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TIOTROPIUM BROMIDE MONOHYDRATE & OLODATEROL HYDROCHLORIDE

All products: Limited Use (codes 459)

Inspiolto Respimat · DIN 02441888 · 2.5mcg & 2.5mcg/Actuation · Inh Sol-60 Actuation Pk

Limited Use — Reason for Use code 459 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 459 required
Write on scriptLU code 459 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 459
Reason for Use code 459 For the long-term treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD-see notes below) who have had an inadequate response to a long-acting bronchodilator (i.e., long-acting beta-2 agonist (LABA), or long-acting muscarinic antagonist (LAMA)). Coverage limit: LU Authorization Period: Indefinite Coverage limit: COPD disease severity is based on spirometry, symptoms and disability (see classification tables below). Classification COPD Stages - Symptoms and disability: Mild: Shortness of breath from COPD when hurrying on the level or walking up a slight hill. Moderate: Shortness of breath from COPD causing the patient to stop after walking approximately 100m (or after a few minutes) on the level Severe: Shortness of breath from COPD resulting in the patient being too breathless to leave the house, breathless when dressing or undressing (MRC 5), or the presence of chronic respiratory failure or clinical signs of right heart failure Classification by impairment of lung function: COPD stage and spirometry (post bronchodilator) FEV1 predicted: Mild: Greater than or equal to 80 percent Moderate: 50 to 79 percent Severe: 30 to 49 percent Very severe: Less than 30 percent
No interchangeable product listed in the Ontario extract
Inspiolto Respimat · DIN 02441888 Manufacturer: Boehringer-Ingelheim (Canada) Ltd./Ltee; listing date 2016-03-30 Health Canada: Marketed since 2015-05-29 · brand INSPIOLTO RESPIMAT · ATC R03AL06 OLODATEROL AND TIOTROPIUM BROMIDE, R03AL06 OLODATEROL AND TIOTROPIUM BROMIDE · form Solution · route Inhalation · ingredients OLODATEROL (OLODATEROL HYDROCHLORIDE) 2.5 MCG/ACT, TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE) 2.5 MCG/ACT · company Boehringer ingelheim (canada) ltd ltee · schedule Prescription
Check this DIN again · Health Canada product record

Inspiolto Respimat: Formulary list price $67.1580/unit (unit not stated in source; not the patient's cost)

Ministry pays: $67.1580 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=92626 · Verify on the e-Formulary ↗ (DIN 02441888)

Source record
DIN 02441888: Inspiolto Respimat Raw flags: sec12=Y, sec3=Y Item: 120808012; group id 217; item number 0394; lccId 00263; manufacturer id BOE Source form: Inh Sol-60 Actuation Pk; strength: 2.5mcg & 2.5mcg/Actuation Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $67.1580; ministry $67.1580 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02441888 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=92626 Therapeutic Notes (formulary) Each actuation of Inspiotto Respimat contains 2.5mcg of tiotropium, supplied as tiotropium bromide monohydrate, and 2.5mcg of olodaterol, supplied as olodaterol hydrochloride.
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02441888
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (12:08:08 Antimuscarinics/Antispasmodics) and how they are covered

Matched class: 12:08:08 Antimuscarinics/Antispasmodics

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: TIOTROPIUM BROMIDE MONOHYDRATE, UMECLIDINIUM 12:08:08 Antimuscarinics/Antispasmodics

TIOTROPIUM BROMIDE MONOHYDRATE

· 4 products · General benefit · strengths: 18mcg, 2.5mcg/Actuation · Inh Cap, Inh Sol-60 Actuation Pk

UMECLIDINIUM

· 1 products · General benefit · strengths: 62.5mcg · Blister Pd Inh-30 Dose Pk

GLYCOPYRROLATE

· 10 products · Limited Use, codes 481 (7), Listed, not a benefit (3) · strengths: 0.2mg/mL, 0.4mg/2mL, 4mg/20mL · Inj Sol, Inj Sol (Preservative Free), Inj Sol (With Preservative)

