Aclidinium

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 .

• 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).ICD-10: J44.9

• The use of TUDORZA PRESSAIR is contraindicated in the following conditions: • Severe hypersensitivity to milk proteins [see Warnings and Precautions (5.5) ] • Hypersensitivity to aclidinium bromide or any of the excipients [see Warnings and Precautions (5.5) ] • Severe hypersensitivity to milk proteins. (4) • Hypersensitivity to any ingredient.contraindicated

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. (2)

• Not for acute use: Not for use as a rescue medication. (5.1) • Paradoxical bronchospasm: Discontinue TUDORZA PRESSAIR and consider other treatments if paradoxical bronchospasm occurs. (5.2) • 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. (5.3) • 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. (5.4) • Immediate hypersensitivity reactions: Discontinue TUDORZA PRESSAIR at once and consider alternatives if immediate hypersensitivity reactions, including angioedema, bronchospasm, or anaphylaxis occur. (5.5) 5.1 Not for Acute Use TUDORZA PRESSAIR is intended as a twice-daily maintenance treatment for COPD and is not indicated for the initial treatment of acute episodes of bronchospasm (i.e., rescue therapy). 5.2 Paradoxical Bronchospasm Inhaled medicines, including TUDORZA PRESSAIR, may cause paradoxical bronchospasm. If this occurs, treatment with TUDORZA PRESSAIR should be stopped and other treatments considered. 5.3 Worsening of Narrow-Angle Glaucoma TUDORZA PRESSAIR should be used with caution in patients with narrow-angle glaucoma. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos, or colored images in association with red eyes from conjunctival congestion and corneal edema).

The following adverse reactions are described in greater detail in other sections: • Paradoxical bronchospasm [see Warnings and Precautions (5.2) ] • Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.3) ] • Worsening of urinary retention [see Warnings and Precautions (5.4) ] • Immediate hypersensitivity reactions [see Warnings and Precautions (5.5) ] Most common adverse reactions (≥3% incidence and greater than placebo) are headache, nasopharyngitis and cough. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma at 1-877-411-2510 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 3-Month and 6-Month Trials TUDORZA PRESSAIR was studied in two 3-month (Trials B and C) and one 6-month (Trial D) placebo-controlled trials in patients with COPD. In these trials, 636 patients were treated with TUDORZA PRESSAIR at the recommended dose of 400 mcg twice daily. The population had a mean age of 64 years (ranging from 40 to 89 years), with 58% males, 94% Caucasian, and had COPD with a mean pre-bronchodilator forced expiratory volume in one second (FEV 1 ) percent predicted of 48%. Patients with unstable cardiac disease, narrow-angle glaucoma, or symptomatic prostatic hypertrophy or bladder outlet obstruction were excluded from these trials.

8.1 Pregnancy Risk Summary There are no adequate and well controlled studies of TUDORZA PRESSAIR in pregnant women to inform drug associated risks. No adverse developmental effects were seen with inhalation administration of aclidinium bromide to pregnant rats and rabbits during organogenesis at 15 or 20 times, respectively, the maximum recommended human daily inhaled dose (MRHDID). However, reduced pup weights were seen when pregnant rats continued inhalation administration through lactation at 5 times the MRHDID of aclidinium bromide. Adverse developmental effects occurred when rabbits were orally dosed with aclidinium bromide at approximately 1,400 times the MRHDID [ see Data ]. The estimated background risk of major birth defects and miscarriage of the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 6-17, no evidence of structural alterations was observed at approximately 15 times the MRHDID [based on summed AUCs of aclidinium bromide and its metabolites at inhaled doses less than or equal to 5.0 mg/kg/day].

Metabolism

Absorption The absolute bioavailability of aclidinium bromide is approximately 6% in healthy volunteers. Following twice-daily oral inhalation administration of 400 mcg aclidinium bromide in healthy subjects, peak steady state plasma levels were observed within 10 minutes after inhalation.

10.1 Human Experience No case of overdose has been reported in clinical studies with TUDORZA PRESSAIR. There were no systemic anticholinergic or other adverse effects following a single inhaled dose of up to 6,000 mcg aclidinium bromide (7.5 times the RHDD) in 16 healthy volunteers.

