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تعداد آیتم قابل مشاهده باقیمانده : 3 مورد

Tiotropium and olodaterol: Drug information

Tiotropium and olodaterol: Drug information
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For additional information see "Tiotropium and olodaterol: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Stiolto Respimat
Brand Names: Canada
  • Inspiolto Respimat
Pharmacologic Category
  • Anticholinergic Agent;
  • Anticholinergic Agent, Long-Acting;
  • Beta2 Agonist;
  • Beta2-Adrenergic Agonist, Long-Acting
Dosing: Adult
Chronic obstructive pulmonary disease, maintenance

Chronic obstructive pulmonary disease, maintenance:

Note: Use combination (long-acting beta agonist and long-acting muscarinic antagonist) in patients with more symptoms (eg, Group B). In addition, a short-acting bronchodilator is used for intermittent symptom relief (Ref).

Soft mist inhaler (tiotropium 2.5 mcg/olodaterol 2.5 mcg per actuation): Oral inhalation: 2 inhalations once daily.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl >60 mL/minute: No dosage adjustment necessary.

CrCl ≤60 mL/minute: No dosage adjustment necessary; monitor closely for anticholinergic adverse effects.

Dosing: Liver Impairment: Adult

No dosage adjustment necessary.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Respiratory: Nasopharyngitis (12%)

1% to 10%:

Neuromuscular & skeletal: Back pain (4%)

Respiratory: Cough (4%)

≤3%, postmarketing, and/or case reports: Angioedema, arthralgia, atrial fibrillation, blurred vision, bronchospasm, constipation, dehydration, dermal ulcer, dizziness, dysphagia, dysuria, epistaxis, gastroesophageal reflux disease, gingivitis, glaucoma, glossitis, hypersensitivity (including immediate reactions), hypertension, increased intraocular pressure, insomnia, intestinal obstruction (including paralytic ileus), joint swelling, laryngitis, oropharyngeal candidiasis, palpitations, pharyngitis, pruritus, sinusitis, skin infection, skin rash, stomatitis, supraventricular tachycardia, tachycardia, urinary retention, urinary tract infection, urticaria, voice disorder, xeroderma, xerostomia

Contraindications

Hypersensitivity to tiotropium, ipratropium, olodaterol, or any component of the formulation; monotherapy (without use of a concomitant inhaled corticosteroid) in the treatment of asthma.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to atropine.

Warnings/Precautions

Concerns related to adverse effects:

• Asthma-related deaths: Monotherapy with a long-acting beta-2 agonist (LABA) is contraindicated in the treatment of asthma. The use of LABAs as monotherapy has been associated with an increased risk of severe exacerbations and asthma-related deaths (SMART 2006; Walters 2007); additional data from other clinical trials suggest risk of asthma-related hospitalization may also be increased with LABA monotherapy in pediatric and adolescent patients. However, data from large randomized, double-blind controlled trials do not show a significant increase in risk of serious asthma related events (including hospitalizations, intubations, and death) in adults, adolescents, and pediatric patients (aged 4 to 11 years of age) when fixed-dose LABAs are used with inhaled corticosteroids combined in a single inhaler compared with inhaled corticosteroid monotherapy (FDA 2017). Tiotropium/olodaterol is not indicated for the treatment of asthma.

• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled beta-2 agonists; this should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue use and institute alternative therapy.

• CNS effects: May cause dizziness and blurred vision; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).

• Hypersensitivity reactions: Immediate hypersensitivity reactions, including anaphylaxis, angioedema, pruritus, rash, and urticaria may occur; discontinue immediately if signs/symptoms of a hypersensitivity reaction occur.

• Serious effects/fatalities: Do not exceed recommended dose or frequency or use with other medications containing LABAs; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (eg, arrhythmias, coronary insufficiency, hypertension, and hypertrophic obstructive cardiomyopathy); beta-agonists may cause elevation in blood pressure and heart rate. Beta-2 agonists may also produce ECG changes (eg, T-wave flattening, QTc prolongation, ST segment depression).