HYOSCINE BUTYLBROMIDE

· 1 products · Limited Use, codes 481 · strengths: 20mg/mL · Inj Sol Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 12:08:08
Full class listing Related classes: Same formulary class, not same indication: class membership alone does not establish equivalent uses.
Other drugs whose Health Canada label lists a similar indication: obstructive pulmonary disease
From Health Canada product monographs; label wording only, not a treatment recommendation. Matching is lexical and uses one held product label per generic; formulations and qualifying criteria may differ. Covered without a code on the Ontario formulary: ACLIDINIUM BROMIDE, GLYCOPYRRONIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE, UMECLIDINIUM ACLIDINIUM BROMIDE · General benefit INDICATIONS AND CLINICAL USE TUDORZA GENUAIR (aclidinium bromide) is indicated as a long-term maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. PM: https://pdf.hres.ca/dpd_pm/00067375.PDF; date not captured; DIN 02409720; fetched 2026-09-10 Product monograph ACLIDINIUM BROMIDE & FORMOTEROL FUMARATE DIHYDRATE · Limited Use, codes 459 INDICATIONS AND CLINICAL USE DUAKLIR GENUAIR (aclidinium bromide/formoterol fumarate dihydrate) is a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA) indicated as a long-term maintenance bronchodilator treatment for airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. PM: https://pdf.hres.ca/dpd_pm/00067361.PDF; date not captured; DIN 02439530; fetched 2026-09-10 Product monograph FLUTICASONE FUROATE & VILANTEROL · Limited Use, codes 330, 456 (1), Limited Use, codes 330 (1) INDICATIONS AND CLINICAL USE COPD BREO ELLIPTA (fluticasone furoate/vilanterol) 100/25 mcg is a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and to reduce exacerbations of COPD in patients with a history of exacerbations. PM: https://pdf.hres.ca/dpd_pm/00049111.PDF; date January 7, 2019; DIN 02408872; fetched 2026-09-10 Product monograph GLYCOPYRRONIUM BROMIDE · General benefit 1 INDICATIONS SEEBRI ® BREEZHALER ® (glycopyrronium bromide) is indicated as a long-term once-daily maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. PM: https://pdf.hres.ca/dpd_pm/00067963.PDF; date October 16, 2012; DIN 02394936; fetched 2026-09-10 Product monograph INDACATEROL & GLYCOPYRRONIUM · Limited Use, codes 459 1 INDICATIONS ULTIBRO BREEZHALER (indacaterol maleate and glycopyrronium bromide) is a combination of a long- acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), indicated for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for the reduction of exacerbations of COPD in patients with a history of exacerbations. PM: https://pdf.hres.ca/dpd_pm/00072513.PDF; date Dec 23, 2013; DIN 02418282; fetched 2026-09-10 Product monograph TIOTROPIUM BROMIDE MONOHYDRATE · General benefit 1 INDICATIONS SPIRIVA (tiotropium bromide monohydrate) is indicated for:  long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. PM: https://pdf.hres.ca/dpd_pm/00065560.PDF; date NOV 20, 2002; DIN 02246793; fetched 2026-09-10 Product monograph UMECLIDINIUM · General benefit 1 INDICATIONS INCRUSE ELLIPTA (umeclidinium) is indicated for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. PM: https://pdf.hres.ca/dpd_pm/00072581.PDF; date April 8, 2014; DIN 02423596; fetched 2026-09-10 Product monograph UMECLIDINIUM & VILANTEROL · Limited Use, codes 459 1 INDICATIONS ANORO ELLIPTA (umeclidinium/vilanterol) is a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA) indicated for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. PM: https://pdf.hres.ca/dpd_pm/00069868.PDF; date March 14, 2014; DIN 02418401; fetched 2026-09-10 Product monograph Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE INSPIOLTO RESPIMAT (tiotropium bromide monohydrate and olodaterol hydrochloride) is a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-adrenergic agonist (LABA) indicated for the long term, once daily maintenance bronchodilator treatment of airflow obstruction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema. INSPIOLTO RESPIMAT is not indicated for the relief of acute deterioration of COPD. INSPIOLTO RESPIMAT is not indicated for asthma use. The safety and effectiveness of INSPIOLTO RESPIMAT in asthma have not been established (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS, General). Geriatrics (> 65 years of age): Elderly patients can use INSPIOLTO RESPIMAT at the recommended dose. No dosage adjustment is required. Pediatrics (< 18 years of age): INSPIOLTO RESPIMAT should not be used in patients under 18 years of age. Inspiolto® Respimat ® Product Monograph Page 3 of 50 https://pdf.hres.ca/dpd_pm/00054220.PDF PM date: November 14, 2019 Source product: INSPIOLTO RESPIMAT; DIN 02441888; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.