• Jul 23, 2012NDANDA202450Azurity
• Mar 29, 2019NDANDA210595Azurity

1. 1Dyspnoea1,87529%
2. 2Device Malfunction1,28120%
3. 3Drug Dose Omission1,01716%
4. 4Asthma81613%
5. 5Chronic Obstructive Pulmonary Disease77912%
6. 6Intentional Product Misuse74112%
7. 7Off Label Use71611%
8. 8Pneumonia69911%
9. 9Wheezing65910%
10. 10Cough65610%
11. 11Product Quality Issue5929.3%
12. 12Device Issue4797.5%
13. 13Obstructive Airways Disorder4527.1%
14. 14Drug Ineffective4056.4%
15. 15Malaise3906.1%

The 10 most recently updated of 47 ClinicalTrials.gov registrations naming Aclidinium as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Salbutamol vs Long-acting Muscarinic Antagonists
  Completed · Observational · 124,117 enrolled · Brigham and Women's Hospital
  NCT05457868updated 2025-07-28
• Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients
  Completed · Phase 3 · Interventional · 1,625 enrolled · AstraZeneca
  NCT03022097updated 2025-03-26
• A Phase I, Open-Label, Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide in Healthy Chinese Participants
  Completed · Phase 1 · Interventional · 20 enrolled · AstraZeneca
  NCT03276052updated 2023-12-11
• Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints
  Completed · Observational · 26,839 enrolled · AstraZeneca
  NCT03290287updated 2023-01-31
• Inhaled Long-acting Bronchodilators With or Without Inhaled Glucocorticosteroids for Preventing Hospitalizations and Death in Elderly Patients With Chronic Obstructive Pulmonary Disease
  Terminated · Phase 4 · Interventional · 843 enrolled · Università degli Studi di Ferrara
  NCT03662711updated 2022-12-28
• A Study in Taiwan Based on Medical Records That Looks at the Occurrence of Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Started LABA/LAMA or LAMA Treatment
  Completed · Observational · 1,617 enrolled · Boehringer Ingelheim
  NCT04011475updated 2022-06-14
• Microbiome Use to Stratify Use of Inhaled Corticosteroids: MUSIC Trial
  Completed · Phase 4 · Interventional · 158 enrolled · University of Dundee
  NCT02972476updated 2020-07-20
• The Effect of Twice Daily vs. Once Daily Bronchodilation on Hyperinflation in COPD Patients During 24 Hours.
  Unknown · Phase 4 · Interventional · 49 enrolled · Maastricht University Medical Center
  NCT03275116updated 2020-03-10
• Pharmacokinetics, Safety and Tolerability of Twice-Daily Aclidinium Bromide/Formoterol Fumarate Fixed Dose Combination in Chinese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
  Completed · Phase 2 · Interventional · 20 enrolled · AstraZeneca
  NCT03276078updated 2019-07-22
• Effect of Aclidinium/Formoterol on Nighttime Lung Function and Morning Symptoms in Chronic Obstructive Pulmonary Disease
  Completed · Phase 4 · Interventional · 40 enrolled · Queen's University
  NCT02429765updated 2019-07-12

Frequently asked questions

How does Aclidinium work?

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 .

What is Aclidinium used for?

According to FDA labeling, Aclidinium carries indications including: 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).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Aclidinium?

Aclidinium is classified as Anticholinergic, Cholinergic Antagonists, Cholinergic Muscarinic Antagonists, Bronchodilation.

What are the brand names for Aclidinium?

Aclidinium is marketed under brand names including Duaklir, Tudorza.

What are the contraindications for Aclidinium?

Aclidinium labeling lists contraindications including: The use of TUDORZA PRESSAIR is contraindicated in the following conditions: • Severe hypersensitivity to milk proteins [see Warnings and Precautions (5.5) ] • Hypersensitivity to aclidinium bromide or any of the excipients [see Warnings and Precautions (5.5) ] • Severe hypersensitivity to milk proteins. (4) • Hypersensitivity to any ingredient.. Always consult the full prescribing information and a clinician.