Aclidinium is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). It is available as inhalation powder. MedsAcross supplies Aclidinium 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.
TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). TUDORZA PRESSAIR is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Source: US FDA prescribing information
Aclidinium bromide is a long-acting antimuscarinic agent, 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 receptor 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. In preclinical in vitro as well as in vivo studies, prevention of acetylcholine-induced bronchoconstriction effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown. The bronchodilation following inhalation of aclidinium bromide is predominantly a site-specific effect.
Source: US FDA prescribing information
The recommended dose of TUDORZA PRESSAIR is one oral inhalation of 400 mcg, twice daily (morning and evening approximately 12 hours apart). For oral inhalation only • One inhalation of TUDORZA PRESSAIR 400 mcg twice daily.
Source: US FDA prescribing information
The use of TUDORZA PRESSAIR is contraindicated in the following conditions: • Severe hypersensitivity to milk proteins • Hypersensitivity to aclidinium bromide or any of the excipients • Severe hypersensitivity to milk proteins. • Hypersensitivity to any ingredient.
Source: US FDA prescribing information
• Not for acute use: Not for use as a rescue medication. • Paradoxical bronchospasm: Discontinue TUDORZA PRESSAIR and consider other treatments if paradoxical bronchospasm occurs. • Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to consult a physician immediately if this occurs. • Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to consult a physician immediately if this occurs. • Immediate hypersensitivity reactions: Discontinue TUDORZA PRESSAIR at once and consider alternatives if immediate hypersensitivity reactions, including angioedema, bronchospasm, or anaphylaxis occur.
Source: US FDA prescribing information
The following adverse reactions are described in greater detail in other sections: • Paradoxical bronchospasm • Worsening of narrow-angle glaucoma • Worsening of urinary retention • Immediate hypersensitivity reactions Most common adverse reactions (≥3% incidence and greater than placebo) are headache, nasopharyngitis and cough.
Source: US FDA prescribing information
In vitro studies suggest limited potential for CYP450-related metabolic drug interactions, thus no formal drug interaction studies have been performed with TUDORZA PRESSAIR. Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administrations of TUDORZA PRESSAIR with other anticholinergic-containing drugs.
Source: US FDA prescribing information
Store TUDORZA PRESSAIR in a dry place at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). Do not store the inhaler on a vibrating surface. The PRESSAIR inhaler should be stored inside the sealed bag and only be opened immediately before use.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Aclidinium, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Tudorza Pressair 400 mcg inhalation powderInhalation | Covis Pharma | 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.
Yes, on request. MedsAcross lists 1 presentations of Aclidinium and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Aclidinium, including Tudorza Pressair.
Yes. The US FDA first approved Aclidinium on 23 July 2012, according to Drugs@FDA.
Yes. Aclidinium has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Aclidinium is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Aclidinium is classified under ATC code R03BB (Anticholinergic).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.