aclidinium

(a-kli-din-ee-um) ,

Tudorza

(trade name)

Classification

Therapeutic: copd agents
Pharmacologic: anticholinergics

Pregnancy Category: C

Indications

Long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema.Not for acute (rescue) use.

Action

Acts as an anticholinergic by inhibiting the M₃ receptor in bronchial smooth muscle.

Therapeutic effects

Bronchodilation with lessened symptoms of COPD.

Pharmacokinetics

Absorption: 6% systemically absorbed following inhalation.

Distribution: Unknown.

Metabolism and Excretion: Rapidly hydrolyzed; metabolites are not pharmacologically active. Metabolites are eliminated in urine (54–65%) and feces (20–33%). 1% excreted unchanged in urine.

Half-life: 5–8 hr.

Time/action profile (improvement in FEV1)

ROUTE	ONSET	PEAK	DURATION
Inhaln	within 1 hr	2–4 hr	12 hr

Contraindications/Precautions

Contraindicated in: None noted.

Use Cautiously in: Narrow-angle glaucoma;Prostatic hyperplasia, bladder neck obstruction;Severe hypersensitivity to milk proteins;History of hypersensitivity to atropine (cross-sensitivity may occur); Obstetric: Use during pregnancy only if potential benefit justifies potential risk to the fetus; Lactation: Use cautiously during lactation; Pediatric: Safe and effective use in children has not been established.

Adverse Reactions/Side Effects

Central nervous system

headache

Ear, Eye, Nose, Throat

worsening of narrow-angle glaucoma

Respiratory

paradoxical bronchospasm

Genitourinary

urinary retention

Miscellaneous

immediate hypersensitivity reactions

Interactions

Drug-Drug interaction

↑ risk of adverse anticholinergic effects with other anticholingerics.

Route/Dosage

Inhalation (Adults) One inhalation (400 mcg) twice daily.

Availability

Dry powder metered-dose inhaler: 400 mcg/actuation

Nursing implications

Nursing assessment

Inhalation: Assess respiratory status (rate, breath sounds, degree of dyspnea, pulse) before administration and at peak of medication. Consult health care professional about alternative medication if severe bronchospasm is present; onset of action is too slow for patients in acute distress. If paradoxical bronchospasm (wheezing) occurs, withhold medication and notify health care professional immediately.

Potential Nursing Diagnoses

Ineffective airway clearance (Indications)
Activity intolerance (Indications)

Implementation

Inhalation: Administer every 12 hr. See for administration of inhalation medications.
- When aclidinium is administered concurrently with other inhalation medications, administer adrenergic bronchodilators first, followed by aclidinium, then corticosteroids. Wait 5 min between medications.

Patient/Family Teaching

Instruct patient in proper use of inhaler and to take medication as directed. Omit missed doses and take next dose at the usual time; do not double doses. Advise patient to read Medication Guide before beginning therapy and with each Rx refill in case of changes.
Advise patient to have a rapid-acting bronchodilator available for use at all times to treat sudden symptoms. Notify health care professional immediately if sudden shortness of breath occurs immediately after using aclidinium inhaler, if breathing becomes worse, if rescue inhaler is needed more often than usual, or if rescue inhaler does not work as well at relieving symptoms.
Caution patient to avoid getting powder into eyes.
Advise patient to inform health care professional if symptoms of new or worsened increased eye pressure (eye pain or discomfort, nausea or vomiting, blurred visions, seeing halos or bright colors around lights, red eyes), new or worsened urinary retention (difficulty urinating, painful urination, urinating frequently, urination in a weak stream or drips), or allergic reactions (rash, hives, swelling of the face, mouth, and tongue, breathing problems) occur.
Advise patient to consult health care professional before taking any Rx, OTC, or herbal products or alcohol concurrently with this therapy. Caution patient also to avoid smoking and other respiratory irritants.
Advise patient to notify health care professional if pregnancy is planned or suspected, or if nursing.
Explain need for pulmonary function tests prior to and periodically during therapy to determine effectiveness of medication.

Evaluation/Desired Outcomes

Decreased dyspnea.
- Improved breath sounds.

References in periodicals archive ?

LAMAs, such as aclidinium, glycopyrrolate, tiotropium, and umeclidinium

Dyspnea and Hyperinflation in Chronic Obstructive Pulmonary Disease: Impact on Physical Activity

The trial is a post-marketing requirement (PMR) that was requested by the US Food and Drug Administration (FDA) to evaluate MACE for up to three years with aclidinium bromide.

Circassia and AstraZeneca reveal positive top-line results in Phase IV study for Tudorza

Aclidinium bromide is also the LAMA in Duaklir (aclidinium bromide/formoterol fumarate), which is marketed in more than 30 countries and under development for the US and China.

China,United States : Tudorza reduces exacerbations and demonstrates cardiovascular safety in COPD patients

Pharmacological characterization of the interaction between aclidinium bromide and formoterol fumarate on human isolated bronchi.

Pharmacokinetics and pharmacodynamics of glycyrrhetinic acid with Paeoniflorin after transdermal administration in dysmenorrhea model mice

AstraZeneca will also own development rights in the United States and Canada for LAS40464, the combination of a fixed dose of aclidinium with formoterol long acting beta agonist (LAMA/LABA) in a dry powder inhaler, which is approved in the EU under the brand name Duaklir Genuair.

Covington's Dargan and Osborne lead on AstraZeneca deal with Actavis

The company also owns the development rights in the US and Canada for LAS40464, the combination of a fixed dose of aclidinium with formoterol long acting beta agonist (LAMA/LABA) in a dry powder inhaler, which is approved in the EU under the brand name Duaklir Genuair.

AstraZeneca Acquires N. American Drug Portfolio from Actavis

In conjunction, AstraZeneca will own the development rights in the US and Canada for LAS40464, the combination of a fixed dose of aclidinium with formoterol long acting beta agonist (LAMA/LABA) in a dry powder inhaler, which is approved in the EU under the brand name Duaklir Genuair.

Actavis announces divestiture of branded respiratory portfolio rights in the US and Canada to focus on core strategic therapeutic categories

This edition has new drugs, including aclidinium bromide, felbamate, icosapent ethyl, linaclotide, peginesatide acetate, perampanel, rotigotine, and teriflunomide, and updated group monographs for antipsychotic agents, benzodiazepenes, calcium channel blocking agents, estrogens, macrolides, opioid analgesics, proton pump inhibitors, selective serotonin reuptake inhibitors, and serotonin 5-HT1 receptor agonists.

Drug facts and comparisons, 2014; pocket version

Aclidinium bromide (Tudorza Pressair; bronchodilator) is a respiratory agent used in chronic obstructive pulmonary disease, chronic bronchitis, and emphysema.

Drugs, pregnancy, and lactation: risks of newly approved drugs

Also, some of the newer long-acting antimuscarinic agents (LAMAs) include drugs such as aclidinium and glycopyrrolate.

Management of COPD and asthma in the 21st century: newer therapies have improved the outlook for patients with both COPD and asthma

Patients inhale aclidinium through the device, which provides a coloured control window which changes to green to give patients the go-ahead to inhale treatment.

COPD patients could soon benefit from new medication

Aclidinium bromide, a long-acting anticholinergic bronchodilator, has been approved as a treatment for chronic obstructive pulmonary disease, for the long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema, the FDA announced last month.