Aclidinium Bromide

Name: Aclidinium Bromide

Advice to Patients

  • Provide a copy of the manufacturer’s patient information to all patients each time the drug is dispensed.1 Importance of instructing patients to read the patient information prior to initiation of therapy and each time the prescription is refilled.1

  • Importance of informing clinician of any history of hypersensitivity reactions to atropine or severe allergy to milk proteins.1

  • Importance of adequate understanding of proper storage and inhalation techniques, including use of the inhalation delivery system (Pressair).1

  • Importance of not using aclidinium to relieve acute symptoms or exacerbations of COPD.1

  • Importance of advising patients that if a dose is missed, the next dose should be taken at the regularly scheduled time; do not take a double dose to make up for a missed dose.1

  • Importance of avoiding inadvertent contact of the drug with the eyes since this may cause blurred vision and pupillary dilation.1

  • Importance of informing clinician immediately if eye pain or discomfort, blurred vision, visual halos, or colored images in association with red eyes from conjunctival congestion or corneal edema occur.1

  • Importance of discontinuing aclidinium and informing clinician if paradoxical bronchospasm occurs.1

  • Importance of informing clinician immediately if urinary retention or dysuria occurs.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (e.g., eye drops) and herbal supplements, as well as any concomitant illnesses (e.g., urinary retention, enlarged prostate, angle-closure glaucoma).1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Aclidinium Bromide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral Inhalation

Powder for Inhalation

400 mcg

Tudorza Pressair

Forest

How supplied

Dosage Forms And Strengths

Inhalation Powder

TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler metering 400 mcg of aclidinium bromide per actuation.

TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) 400 mcg is supplied in a sealed labeled aluminum pouch and is available in 60 metered doses (NDC 0310-0800-60) and 30 metered doses (NDC 0310-0800-39).

The active ingredient is administered using a multi-dose dry powder inhaler, PRESSAIR®, which delivers 60 doses or 30 doses of aclidinium bromide powder for oral inhalation. The PRESSAIR inhaler is a white and green colored device and is comprised of an assembled plastic dosing mechanism with a dose indicator, a drug-product storage unit containing the drug-product formulation, and a mouthpiece covered by a green protective cap. The inhaler should be discarded when the marking “0” with a red background shows in the middle of the dose indicator or when the device locks out, whichever comes first.

Storage And Handling

Store TUDORZA PRESSAIR in a dry place at 25 °C (77 °F); excursions permitted to 15-30 °C (59-86 °F) [see USP Controlled Room Temperature].

The PRESSAIR inhaler should be stored inside the sealed pouch and only be opened immediately before use.

Discard the PRESSAIR inhaler 45 days after opening the pouch, after the marking “0” with a red background shows in the middle of the dose indicator, or when the device locks out, whichever comes first.

Keep out of reach of children.

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 Under license of ALMIRALL, S.A. Revised: Mar 2016

Warnings

Included as part of the PRECAUTIONS section.

Overdose

Human Experience

No case of overdose has been reported in clinical studies with TUDORZA PRESSAIR. There were no systemic anticholinergic or other adverse effects following a single inhaled dose of up to 6,000 mcg aclidinium bromide (7.5 times the RHDD) in 16 healthy volunteers.

Side effects

The following adverse reactions are described in greater detail in other sections:

  • Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS]
  • Worsening of narrow-angle glaucoma [see WARNINGS AND PRECAUTIONS]
  • Worsening of urinary retention [see WARNINGS AND PRECAUTIONS]
  • Immediate hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

3-Month And 6-Month Trials

TUDORZA PRESSAIR was studied in two 3-month (Trials B and C) and one 6-month (Trial D) placebo-controlled trials in patients with COPD. In these trials, 636 patients were treated with TUDORZA PRESSAIR at the recommended dose of 400 mcg twice daily.

The population had a mean age of 64 years (ranging from 40 to 89 years), with 58% males, 94% Caucasian, and had COPD with a mean pre-bronchodilator forced expiratory volume in one second (FEV1) percent predicted of 48%. Patients with unstable cardiac disease, narrow-angle glaucoma, or symptomatic prostatic hypertrophy or bladder outlet obstruction were excluded from these trials.

Table 1 shows all adverse reactions that occurred with a frequency of greater than or equal to 1% in the TUDORZA PRESSAIR group in the two 3-month and one 6-month placebo-controlled trials where the rates in the TUDORZA PRESSAIR group exceeded placebo.

Table 1: Adverse Reactions (% Patients) in Placebo-Controlled Clinical Trials

Adverse Reactions
Preferred Term
Treatment
TUDORZA PRESSAIR
(N=636)
n (%)
Placebo
(N=640)
n (%)
Headache 42 (6.6) 32 (5.0)
Nasopharyngitis 35 (5.5) 25 (3.9)
Cough 19 (3.0) 14 (2.2)
Diarrhea 17 (2.7) 9 (1.4)
Sinusitis 11 (1.7) 5 (0.8)
Rhinitis 10 (1.6) 8 (1.2)
Toothache 7 (1.1) 5 (0.8)
Fall 7 (1.1) 3 (0.5)
Vomiting 7 (1.1) 3 (0.5)

In addition, among the adverse reactions observed in the clinical trials with an incidence of less than 1% were diabetes mellitus, dry mouth, 1st degree AV block, osteoarthritis, cardiac failure, and cardio-respiratory arrest.

Long-term Safety Trials

TUDORZA PRESSAIR was studied in three long term safety trials, two double blind and one open label, ranging from 40 to 52 weeks in patients with moderate to severe COPD. Two of these trials were extensions of the 3-month trials, and one was a dedicated long term safety trial. In these trials, 891 patients were treated with TUDORZA PRESSAIR at the recommended dose of 400 mcg twice daily. The demographic and baseline characteristics of the long term safety trials were similar to those of the placebo-controlled trials. The adverse events reported in the long term safety trials were similar to those occurring in the placebo-controlled trials of 3 to 6 months. No new safety findings were reported compared to the placebo controlled trials.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of drug TUDORZA PRESSAIR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In postmarketing experience with TUDORZA PRESSAIR, immediate hypersensitivity reactions, including anaphylaxis, angioedema (including swelling of the lips, tongue, or throat), urticaria, rash, bronchospasm, or itching have been reported. Additionally, nausea, dysphonia, blurred vision, urinary retention, tachycardia and stomatitis have been observed.

Read the entire FDA prescribing information for Tudorza Pressair (Aclidinium Bromide)

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