Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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 (5.1) ] .
The following adverse reactions are described in greater detail elsewhere in the labeling: • Paradoxical bronchospasm [see Warnings and Precautions (5.4) ] • Immediate hypersensitivity reactions [see Contraindications (4) , Warnings and Precautions (5.5) ] • Cardiovascular effects [see Warnings and Precautions (5.6)] • Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.9) ] • Worsening of urinary retention [see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence ≥ 3% and more common than with placebo) include: upper respiratory tract infection, headache and, back pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma at 1-877-411-2510 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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 placebo-controlled 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.
5 WARNINGS AND PRECAUTIONS • Asthma-related death: Long-acting beta 2 -adrenergic agonists as monotherapy (without an inhaled corticosteroid) for asthma increase the risk of serious asthma-related events.
( 5.1 ) • Do not initiate in acutely deteriorating COPD or to treat acute symptoms.
( 5.2 ) • Do not use in combination with an additional medicine containing a LABA because of risk of overdose.
( 5.3 ) • If paradoxical bronchospasm occurs, discontinue DUAKLIR PRESSAIR and institute alternative therapy.
( 5.4 ) • Use with caution in patients with cardiovascular disorders.
Like all medications, Duaklir Pressair can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: