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Aclidinium

Medically reviewed by Drugs.com. Last updated on Jul 26, 2019.

Pronunciation

(a kli DIN ee um)

Index Terms

  • 14115700
  • Aclidinium Bromide
  • LAS-34273
  • LAS-34273 Micronized
  • LAS-W-330

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Powder Breath Activated, Inhalation, as bromide:

Tudorza Pressair: 400 mcg/actuation (1 ea) [contains lactose monohydrate]

Brand Names: U.S.

  • Tudorza Pressair

Pharmacologic Category

  • Anticholinergic Agent
  • Anticholinergic Agent, Long-Acting

Pharmacology

Competitively and reversibly inhibits the action of acetylcholine at type 3 muscarinic (M3) receptors in bronchial smooth muscle causing bronchodilation

Distribution

Vd: ~300 L (following IV administration)

Metabolism

Rapid and extensive hydrolysis via plasma esterases to inactive alcohol and acid metabolites

Excretion

Urine (<1% each of an inhaled dose)

Time to Peak

Plasma: Within 10 minutes (steady state, following inhalation)

Half-Life Elimination

5 to 8 hours (following inhalation)

Use: Labeled Indications

Chronic obstructive pulmonary disease: Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Contraindications

Hypersensitivity to aclidinium or any component of the formulation; severe hypersensitivity to milk proteins

Dosing: Adult

COPD: Oral inhalation: Dry powder inhaler: 400 mcg (one inhalation) twice daily

Dosing: Geriatric

Refer to adult dosing.

Administration

Oral inhalation: Dry powder inhaler: Administer via oral inhalation in the morning and evening ~12 hours apart; inhaler device is breath actuated. Remove inhaler from sealed pouch immediately prior to first use. Prior to each use, remove protective cap from the inhaler and prepare inhaler by pressing and releasing the green button to lead the dose; make sure the control window has changed from red to green (indicates inhaler ready for use). If the control window is red, retry activating the inhaler again by pressing and releasing the green button. Prior to inhaling the dose, breathe out completely before forming a tight seal with lips around mouthpiece and breathe in; there will be a “clicking” sound to ensure that the full dose has been given, although some patients may not hear the “click.” Use the control window, which should turn red after inhalation, to make sure the dose was inhaled correctly. If the control window is still green, repeat inhalation steps.

Storage

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Product should be stored inside sealed pouch and only removed immediately before use. Discard product 45 days after opening pouch, when device locks out, or when dose indicator displays “0”, whichever comes first.

Drug Interactions

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy

Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Anticholinergic Agents: Aclidinium may enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Monitor therapy

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination

Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Monitor therapy

Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy

Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Avoid combination

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Consider therapy modification

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Adverse Reactions

1% to 10%:

Central nervous system: Headache (7%), falling (1%)

Gastrointestinal: Diarrhea (3%), toothache (1%), vomiting (1%)

Respiratory: Nasopharyngitis (6%), cough (3%), rhinitis (2%), sinusitis (2%)

<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, blurred vision, bronchospasm, cardiac failure, diabetes mellitus, first-degree atrioventricular block, nausea, osteoarthritis, pruritus, skin rash, stomatitis, tachycardia, type 1 hypersensitivity reaction, urinary retention, urticaria, voice disorder, xerostomia

Warnings/Precautions

Concerns related to adverse effects:

• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled agents; this should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue use and institute alternative therapy.

• Hypersensitivity reactions: Immediate hypersensitivity reactions, including anaphylaxis, angioedema, pruritus, rash, and urticaria, may occur; discontinue immediately if signs/symptoms of a hypersensitivity reaction occur.

Disease-related concerns:

• Glaucoma: Use with caution in patients with narrow angle glaucoma; may increase intraocular pressure.

• Urinary retention: Use with caution in patients with urinary retention. Monitor for signs and symptoms of urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Lactose: Powder for oral inhalation may contain lactose; use is contraindicated in patients with severe milk protein allergy.

Other warnings/precautions:

• Appropriate use: Not indicated for the initial (rescue) treatment of acute episodes of bronchospasm.

Monitoring Parameters

FEV1, peak flow, and/or other pulmonary function tests; signs/symptoms of glaucoma; hypersensitivity reactions; urinary retention

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, sore throat, or stuffy nose. Have patient report immediately to prescriber vision changes, blurred vision, eye pain, severe eye irritation, seeing halos or bright colors around lights, unable to pass urine, painful urination, passing a lot of urine, or signs of breathing problems (shortness of breath, wheezing, coughing, or breathing gets worse) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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