Brand Name

Stiolto Respimat

Generic Name
Olodaterol
View Brand Information
FDA approval date: May 21, 2015
Classification: Anticholinergic
Form: Spray

What is Stiolto Respimat (Olodaterol)?

Living with chronic obstructive pulmonary disease (COPD) often means feeling short of breath during daily tasks that once felt effortless. For many patients, medications that open the airways and make breathing easier can dramatically improve quality of life. Stiolto Respimat is one such inhaler prescribed for long-term maintenance treatment of COPD, including chronic bronchitis and emphysema. It is not a rescue inhaler for sudden breathing problems, but a daily medication designed to help patients breathe more comfortably over time.

Stiolto Respimat combines two long-acting bronchodilators, tiotropium bromide and olodaterol that work together to relax the airway muscles. This dual-action approach has made it a cornerstone in COPD management for patients who need more than a single-agent inhaler to control symptoms.

What does Stiolto Respimat do?

Stiolto Respimat helps people with COPD breathe easier by keeping their airways open throughout the day. COPD causes airway narrowing and inflammation, leading to chronic coughing, wheezing, and difficulty exhaling. This inhaler improves airflow, reduces breathlessness, and supports better exercise tolerance and daily activity levels.

Clinical studies have shown that the combination of tiotropium and olodaterol provides significantly greater improvement in lung function compared to either drug alone (FDA, 2015). Many patients notice fewer flare-ups and reduced need for short-acting rescue inhalers when using Stiolto Respimat consistently.

Because it is a maintenance medication, Stiolto Respimat is taken every day, even when symptoms are under control, to help maintain steady airway relaxation and prevent worsening COPD symptoms.

How does Stiolto Respimat work?

Stiolto Respimat contains two different types of bronchodilators:

  • Tiotropium bromide, a long-acting muscarinic antagonist (LAMA), works by blocking specific receptors in the airway muscles that normally cause them to tighten.
  • Olodaterol, a long-acting beta-agonist (LABA), activates another receptor type that signals the muscles to relax.

Together, these agents provide dual bronchodilation, a complementary mechanism that keeps airways open for 24 hours. The result is smoother airflow, less effort during breathing, and better oxygen delivery to the lungs.

From a clinical standpoint, this dual mechanism is valuable because COPD involves multiple pathways of airway constriction. By targeting both, Stiolto Respimat helps achieve more complete and sustained symptom relief.

Stiolto Respimat side effects

Most people tolerate Stiolto Respimat well, but like all prescription drugs, it can cause side effects. Understanding what to expect helps patients use it safely and confidently.

Common side effects may include:

  • Cough, sore throat, or mild irritation after inhalation
  • Headache or dizziness
  • Dry mouth or mild constipation

Less common but potentially significant effects include:

  • Rapid heartbeat or palpitations
  • Urinary retention (trouble passing urine), especially in men with prostate enlargement
  • Eye pain or blurred vision, which may signal accidental eye exposure during use

Seek immediate medical care if you experience:

  • Severe allergic reactions such as rash, swelling, or difficulty breathing
  • Worsening shortness of breath soon after inhalation (paradoxical bronchospasm)

Patients with certain conditions such as glaucoma, bladder obstruction, or cardiovascular disease, should discuss risks and benefits with their doctor before starting treatment (Mayo Clinic, 2024).

The tone of monitoring is preventive, not alarming. Regular communication with your healthcare provider ensures that any side effects are identified and managed early.

Stiolto Respimat dosage

Stiolto Respimat is delivered as a soft-mist inhaler, which creates a fine spray for gentle, deep lung delivery. It is typically used once daily, at the same time each day, following specific inhaler instructions to ensure proper dose administration.

Although no routine blood tests are usually required, doctors may:

  • Review lung function tests to assess treatment response
  • Monitor heart rate and blood pressure in patients with cardiac conditions
  • Reinforce inhaler technique to maximize benefit and minimize local irritation

For older adults or those with kidney or liver impairment, dosing adjustments are generally unnecessary, but physicians may recommend more frequent clinical check-ins to track tolerance and response.

Patients should not exceed the prescribed number of inhalations or combine Stiolto Respimat with other LABA- or LAMA-containing inhalers, as this increases the risk of side effects without improving effectiveness (NIH MedlinePlus, 2024).

Does Stiolto Respimat have a generic version?

As of 2025, Stiolto Respimat does not have an FDA-approved generic equivalent. It is manufactured by Boehringer Ingelheim Pharmaceuticals and remains available only as the brand-name product. However, international versions may exist in other markets.

While other COPD inhalers may contain similar types of bronchodilators, the specific combination of tiotropium and olodaterol delivered via the Respimat device is unique to Stiolto.

When a generic version eventually becomes available, it must meet the same rigorous FDA standards for safety, purity, and effectiveness as the original brand product. In the meantime, patients concerned about cost can discuss manufacturer savings programs or insurance formulary options with their healthcare provider or pharmacist.

