LAMA + LABA Pregnancy: As a precautionary measure, it is preferable to avoid use during pregnancy — there is a very limited amount of data for tiotropium and no clinical data on exposed pregnancies for olodaterol. Like other beta2-adrenergic agonists, olodaterol may inhibit labour due to a relaxant effect on uterine smooth muscle. Breast-feeding: no clinical data in nursing women; it is not known whether tiotropium and/or olodaterol pass into human breast milk (both detected in the milk of lactating rats) — a decision on whether to continue/discontinue breast-feeding or therapy should take account of the benefits to child and woman. Fertility: no clinical data; preclinical studies showed no indication of any adverse effect on fertility.

Tiotropium with olodaterol

Brand names: Spiolto Respimat

Tiotropium with olodaterol is a fixed-dose maintenance inhaler combining a long-acting muscarinic antagonist (LAMA) with a long-acting beta-2 agonist (LABA), delivered once daily by soft-mist inhaler for COPD. It is a regular bronchodilator, not a reliever.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 5 microgram tiotropium and 5 microgram olodaterol given as two puffs from the Respimat inhaler once daily, at the same time of the day

Route: Inhalation use only (Respimat re-usable inhaler; two puffs comprise one medicinal dose) — source product: Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution

Frequency: Once daily

Max: The recommended dose (two puffs once daily) should not be exceeded

Source: UK SPC (eMC) §4.2 for Spiolto Respimat 2.5 microgram/2.5 microgram inhalation solution (https://www.medicines.org.uk/emc/product/6902/smpc). Verbatim: 'The recommended dose is 5 microgram tiotropium and 5 microgram olodaterol given as two puffs from the Respimat inhaler once daily, at the same time of the day. The recommended dose should not be exceeded.' ELDERLY: elderly patients can use Spiolto Respimat at the recommended dose. HEPATIC: patients with mild and moderate hepatic impairment can use the recommended dose; no data available in severe hepatic impairment (olodaterol). PAEDIATRIC: 'There is no relevant use of Spiolto Respimat in the paediatric population (under 18 years)' — no paediatric dose is stated, so paedDose is null; verify any under-18 use against a children's formulary. ADMINISTRATION: inhalation use only; the cartridge can only be inserted and used in the Respimat inhaler; if not used for more than 7 days release one puff towards the ground, and if not used for more than 21 days repeat the priming steps until a cloud is visible then three more times. §4.4: should NOT be used in asthma (efficacy and safety in asthma have not been studied) and is NOT indicated for acute episodes of bronchospasm (not for rescue use).

Dose adjustments

Renal

Renally impaired patients can use Spiolto Respimat at the recommended dose; for patients with moderate to severe impairment (creatinine clearance ≤ 50 ml/min) it should be used only if the expected benefit outweighs the potential risk, as plasma concentration of tiotropium increases with decreased renal function. There is limited experience with olodaterol in severe renal impairment and no long-term experience in severe renal impairment.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1
History of hypersensitivity to atropine or its derivatives, e.g. ipratropium or oxitropium

Side effects

Uncommon: dizziness, headache, tachycardia, cough, dysphonia, dry mouth
Rare: atrial fibrillation, supraventricular tachycardia, palpitations, hypertension
Rare: vision blurred; not known: glaucoma, increased intraocular pressure (patients should avoid getting the spray into their eyes)
Rare: bronchospasm, laryngitis, pharyngitis, epistaxis, oropharyngeal candidiasis, constipation, stomatitis, gingivitis, nausea
Rare: hypersensitivity, angioedema, urticaria, pruritus, rash; urinary retention, urinary tract infection, dysuria; not known: intestinal obstruction/paralytic ileus, dental caries, anaphylactic reaction

Clinical monograph

How it works

Tiotropium blocks muscarinic receptors to reduce cholinergic bronchoconstriction, while olodaterol stimulates beta-2 adrenoceptors to relax airway smooth muscle, giving complementary sustained bronchodilatation.

Prescribing in practice

Avoid the tiotropium component in closed-angle glaucoma and use cautiously in significant bladder-outflow obstruction or prostatic disease because of antimuscarinic effects.
The olodaterol LABA component warrants caution in cardiovascular disease, arrhythmias and hyperthyroidism, with additive hypokalaemia risk alongside steroids and diuretics.
It is for regular maintenance only and a separate short-acting bronchodilator should be supplied for acute breathlessness.

Monitoring

Monitor inhaler technique, symptom control and exacerbation frequency, with attention to antimuscarinic side effects and cardiovascular tolerability.

Counselling the patient

Take it at the same time each day for prevention; it will not relieve a sudden attack.
Report eye pain or visual halos, or difficulty passing urine, promptly.

Evidence & guidelines

Fixed LAMA/LABA combinations like this are supported by COPD trials and NICE guidance showing improved lung function and symptoms over single bronchodilators.

Reference: NICE NG115; GOLD; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Drugs

Umeclidinium with vilanterol · LAMA + LABA

Pathways