Incruse Ellipta 62.5 ug/1
umeclidinium · AEROSOL, POWDER · GlaxoSmithKline LLC
Incruse Ellipta is a aerosol, powder containing umeclidinium at 62.5 ug/1, taken oral. Manufactured by GlaxoSmithKline LLC.
Key Facts
- Brand Name
- Incruse Ellipta
- Generic Name
- umeclidinium
- NDC Code (Product)
0173-0873- Manufacturer
- GlaxoSmithKline LLC
- Strength
- 62.5 ug/1
- Dosage Form
- AEROSOL, POWDER
- Route
- ORAL
- Marketing Status
- Application #
- NDA205382
- Marketing Start
- 04/30/2014
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE INCRUSE ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). INCRUSE ELLIPTA is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage of INCRUSE ELLIPTA for maintenance treatment of COPD is 1 actuation (umeclidinium 62.5 mcg) once daily by oral inhalation. • INCRUSE ELLIPTA should be used at the same time every day. Do not use INCRUSE ELLIPTA more than 1 time every 24 hours. • No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment [see Clinical Pharmacology ( 12.3 )] . • For oral inhalation only. ( 2 ) • Maintenance treatment of COPD: 1 actuation of INCRUSE ELLIPTA once daily administered by oral inhalation. ( 2 )
Contraindications
4 CONTRAINDICATIONS INCRUSE ELLIPTA is contraindicated in the following conditions: • Severe hypersensitivity to milk proteins [see Warnings and Precautions ( 5.3 )] • Hypersensitivity to umeclidinium or any of the excipients [see Warnings and Precautions ( 5.3 ), Description ( 11 )] • Severe hypersensitivity to milk proteins. ( 4 ) • Hypersensitivity to any ingredient. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of INCRUSE ELLIPTA with other anticholinergic-containing drugs. ( 7.1 ) 7.1 Anticholinergics There is potential for an additive interaction with concomitantly used anticholinergic medicines. Therefore, avoid coadministration of INCRUSE ELLIPTA with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects [see Warnings and Precautions ( 5.4 , 5.5 )] .
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: • Paradoxical bronchospasm [see Warnings and Precautions ( 5.2 )] • Worsening of narrow-angle glaucoma [see Warnings and Precautions ( 5.4 )] • Worsening of urinary retention [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence ≥2% and more common than placebo) include nasopharyngitis, upper respiratory tract infection, cough, arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the 8 clinical trials conducted to support initial approval of INCRUSE ELLIPTA, a total of 1,663 subjects with COPD (mean age: 62.7 years; 89% white; 65% male across all treatments, including placebo) received at least 1 inhalation dose of umeclidinium at doses of 62.5 or 125 mcg. In the 4…
Frequently Asked Questions
What is Incruse Ellipta used for?
Incruse Ellipta contains umeclidinium. It is a aerosol, powder taken oral. Consult your doctor for specific uses.
Is Incruse Ellipta a controlled substance?
Incruse Ellipta is not classified as a controlled substance by the DEA.
What is the generic name for Incruse Ellipta?
The generic name for Incruse Ellipta is umeclidinium. There are 3 other brand versions of umeclidinium.
What is the NDC code for Incruse Ellipta 62.5 ug/1?
The NDC (National Drug Code) for Incruse Ellipta 62.5 ug/1 is 0173-0873, listed by GlaxoSmithKline LLC.