DUAKLIR PRESSAIR

AbsorptionFollowing twice-daily oral inhalation administration of DUAKLIR PRESSAIR in COPD patients, mean maximum aclidinium and formoterol concentrations of 128 pg/mL and 17 pg/mL, respectively, occurred within 5 minutes after inhalation. Steady state was achieved within 5 days.

DistributionAclidinium: Aclidinium shows a volume of distribution of approximately 300 L following intravenous administration of 400 mcg in humans. Formoterol: Over the concentration range of 10-500 nmol/L, plasma pro...

The safety and efficacy of DUAKLIR PRESSAIR was evaluated in a clinical development program that included three dose ranging trials, one active and two placebo-controlled lung function trials of 24 weeks duration; and one 28-week long-term safety extension study. The efficacy of DUAKLIR was primarily based on one dose ranging trial in 128 subjects with COPD and the three 6-month duration confirmatory trials in 5015 subjects with COPD, including chronic bronchitis and emphysema. 14.1 Dose-Ranging Trials Dose selection for DUAKLIR PRESSAIR for COPD was primarily based on data for the individual ...

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) ]
• Cardiovas...

Use of a long-acting beta 2 -adrenergic agonist (LABA), including formoterol fumarate, one of the active ingredients in DUAKLIR PRESSAIR, without an inhaled corticosteroid is contraindicated in patients with asthma [see Warnings and Precautions (5.1) ] . DUAKLIR PRESSAIR is not indicated for the treatment of asthma. DUAKLIR PRESSAIR is contraindicated in patients with:

• Severe hypersensitivity to...

• 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 wit...

7 DRUG INTERACTIONS No formal drug interaction studies have been performed with DUAKLIR PRESSAIR.

• Use of other adrenergic by any route may potentiate the effect of DUAKLIR PRESSAIR. Use with caution. ( 5.3 , 7.1 )
• Xanthine derivatives, steroids, diuretics or non-potassium sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution. ( 7.2 , 7.3 )
• Diuretics: Use with caution....