Classes
DEA Class; Rx
Common Brand Names; Duaklir Pressair
- Respiratory Inhalant Combos
Description
Inhaled long-acting muscarinic antagonist (LAMA); given twice daily
Used in adults for the maintenance treatment of COPD, including chronic bronchitis and/or emphysema
Not indicated for the treatment of acute bronchospasm or asthma
Formoterol: Long-acting selective beta-2 agonist (LABA); elicits bronchial smooth muscle relaxation by stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3′, 5′-adenosine monophosphate (cyclic AMP); increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibit release of mediators of immediate hypersensitivity from cells, especially from mast cells
Indications
Indicated for maintenance treatment of chronic obstructive pulmonary disease (COPD)
Contraindications
Severe hypersensitivity to milk proteins
Hypersensitivity to aclidinium bromide, formoterol fumarate, or any product component
Not indicated for asthma; use of long-acting beta2-adrenergic agonists (LABAs), including formoterol fumarate, without an inhaled corticosteroid is contraindicated in patients with asthma
Adverse Effects
1-10%
- Upper respiratory tract infection (8.9%)
- Headache (6.3%)
- Back pain (3.8%)
- Cough (1-3%)
- Sinusitis (1-3%)
- Influenza (1-3%)
- Tooth abscess (1-3%)
- Insomnia (1-3%)
- Dizziness (1-3%)
- Dry mouth (1-3%)
- Oropharyngeal pain (1-3%)
- Muscle spasms (1-3%)
- Musculoskeletal pain (1-3%)
- Arthralgia (1-3%)
- Pain in extremity (1-3%)
- Urinary tract infection (1-3%)
- Blood creatine phosphokinase increased (1-3%)
Warnings
Safety and efficacy not established for patients with asthma; not indicated for asthma; use of LABA as monotherapy (without inhaled corticosteroids) for asthma associated with increase asthma-related deaths; available data do not suggest increased risk of death with LABAs in patients with COPD
Do not initiate in acutely deteriorating COPD, which may be a life-threatening condition; aclidinium/formoterol is intended as maintenance treatment and should not be used for relief of acute symptoms (ie, rescue therapy for acute bronchospasm)
Instruct patients who have been taking oral or inhaled, short-acting beta2-agonists on a regular basis (eg, 4x/day) to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms
Pregnancy and Lactation
There are no adequate and well-controlled studies of aclidinium in pregnant women to assess drug-associated risks
There are no available data on the breastfed child or on milk production or presence in human milk
Maximum Dosage
1 inhalation PO BID
Not to exceed 1 inhalation BID
No overall differences in safety or effectiveness were observed between adults aged ≥60 yr compared with younger adults