Chemical formula: C₂₉H₃₄BrNO₂ Molecular mass: 428.595 g/mol PubChem compound: 11519070
Umeclidinium interacts in the following cases:
Umeclidinium bromide has not been studied in patients with severe hepatic impairment and should be used with caution.
Due to its antimuscarinic activity, umeclidinium bromide should be used with caution in patients with urinary retention or with narrow-angle glaucoma.
Umeclidinium bromide should be used with caution in patients with severe cardiovascular disorders, particularly cardiac arrhythmias.
There are no data from the use of umeclidinium bromide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Umeclidinium bromide should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.
It is unknown whether umeclidinium bromide is excreted in human milk. A risk to breastfed newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue umeclidinium bromide therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
There are no data on the effects of umeclidinium bromide on human fertility. Animal studies indicate no effects of umeclidinium bromide on fertility.
Umeclidinium bromide has no or negligible influence on the ability to drive and use machines.
The most frequently reported adverse reactions are nasopharyngitis (6%) and upper respiratory tract infection (5%).
The safety profile of umeclidinium bromide was evaluated in patients with COPD who received doses of 55 micrograms or greater for up to one year. This includes patients who received the recommended dose of 55 micrograms once daily.
The frequencies assigned to the adverse reactions identified in the table below include crude incidence rates observed from efficacy studies, the long-term safety study (which involved patients who received umeclidinium bromide), post-marketing studies and spontaneous reporting.
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
| System Organ Class | Adverse reactions | Frequency |
|---|---|---|
| Infections and infestations | Nasopharyngitis Upper respiratory tract infection Urinary tract infection Sinusitis Pharyngitis | Common Common Common Common Uncommon |
| Immune system disorders | Hypersensitivity reactions including: Rash, urticaria and pruritus Anaphylaxis | Uncommon Rare |
| Nervous system disorders | Headache Dysgeusia Dizziness | Common Uncommon Not known |
| Eye disorders | Eye pain Glaucoma Vision blurred Intraocular pressure increased | Rare Not known Not known Not known |
| Cardiac disorders | Tachycardia Atrial fibrillation Rhythm idioventricular Supraventricular tachycardia Supraventricular extrasystoles | Common Uncommon Uncommon Uncommon Uncommon |
| Respiratory, thoracic and mediastinal disorders | Cough | Common |
| Gastrointestinal disorders | Constipation Dry mouth | Common Uncommon |
| Renal and urinary disorders | Urinary retention Dysuria | Not known Not known |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
