Duaklir Pressair

What Is Duaklir Pressair?

Duaklir Pressair (aclidinium bromide and formoterol fumarate) is a combination of an anticholinergic and a long-acting beta2-adrenergic agonist (LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

What Are Side Effects of Duaklir Pressair?

Common side effects of Duaklir Pressair include:

• upper respiratory tract infection,
• headache,
• back pain,
• cough,
• sinusitis,
• influenza,
• tooth abscess,
• insomnia,
• dizziness,
• dry mouth,
• sore throat,
• muscle spasms,
• musculoskeletal pain,
• joint pain,
• pain in extremities,
• urinary tract infection (UTI), and
• increased blood creatine phosphokinase

Dosage for Duaklir Pressair

The dose of Duaklir Pressair is 400 mcg/12 mcg, twice daily (once in the morning and once in the evening).

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

Duaklir Pressair may interact with other adrenergic drugs, xanthine derivatives, steroids, diuretics or non-potassium sparing diuretics, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, beta-blockers, QTc prolonging drugs, or anticholinergics. Tell your doctor all medications and supplements you use.

Duaklir Pressair During Pregnancy or Breastfeeding

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

Additional Information

Our Duaklir Pressair (aclidinium bromide and formoterol fumarate) Inhalation Powder, for Oral Inhalation Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Duaklir Pressair Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult 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 medicine;
• worsening breathing problems;
• tremors, nervousness, chest pain, fast or pounding heartbeats;
• severe headache, pounding in your neck or ears;
• painful or difficult urination, or urinating more often;
• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
• high blood sugar--increased thirst or urination, hunger, dry mouth, fruity breath odor; or
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

• headache;
• back pain; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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 Duaklir Pressair (Aclidinium Bromide and Formoterol Fumarate Inhalation Powder)

 

Duaklir Pressair Professional Information

SIDE EFFECTS

LABAs, such as formoterol fumarate, one of the active ingredients in DUAKLIR PRESSAIR, increase the risk of asthma-related death. DUAKLIR PRESSAIR is not indicated for the treatment of asthma [see WARNINGS AND PRECAUTIONS].

The following adverse reactions are described in greater detail elsewhere in the labeling:

• Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS]
• Immediate hypersensitivity reactions [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS]
• Cardiovascular effects [see WARNINGS AND PRECAUTIONS]
• Worsening of narrow-angle glaucoma [see WARNINGS AND PRECAUTIONS]
• Worsening of urinary retention [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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The clinical program for DUAKLIR PRESSAIR included 6501 subjects with COPD in 2 placebocontrolled and 1 active-controlled 24-week lung function trials, one long-term safety extension study of 28 weeks and 2 other clinical trials. A total of 1893 subjects have received at least 1 dose of DUAKLIR PRESSAIR.

24-Week Trials

The frequency of common adverse reactions in Table 1 below is based upon pooled data from two, double-blind, placebo-controlled parallel group clinical trials (Trials 1 and 2, n=1729 and n=1669) in 3398 adult patients with moderate to severe COPD. Of these, 60% were male and 94% were Caucasian. They had a mean age of 64 years and an average smoking history of 46 pack-years, with 49% identified as current smokers. At screening, the mean post-bronchodilator percent predicted forced expiratory volume in 1 second (FEV₁) was 54% (range: 28% to 80%) and the mean percent reversibility was 15% (range: -19% to 69%).

Table 1 shows all adverse reactions that occurred with a frequency of greater than or equal to 3% in the DUAKLIR PRESSAIR group in the two 24-week placebo-controlled trials where the rates in the DUAKLIR PRESSAIR group exceeded placebo.

Table 1: Adverse Reactions with DUAKLIR PRESSAIR ≥3% Incidence and More Common than with Placebo in Subjects with COPD

Adverse Reactions Preferred Term	Treatment
	DUAKLIR PRESSAIR (N=720) %	Aclidinium (N=722) %	Formoterol (N=716) %	Placebo (N=526) %
Upper respiratory tract infectiona	8.9	7.6	8.9	6.3
Headache	6.3	6.6	7.7	5.1
Backpain	3.8	3.3	3.5	3.4
aIncludes Viral Upper Respiratory Tract Infection and Upper Respiratory Tract Infection

Other adverse reactions reported in clinical studies with an incidence of >1% but less than 3% with DUAKLIR PRESSAIR but more common than with placebo were cough, sinusitis, influenza, tooth abscess, insomnia, dizziness, dry mouth, oropharyngeal pain, muscle spasms, musculoskeletal pain, arthralgia, pain in extremity, urinary tract infection, and blood creatine phosphokinase increased.

The adverse events reported in the 24-week active-controlled trial were consistent with those observed in 24-week placebo-controlled trials.

Long-Term Safety Extension Trial

In a 28-week safety extension trial, 918 subjects who successfully completed Trial 2 were treated for up to an additional 28 weeks for a total treatment period of up to 52 weeks with DUAKLIR PRESSAIR, aclidinium 400 mcg, formoterol fumarate 12 mcg administered twice daily or placebo. Because the subjects continued from Trial 2 into the safety extension trial, the demographic and baseline characteristics of the long-term safety extension trial were similar to those of the placebocontrolled efficacy trials described above. The adverse reactions reported in the long-term safety trial were consistent with those observed in the 24-week placebo-controlled trials.

Read the entire FDA prescribing information for Duaklir Pressair (Aclidinium Bromide and Formoterol Fumarate Inhalation Powder)