Tudorza Pressair

What Is Tudorza Pressair?

Tudorza Pressair (aclidinium bromide) inhalation powder is an anticholinergic indicated for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

What Are Side Effects of Tudorza Pressair?

Common side effects of Tudorza Pressair include:

• headache,
• common cold symptoms,
• runny or stuffy nose,
• cough,
• diarrhea,
• sinus infection,
• vomiting,
• toothache,
• urinary tract infection, and
• dry mouth.

Serious side effects of Tudorza Pressair include:

• diabetes mellitus,
• 1st degree AV block,
• osteoarthritis,
• cardiac failure,
• sudden shortness of breath immediately after taking this medicine,
• new or worsened pressure in the eyes (acute narrow-angle glaucoma), and
• cardio-respiratory arrest.

Dosage for Tudorza Pressair

Tudorza Pressair is available for oral inhalation only. The recommended dosage of Tudorza Pressair is one inhalation (400 mcg of aclidinium bromide) twice daily.

What Drugs, Substances, or Supplements Interact with Tudorza Pressair?

Tudorza Pressair may interact with anticholinergic medications. Tell your doctor all medications and supplements you use.

Tudorza Pressair During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Tudorza Pressair; it is unknown if it will affect a fetus. Tudorza Pressair likely passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Tudorza Pressair Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Tudorza Pressair Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching, rash; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medication;
• blurred vision, nausea, vomiting, eye pain or redness, or seeing halos or bright colors around lights;
• increased urination, painful or difficult urination;
• little or no urinating; or
• worsening or no improvement in your symptoms.

Common side effects may include:

• stuffy nose, sore throat, sinus pain;
• cough; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tudorza Pressair (Aclidinium Bromide)

 

Tudorza Pressair Professional Information

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 cardiorespiratory 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.

Long-Term Trial Of Up To 3-Years

In a long-term safety trial with 3630 moderate to very severe COPD patients with previous major cardiac events or cardiovascular risk factors at baseline, the adverse reactions reported with a frequency ≥2% in the TUDORZA PRESSAIR group in which the exposure-adjusted incidence rate exceeds the placebo group were nausea, back pain, cough, hypertension, sinusitis, constipation, arthralgia, anemia, muscle spasms, cardiac failure congestive, cellulitis, and gastroesophageal reflux disease. No other new adverse reactions were identified.

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)