizure disorder, aneurysm. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity (e.g. angioedema), increased serum glucose, decreased serum K, CNS stimulation/excitation, thyroid activity stimulation; CV effects (e.g. increased pulse rate, and blood pressure, ECG changes), hypokalaemia, hyperglycaemia.
Infections and infestations: UTI.
Musculoskeletal and connective tissue disorders: Arthralgia, back pain.
Nervous system disorders: Dizziness.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, bronchitis.
Skin and subcutaneous tissue disorders: Rash.
Potentially Fatal: Paradoxical bronchospasm.
Inhalation/Respiratory: C
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor pulmonary function including FEV1 and FVC, blood pressure, heart rate, serum glucose and K levels; CNS stimulation.
Overdosage
Symptoms: Myocardial ischaemia, angina pectoris, hypertension or hypotension, tachycardia, arrhythmia, palpitation, dizziness, nervousness, insomnia, anxiety, headache, tremor, dry mouth, muscle spasm, nausea, fatigue, malaise, hypokalaemia, hyperglycaemia, metabolic acidosis. Management: Symptomatic and supportive treatment. May consider use of cardioselective β-blockers with extreme caution. Cardiac monitoring.
Drug Interactions
Increased risk of adverse CV effect with halogenated hydrocarbon anaesthetics. Increased risk of ventricular arrhythmia with drugs that prolong QT-interval (e.g. MAOIs, TCAs). Antagonistic effect with β-blockers. Increased risk of hypokalaemia with xanthine derivatives, corticosteroids, or non-K sparing diuretics. Increased plasma concentration with CYP enzyme inhibitor (e.g. ketoconazole).
Potentially Fatal: Additive sympathomimetic effect with other long-acting beta2-adrenergic agents.
Action
Description: Olodaterol is a long acting beta2-receptor agonist. It stimulates intracellular adenyl cyclase, thereby increasing cyclic-3′, 5′-adenosine monophosphate (cAMP) levels, resulting in bronchodilation by relaxation of airway smooth muscle.
Onset: 5 minutes.
Duration: Approx 24 hours.
Pharmacokinetics:
Absorption: Rapidly absorbed systemically via lungs. Time to peak plasma concentration: 10-20 minutes. Absolute bioavailability: Approx 30%.
Distribution: Volume of distribution: 1,110 L. Plasma protein binding: Approx 60%.
Metabolism: Metabolised via direct glucuronidation by UGT2B7, UGT1A1, UGT1A7, and UGT1A9 and via O-demethylation primarily by CYP2C9 and CYP2C8; further metabolised via conjugation.
Excretion: Via urine (5-7%, as unchanged drug). Elimination half-life: 7.5 hours.
Chemical Structure

Chemical Structure Image
Olodaterol

Source: National Center for Biotechnology Information. PubChem Database. Olodaterol, CID=11504295, https://pubchem.ncbi.nlm.nih.gov/compound/Olodaterol (accessed on Jan. 22, 2020)

Storage
Store at 25°C. Do not freeze.
ATC Classification
R03AC19 - olodaterol ; Belongs to the class of adrenergic inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.
References
Anon. Olodaterol. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/02/2018.

Buckingham R (ed). Olodaterol Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/02/2018.

Joint Formulary Committee. Olodaterol. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/02/2018.

McEvoy GK, Snow EK, Miller J et al (eds). Olodaterol Hydrochloride. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 07/02/2018.

Olodaterol. Drugs and Lactation Database (LactMed) [Internet]. Bethesda, MD. U.S. National Library of Medicine. https://www.ncbi.nlm.nih.gov/books/NBK501922/. Accessed 09/02/2018.

Striverdi Respimat Inhalation Spray, Metered (Boehringer Ingelheim Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 07/02/2018.

Disclaimer: This information is independently developed by MIMS based on Olodaterol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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