Classes
DEA Class; Rx
Common Brand Names; Stiolto Respimat
- Respiratory Inhalant Combos
Description
Inhaled long-acting muscarinic antagonist (LAMA), (tiotropium) with a long-acting beta-2 adrenergic agonist (LABA), (olodaterol); used once daily
Used in adults for the maintenance treatment of COPD, including chronic bronchitis and/or emphysema
Not indicated for the relief of acute bronchospasm or for the treatment of asthma
Indications
Indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) (e.g., chronic bronchitis or emphysema).
Contraindications
Use of a LABA without an inhaled corticosteroid; tiotropium/olodaterol inhaled is not indicated for asthma
Hypersensitivity to tiotropium ipratropium, olodaterol, or other ingredients
Postmarketing experience with tiotropium, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash reported; hypersensitivity reactions were also reported in clinical trials with tiotropium/olodaterol inhaled
Adverse Effects
- Incidence similar to individual components
- Nasopharyngitis (12.4%)
- Cough (3.9%)
- Back pain (3.6%)
- Dehydration
- Dizziness, insomnia
- Glaucoma, intraocular pressure increased, vision blurred
- Atrial fibrillation, palpitations, supraventricular tachycardia, tachycardia, hypertension
- Epistaxis, pharyngitis, dysphonia, bronchospasm, laryngitis, sinusitis
- Dry mouth, constipation, oropharyngeal candidiasis, dysphagia, gastroesophageal reflux disease, gingivitis, glossitis, stomatitis, intestinal obstruction including paralytic ileus
- Rash, pruritus, angioneurotic edema, urticaria, skin infection, and skin ulcer, dry skin, hypersensitivity (including immediate reactions)
- Arthralgia, joint swelling
- Urinary retention, dysuria, and urinary tract infection
Warnings
Safety and efficacy in patients with asthma not established; not indicated for asthma; monotherapy [without inhaled corticosteroids (ICS)] for asthma is associated with an increased risk of asthma-related death (see Black Box Warnings)
Available data do not suggest an increased risk of death with use of LABA in patients with COPD
Do not initiate in acutely deteriorating COPD
Do not use for relief of acute symptoms; concomitant short-acting beta2 agonists can be used as needed for acute relief
Do not exceed the recommended dose; excessive use, or use in conjunction with other medications containing LABA, can result in clinically significant cardiovascular effects and may be fatal
Immediate hypersensitivity reactions reported; discontinue immediately and consider alternatives if immediate hypersensitivity reactions, including angioedema, bronchospasm, or anaphylaxis, occur (see Contraindications)
Life-threatening paradoxical bronchospasm can occur; discontinue immediately
Pregnancy and Lactation
There are no adequate and well-controlled clinical studies with or its individual components, tiotropium bromide and olodaterol, in pregnant women to inform of drug-associated risk of adverse pregnancy-related outcomes
There are no data on presence of tiotropium or olodaterol in human milk, effects on breastfed infant, or on milk production
Maximum Dosage
5 mcg/day of tiotropium and 5 mcg/day of olodaterol via oral inhalation (i.e., 2 inhalations/day of Stiolto Respimat 2.5/2.5).
5 mcg/day of tiotropium and 5 mcg/day of olodaterol via oral inhalation (i.e., 2 inhalations/day of Stiolto Respimat 2.5/2.5).
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
Not indicated.
How supplied
Tiotropium bromide/olodaterol inhaled
inhalation spray
- (3.124mcg/2.736mcg)/actuation (equivalent to 2.5mcg/2.5mcg)