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

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            Contraindicated (1)

            • umeclidinium bromide/vilanterol inhaled

              aclidinium, umeclidinium bromide/vilanterol inhaled. Either increases toxicity of the other by pharmacodynamic synergism. Contraindicated. Duplicate therapy.

            Serious - Use Alternative (4)

            • glucagon

              glucagon increases toxicity of aclidinium by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of anticholinergic drugs and glucagon increase the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. .

            • glucagon intranasal

              glucagon intranasal increases toxicity of aclidinium by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of anticholinergic drugs and glucagon increase the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. .

            • pramlintide

              pramlintide, aclidinium. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Synergistic inhibition of GI motility.

            • revefenacin

              revefenacin and aclidinium both decrease cholinergic effects/transmission. Avoid or Use Alternate Drug. Coadministration may cause additive anticholinergic effects.

            Monitor Closely (97)

            • abobotulinumtoxinA

              abobotulinumtoxinA increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .

            • amantadine

              aclidinium, amantadine. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Potential for increased anticholinergic adverse effects.

            • amitriptyline

              aclidinium and amitriptyline both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • amoxapine

              aclidinium and amoxapine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • anticholinergic/sedative combos

              anticholinergic/sedative combos and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • aripiprazole

              aclidinium decreases levels of aripiprazole by pharmacodynamic antagonism. Use Caution/Monitor.

              aripiprazole increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • atracurium

              atracurium and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • atropine

              atropine and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • atropine IV/IM

              atropine IV/IM and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • belladonna alkaloids

              belladonna alkaloids and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • belladonna and opium

              belladonna and opium and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • benperidol

              aclidinium decreases levels of benperidol by pharmacodynamic antagonism. Use Caution/Monitor.

              benperidol increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • benztropine

              benztropine and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • bethanechol

              bethanechol increases and aclidinium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • carbachol

              carbachol increases and aclidinium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • cevimeline

              cevimeline increases and aclidinium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • chlorpromazine

              aclidinium decreases levels of chlorpromazine by pharmacodynamic antagonism. Use Caution/Monitor.

              chlorpromazine increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • cisatracurium

              cisatracurium and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • clomipramine

              aclidinium and clomipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • clozapine

              aclidinium decreases levels of clozapine by pharmacodynamic antagonism. Use Caution/Monitor.

              clozapine increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • cyclizine

              cyclizine and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • cyclobenzaprine

              cyclobenzaprine and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • darifenacin

              darifenacin and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • desipramine

              aclidinium and desipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • dicyclomine

              dicyclomine and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • diphenhydramine

              diphenhydramine and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • donepezil

              donepezil increases and aclidinium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • dosulepin

              aclidinium and dosulepin both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • doxepin

              aclidinium and doxepin both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • droperidol

              aclidinium decreases levels of droperidol by pharmacodynamic antagonism. Use Caution/Monitor.

              droperidol increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • echothiophate iodide

              echothiophate iodide increases and aclidinium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • fesoterodine

              fesoterodine and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • flavoxate

              flavoxate and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • fluphenazine

              aclidinium decreases levels of fluphenazine by pharmacodynamic antagonism. Use Caution/Monitor.

              fluphenazine increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • galantamine

              galantamine increases and aclidinium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • glycopyrrolate

              glycopyrrolate and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • glycopyrrolate inhaled

              glycopyrrolate inhaled and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • glycopyrronium tosylate topical

              glycopyrronium tosylate topical, aclidinium. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.

            • haloperidol

              aclidinium decreases levels of haloperidol by pharmacodynamic antagonism. Use Caution/Monitor.

              haloperidol increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • henbane

              henbane and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • homatropine

              homatropine and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • huperzine A

              huperzine A increases and aclidinium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • hyoscyamine

              hyoscyamine and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • hyoscyamine spray

              hyoscyamine spray and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • iloperidone

              aclidinium decreases levels of iloperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              iloperidone increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • imipramine

              aclidinium and imipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • ipratropium

              ipratropium and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • levodopa

              aclidinium, levodopa. Other (see comment). Use Caution/Monitor. Comment: Anticholinergic agents may enhance the therapeutic effects of levodopa; however, anticholinergic agents can exacerbate tardive dyskinesia. In high dosage, anticholinergics may decrease the effects of levodopa by delaying its GI absorption. .

            • lofepramine

              aclidinium and lofepramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • loxapine

              aclidinium decreases levels of loxapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              aclidinium decreases levels of loxapine by pharmacodynamic antagonism. Use Caution/Monitor.

              loxapine increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • loxapine inhaled

              loxapine inhaled increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              aclidinium decreases levels of loxapine inhaled by pharmacodynamic antagonism. Use Caution/Monitor.

            • maprotiline

              aclidinium and maprotiline both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • meclizine

              meclizine and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • methscopolamine

              methscopolamine and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • neostigmine

              neostigmine increases and aclidinium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • nortriptyline

              aclidinium and nortriptyline both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • olanzapine

              aclidinium decreases levels of olanzapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              aclidinium decreases levels of olanzapine by pharmacodynamic antagonism. Use Caution/Monitor.

              olanzapine increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • oliceridine

              aclidinium increases toxicity of oliceridine by Other (see comment). Use Caution/Monitor. Comment: Anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Monitor for signs of urinary retention or reduced gastric motility if oliceridine is coadministered with anticholinergics.