Conclusion

Stiolto Respimat represents an important advancement in COPD management by combining two complementary long-acting bronchodilators into a single, easy-to-use inhaler. For patients struggling with chronic breathlessness, daily use of this medication can lead to more comfortable breathing, fewer flare-ups, and a noticeable improvement in day-to-day energy and confidence.

While side effects are generally mild, regular medical follow-up ensures the treatment remains both safe and effective. Each person’s experience may differ, but consistent use and proper inhaler techniques are key to achieving the best outcomes.

When prescribed and monitored by a qualified healthcare provider, Stiolto Respimat is a safe, effective long-term option for improving airflow and helping people with COPD reclaim control over their breathing and their lives.

References

  1. U.S. Food and Drug Administration (FDA). Stiolto Respimat Prescribing Information. 2015. https://www.fda.gov/
  2. Mayo Clinic. “Tiotropium and Olodaterol (Inhalation Route).” Updated 2024. https://www.mayoclinic.org/
  3. NIH MedlinePlus. “Tiotropium and Olodaterol Oral Inhalation.” Accessed 2024. https://medlineplus.gov/

Brand Information

Stiolto Respimat (tiotropium bromide and olodaterol)
1CONTRAINDICATIONS
Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid is contraindicated in patients with asthma
STIOLTO RESPIMAT is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, olodaterol, or any component of this product
In clinical trials and postmarketing experience with tiotropium, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported. Hypersensitivity reactions were also reported in clinical trials with STIOLTO RESPIMAT.
2ADVERSE REACTIONS
LABA, such as olodaterol, one of the active components in STIOLTO RESPIMAT, as monotherapy (without an inhaled corticosteroid) for asthma, increase the risk of asthma-related events. STIOLTO RESPIMAT is not indicated for the treatment of asthma
The following adverse reactions are described, or described in greater detail, in other sections:
  • Immediate hypersensitivity reactions
  • Paradoxical bronchospasm
  • Worsening of narrow-angle glaucoma
  • Worsening of urinary retention
2.1Clinical Trials Experience in Chronic Obstructive Pulmonary Disease
Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions observed in the clinical trials of a drug cannot be directly compared to the incidences in the clinical trials of another drug and may not reflect the incidences observed in practice.
The clinical program for STIOLTO RESPIMAT included 7,151 subjects with COPD in two 52-week active-controlled trials, one 12-week placebo-controlled trial, three 6-week placebo-controlled cross-over trials, and four additional trials of shorter duration. A total of 1,988 subjects received at least 1 dose of STIOLTO RESPIMAT. Adverse reactions observed in the ≤12-week trials were consistent with those observed in the 52-week trials, which formed the primary safety database.
The primary safety database consisted of pooled data from the two 52-week double-blind, active-controlled, parallel group confirmatory clinical trials (Trials 1 and 2). These trials included 5,162 adult COPD patients (72.9% males and 27.1% females) 40 years of age and older. Of these patients, 1,029 were treated with STIOLTO RESPIMAT once daily. The STIOLTO RESPIMAT group was composed of mostly Caucasians (71.1%) with a mean age of 63.8 years and a mean percent predicted FEV
In these two clinical trials, 74% of patients exposed to STIOLTO RESPIMAT reported an adverse reaction compared to 76.6% and 73.3% in the olodaterol 5 mcg and tiotropium 5 mcg groups, respectively. The proportion of patients who discontinued due to an adverse reaction was 7.4% for STIOLTO RESPIMAT treated patients compared to 9.9% and 9.0% for olodaterol 5 mcg and tiotropium 5 mcg treated patients. The adverse reaction most commonly leading to discontinuation was worsening COPD.
The most common serious adverse reactions were COPD exacerbation and pneumonia.
Table 1 shows all adverse drug reactions that occurred with an incidence of >3% in the STIOLTO RESPIMAT treatment group and a higher incidence rate than the active comparator groups listed.
Other adverse drug reactions in patients receiving STIOLTO RESPIMAT that occurred in ≤3% of patients in clinical studies are listed below:
Metabolism and nutrition disorders: dehydration
Nervous system disorders: dizziness, insomnia
Eye disorders: glaucoma, intraocular pressure increased, vision blurred
Cardiac/vascular disorders: atrial fibrillation, palpitations, supraventricular tachycardia, tachycardia, hypertension
Respiratory, thoracic, and mediastinal disorders: epistaxis, pharyngitis, dysphonia, bronchospasm, laryngitis, sinusitis
Gastrointestinal disorders: dry mouth, constipation, oropharyngeal candidiasis, dysphagia, gastroesophageal reflux disease, gingivitis, glossitis, stomatitis, intestinal obstruction including ileus paralytic
Skin and subcutaneous disorders: rash, pruritus, angioneurotic edema, urticaria, skin infection, and skin ulcer, dry skin, hypersensitivity (including immediate reactions)
Musculoskeletal and connective tissue disorders: arthralgia, joint swelling
Renal and urinary disorders: urinary retention, dysuria, and urinary tract infection
3OVERDOSAGE
STIOLTO RESPIMAT contains both tiotropium bromide and olodaterol; therefore, the risks associated with overdosage for the individual components described below apply to STIOLTO RESPIMAT.
4DESCRIPTION
STIOLTO RESPIMAT is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta
The drug substance tiotropium bromide monohydrate is chemically described as (1α, 2ß, 4ß, 5α, 7ß)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.0
The structural formula is:
Chemical Structure
Tiotropium bromide (monohydrate) has a molecular mass of 490.4 and a molecular formula of C
The drug substance olodaterol hydrochloride is chemically described as 2H-1,4-Benzoxazin-3H(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-methoxyphenyl)-1,1-dimethylethyl]-amino]ethyl]-, monohydrochloride. Olodaterol hydrochloride is a white to off-white powder that is sparingly-slightly soluble in water and slightly soluble in ethanol. The molecular weight is 422.9 g/mole (salt): 386.5 g/mole (base), and the molecular formula is C
The structural formula is:
Chemical Structure
The drug product, STIOLTO RESPIMAT, is composed of a sterile aqueous solution of tiotropium bromide and olodaterol hydrochloride filled into a 4.5 mL plastic container crimped into an aluminum cylinder (STIOLTO RESPIMAT cartridge) for use with the STIOLTO RESPIMAT inhaler.
Excipients include, benzalkonium chloride, edetate disodium, hydrochloric acid, and water for injection.
The STIOLTO RESPIMAT cartridge is only intended for use with the STIOLTO RESPIMAT inhaler. The STIOLTO RESPIMAT inhaler is a hand held, pocket sized oral inhalation device that uses mechanical energy to generate a slow-moving aerosol cloud of medication from a metered volume of the drug solution. The STIOLTO RESPIMAT inhaler has a light green-colored cap.
When used with the STIOLTO RESPIMAT inhaler each cartridge, containing 4 grams of sterile aqueous solution, delivers the labeled number of metered actuations after preparation for use. Each dose (one dose equals two actuations) from the STIOLTO RESPIMAT inhaler delivers 5 mcg tiotropium (equivalent to 6.247 mcg tiotropium bromide monohydrate) and 5 mcg olodaterol (equivalent to 5.473 mcg olodaterol hydrochloride) in 22.1 mcL from the mouthpiece. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds).
5CLINICAL STUDIES
The safety and efficacy of STIOLTO RESPIMAT were evaluated in a clinical development program that included three dose ranging trials, two active-controlled trials, three active- and placebo-controlled trials, and one placebo-controlled trial. The efficacy of STIOLTO RESPIMAT is based primarily on two 4-week dose-ranging trials in 592 COPD patients and two confirmatory active-controlled 52-week trials (Trials 1 and 2) in 5,162 COPD patients.
6HOW SUPPLIED/STORAGE AND HANDLING
STIOLTO RESPIMAT Inhalation Spray is supplied in a labeled carton containing one STIOLTO RESPIMAT cartridge and one STIOLTO RESPIMAT inhaler.
The STIOLTO RESPIMAT cartridge is provided as an aluminum cylinder with a tamper protection seal on the cap. The STIOLTO RESPIMAT cartridge is only intended for use with the STIOLTO RESPIMAT inhaler and should not be interchanged with any other RESPIMAT device delivered product.
The STIOLTO RESPIMAT inhaler is a cylindrical shaped plastic inhalation device with a gray colored body and a clear base. The clear base is removed to insert the cartridge. The inhaler contains a dose indicator. The light green-colored cap and the written information on the label of the gray inhaler body indicate that it is labeled for use with the STIOLTO RESPIMAT cartridge.
STIOLTO RESPIMAT Inhalation Spray is available as:
  • STIOLTO RESPIMAT Inhalation Spray: 60 metered actuations (NDC 0597-0155-61)
  • STIOLTO RESPIMAT Inhalation Spray: 10 metered actuations (NDC 0597-0155-70) (institutional pack)
The STIOLTO RESPIMAT cartridge has a net fill weight of at least 4 grams and when used with the STIOLTO RESPIMAT inhaler, is designed to deliver the labeled number of metered actuations after preparation for use.
When the labeled number of actuations has been dispensed from the inhaler, the RESPIMAT locking mechanism will be engaged and no more actuations can be dispensed.
After assembly, the STIOLTO RESPIMAT inhaler should be discarded at the latest 3 months after first use or when the locking mechanism is engaged, whichever comes first.
Keep out of reach of children. Do not spray into eyes.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
8PRINCIPAL DISPLAY PANEL - 2.5 mcg/2.5 mcg Cartridge Carton
NDC 0597-0155-61
Stiolto
2.5 mcg/2.5 mcg per actuation*
FOR ORAL INHALATION ONLY
ATTENTION PHARMACIST:
Rx only
4 Grams
Boehringer
PRINCIPAL DISPLAY PANEL - 2.5 mcg/2.5 mcg Cartridge Carton