Regulatory Information
GLAXOSMITHKLINE PTE LTD
GLAXOSMITHKLINE PTE LTD
Therapeutic
Prescription Only
Formulation Information
POWDER, METERED
**Dosage and Administration** Pharmaceutical form: Inhalation powder, pre-dispensed. _INCRUSE ELLIPTA_ is for oral inhalation only. _INCRUSE ELLIPTA_ should be administered once daily at the same time of the day each day. **Adults** The recommended dose is one inhalation of _INCRUSE ELLIPTA_ once daily. **Children** Use in patients less than 18 years of age is not relevant given the indication for this product. **Elderly** No dosage adjustment is required in patients over 65 years (see _Pharmacokinetics – Special Patient Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Renal impairment** No dosage adjustment is required in patients with renal impairment (see _Pharmacokinetics — Special Patient Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Hepatic impairment** No dosage adjustment is required in patients with mild or moderate hepatic impairment. _INCRUSE ELLIPTA_ has not been studied in patients with severe hepatic impairment (see _Pharmacokinetics — Special Patient Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
RESPIRATORY (INHALATION)
Medical Information
**Indications** _INCRUSE ELLIPTA_ is indicated for maintenance bronchodilator treatment to relieve symptoms associated with chronic obstructive pulmonary disease (COPD).
**Contraindications** _INCRUSE ELLIPTA_ is contraindicated in patients with severe milk-protein allergy. Hypersensitivity to the active substance(s) or to any of the excipients (see _List of Excipients_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
R03BB07
umeclidinium bromide
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)
GlaxoSmithKline LLC
Active Ingredients
Documents
Package Inserts
Incruse Ellipta Inhalation Powder PI.pdf
Approved: May 9, 2023