Description

Simple

An inhaled medication that opens the airways and is used to treat a type of lung disease called chronic obstructive pulmonary disease (COPD).

Clinical

An inhaled long-acting anticholinergic used as a maintenance bronchodilator in patients with chronic obstructive pulmonary disease (COPD).

Overview

Aclidinium is an anticholinergic for the long-term management of chronic obstructive pulmonary disease (COPD). It has a much higher propensity to bind to muscarinic receptors than nicotinic receptors. FDA approved on July 24, 2012.

Pharmacology

Indication

Aclidinium bromide inhalation powder is indicated for the long-term, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Pharmacodynamic

Aclidinium does not prolong the QTc interval or have significant effects on cardiac rhythm.

Mechanism of action

Aclidinium is a long-acting, competitive, and reversible anticholinergic drug that is specific for the acetylcholine muscarinic receptors. It binds to all 5 muscarinic receptor subtypes to a similar affinity. Aclidinium's effects on the airways are mediated through the M3 receptor at the smooth musc... Read more

Absorption

Bioavailability, healthy subjects = 6%;
T max, healthy subjects = 10 minutes;
Time to steady state, healthy subjects = 2 days;

Protein binding

Information currently not available.

Volume of distribution

Following IV administration, the volume of distribution is 300 L

Clearance

Total clearance, IV dose, young healthy subjects = 170 L/h (inter-individual variability of 36%)

Half life

Plasma half-life = 2.4 minutes (indicating that aclidinium is very rapidly hydrolyzed in plasma into its two inactive metabolites and has a low chance of causing systemic side effects).
Effective half-life = 5-8 hours.

Route of elimination

Intravenously administered radiolabelled aclidinium bromide was administered to healthy volunteers and was extensively metabolized with 1% excreted as unchanged aclidinium. Approximately 54% to 65% of the radioactivity was excreted in urine and 20% to 33% of the dose was excreted in feces. The combi... Read more

Toxicity

Most common adverse reactions (≥3% incidence and greater than placebo) are headache, nasopharyngitis and cough.

Adverse Effects

Effect Regions Age Groups Incidences Evidence Type
Headache US
  • Kind: experimental
    • Percent: 6.6%
  • Kind: placebo
    • Percent: 5%
  • Clinical Trial
    Nasopharyngitis US
  • Kind: experimental
    • Percent: 5.5%
  • Kind: placebo
    • Percent: 3.9%
  • Clinical Trial
    Cough US
  • Kind: experimental
    • Percent: 3%
  • Kind: placebo
    • Percent: 2.2%
  • Clinical Trial
    Diarrhea US
  • Kind: experimental
    • Percent: 2.7%
  • Kind: placebo
    • Percent: 1.4%
  • Clinical Trial
    Sinusitis US
  • Kind: experimental
    • Percent: 1.7%
  • Kind: placebo
    • Percent: 0.8%
  • Clinical Trial
    Rhinitis US
  • Kind: experimental
    • Percent: 1.6%
  • Kind: placebo
    • Percent: 1.2%
  • Clinical Trial
    Vomiting US
  • Kind: experimental
    • Percent: 1.1%
  • Kind: placebo
    • Percent: 0.5%
  • Clinical Trial
    Fall US
  • Kind: experimental
    • Percent: 1.1%
  • Kind: placebo
    • Percent: 0.5%
  • Clinical Trial
    Toothache US
  • Kind: experimental
    • Percent: 1.1%
  • Kind: placebo
    • Percent: 0.8%
  • Clinical Trial
    Cardiorespiratory Arrest US
  • Kind: experimental
    • Percent: <1%
  • Clinical Trial
    Osteoarthritis US
  • Kind: experimental
    • Percent: <1%
  • Clinical Trial
    Cardiac Failure US
  • Kind: experimental
    • Percent: <1%
  • Clinical Trial
    First Degree Atrioventricular Block US
  • Kind: experimental
    • Percent: <1%
  • Clinical Trial
    Dry Mouth US
  • Kind: experimental
    • Percent: <1%
  • Clinical Trial
    Diabetes Mellitus US
  • Kind: experimental
    • Percent: <1%
  • Clinical Trial
    Urinary Retention US
    Post Marketing
    Blurred vision US
    Post Marketing
    Stomatitis US
    Post Marketing
    Tachycardia US
    Post Marketing
    Bronchospasm US
    Post Marketing
    Itching US
    Post Marketing
    Nausea US
    Post Marketing
    Dysphonia US
    Post Marketing
    Anaphylaxis US
    Post Marketing
    Angioedema US
    Post Marketing
    Urticaria US
    Post Marketing
    Rash US
    Post Marketing
    Narrow-angle glaucoma US
    Varying Reports
    Paradoxical bronchospasm US
    Unclassified
    Bladder-neck obstruction US
    Varying Reports
    Prostatic Hyperplasia US
    Varying Reports
    Angioedema US
    Varying Reports
    Anaphylaxis US
    Varying Reports
    Rash US
    Varying Reports
    Urticaria US
    Varying Reports
    Itching US
    Varying Reports
    Bronchospasm US
    Varying Reports

    Contraindications

    • Route:
      • Respiratory (inhalation)
    • Dose Form:
      • Powder
    • Hypersensitivity:
      • true
      • Milk proteins
    • Regions: US
    • Route:
      • Respiratory (inhalation)
    • Dose Form:
      • Powder
    • Hypersensitivity:
      • true
    • Regions: US

    Food Interactions

    Information currently not available.