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Aclidinium

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 milk protein]

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

5-8 hours (following inhalation)

Use: Labeled Indications

Chronic obstructive pulmonary disease: Long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) including bronchitis and emphysema

Contraindications

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

Dosing: Adult

COPD, maintenance treatment: Inhalation, oral: 400 mcg (one inhalation) twice daily

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment necessary.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the US labeling (has not been studied); however, aclidinium is not hepatically eliminated. The Canadian labeling indicates that no dosage adjustment is necessary.

Administration

Administer via oral inhalation. 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 (while keeping the green button straight up and avoiding tilting the inhaler). After this step, ensure that the inhaler is ready for use by the colored control window which should have changed from red to green. The green control window indicates the inhaler is 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, exhale fully (do not exhale into the inhaler), then close lips tightly around the inhaler mouthpiece and inhale (rapidly, steadily, and deeply); do not hold the green button down while inhaling. Keep breathing in until a “click” is heard to ensure that the full dose has been given. Hold breath as long as possible, then breathe out slowly through nose. Ensure the dose was delivered correctly by observing the control window which should have changed from green to red. If the control window is still green, repeat inhalation steps. When control window has been verified as red, replace the protective cap for next use.

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

AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy

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

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

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

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. Avoid combination

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

OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. 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

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

RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to 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% (Limited to important or life-threatening): Cardiac failure, cardiopulmonary arrest, dizziness, dysuria, first degree atrioventricular block, hypersensitivity reaction, nausea, palpitations, skin rash, tachycardia, urinary retention

Warnings/Precautions

Concerns related to adverse effects:

• Bronchospasm: Rarely, paradoxical bronchospasm may occur with use of inhaled bronchodilating agents; discontinue use and consider other therapy if bronchospasm occurs.

• Hypersensitivity reactions: Immediate hypersensitivity reactions (eg, anaphylaxis, urticaria, angioedema, rash, bronchospasm, itching) may occur; discontinue immediately if signs/symptoms of a hypersensitivity reaction occur. Use with caution in patients with a history of hypersensitivity to atropine; aclidinium has a similar structure to atropine.

Disease-related concerns:

• Cardiovascular disease: Use with caution; patients with unstable cardiac disease were excluded from clinical trials. Cardiac effects (eg, cardiac failure, 1st degree AV block, cardiopulmonary arrest) were observed at an incidence of <1% in clinical trials.

• Glaucoma: Use with caution in patients with narrow angle glaucoma; may worsen symptoms. Monitor for signs/symptoms (eg, eye pain/discomfort, blurred vision, visual halos or colored images associated with red eyes from conjunctival congestion and corneal edema).

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; may worsen symptoms.

• Prostatic hyperplasia/bladder neck obstruction: Use with caution in patients with prostatic hyperplasia and/or bladder neck obstruction (eg, dysuria, difficulty in passing urine); may worsen symptoms.

Dosage form specific issues:

• Lactose: Powder for oral inhalation contains 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 (or other pulmonary function studies)

Pregnancy Risk Factor

C

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, pharyngitis, or rhinitis. Have patient report immediately to prescriber vision changes, blurred vision, eye pain, severe eye irritation, visual halos or bright colors around lights, urinary retention, painful urination, polyuria, 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.

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