Tiotropium

ATC code

R03BB04

Therapeutic class

Long-acting muscarinic antagonist (LAMA) · Muscarinic receptor antagonist

Forms

inhalation solution, inhalation powder

Brand names

Spiriva (Global) · Spiriva Respimat (ES) · Tiotropium Viatris (FR) · Stiolto Respimat (US)

Overall confidence

high

Regulatory sources consulted

openfda-label-79996212-633b-464e-9967-834039fb13a4
aemps-ft-69589
ansm-rcp-63653114
PubMed PMID:35050462 ↗
PubMed PMID:35658383 ↗
OpenFDA · R03BB04
RxNorm rxcui 69120 ↗
PubMed PMID:37492909 ↗
PubMed PMID:39696097 ↗

Approved indications

Long-term, once-daily maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).
Add-on therapy in children and adolescents with severe asthma who remain symptomatic despite treatment with inhaled corticosteroids and LABAs. · off-label
Treatment of bronchiectasis (investigational use). · investigational

Contraindications

Absolute

Hypersensitivity to tiotropium, atropine or its derivatives (e.g., ipratropium, oxitropium).

Clinical warnings

Major warning · Not indicated for the treatment of acute episodes of bronchospasm (rescue therapy). — ANSM SPC
Use with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction. — ANSM SPC
Major warning · Immediate hypersensitivity reactions, including angioedema, may occur. — ANSM SPC

Drug interactions

HighOther anticholinergic drugs (e.g., ipratropium, aclidinium, umeclidinium)R03BB
Mechanism: Additive anticholinergic effect, increasing the risk of adverse effects such as dry mouth, urinary retention, and glaucoma.
Recommendation: Avoid co-administration. Concomitant use has not been studied and is not recommended.
ANSM SPCAEMPS SPC

Adverse events

Common (≥1%)

dry mouth

Rare but serious

glaucoma · urinary retention · intestinal obstruction · angioedema · atrial fibrillation · supraventricular tachycardia

Pregnancy and lactation

Limited data in pregnancy. As a precautionary measure, it is preferable to avoid use. Not recommended during lactation as it is unknown if excreted in human milk.

Recent literature (PubMed)

Recent Advances in Long-Term Management of Asthma.
Jat KR, et al. · Indian J Pediatr · 2022 · Relevance 4/5
Revisión sobre avances en el manejo del asma. Destaca el uso de tiotropio como terapia complementaria (add-on) en un subgrupo de niños con asma grave, como parte de un enfoque terapéutico personalizado basado en fenotipos y endotipos.
[Annual review of bronchiectasis in 2021].
Wang L, et al. · Zhonghua Jie He He Hu Xi Za Zhi · 2022 · Relevance 3/5
Revisión anual sobre bronquiectasias que menciona la publicación de importantes ensayos clínicos, incluyendo los de bromuro de tiotropio, lo que impulsa el proceso de terapia individualizada para los pacientes con esta condición.