Name: Anoro Ellipta
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Anoro Ellipta Drug Class
Anoro Ellipta is part of the drug class:
Inhaled adrenergic and other drugs for obstructive airway diseases
Tell your healthcare provider about all of your health conditions, including if you:
- have heart problems
- have high blood pressure
- have seizures
- have thyroid problems
- have diabetes
- have liver problems
- have eye problems such as glaucoma. Anoro Ellipta may make your glaucoma worse.
- have prostate or bladder problems, or problems passing urine. Anoro Ellipta may make these problems worse.
- are allergic to any of the ingredients in Anoro Ellipta, any other medicines, or food products.
- have any other medical conditions
- are pregnant or planning to become pregnant. It is not known if Anoro Ellipta may harm your unborn baby.
- are breastfeeding. It is not known if the medicines in Anoro Ellipta pass into your milk and if they can harm your baby.
Anoro Ellipta Dosage
Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The recommended dose of Anoro Ellipta is 1 inhalation once daily inhaled orally.
What is umeclidinium and vilanterol?
Umeclidinium is an anticholinergic. Vilanterol is a bronchodilator. These medications work by relaxing muscles in the airways to improve breathing.
Umeclidinium and vilanterol is a combination medicine used to prevent airflow obstruction or bronchospasm in people with COPD (chronic obstructive pulmonary disease).
Umeclidinium and vilanterol may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking umeclidinium and vilanterol?
You should not use this medicine if you are allergic to umeclidinium, vilanterol, or milk proteins. Umeclidinium and vilanterol is for use only in people with COPD and should not be used to treat asthma.
To make sure this medicine is safe for you, tell your doctor if you have:
heart disease, high blood pressure;
epilepsy or other seizure disorder;
diabetes (or ketoacidosis);
thyroid disorder; or
an enlarge prostate, bladder obstruction, or urination problems.
Vilanterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Talk with your doctor about your individual risks and benefits of using this medicine. Follow all patient instructions for safe use.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether umeclidinium and vilanterol passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
This medicine is not approved for use by anyone younger than 18 years old.
What happens if I miss a dose?
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose. Do not use more than 1 inhalation in a single day.
What should I avoid while using umeclidinium and vilanterol?
Do not use a second inhaled bronchodilator similar to vilanterol, such as salmeterol (Advair, Serevent), formoterol or arformoterol (Foradil, Perforomist, Symbicort, Brovana) unless your doctor has told you to.
Umeclidinium and vilanterol side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
wheezing, choking, or other breathing problems after using this medication;
fast or pounding heartbeats;
blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
painful or difficult urination, urinating more or less than usual;
increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, confusion, chest pain;
high blood sugar--increased thirst or urination, hunger, dry mouth, fruity breath odor; or
low potassium--leg cramps, constipation, irregular heartbeats, numbness or tingling, muscle weakness or limp feeling.
Common side effects may include:
stuffy nose, sinus pain, sore throat;
mild chest pain, cough with mucus;
muscle spasms; or
pain in your neck, arms, or legs.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect umeclidinium and vilanterol?
Tell your doctor about all your current medicines and any you start or stop using, especially:
an antibiotic, antifungal medicine, or antiviral medicine (to treat hepatitis C or HIV/AIDS);
bladder or urinary medicines;
cold or allergy medicine that contains an antihistamine;
medication for Parkinson's disease; or
medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome.
This list is not complete. Other drugs may interact with umeclidinium and vilanterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
How do I store and/or throw out Anoro Ellipta?
- Store at room temperature.
- Protect from heat.
- Protect from light.
- Store in a dry place. Do not store in a bathroom.
- After opening, throw away any part not used after 6 weeks or when the indicator reads zero, whichever comes first.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
No case of overdose has been reported with Anoro Ellipta.
Anoro Ellipta contains both umeclidinium and vilanterol; therefore, the risks associated with overdosage for the individual components described below apply to Anoro Ellipta. Treatment of overdosage consists of discontinuation of Anoro Ellipta together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm. Cardiac monitoring is recommended in cases of overdosage.
High doses of umeclidinium may lead to anticholinergic signs and symptoms. However, there were no systemic anticholinergic adverse effects following a once-daily inhaled dose of up to 1,000 mcg umeclidinium (16 times the maximum recommended daily dose) for 14 days in subjects with COPD.
The expected signs and symptoms with overdosage of vilanterol are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms of beta-adrenergic stimulation (e.g., angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, seizures, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis). As with all inhaled sympathomimetic medicines, cardiac arrest and even death may be associated with an overdose of vilanterol.