Umeclidinium and Vilanterol (Inhalation)

Umeclidinium bromide/vilanterol (Anoro Ellipta) is prescribed for lung illnesses to open and relax air passages in the lungs when there is a blockage of airflow, resulting in an easier time breathing for the patient.

Overview

Umeclidinium and vilanterol comes in powder form and helps to open airways in the lungs.

Umeclidinium is an anticholinergic when inhaled, and vilanterol is a long-lasting bronchodilator when inhaled. A bronchodilator is a type of medication that is ingested by breathing the powdered medication in by mouth to expand the airways (bronchial tubes) within the lungs.

A patient must obtain a prescription for umeclidinium and vilanterol by a physician prior to taking the medication. A doctor can be sure that the patient will have a reduced chance of experiencing side effects from potential food or medicine interactions. Patients who have asthma or who have severe breathing issues should not take umeclidinium and vilanterol.

Prior to Use

When contemplating whether or not an individual should take a medication, they should compare and contrast the side effects of the medicine against how much it will help the patient. The doctor and the patient must work together to figure out if this is the right decision for the patient. See the summary on Warnings and Interactions for more information.

Allergies

Be sure the physician is informed if there are any allergic or uncommon reactions to the medication including hives, skin rash, or any other skin abnormalities. Stop using the medication immediately if an allergic reaction occurs and consult a doctor.

The health care professional needs to also be aware of any other allergies (for example to animals, foods, preservatives, or dyes). Be sure to carefully read the package instructions or direction label for any over-the-counter products and be knowledgeable about any ingredients that may cause negative interactions.

Directions and Unpackaging

Only take this medication as instructed by a physician. Amounts that are more or less than the doctor ordered (or doses that are taken more or less frequently) may increase the chances of adverse side effects.

A medication guide or patient directions will always come with the inhaled umeclidinium and vilanterol combination. Instructions and medication summary should be read carefully prior to taking this medication. A doctor can show patients how to use this medication if they are new to inhalers or if the instructions are unclear. A doctor can also assist patients in monitoring how they are using the inhaler to ensure proper use.

To unpackage the inhaler:

  • Peel back foil lid to open tray.
  • Slide inhaler cover in a downward motion until a clicking sound is heard.

Note: The inhaler is then ready for use. If the inhaler cover is opened again, medicine will escape. Only open and shut the inhaler when prepared for use.

To take the medication:

  1. Breathe out completely, and do not face head toward inhaler or breathe into inhaler.
  2. Place mouthpiece on lips and hold lips around device. Ensure not to block air vent with fingers.
  3. Take a deep breath through mouth as deeply as possible. Be sure not to take air in or out through nose during this process.
  4. Hold breath for a total of 3-4 seconds.
  5. Take mouthpiece off mouth.
  6. Breathe out gently to allow medication to settle in lungs.

There is a display area on the inhaler displaying the amount of doses left in the inhaler; this is useful for seeing when the medication is running low. Once the inhaler has reached 10 doses it will display a red portion of the counter as a prescription refill reminder.

To clean inhaler:

  1. Use a dry tissue to clean the inhaler.
  2. Close inhaler cover.

Specific Demographic Use

Pediatric

Children should not take umeclidinium and vilanterol because it has not yet been confirmed whether or not this medication is effective and safe for children.

Geriatric

There has not been adequate research to demonstrate whether or not elderly adults encounter problems after taking umeclidinium and vilanterol.

Pregnancy

Umeclidinium and vilanterol is reported to be safe for all trimesters as demonstrated by animal studies (not pregnant). There has not been a comparable study in a pregnant woman or animal.

Breastfeeding

While breastfeeding, compare and contrast the risk of using umeclidinium and vilanterol. There have not been any suitable studies or findings regarding whether or not this medication will be safe for the mother and baby while breastfeeding.

Hepatic Impairment

Protein attachment did not fluctuate among subjects with moderate hepatic impairment when measured against healthy controls. Cases of individuals with severe hepatic impairment have not been yet been studied.

Renal Impairment

Substantial increases did not occur in umeclidinium or vilanterol exposure in patients who were experiencing severe renal impairment and equated with healthy subjects. Patients who have renal impairment do not require any additional dosage adjustment.

Conditions treated

  • Bronchitis (chronic)
  • Chest tightness & cough caused by chronic obstructive pulmonary disease (COPD)
  • Emphysema
  • Shortness of breath
  • Wheezing

Type of medicine

Combination drug: umeclidinium, anticholinergic; vilanterol, long-acting beta-agonist (LABs)

Side Effects

The following side effects may not occur for patients, but if they occurred they would require medical attention. Consult a physician if any of these side effects are experienced:

Less Common Side Effects (Medical care required)

  • Breathing issues
  • Chest pain or tightness
  • Cough
  • Fever
  • Headache
  • Runny or stuffy nose
  • Soreness or dryness of the throat
  • Swallowing difficulty
  • Neck glands swollen or tender
  • Tenderness or pain near the cheekbones or eyes
  • Voice fluctuations (hoarse)

Rare Side Effects (Medical care required)

  • Arm pain or discomfort
  • Back pain or discomfort
  • Chest pain or discomfort
  • Fainting
  • Heartbeat irregularity (or fast beating)
  • Jaw pain or discomfort
  • Nausea
  • Neck pain or discomfort
  • Sweating
  • Vomiting

Occasionally, side effects happen to patients but do not require medical care. As the body becomes more familiar with the medication and learns more about how the body reacts to it, these side effects can improve on their own. It is important to consult a physician with all side effects experienced, if any. A physician should be knowledgeable about methods to reduce or prevent certain side effects, and can answer questions or discuss bothersome symptoms.