            • onabotulinumtoxinA

              onabotulinumtoxinA and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • orphenadrine

              aclidinium and orphenadrine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • oxybutynin

              oxybutynin and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • oxybutynin topical

              oxybutynin topical and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • oxybutynin transdermal

              oxybutynin transdermal and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • paliperidone

              aclidinium decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • pancuronium

              pancuronium and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • perphenazine

              aclidinium decreases levels of perphenazine by pharmacodynamic antagonism. Use Caution/Monitor.

              perphenazine increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • physostigmine

              physostigmine increases and aclidinium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • pilocarpine

              pilocarpine increases and aclidinium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • pilocarpine ophthalmic

              pilocarpine ophthalmic increases and aclidinium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • pimozide

              aclidinium decreases levels of pimozide by pharmacodynamic antagonism. Use Caution/Monitor.

              pimozide increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • pralidoxime

              pralidoxime and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • prochlorperazine

              aclidinium decreases levels of prochlorperazine by pharmacodynamic antagonism. Use Caution/Monitor.

              prochlorperazine increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • promethazine

              aclidinium decreases levels of promethazine by pharmacodynamic antagonism. Use Caution/Monitor.

              promethazine increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • propantheline

              propantheline and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • protriptyline

              aclidinium and protriptyline both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • pyridostigmine

              pyridostigmine increases and aclidinium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • quetiapine

              aclidinium decreases levels of quetiapine by pharmacodynamic antagonism. Use Caution/Monitor.

              quetiapine increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • rapacuronium

              rapacuronium and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • rimantadine

              aclidinium, rimantadine. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced CNS side effects.

            • risperidone

              aclidinium decreases levels of risperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              risperidone increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • rivastigmine

              rivastigmine increases and aclidinium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • rocuronium

              rocuronium and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • scopolamine

              scopolamine and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • solifenacin

              solifenacin and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • succinylcholine

              succinylcholine increases and aclidinium decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • thioridazine

              aclidinium decreases levels of thioridazine by pharmacodynamic antagonism. Use Caution/Monitor.

              thioridazine increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • thiothixene

              aclidinium decreases levels of thiothixene by pharmacodynamic antagonism. Use Caution/Monitor.

              thiothixene increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • tolterodine

              aclidinium and tolterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • trazodone

              aclidinium and trazodone both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • trifluoperazine

              aclidinium decreases levels of trifluoperazine by pharmacodynamic antagonism. Use Caution/Monitor.

              trifluoperazine increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • trihexyphenidyl

              aclidinium and trihexyphenidyl both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • trimipramine

              aclidinium and trimipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • trospium chloride

              aclidinium and trospium chloride both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • umeclidinium bromide

              umeclidinium bromide and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

            • vecuronium

              aclidinium and vecuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.

            • ziprasidone

              aclidinium decreases levels of ziprasidone by pharmacodynamic antagonism. Use Caution/Monitor.

              ziprasidone increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • zotepine

              aclidinium decreases levels of zotepine by pharmacodynamic antagonism. Use Caution/Monitor.

            Minor (4)

            • dimenhydrinate

              dimenhydrinate increases toxicity of aclidinium by pharmacodynamic synergism. Minor/Significance Unknown. Additive anticholinergic effects.

            • donepezil

              donepezil decreases effects of aclidinium by pharmacodynamic antagonism. Minor/Significance Unknown.

            • galantamine

              galantamine decreases effects of aclidinium by pharmacodynamic antagonism. Minor/Significance Unknown.

            • rimantadine

              rimantadine increases effects of aclidinium by pharmacodynamic synergism. Minor/Significance Unknown.

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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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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Tudorza Pressair inhalation
            -
            400 mcg/actuation aerosol
            Tudorza Pressair inhalation
            -
            400 mcg/actuation aerosol
            Tudorza Pressair inhalation
            -
            400 mcg/actuation aerosol
            Tudorza Pressair inhalation
            -
            400 mcg/actuation aerosol

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            aclidinium bromide inhalation

            ACLIDINIUM POWDER INHALER - ORAL INHALATION

            (A-kli-DIN-ee-um)

            COMMON BRAND NAME(S): Tudorza

            USES: Aclidinium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Aclidinium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school.This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

            HOW TO USE: Read the Patient Information Leaflet and instruction sheet if available from your pharmacist before you start using aclidinium and each time you get a refill. Learn how to use this inhaler properly. If you have any questions, ask your doctor or pharmacist.Inhale this medication by mouth as directed by your doctor, usually twice daily (every 12 hours). Do not breathe out into the mouthpiece at any time. Avoid getting this medication into your eyes. It may cause eye irritation and temporary blurred vision.If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication.Use this medication regularly to get the most benefit from it. This medication works best if used at evenly spaced intervals. To help you remember, use it at the same times each day. Do not increase your dose, use this medication more often, or stop using it without first consulting your doctor.Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.Tell your doctor if your symptoms do not improve or if they worsen.

            SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Rarely, this medication may cause severe sudden worsening of breathing problems right after use. If you have sudden worsening of breathing, use your quick-relief inhaler and get medical help right away.Tell your doctor right away if you have any serious side effects, including: difficult/painful urination.Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision).A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before using aclidinium, tell your doctor or pharmacist if you are allergic to it; or to atropine or other belladonna-type drugs; or if you have any other allergies. This product may contain inactive ingredients (such as milk proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of glaucoma (angle-closure type), difficulty urinating (for example, due to enlarged prostate).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.

            MISSED DOSE: If you miss a dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from moisture. Do not store in the bathroom. Keep new inhalers in the sealed pouch until you are ready to use them. The inhaler should be discarded when the dose indicator shows "0", when the inhaler becomes locked, or 45 days after removing the inhaler from the sealed pouch, whichever comes first. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

            Information last revised June 2020. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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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.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • 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.
            Additional Offers
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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.