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- Umeclidinium Bromide
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Aerosol Powder Breath Activated, Inhalation:
Incruse Ellipta: 62.5 mcg/inhalation (7 ea, 30 ea) [contains lactose monohydrate]
Brand Names: U.S.
- Incruse Ellipta
- Anticholinergic Agent
- Anticholinergic Agent, Long-Acting
Competitively and reversibly inhibits the action of acetylcholine at type 3 muscarinic (M3) receptors in bronchial smooth muscle causing bronchodilation.
Lung; minimum contribution from oral absorption.
Vd: 86 L (following IV administration)
Hepatic via CYP2D6 and is a substrate for the P-glycoprotein (P-gp) transporter.
Urine <1%; feces 92% (following oral administration)
Time to Peak
5 to 15 minutes
Use: Labeled Indications
Chronic obstructive pulmonary disease: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Limitations of use: Not indicated for relief of acutely deteriorating COPD.
Hypersensitivity to umeclidinium or any component of the formulation; severe hypersensitivity to milk proteins
Chronic obstructive pulmonary disease (COPD): Oral inhalation: 1 inhalation (62.5 mcg) once daily; maximum dose: 1 inhalation (62.5 mcg) once daily
Refer to adult dosing
Dosing: Renal Impairment
No dosage adjustment necessary.
Dosing: Hepatic Impairment
Mild to moderate hepatic impairment: No dosage adjustment necessary.
Severe hepatic impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Inhalation: Administer via oral inhalation once daily at the same time each day; do not use more than 1 inhalation every 24 hours. Do not shake inhaler. Remove from sealed pouch immediately prior to first use. Slide cover of mouthpiece down until a “click” is heard. Prior to inhaling the dose, exhale fully (do not exhale into the inhaler); close lips tightly around the inhaler mouthpiece and inhale (rapidly, steadily, and deeply); do not breathe through nose or block air vent with fingers. Remove inhaler and hold breath for a few seconds then breathe out slowly and gently. Only open inhaler cover when ready for administration; opening and closing the cover without inhaling the medicine will cause a dose to be lost (the lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled). Do not close inhaler cover until medication has been inhaled.
Store between 68°F and 77°F (20°C and 25°C); excursions are permitted between 59°F and 86°F (15°C and 30°C). Protect from moisture, heat or sunlight. Remove inhaler from tray immediately prior to initial use. Discard inhaler 6 weeks after opening the foil tray or after the labeled number of inhalations have reached zero, whichever comes first.
AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Analgesics (Opioid): Anticholinergic Agents may enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy
Anticholinergic Agents: Umeclidinium may enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Avoid combination
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination
Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy
OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy
RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to secretin. Consider therapy modification
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy
1% to 10%:
Cardiovascular: Tachycardia (1%)
Gastrointestinal: Toothache (1%), upper abdominal pain (1%)
Hematologic & oncologic: Bruise (1%)
Neuromuscular & skeletal: Arthralgia (2%), myalgia (1%)
Respiratory: Nasopharyngitis (8%), upper respiratory tract infection (5%), cough (3%), pharyngitis (1%), viral upper respiratory tract infection (1%)
<1% (Limited to important or life-threatening): Atrial fibrillation
Concerns related to adverse effects:
• Bronchospasm: Paradoxical bronchospasm may occur with the use of inhaled agents, which may be life threatening; discontinue use immediately and consider other therapy if bronchospasm occurs.
• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, may occur. Use is contraindicated in patients with severe milk protein allergy.
• Glaucoma: May worsen symptoms of narrow-angle glaucoma; use with caution.
• Prostatic hyperplasia/bladder neck obstruction: May worsen the symptoms of prostatic hyperplasia and/or bladder neck obstruction; use with caution.
Dosage form specific issues:
• Lactose: Powder for oral inhalation contains lactose; use is contraindicated in patients with severe milk protein allergy.
• Appropriate use: Do not use for acute episodes of chronic obstructive pulmonary disease (COPD). Do not initiate in patients with significantly worsening or acutely deteriorating COPD. Do not increase the daily dose beyond the recommended dose.
FEV1, peak flow, and/or other pulmonary function tests; signs and symptoms of narrow angle glaucoma and urinary retention
Pregnancy Risk Factor
Adverse events were not observed in animal reproduction studies. Systemic absorption following oral inhalation in negligible.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience rhinitis, pharyngitis, rhinorrhea, muscle pain, joint pain, abdominal pain, or toothache. Have patient report immediately to prescriber bruising, angina, tachycardia, arrhythmia, tremors, vision changes, eye pain, severe eye irritation, visual halos around lights, eye redness, urinary retention, change in amount of urine passed, polyuria, painful urination, or difficulty breathing, wheezing, or cough (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
More about umeclidinium
- Other brands: Incruse Ellipta