aclidinium (Rx)

Brand and Other Names:Tudorza Pressair
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

metered-dose inhaler (dry powder)

  • 400mcg/actuation

Chronic Obstructive Pulmonary Disease

Breath-activated dry powder inhaler indicated for maintenance treatment of chronic obstructive pulmonary disease (COPD)

400 mcg (1 actuation) inhaled PO BID

Dosage Modifications

Renal impairment: No dosage adjustment required

Hepatic impairment: Not studied

Safety and efficacy not established

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Interactions

Interaction Checker

and aclidinium

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Headache (6.6%)

            Nasopharyngitis (5.5%)

            Cough (3%)

            Diarrhea (2.7%)

            Sinusitis (1.7%)

            Rhinitis (1.6%)

            Toothache (1.1%)

            Fall (1.1%)

            Vomiting (1.1%)

            Postmarketing reports

            Anaphylaxis

            Angioedema (including swelling of lips and tongue or throat)

            Urticaria

            Rash

            Bronchospasm

            Itching

            Nausea

            Dysphonia

            Blurred vision

            Urinary retention

            Tachycardia

            Stomatitis

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            Warnings

            Contraindications

            Hypersensitivity to drug or formulation components or severe hypersensitivity to milk proteins

            Cautions

            Not for acute episodes of bronchospasm (ie, not for rescue therapy)

            May cause paradoxical bronchospasm; if this occurs, discontinue and consider other treatments

            Worsening of narrow-angle glaucoma may occur; use with caution in patients with narrow-angle glaucoma; instruct patients to consult a physician immediately if it occurs

            Worsening of urinary retention may occur (eg, prostatic hyperplasia, bladder-neck obstruction); use with caution in patients with prostatic hyperplasia or bladder-neck obstruction; instruct patients to consult a physician immediately if it occurs

            Immediate hypersensitivity reactions, including angioedema, bronchospasm, or anaphylaxis, may occur after administration; if hypersensitivity occurs, discontinue immediately and consider alternate treatment

            Coadministration with other anticholinergics may increase risk for adverse effects

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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled studies of aclidinium in pregnant women to assess drug-associated risks

            Animal studies

            • 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)

            Lactation

            There are no available data on the breastfed child or on milk production or presence in human milk

            Aclidinium bromide is present in rat milk; when a drug is present in animal milk, it is likely that the drug will be present in human milk

            Animal studies

            • Aclidinium bromide reduced pup weights when pregnant rats continued inhalation administration through lactation at 5 times the MRHDID

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Long-acting muscarinic antagonist (LAMA), often referred to as an anticholinergic; selective muscarinic antagonist with affinity for the M3 (subscript) receptor in the airways; produces bronchodilation by inhibiting acetylcholine’s effect on muscarinic receptors in the airway smooth muscle

            Absorption

            ~55% of administered dose is swallowed, but negligible oral absorption is observed; fraction of inhaled dose that reaches systemic circulation is low (<5%)

            Peak Plasma Time: 10-15 minutes (in COPD)

            Peak Plasma Concentration: 80 pg/mL (in COPD)

            Distribution

            Whole lung deposition: 30% of the metered dose

            Vd: 300 L (IV administration)

            Metabolism

            Aclidinium bromide is rapidly hydrolyzed in plasma into its alcohol (LAS34823) and acid (LAS34850) metabolites by both enzymatic and non-enzymatic cleavage; neither of these metabolites are active

            Elimination

            Half-life: 5-8 hr following repeat BID administration

            Renal clearance: Low

            Total clearance: 170 L/hr (IV administration)

            Excretion: Urine 0.1% (as aclidinium bromide), 65% (as metabolites); feces 33% (as metabolites)

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.