Version October 2024
Chronic obstructive pulmonary disease, maintenance:
Note: Depending on symptoms and exacerbation risk, may use monotherapy long-acting bronchodilator (long-acting beta agonist or long-acting muscarinic antagonist). In patients with more symptoms (eg, Group B), use in combination with long-acting beta agonist. In addition, a short-acting bronchodilator is used for intermittent symptom relief (Ref).
Dry powder inhaler (400 mcg/actuation): Oral inhalation: 1 inhalation twice daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
No dosage adjustment necessary.
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.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
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
Hypersensitivity to aclidinium or any component of the formulation; severe hypersensitivity to milk proteins
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.
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.
Tudorza Pressair inhaler contains 60 actuations.
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]
No
Aerosol powder (Tudorza Pressair Inhalation)
400 mcg/ACT (per each): $324.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Aerosol Powder Breath Activated, Inhalation, as bromide:
Tudorza Genuair: 400 mcg/actuation (1 ea) [contains milk protein]
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.
Chronic obstructive pulmonary disease, maintenance: Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Aclidinium may be confused with clidinium
Tudorza may be confused with Jolessa, Lodosyn, Taclonex, Tekturna HCT, Tekturna, Tikosyn, Tobrex, Toradol, Truvada, Tubersol, Zaditor
Pressair may be confused with Provera, Precose, Primacor
Substrate of CYP2D6 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Agents with Clinically Relevant Anticholinergic Effects: Aclidinium may enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid combination
Inhaled Anticholinergic Agents: May enhance the anticholinergic effect of other Inhaled Anticholinergic Agents. Risk C: Monitor therapy
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. Risk X: Avoid combination
Methacholine: Long-acting muscarinic antagonists (LAMAs) may diminish the therapeutic effect of Methacholine. Management: Hold long-acting muscarinic antagonists (LAMAs) for at least 7 days before methacholine use. Risk D: Consider therapy modification
Adverse events have been observed in animal reproduction studies.
It is not known if aclidinium is present in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
FEV1, peak flow, and/or other pulmonary function tests; signs/symptoms of glaucoma; hypersensitivity reactions; urinary retention
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
Bioavailability: ~6% (following inhalation)
Half-life elimination: 5 to 8 hours (following inhalation)
Time to peak, plasma: Within 10 minutes (steady state, following inhalation)
Excretion: Urine (<1% each of an inhaled dose)
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