Umeclidinium and vilanterol

Umeclidinium/vilanterol is a prescription medication used for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD).

This medication is a combination of umeclidinium, an inhaled anticholinergic that affects the muscles around the large airways and stops the muscles from tightening, and vilanterol, a long-acting beta2-adrenergic agonist (LABA) that improves breathing by relaxing the muscles of the airways to allow more air to flow into and out of the lungs.

Umeclidinium/vilanterol comes as an inhaler to be inhaled into the lungs, once daily.

The most common side effects reported include sore throat, sinus infection, lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck pain, and chest pain.

• People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as vilanterol, have an increased risk of death from asthma problems. 
• It is not known if LABA medicines, such as vilanterol, increase the risk of death in people with COPD. 
• Call your healthcare provider if breathing problems worsen over time while using umeclidinium/vilanterol. You may need different treatment.

• Sudden breathing problems immediately after inhaling your medicine 
• Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction: 
  • rash 
  • hives 
  • swelling of the face, mouth, and tongue 
  • breathing problems 
• Effects on your heart
  • increased blood pressure 
  • a fast and/or irregular heartbeat 
  • chest pain 
• Effects on your nervous system 
  • tremor 
  • nervousness 
• New or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include: 
  • eye pain or discomfort 
  • nausea or vomiting 
  • blurred vision 
  • seeing halos or bright colors around lights 
  • red eyes 
• Urinary retention. People who take umeclidinium/vilanterol may develop new or worse urinary retention. Symptoms of urinary retention may include: 
  • difficulty urinating 
  • painful urination 
  • urinating frequently 
  • urination in a weak stream or drips 
• Changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia) 

Get emergency medical care if: 

• your breathing problems worsen quickly 
• you use your rescue inhaler, but it does not relieve you

Do not use umeclidinium/vilanterol if you: 

• have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure. 
• are allergic to umeclidinium, vilanterol, or any of the ingredients in this medication

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

One inhalation (umeclidinium 62.5 mcg-vilanterol 25 mcg) orally once a day
Maximum dose: One inhalation every 24 hours

Use: Long term treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

• If you have an allergy to umeclidinium, vilanterol, or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have a milk allergy.
• If you are taking or will be taking another drug like this one.
• If you take other drugs called anticholinergics, like ipratropium or oxybutynin. Ask your doctor if you are not sure if any of your drugs are anticholinergic.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with umeclidinium and vilanterol.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take umeclidinium and vilanterol. This includes your doctors, nurses, pharmacists, and dentists.
• Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
• Have your blood pressure checked often. Talk with your doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Do not take more of this medicine or use it more often than you have been told. Deaths have happened when too much of this type of drug has been taken. Talk with your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using umeclidinium and vilanterol while you are pregnant.

(ue me kli DIN ee um & VYE lan ter ol)

Chronic obstructive pulmonary disease: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema

Limitations of use: Not for the relief of acute bronchospasm or for asthma treatment

No dosage adjustment necessary.

Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, increase the risk of asthma-related death. Data from a large placebo-controlled US trial that compared the safety of another LABA (salmeterol) with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all LABA.

The safety and efficacy of umeclidinium/vilanterol in patients with asthma have not been established. Umeclidinium/vilanterol is not indicated for the treatment of asthma.

FEV1, peak flow, and/or other pulmonary function tests; blood pressure, heart rate; CNS stimulation; ocular changes

One inhalation (umeclidinium 62.5 mcg-vilanterol 25 mcg) orally once a day
Maximum dose: One inhalation every 24 hours

Use: Long term treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema