aclidinium

(redirected from Tudorza)

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)

ROUTEONSETPEAKDURATION
Inhalnwithin 1 hr2–4 hr12 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 ?
As previously announced, the strategic transaction strengthens AstraZeneca s respiratory franchise globally and builds on the acquisition of Almirall s respiratory portfolio in 2014 by extending the company s development and commercialisation rights into the US for both Tudorza Pressair and Duaklir Genuair.
Following the sale, AstraZeneca will own the development and commercial rights in the US and Canada to Tudorza Pressair (aclidinium bromide inhalation powder), a twice-daily long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD).
The product, a dry powder inhaler used twice a day, will be marketed as Tudorza Pressair by Forest Pharmaceuticals, a subsidiary of Forest Laboratories.
Tudorza (aclidinium bromide inhalation powder), an anticholinergic indicated for the long-term maintenance treatment of bronchospasm associated with COPD recorded initial trade stocking of $12.
With the addition of Tudorza and Daliresp, we will benefit from an immediate boost to revenue in our biggest market, further strengthening our growing respiratory franchise.
Aclidinium bromide was approved by the EMA and by the US Food and Drug Administration (FDA) in 2012 and is available in in 24 countries marketed under the trade names Eklira Genuair, Bretaris Genuair, Tudorza Pressair and Tudorza Genuair.
During the quarter we and our partner Almirall were pleased to announce the approval of Tudorza (aclidinium).
As the first long-acting inhaled anticholinergic agent approved in over 8 years for COPD, Tudorza will be an important treatment option available for the millions of patients living with this serious disease.
Food and Drug Administration today approved Tudorza Pressair (aclidinium bromide) for the long-term maintenance treatment of bronchospasm (narrowing of the airways in the lung) associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
On July 23rd, 2012, we received FDA approval for aclidinium, which will be launched later this year under the brand name TUDORZA, and we are expecting FDA approval of linaclotide in September - powerful proof that our long-term pipeline planning is bearing fruit.
We recently received FDA approval for aclidinium, which will be launched later this year under the brand name TUDORZA, and we are expecting FDA approval of linaclotide in September - powerful proof that our long-term pipeline planning is bearing fruit.