Classes
DEA Class; Rx
Common Brand Names; Tudorza Pressair
- Anticholinergics, Respiratory
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
Indications
For the maintenance treatment of chronic obstructive pulmonary disease (COPD) (e.g., chronic bronchitis and emphysema).
Contraindications
Hypersensitivity to drug or formulation components or severe hypersensitivity to milk proteins
Adverse Effects
1-10%
- Headache (6.6%)
- Nasopharyngitis (5.5%)
- Cough (3%)
- Diarrhea (2.7%)
- Sinusitis (1.7%)
- Rhinitis (1.6%)
- Toothache (1.1%)
- Fall (1.1%)
- Vomiting (1.1%)
Postmarketing reports
- Anaphylaxis
- Angioedema (including swelling of lips and tongue or throat)
- Urticaria
- Rash
- Bronchospasm
- Itching
- Nausea
- Dysphonia
- Blurred vision
- Urinary retention
- Tachycardia
- Stomatitis
Warnings
Not for acute episodes of bronchospasm (ie, not for rescue therapy)
May cause paradoxical bronchospasm; if this occurs, discontinue and consider other treatments
Worsening of narrow-angle glaucoma may occur; use with caution in patients with narrow-angle glaucoma; prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (eg,eye pain or discomfort, blurred vision, visual halos, or colored images in association with red eyesfrom conjunctival congestion and corneal edema; instruct patients to consult a physician immediately if it occurs
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
800 mcg (2 actuations)/day via oral inhalation.
800 mcg (2 actuations)/day via oral inhalation.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
