Fixed-dose combination
Olodaterol and Tiotropium is a fixed-dose combination of an anticholinergic and a beta2-adrenergic agonist indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), among other approved uses. MedsAcross supplies Olodaterol and Tiotropium for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
STIOLTO RESPIMAT is a combination of tiotropium bromide, an anticholinergic and olodaterol, a long-acting beta 2 -adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Important limitations: STIOLTO RESPIMAT is NOT indicated to treat acute deterioration of COPD. STIOLTO RESPIMAT is NOT indicated to treat asthma.
Source: US FDA prescribing information
STIOLTO RESPIMAT STIOLTO RESPIMAT contains both tiotropium and olodaterol. The properties described below for the individual components apply to STIOLTO RESPIMAT. These drugs represent 2 different classes of medication (an anticholinergic and a beta-agonist) that have different effects on clinical and physiological indices. Tiotropium Tiotropium is a long-acting, muscarinic antagonist which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors, M 1 to M 5. In the airways, it exhibits pharmacological effects through inhibition of M 3 -receptors at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations.
Source: US FDA prescribing information
For oral inhalation only. Two inhalations of STIOLTO RESPIMAT once-daily at the same time of day. Recommended Dosage The recommended dosage of STIOLTO RESPIMAT is two inhalations once-daily at the same time of the day. Do not use STIOLTO RESPIMAT more than two inhalations every 24 hours.
Source: US FDA prescribing information
Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid is contraindicated in patients with asthma. STIOLTO RESPIMAT is not indicated for the treatment of 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.
Source: US FDA prescribing information
LABA as monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. Do not initiate STIOLTO RESPIMAT in acutely deteriorating COPD patients. Do not use for relief of acute symptoms. Concomitant short-acting beta 2 -agonists can be used as needed for acute relief. Do not exceed the recommended dosage. Excessive use of STIOLTO RESPIMAT, or use in conjunction with other medications containing LABA can result in clinically significant cardiovascular effects and may be fatal. Immediate hypersensitivity reactions: Discontinue STIOLTO RESPIMAT at once and consider alternatives if immediate hypersensitivity reactions, including angioedema, urticaria, rash, bronchospasm, or anaphylaxis, occur. Life-threatening paradoxical bronchospasm can occur. Discontinue STIOLTO RESPIMAT immediately.
Source: US FDA prescribing information
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 The most common adverse reactions (>3% incidence and more than an active control) were nasopharyngitis, cough, and back pain.
Source: US FDA prescribing information
Other adrenergic drugs may potentiate effect. Use with caution. Xanthine derivatives, steroids, diuretics, or non-potassium sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution. MAO inhibitors, tricyclic antidepressants, and drugs that prolong QTc interval may potentiate effect on cardiovascular system. Use with extreme caution. Beta-blockers may decrease effectiveness. Use with caution and only when medically necessary. Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of STIOLTO RESPIMAT with other anticholinergic-containing drugs.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Avoid freezing.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Olodaterol and Tiotropium, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Stiolto Respimat 2.736 mcg/3.124 mcg sprayInhalation | Olodaterol and Tiotropium | Boehringer Ingelheim Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 21 May 2015 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Olodaterol and Tiotropium and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Olodaterol and Tiotropium, including Stiolto Respimat.
Yes. The US FDA first approved Olodaterol and Tiotropium on 21 May 2015, according to Drugs@FDA.
No listed presentation of Olodaterol and Tiotropium is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.