- Approval Id
- 77740e22136b8604
- Drug Name
- SPIOLTO® RESPIMAT® RE-USABLE SOLUTION FOR INHALATION 2.5 MICROGRAM / 2.5 MICROGRAM
- Product Name
- SPIOLTO® RESPIMAT® RE-USABLE SOLUTION FOR INHALATION 2.5 MICROGRAM / 2.5 MICROGRAM
- Approval Number
- SIN15890P
- Approval Date
- 2020-02-25
- Registrant
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
- Licence Holder
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>The recommended dose for adults 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 (see Handling Instructions – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Elderly</u><br>
Elderly patients can use SPIOLTO RESPIMAT re-usable at the recommended dose.</p>
<p><u>Hepatic impairment and renal impairment</u><br>
SPIOLTO RESPIMAT re-usable contains tiotropium which is a predominantly renally excreted drug and olodaterol, which is predominantly metabolized in the liver.</p>
<p><u>Hepatic impairment</u><br>
Patients with mild and moderate hepatic impairment can use SPIOLTO RESPIMAT re-usable at the recommended dose.</p>
<p>There are no data available for use of olodaterol in patients with severe hepatic impairment.</p>
<p><u>Renal impairment</u><br>
Renally impaired patients can use SPIOLTO RESPIMAT re-usable at the recommended dose.</p>
<p>SPIOLTO RESPIMAT re-usable contains tiotropium, which is a predominantly renally excreted drug. For patients with moderate to severe impairment (creatinine clearance ≤ 50 ml/min, see Special warnings and precautions for use and Pharmacokinetic properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Paediatric population</u><br>
There is no relevant use of SPIOLTO RESPIMAT re-usable in the paediatric population in COPD. The safety and effectiveness of SPIOLTO RESPIMAT re-usable in the paediatric population have not been established.</p>
- Route Of Administration
- RESPIRATORY (INHALATION)
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>SPIOLTO RESPIMAT re-usable is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>SPIOLTO RESPIMAT re-usable is contraindicated in patients with hypersensitivity to tiotropium or olodaterol or to any of the excipients.</p>
<p>SPIOLTO RESPIMAT re-usable is also contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, e.g. ipratropium or oxitropium.</p>
- Atc Code
- R03AL06
- Atc Item Name
- olodaterol and tiotropium bromide
- Pharma Manufacturer Name
- BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/boehringer-ingelheim-singapore-pte-ltd
