Aclidinium
Regulatory sources consulted
- AEMPS CIMA FT 12781002: https://cima.aemps.es/cima/dochtml/ft/12781002/FT_12781002.html
- AEMPS CIMA · nº registro 12781002 ↗
- RxNorm rxcui 1303098 ↗
Approved indications
- Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Contraindications
Absolute
- Hypersensitivity to aclidinium bromide, atropine or its derivatives (such as ipratropium or tiotropium), or to any of the excipients (lactose).
Clinical warnings
- Major warning · Paradoxical bronchospasm: As with other inhalation therapies, administration of aclidinium may cause paradoxical bronchospasm. If this occurs, treatment should be discontinued immediately. — AEMPS CIMA
- Anticholinergic effects: Use with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction. — AEMPS CIMA
Drug interactions
- ModerateOther anticholinergic drugsR03B
Mechanism: Increased risk of additive anticholinergic adverse effects (dry mouth, urinary retention, constipation, blurred vision).
Recommendation: The co-administration of aclidinium bromide with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended.
AEMPS CIMA
Adverse events
Common (≥1%)
nasopharyngitis · headache · cough · diarrhea
Rare but serious
hypersensitivity reactions · angioedema · paradoxical bronchospasm · blurred vision · urinary retention
Pregnancy and lactation
Pregnancy: There are no data on use in pregnant women. As a precautionary measure, it is preferable to avoid its use. Lactation: It is unknown whether it is excreted in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue therapy.