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aclidinium (Rx)Brand and Other Names:Tudorza Pressair

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

metered-dose inhaler (dry powder)

  • 400mcg/actuation
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COPD

Breath-activated dry powder inhaler indicated for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema

400 mcg (1 actuation) inhaled PO BID

Renal & Hepatic Impairment

Renal impairment: No dosage adjustment required

Hepatic impairment: Not studied

Safety and efficacy not established

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Interactions

Interaction Checker

aclidinium and

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%)

            <1%

            Diabetes mellitus

            Dry mouth

            1st degree AV block

            Osteoarthritis

            Cardiac failure

            Cardiorespiratory arrest

            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 Category: C

            Lactation: Distributed in human breast milk is probable

            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

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            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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