• Diabetes: Use with caution in patients with diabetes mellitus; beta-2 agonists may increase serum glucose and aggravate preexisting diabetes mellitus and ketoacidosis.

• Glaucoma: Use with caution in patients with narrow angle glaucoma; may increase intraocular pressure.

• Hyperthyroidism: Use with caution in patients with hyperthyroidism; beta-2 agonists may stimulate thyroid activity.

• Hypokalemia: Use with caution in patients with hypokalemia; beta-2 agonists may decrease serum potassium (transient).

• Renal impairment: Use with caution in patients with moderate to severe renal impairment (creatinine clearance of <60 mL/minute); monitor closely for anticholinergic adverse events.

• Seizures: Use with caution in patients with seizure disorders; beta-2 agonists may result in CNS stimulation/excitation.

• Urinary retention: Use with caution in patients with urinary retention. Monitor for signs and symptoms of urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction.

Special populations:

• Pediatric: LABAs, when used as monotherapy, may increase the risk of asthma-related hospitalization in pediatric and adolescent patients. When LABAs are used in a fixed-dose combination with inhaled corticosteroids, data from large clinical trials in adolescents do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to inhaled corticosteroids alone.

Other warnings/precautions:

• Appropriate use: Not indicated for the initial (rescue) treatment of acute episodes of bronchospasm or with acutely deteriorating or potentially life-threatening COPD; after initiation of therapy, patients should use short-acting bronchodilators only on an as needed basis for acute symptoms.

Dosage Forms Considerations

Stiolto Respimat 4 g contains 60 inhalations

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Solution, Inhalation:

Stiolto Respimat: Tiotropium 2.5 mcg and olodaterol 2.5 mcg per actuation (4 g) [contains benzalkonium chloride, edetate (edta) disodium]

Generic Equivalent Available: US

No

Pricing: US

Aerosol solution (Stiolto Respimat Inhalation)

2.5-2.5 mcg/ACT (per gram): $22.50

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Solution, Inhalation:

Inspiolto Respimat: Tiotropium 2.5 mcg and olodaterol 2.5 mcg per actuation (1 ea) [contains benzalkonium chloride, edetate (edta) disodium]

Administration: Adult

Oral inhalation: Soft mist inhaler: For oral inhalation only. Administer at the same time each day. Prime inhaler prior to initial use or if not used for >21 days; point inhaler toward ground and actuate until aerosol cloud is seen, then repeat 3 additional times before use. If not used for >3 days (but ≤21 days), actuate once before use. When dose is ready to be administered, breathe in slowly through the mouth and press the dose-release button; continue to breathe in slowly as long as possible, then hold breath for 10 seconds or for as long as comfortable. Repeat for second inhalation.

Use: Labeled Indications

Chronic obstructive pulmonary disease, maintenance: Maintenance treatment of patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema.

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetylcholinesterase Inhibitors: May decrease therapeutic effects of Agents with Clinically Relevant Anticholinergic Effects. Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Acetylcholinesterase Inhibitors. Risk C: Monitor

Aclidinium: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid

Acrivastine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor

Agents with Clinically Relevant Anticholinergic Effects: May increase anticholinergic effects of Tiotropium. Risk X: Avoid

Amantadine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor

Atazanavir: May increase serum concentration of UGT1A1 Substrates. Management: Do not use UGT1A1 substrates for which small increases in exposure can cause serious adverse effects together with atazanavir, and use caution with any UGT1A1 substrate, even when small changes in exposure are less likely to cause serious adverse effects. Risk D: Consider Therapy Modification

Atomoxetine: May increase hypertensive effects of Sympathomimetics. Atomoxetine may increase tachycardic effects of Sympathomimetics. Risk C: Monitor

Atomoxetine: May increase tachycardic effects of Beta2-Agonists. Atomoxetine may increase hypertensive effects of Beta2-Agonists. Risk C: Monitor

Atosiban: Beta2-Agonists may increase adverse/toxic effects of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor

Belumosudil: May increase serum concentration of UGT1A1 Substrates. Management: Avoid coadministration of belumosudil with substrates of UGT1A1 for which minimal concentration increases can cause serious adverse effects. If coadministration is required, dose reductions of the UGT1A1 substrate may be required. Risk D: Consider Therapy Modification

Benperidol: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Benperidol. Risk C: Monitor

Beta-Blockers (Beta1 Selective): May decrease bronchodilatory effects of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Risk C: Monitor

Beta-Blockers (Nonselective): May decrease bronchodilatory effects of Beta2-Agonists. Risk X: Avoid

Beta2-Agonists (Long-Acting): May increase adverse/toxic effects of Beta2-Agonists (Long-Acting). Risk X: Avoid

Botulinum Toxin-Containing Products: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor

Bromperidol: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Bromperidol. Risk C: Monitor

Caffeine and Caffeine Containing Products: May increase adverse/toxic effects of Olodaterol. Caffeine and Caffeine Containing Products may increase hypokalemic effects of Olodaterol. Risk C: Monitor

Cannabinoid-Containing Products: Agents with Clinically Relevant Anticholinergic Effects may increase tachycardic effects of Cannabinoid-Containing Products. Risk C: Monitor

Cannabinoid-Containing Products: May increase tachycardic effects of Sympathomimetics. Risk C: Monitor

Chlorprothixene: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Chlorprothixene. Risk C: Monitor

Cimetropium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Cimetropium. Risk X: Avoid

Cocaine (Topical): May increase hypertensive effects of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider Therapy Modification

Dihydralazine: Sympathomimetics may decrease therapeutic effects of Dihydralazine. Risk C: Monitor

Doxofylline: Sympathomimetics may increase adverse/toxic effects of Doxofylline. Risk C: Monitor

DroNABinol: Agents with Clinically Relevant Anticholinergic Effects may increase tachycardic effects of DroNABinol. Risk X: Avoid

Eluxadoline: Agents with Clinically Relevant Anticholinergic Effects may increase constipating effects of Eluxadoline. Risk X: Avoid

Esketamine (Injection): May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for elevated heart rate, hypertension, and arrhythmias may be increased. Risk C: Monitor

Gastrointestinal Agents (Prokinetic): Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Gastrointestinal Agents (Prokinetic). Risk C: Monitor

Gepotidacin: May decrease anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor

Glucagon: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor

Glycopyrrolate (Oral Inhalation): Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Glycopyrrolate (Oral Inhalation). Risk X: Avoid

Glycopyrronium (Topical): May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid

Guanethidine: May increase hypertensive effects of Sympathomimetics. Guanethidine may increase arrhythmogenic effects of Sympathomimetics. Risk C: Monitor

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of Haloperidol. Risk C: Monitor

Ipratropium (Nasal): May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor

Ipratropium (Oral Inhalation): May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid

Itopride: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Itopride. Risk C: Monitor

Kratom: May increase adverse/toxic effects of Sympathomimetics. Risk X: Avoid

Levosulpiride: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Levosulpiride. Risk X: Avoid

Levothyroxine: May increase therapeutic effects of Sympathomimetics. Sympathomimetics may increase therapeutic effects of Levothyroxine. Levothyroxine may increase adverse/toxic effects of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Risk C: Monitor

Linezolid: May increase hypertensive effects of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider Therapy Modification

Loop Diuretics: Beta2-Agonists may increase hypokalemic effects of Loop Diuretics. Risk C: Monitor

Loxapine: Agents to Treat Airway Disease may increase adverse/toxic effects of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid

Melperone: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor

Methacholine: Beta2-Agonists (Long-Acting) may decrease therapeutic effects of Methacholine. Management: Hold long-acting beta2 agonists for 36 hours before methacholine use. Risk D: Consider Therapy Modification

Methacholine: Long-acting muscarinic antagonists (LAMAs) may decrease therapeutic effects of Methacholine. Management: Hold long-acting muscarinic antagonists (LAMAs) for at least 7 days before methacholine use. Risk D: Consider Therapy Modification

Mirabegron: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Mirabegron. Risk C: Monitor

Mitapivat: May decrease serum concentration of UGT1A1 Substrates. Risk C: Monitor

Monoamine Oxidase Inhibitors: May increase adverse/toxic effects of Beta2-Agonists. Risk C: Monitor

Nitroglycerin: Agents with Clinically Relevant Anticholinergic Effects may decrease absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor

Opioid Agonists: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor

Oxatomide: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid

Perazine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor

Potassium Chloride: Agents with Clinically Relevant Anticholinergic Effects may increase ulcerogenic effects of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid

Potassium Citrate: Agents with Clinically Relevant Anticholinergic Effects may increase ulcerogenic effects of Potassium Citrate. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium citrate. Risk X: Avoid

Pramlintide: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. These effects are specific to the GI tract. Risk X: Avoid

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QuiNIDine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor

Ramosetron: Agents with Clinically Relevant Anticholinergic Effects may increase constipating effects of Ramosetron. Risk C: Monitor

Revefenacin: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Revefenacin. Risk X: Avoid

Rivastigmine: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Rivastigmine. Rivastigmine may decrease therapeutic effects of Agents with Clinically Relevant Anticholinergic Effects. Management: Use of rivastigmine with an anticholinergic agent is not recommended unless clinically necessary. If the combination is necessary, monitor for reduced anticholinergic effects. Risk D: Consider Therapy Modification

Secretin: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider Therapy Modification

Sofpironium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Sofpironium. Risk X: Avoid

Solriamfetol: Sympathomimetics may increase hypertensive effects of Solriamfetol. Sympathomimetics may increase tachycardic effects of Solriamfetol. Risk C: Monitor

Sympathomimetics: May increase adverse/toxic effects of Sympathomimetics. Risk C: Monitor

Tedizolid: May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for increased blood pressure and heart rate may be increased. Risk C: Monitor

Theophylline Derivatives: May increase hypokalemic effects of Beta2-Agonists. Beta2-Agonists may increase adverse/toxic effects of Theophylline Derivatives. Specifically, sympathomimetic effects may be increased. Risk C: Monitor

Thiazide and Thiazide-Like Diuretics: Agents with Clinically Relevant Anticholinergic Effects may increase serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

Tiapride: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Tiapride. Risk C: Monitor

Topiramate: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Topiramate. Risk C: Monitor

Trimethobenzamide: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Trimethobenzamide. Risk C: Monitor

Umeclidinium: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination. Beta-agonists have the potential to affect uterine contractility if administered during labor. See individual monographs.

Breastfeeding Considerations

It is not known if olodaterol or tiotropium are present in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. See individual monographs.

Monitoring Parameters

FEV1, peak flow and/or other pulmonary function tests; anticholinergic adverse reactions (patients with CrCl ≤60 mL/minute); serum potassium; serum glucose; blood pressure, heart rate; CNS stimulation; signs and symptoms of glaucoma; hypersensitivity reactions; urinary retention.

Mechanism of Action

Tiotropium: Competitively and reversibly inhibits the action of acetylcholine at type 3 muscarinic (M3) receptors in bronchial smooth muscle causing bronchodilation.

