Aclidinium Bromide (2 brand names, 1 dosage form, 1 route)
Available dosage forms: POWDER, METERED.
Routes of administration: INHALATION.
Brand Names
- DUAKLIR PRESSAIR
- TUDORZA PRESSAIR
Indications and Usage
DUAKLIR PRESSAIR is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: DUAKLIR PRESSAIR is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.4)].
Dosage and Administration
The recommended dose of DUAKLIR PRESSAIR is one oral inhalation of 400 mcg/12 mcg, twice daily (once in the morning and once in the evening). Do not take more than one inhalation twice daily.
Contraindications
Use of a long-acting beta2-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 milk proteins [see Warnings and Precautions (5.5)]. •Hypersensitivity to aclidinium bromide, formoterol fumarate, or to any component of the product [see Warnings and Precautions (5.5)].
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)]
Drug Interactions
No formal drug interaction studies have been performed with DUAKLIR PRESSAIR.
Mechanism of Action
DUAKLIR PRESSAIR DUAKLIR PRESSAIR contains two bronchodilators: aclidinium a long-acting muscarinic antagonist (also known as an anticholinergic) and formoterol a long-acting beta2-adrenergic agonist. Further information regarding these two substances is provided below. The mechanism of action described below for the individual components apply to DUAKLIR PRESSAIR. These drugs represent two different classes of medications (a long-acting antimuscarinic agent and a selective long-acting beta2-adrenergic receptor agonist) that have different effects on clinical and physiological indices of COPD. Aclidinium bromide Aclidinium bromide is a long-acting antimuscarinic agent, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptors at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo studies, prevention of acetylcholine-induced bronchoconstriction effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown. The bronchodilation following inhalation of aclidinium bromide is predominantly a site-specific effect. Formoterol fumarate Formoterol fumarate is a long-acting selective beta2-adrenergic receptor agonist (LABA) (beta2-agonist). Inhaled formoterol fumarate acts locally in the lung as a bronchodilator. In-vitro studies have shown that formoterol has more than 200-fold greater agonist activity at beta2-receptors than at beta1-receptors. The in-vitro binding selectivity to beta2-over beta1-adrenoceptors is higher for formoterol than for albuterol (5 times), whereas salmeterol has a higher (3 times) beta‑selectivity ratio than formoterol. Although beta2-receptors are the predominant adrenergic receptor
Overdosage
DUAKLIR PRESSAIR contains both aclidinium and formoterol fumarate; therefore, the risks associated with overdosage for the individual components described below apply to DUAKLIR PRESSAIR. The most common symptoms are blurred vision, dry mouth, nausea, muscle spasms, tremor, headache, palpitations, and systolic hypertension. Treatment of overdosage consists of discontinuation of DUAKLIR PRESSAIR together with institution of appropriate symptomatic and/or supportive therapy.