What is the composition of Spiolto (tiotropium and olodaterol)?

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Spiolto Composition

Spiolto Respimat is a fixed-dose combination inhaler containing tiotropium bromide 2.5 mcg and olodaterol 2.5 mcg per actuation, delivering a total dose of 5 mcg tiotropium and 5 mcg olodaterol per complete dose (two actuations). 1

Active Pharmaceutical Ingredients

Tiotropium Component:

  • Each dose delivers 5 mcg of tiotropium (equivalent to 6.247 mcg tiotropium bromide monohydrate) 1
  • Tiotropium is a long-acting muscarinic antagonist (LAMA) that provides anticholinergic bronchodilation 1, 2
  • Chemical name: (1α, 2ß, 4ß, 5α, 7ß)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4] nonane bromide monohydrate 1
  • Molecular formula: C19H22NO4S2Br ∙ H2O with molecular mass of 490.4 1

Olodaterol Component:

  • Each dose delivers 5 mcg of olodaterol (equivalent to 5.473 mcg olodaterol hydrochloride) 1
  • Olodaterol is a long-acting beta2-adrenergic agonist (LABA) 1, 2
  • Chemical name: 2H-1,4-Benzoxazin-3H(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-methoxyphenyl)-1-dimethylethyl]-amino]ethyl]-, monohydrochloride 1
  • Molecular formula: C21H26N2O5 × HCl with molecular weight of 422.9 g/mole (salt) 1

Inactive Ingredients (Excipients)

The sterile aqueous solution contains: 1

  • Benzalkonium chloride (preservative)
  • Edetate disodium
  • Hydrochloric acid
  • Water for injection

Delivery System Specifications

Respimat Soft Mist Inhaler:

  • Each cartridge contains 4 grams of sterile aqueous solution 1
  • Each complete dose requires two actuations 1
  • Each actuation delivers 22.1 mcL of solution from the mouthpiece 1
  • The inhaler uses mechanical energy to generate a slow-moving aerosol cloud 1
  • Spray duration is 1.5 seconds 1

Clinical Pharmacology Context

Dual Bronchodilator Mechanism:

  • This LAMA/LABA combination provides complementary bronchodilation through two distinct pathways 2, 3
  • Tiotropium blocks muscarinic receptors to reduce cholinergic bronchoconstriction 4
  • Olodaterol stimulates beta2-adrenergic receptors to relax airway smooth muscle 4
  • The combination demonstrates superior lung function improvement compared to either monocomponent 2, 3

Dosing Regimen:

  • Administered once daily at the same time each day 1
  • Two actuations constitute one complete dose 1
  • The fixed-dose combination eliminates the need for multiple inhalers 2

References

3
Research

Efficacy of tiotropium-olodaterol fixed-dose combination in COPD.

International journal of chronic obstructive pulmonary disease, 2016

4
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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