Consult a physician if any of these side effects are experienced:

Less Common Side Effects (Medical care not required)

  • Bowel movement/stool passing difficulty
  • Diarrhea
  • Muscle spasms

Rare Side Effects (Medical care not required)

  • Eye itchiness, burning, redness, pain, dryness, tearing, swelling, or excessive discharge
  • Heartburn
  • Indigestion
  • Loss or lack of strength
  • Mouth dryness
  • Skin itchiness or rash
  • Stomach acidity/sour sensation, upset, pain, or discomfort

Some patients may experience additional side effects that are unlisted. It is highly important to always consult a healthcare professional if other side effects are noticed.

Consult a physician for medical direction, side effects may also be reported to the FDA (1-800-FDA-1088).

Dosage

Different patients will require different dosage amounts and frequencies. Be sure to carefully follow the instructions on the prescription bottle label from the physician. For informational purposes, the following data will summarize the average dose of the medication. Do not alter any dosage of any medication without prior approval from a physician. The medication strength will affect the amount prescribed.

The total number of doses taken per day will impact the effectiveness of the prescription in addition to amount of time in between each dose, the medical problem, and how long the medication is inhaled for.

Dosage instructions for powder form inhalation are as follows (and are intended for management of COPD): for use in adults only; one inhalation per day; not to exceed more than one every 24 hours.

Missed Dose

This medication should be taken immediately once it is discovered that a dose has been missed. Unless it is closer to the scheduled next dose, the previous dose can be skipped and the dosage schedule can be resumed. Never double dose.

Overdose

There have not been any cases of umeclidinium and vilanterol overdose reported. As this is a combination drug, there are lower risks for overdosing on the following components. Overdosing must result in termination of this medication with appropriate medical care, conceivably including supportive therapy. Patients who overdose should begin cardiac monitoring as soon as possible.

Umeclidinium

Overdosing on umeclidinium could result in symptoms and signs of an anticholinergic agent. For 14 days, once per day inhalations did not demonstrate any signs of anticholinergic negative effects for subjects at a dose of no more than 1,000 mcg umeclidinium daily (this is also about 16 times the suggested dose).

Vilanterol

An overdose of vilanterol may cause extreme beta-adrenergic stimulus and/or occurrence or overemphasis of any of the symptoms of beta-adrenergic stimulation. The following signs could signal an overdose: angina, arrhythmia, dizziness, dry mouth, fatigue, headache, heart rates up to 200 beats per minute, hyperglycemia, hypertension, hypokalemia, hypotension, insomnia, malaise, metabolic acidosis, muscle cramps, nausea, nervousness, palpitation, tremor, and seizures.

It is important for patients to remember that as with all medicines that are inhaled sympathomimetic, death or cardiac arrest could be associated with a vilanterol overdose.

Interactions

Some medications should not be taken around or close to the time of food consumption due to the possible interactions with food that can arise. Tobacco or alcohol use can also cause the onset of interaction.

Grapefruit juice can potentially cause a significant interaction, which is why it is not recommended to eat grapefruit while taking umeclidinium and vilanterol. It is important to consult a physician if a patient is currently eating a diet with grapefruit and taking this medication. There could potentially be more food interactions with umeclidinium and vilanterol that are currently unknown, which is why it is recommended to avoid food while taking this medication.

Drug Interactions

In certain cases, some medicines should not be combined under any circumstances. Other times, two medications can be used simultaneously even if there is a chance of possible interaction. During instances where it is okay to combine the medications, the doctor may adjust the dose of one or may take other precautions.

While taking this medication, patients must inform their physician if they are also already taking any of the following medications. These interactions would be significant and should be avoided; this list is not necessarily comprehensive. Combining any of the below medications is not recommended. A physician may not prescribe this medication or may change the other medications a patient is taking if they need to take umeclidinium and vilanterol.

Other medications should not be taken concurrently with umeclidinium and vilanterol unless preapproved by a physician. Vitamin supplements and herbal medications should be cleared by a doctor, as well as over-the-counter nonprescription medications.

Do Not Combine

Never combine use with similar inhalers, including:

  • Arformoterol (Brovana®)
  • Budesonide/formoterol (Symbicort®)
  • Formoterol (Foradil®
  • Perforomist®)
  • Indacaterol (Onbrez®)
  • Salmeterol (Serevent®)

Not Recommended

  • Amifampridine
  • Amisulpride
  • Bepridil
  • Cisapride
  • Dronedarone
  • Fluconazole
  • Ketoconazole
  • Mesoridazine
  • Nelfinavir
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Typically Not Recommended

In some cases, a physician may allow a patient to combine this medication with one on the list of medications below. It is typically not recommended to combine the following medications with umeclidinium and vilanterol, but certain conditions may require it. The physician may adjust the dosage or frequency of doses when prescribing any of the following medications in addition to umeclidinium and vilanterol.