Olodaterol: Long acting beta2-receptor agonist; activates beta2 airway receptors, resulting in the stimulation of intracellular adenyl cyclase and a subsequent increase in the synthesis of cyclic-3’,5’ adenosine monophosphate (cAMP). Elevated cAMP levels induce bronchodilation by relaxation of airway smooth muscle cells. Has much greater affinity for beta2-receptors than for beta1- or beta3-receptors.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Spiolto respimat;
  • (AR) Argentina: Spiolto respimat;
  • (AT) Austria: Spiolto respimat;
  • (AU) Australia: Spiolto respimat;
  • (BE) Belgium: Spiolto respimat | Yanimo;
  • (BG) Bulgaria: Spiolto respimat;
  • (BR) Brazil: Spiolto;
  • (CH) Switzerland: Spiolto respimat;
  • (CL) Chile: Spiolto respimat;
  • (CN) China: Spiolto respimat | Tiotropium bromide and olodaterol hydrochloride;
  • (CO) Colombia: Spiolto respimat;
  • (CZ) Czech Republic: Spiolto respimat | Yanimo respimat;
  • (DE) Germany: Spiolto respimat | Yanimo respimat;
  • (EC) Ecuador: Spiolto respimat;
  • (EE) Estonia: Spiolto respimat;
  • (EG) Egypt: Spiolto respimat;
  • (ES) Spain: Spiolto respimat | Yanimo;
  • (FI) Finland: Inspiolto respimat | Yanimo respimat;
  • (FR) France: Spiolto respimat;
  • (GB) United Kingdom: Spiolto respimat | Yanimo respimat;
  • (GR) Greece: Spiolto respimat;
  • (HK) Hong Kong: Spiolto respimat;
  • (HR) Croatia: Spiolto respimat;
  • (HU) Hungary: Spiolto respimat | Yanimo respimat;
  • (ID) Indonesia: Spiolto respimat;
  • (IE) Ireland: Spiolto respimat;
  • (IT) Italy: Spiolto respimat;
  • (JO) Jordan: Spiolto respimat;
  • (JP) Japan: Spiolto respimat;
  • (KR) Korea, Republic of: Vahelva respimat;
  • (LB) Lebanon: Spiolto respimat;
  • (LT) Lithuania: Spiolto respimat;
  • (LU) Luxembourg: Spiolto respimat | Yanimo respimat;
  • (LV) Latvia: Spiolto respimat;
  • (MA) Morocco: Spiolto respimat;
  • (MX) Mexico: Spiolto | Spiolto respimat;
  • (MY) Malaysia: Spiolto respimat;
  • (NL) Netherlands: Spiolto respimat;
  • (NO) Norway: Spiolto respimat;
  • (NZ) New Zealand: Spiolto respimat;
  • (PA) Panama: Spiolto respimat;
  • (PE) Peru: Spiolto respimat;
  • (PH) Philippines: Spiolto respimat;
  • (PL) Poland: Spiolto respimat | Yanimo;
  • (PT) Portugal: Spiolto respimat;
  • (PY) Paraguay: Spiolto respimat;
  • (QA) Qatar: Spiolto Respimat;
  • (RO) Romania: Spiolto respimat;
  • (RU) Russian Federation: Spiolto respimat;
  • (SA) Saudi Arabia: Spiolto respimate;
  • (SE) Sweden: Spiolto respimat;
  • (SG) Singapore: Spiolto respimat;
  • (SI) Slovenia: Spiolto respimat;
  • (SK) Slovakia: Spiolto respimat;
  • (TH) Thailand: Spiolto respimat;
  • (TN) Tunisia: Spiolto respimat;
  • (TR) Turkey: Spiolto respimat;
  • (TW) Taiwan: Spiolto respimat;
  • (UA) Ukraine: Spiolto respimat;
  • (UY) Uruguay: Spiolto respimat
  1. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. https://ginasthma.org/gina-reports/. Updated 2022. Accessed September 23, 2022.
  2. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for prevention, diagnosis and management of COPD: 2024 report. https://goldcopd.org/2024-gold-report/. Updated 2024. Accessed August 30, 2024.
  3. Inspiolto Respimat (tiotropium bromide/olodaterol) [product monograph]. Burlington, Ontario, Canada: Boehringer Ingelheim (Canada) Ltd; November 2019.
  4. Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM; SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006;129(1):15-26. [PubMed 16424409]
  5. Stiolto Respimat (tiotropium bromide and olodaterol) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals; August 2020.
  6. US Department of Health and Human Services; National Institutes of Health; National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report 2007. http://www.nhlbi.nih.gov/files/docs/guidelines/asthgdln.pdf. Published August 28, 2007.
  7. US Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS). https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-review-finds-no-significant-increase-risk-serious-asthma-outcomes. Published December 20, 2017.
  8. Walters EH, Gibson PG, Lasserson TJ, Walters JA. Long-acting beta2-agonists for chronic asthma in adults and children where background therapy contains varied or no inhaled corticosteroid. Cochrane Database Syst Rev. 2007;(1):CD001385. doi:10.1002/14651858.CD001385.pub2 [PubMed 17253458]
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