  • Amineptine
  • Amiodarone
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Anagrelide
  • Aripiprazole
  • Atazanavir
  • Boceprevir
  • Bupropion
  • Buserelin
  • Butriptyline
  • Ceritinib
  • Clarithromycin
  • Clomipramine
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Dabrafenib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Dibenzepin
  • Donepezil
  • Dothiepin
  • Doxepin
  • Efavirenz
  • Escitalopram
  • Gonadorelin
  • Goserelin
  • Histrelin
  • Hydroxychloroquine
  • Hydroxyzine
  • Idelalisib
  • Imipramine
  • Indinavir
  • Iprindole
  • Itraconazole
  • Ivabradine
  • Leuprolide
  • Levofloxacin
  • Lofepramine
  • Lopinavir
  • Melitracen
  • Metronidazole
  • Nafarelin
  • Nefazodone
  • Nilotinib
  • Nortriptyline
  • Opipramol
  • Oxymorphone
  • Panobinostat
  • Pasireotide
  • Pimavanserin
  • Pitolisant
  • Propizepine
  • Protriptyline
  • Quetiapine
  • Ritonavir
  • Sotalol
  • Sulpiride
  • Tacrolimus
  • Telaprevir
  • Telithromycin
  • Tianeptine
  • Tiotropium
  • Tipranavir
  • Trimipramine
  • Triptorelin
  • Troleandomycin
  • Vemurafenib
  • Vinflunine
  • Voriconazole
  • Zuclopenthixol

Warnings

Consult a doctor as soon as possible if difficulty breathing, wheezing, shortness of breath, or coughing occurs after taking this medication. Paradoxical bronchospasm may occur while taking this medication; this is when the wheezing or breathing becomes exacerbated and may get worse. Paradoxical bronchospasm could be a life-threatening condition.

This medication can cause problems if the patient has any pre-existing medical issues. Seek medical care or consult a doctor immediately if any of the following occur:

  • Allergic to proteins in dairy, specifically milk' do not use this medication
  • Angle-Closure, Closed-Angle or Narrow-Angle com/health/coma/">Glaucoma
  • Bladder blockage
  • Blood vessel or heart disease
  • Diabetes
  • Enlarged prostate
  • Heart rhythm problems (prolonged QT interval or arrhythmia)
  • Hypertension
  • Hyperthyroidism (overactive thyroid)
  • Hypokalemia (potassium deficiency in blood)
  • Ketoacidosis (ketone excess in blood)
  • Urination difficulty
  • Seizures 'take caution, causes ailments to become worse
  • Short-acting inhaler not properly working and is needed more frequently than usual (for example, if an entire container of the short-acting inhaler is used in eight weeks, or if the short-acting inhaler is needed more frequently than two days concurrently while taking four or more inhalations)
  • Symptoms are not considerably improved after one week of taking this medication
  • Symptoms become worse

Patients who will be taking this medication long-term should ensure a medical professional reviews their progress at regular checkups. This will allow unwanted outcomes to be minimized and to monitor whether or not the medicine is working right.

Ensure the medical professional is aware of any other medications taken for COPD.

This medication should not be used if signs of a COPD attack have already begun or if a severe COPD attack has already taken place. In case of a patient having severe COPD attacks, a doctor may prescribe a different medication. It is important to give the physician feedback as to whether or not the other medication works as effectively as umeclidinium and vilanterol.

Potassium and blood sugar levels may be affected by this medication. Patients who are diabetic or have heart disease and see a noticeable shift in blood results, potassium tests, or urine sugar should see a doctor.

If vision changes, difficulty reading or blurred vision occurs after treatment, a doctor should be notified. The patient may be referred to an ophthalmologist (eye doctor) who can diagnose the condition appropriately.

Storage

Ensure this medication is kept away from children. Do not keep medication past expiration date or once it is not necessary anymore. Consult your physician to find out how best to dispose of unused medicine.

Umeclidinium and vilanterol should be stored in a container that is shut and kept at room temperature. Do not store the container in direct light, near heat, or freezing temperatures. Dispose of container no more than six weeks after opening.

Summary

Umeclidinium and vilanterol is an inhaler that treats lung illnesses, specifically by relaxing air passages within the lungs after airflow blockages. This medication has extreme side effects, and patients should be familiar with all risks and information regarding this medication prior to use. Consult a physician to ensure that potential medication interactions or allergic reactions do not occur. It is important for a doctor to monitor changes in blood sugar levels and the patient's general reaction to the medication. Patients considering this medication should review interactions and warnings; those with serious breathing difficulty should not take this medicine.

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Last Reviewed:
December 25, 2017
Last Updated:
April 05, 2018
Content Source: