Umeclidinium

Umeclidinium is a muscarinic antagonist (LAMA) monotherapy that is long-acting, a kind of bronchodilator also referred to as anticholinergic. Below is more information about this essential drug.

Overview

The U.S. brand name of Umeclidinium inhalation powder is Incruse Ellipta. Umeclidinium is a bromide, a white powder with a molecular weight of 508.5 g/mol. It is slightly water soluble.

The drug Incruse Ellipta is sold as a light green and light grey plastic inhaler that contains a foil blister strip. Each blister includes a mix of micronized umeclidinium bromide (contains an equivalent of 62.5mcg of umeclidinium) and other additives.

A patient taking the medicine activates the inhaler, which exposes the powder within the blister. Once exposed, the dose within the blister is ready for dispersion into the stream of air created when the patient inhales through the mouthpiece.

This drug is administered by oral inhalation only. It belongs to the therapeutic class of respiratory agents and the pharmacologic class of antimuscarinic. It received FDA approval in May 2014 and is manufactured by Glaxo Wellcome.

It is a prescription only medication and is not recommended for use without the supervision of a medical practitioner.

Indications

Airway obstruction in people with:

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Chronic bronchitis and emphysema

Type of Medicine

  • Respiratory agent

Side Effects

Any allergic reactions to this medicine should be reported immediately to a healthcare professional. Such symptoms include the following:

  • Hives
  • Itching
  • Shortness of breath
  • Rash
  • Cough
  • Wheezing
  • Swelling tongue, throat, face, and lips
  • Any other symptoms that are indicative of an allergic reaction

The following are umeclidinium side effects that should also be reported to a doctor immediately once they occur. They are not commonly observed:

  • Cloudy or bloody urine
  • Pain in the bladder
  • Difficult or painful urination
  • Hoarseness or a cough
  • Breathing with difficulty
  • Passing out
  • Irregular, pounding or fast heartbeat or pulse
  • Chills or fever
  • Loss of voice
  • Side or lower back pain
  • A sore throat
  • Unusual weakness or tiredness

The following side effects also require the immediate attention of a medical practitioner, but their incidence is not entirely known.

  • Eye pain or discomfort
  • Blurred vision
  • Difficulties passing urine (dribbling)
  • Decreased urination

Some side effects of this drug are not severe and do not require the attention of a healthcare professional. As the body of the patient adjusts to the medication, these side effects often go away.

Should these unwanted effects persist or become bothersome, the advice of a doctor or other medical professional can be sought. The medical practitioner can give tips on how to prevent these effects or how to reduce their impact.

Here is a list of these side effects, all of which are not so commonly seen.

  • Sour or acid stomach
  • Depression
  • Body pains and aches/joint pain
  • Diarrhea
  • Lightheadedness
  • Nausea
  • Rash
  • Spinning sensation or dizziness
  • Stomach or upper abdominal pain

Other side effects that are associated with the use of this drug include the following:

  • Dysuria
  • Disorders of the immune system. These include pruritus, anaphylaxis, urticaria, and angioedema
  • A worsening of narrow-angle glaucoma. This problem is characterized by pain in the eye and blurred vision
  • Nasopharyngitis
  • Upper respiratory tract infection
  • Pharyngitis
  • Viral upper respiratory tract infection
  • Cardiac disorders such as tachycardia
  • Pneumonia
  • Rhinitis
  • Supraventricular extrasystole
  • Idioventricular rhythm
  • Sinus headache
  • Headache
  • Cough
  • Back pain
  • Neck pain
  • Pain in extremities
  • Myalgia
  • Nausea
  • Depression
  • Vertigo
  • Paradoxical bronchospasm
  • A worsening of urine retention. Symptoms include pain or difficulty passing urine.

Dosage

  • The dosage strength made reference to here is 62.5mcg (0.0625mg)/inh.
  • Umeclidinium should be administered by the oral inhalation route - one inhalation, once a day.
  • It should be taken at the same time every day, and never more than once within 24 hours.
  • Efficacy and safety have not been established for patients younger than 18 years.
  • No dose adjustments are required for patients with renal impairment, or those with moderate hepatic impairment. No studies have been done for patients with severe hepatic impairments.
  • No data is available on the safety of this drug for patients who are on dialysis treatment.
  • No dose adjustments are necessary when this medicine is administered to geriatric patients, though increased sensitivity has not been entirely ruled out in some senior patients. Clinical trials done using umeclidinium did not report any differences in the safety and effectiveness of this drug in younger patients compared to older ones.

Overdose

No case has been reported of umeclidinium overdose. High doses, however, are expected to result in anticholinergic signs and symptoms.

There were no notable systemic anticholinergic adverse effects after a once-daily dose of up to 1000mcg of umeclidinium (which is 16 times the daily recommended dose for adults) was administered for 14 days to persons with COPD.

If too much is administered, overdose is treated by withdrawal of the drug and appropriate supportive and symptomatic therapy.

Administration

  1. Before using this drug, instructions for use should be obtained from the product information leaflet attached by the manufacturer.
  2. The maximum dose per day of this drug should be one inhalation. Extra medicine should not be inhaled at all, even to relieve acute symptoms. The recommended treatment for severe symptoms should be a short-acting beta2-agonist administered by inhalation.
  3. Therapy with Umeclidinium should be discontinued should paradoxical bronchospasm occur.
  4. Treatment should also be immediately discontinued should symptoms get worse.
  5. Patients should not stop using this drug without the advice of a medical professional as symptoms could recur.
  6. A doctor should be consulted immediately if a patient needs their rescue inhaler more than usual or if they develop signs of urinary retention or narrow-angle glaucoma.

Interactions

Anticholinergics used concomitantly have shown potential for an additive interaction. Administration of umeclidinium with other anticholinergic-containing drugs is to be avoided as it could worsen combined side effects.

Drug interactions

Umeclidinium interacts with 365 distinct drugs (2665 generic and brand names). 364 (2663 generic and brand names) of these medicines have moderate interactions with umeclidinium while 1 (2 generic and brand names) has minor interactions with this drug.

A moderate interaction of two drugs is clinically significant, and combinations of such drugs are to be avoided. Two drugs with moderate interactions are to be used together only under exceptional circumstances.

A minor interaction of two drugs is minimally clinically significant, and an alternative medicine should be sought in such a case. However, the drugs can be used together if steps are taken to avoid the interaction risk or a monitoring plan is introduced.

The following drugs are often checked whenever umeclidinium is prescribed:

  • Advair Diskus (Fluticasone/Salmeterol)
  • Repreve (Ropinirole)
  • AirDuo Respiclick(Fluticasone/Salmeterol)
  • Reprexain (Hydrocodone/ Ibuprofen)
  • AllerClear D-24 hour (Loratadine/pseudoephedrine)
  • Symbicort (budesonide/formoterol)
  • Aureomycin (chlortetracycline ophthalmic)
  • Tylenol with Codeine #3 (acetaminophen/codeine)
  • Ventolin (albuterol)
  • Breo Ellipta (fluticasone /vilanterol)
  • Ventolin HFA (albuterol)
  • Ibudone (hydrocodone/ ibuprofen)
  • Vicoprofen (hydrocodone/ibuprofen)
  • Myrbetriq (mirabegron)
  • Norco (acetaminophen/hydrocodone)
  • Remeron (Mirtazapine)
  • Vitamin B12 (cyanocobalamin)
  • Vitamin D3 (cholecalciferol)
  • Voltaren (diclofenac)
  • Voltaren gel (diclofenac topical)

Disease interactions

Umeclidinium interacts with two diseases namely

  • Milk protein allergies
  • Severe liver impairment

Warnings

  1. Umeclidinium should not be used in patients experiencing rapidly worsening or probably life-threatening episodes of COPD. Safety and efficacy in situations where COPD is acutely deteriorating have not been established. The drug should never be used as rescue therapy for treating a patient who is experiencing acute signs of bronchospasms. Extra doses of this drug should never be given for such severe episodes. Never should the once-only daily dose be exceeded.
  2. If COPD symptoms deteriorate chronically over a few days or acutely over a few hours and prescribed drugs are not effective, a dose of umeclidinium should not be added. The patient should seek immediate medical advice if the preceding or any other markers of the worsening state of the disease are observed.
  3. Paradoxical Bronchospasm. Following dosing with umeclidinium, symptoms of paradoxical bronchospasm may occur and may be life-threatening. If such symptoms occur, they should be treated immediately with a short-acting, inhaled bronchodilator. Umeclidinium should be discontinued and alternative treatment initiated.
  4. Hypersensitivity reactions such as angioedema, pruritus, anaphylaxis, urticaria, and rash after umeclidinium has been administered have been observed. If such reactions occur, use of this drug should be discontinued. Patients with severe milk allergy who have experienced anaphylactic reactions when they inhale other powder products that contain lactose should not be given this medicine.
  5. Narrow-angle glaucoma getting worse. Patients and prescribers should look out for symptoms of narrow-angle glaucoma. Patients should consult their healthcare provider immediately when any one of the following symptoms and signs are seen:
  • Blurred vision
  • Eye discomfort or pain
  • Colored images or visual halos, accompanied by red eyes from corneal edema and conjunctival congestion.
  1. Worsening of retention of urine. Umeclidinium should be used with caution for people who have urinary retention. Signs of urinary retention include painful urination and difficulty passing urine. These symptoms and signs should be carefully monitored especially in people with bladder neck obstruction or prostatic hyperplasia.
  2. Use in pregnancy. There are no well-controlled and adequate studies on the use of umeclidinium during pregnancy. Studies involving animals during reproduction cannot be used to predict human response. If the benefits to a pregnant woman far outweigh the risk to the fetus, umeclidinium can be prescribed. It is a pregnancy category C drug. A woman taking this medication who becomes pregnant should inform a healthcare professional. Rats and rabbits given approximately 50 and 200 times respectively the daily dose recommended for humans showed no teratogenic effects.
  3. Labor and delivery. There are no well-controlled and adequate studies to determine the safety of this drug during labor and delivery. It should only be used at such times if the benefits of using it outweigh potential risks.
  4. Use by breastfeeding mothers. It is not known if umeclidinium is excreted in breast milk. Care should be taken when administering this drug to nursing mothers as most medicines are excreted in human milk. A decision should be made to discontinue umeclidinium or nursing, bearing in mind the benefits of the drug to a breastfeeding mother. Animal studies using rats indicated the presence of umeclidinium in the nursing young. This evidence suggests the medicine could be passed into breast milk.

Storage

It is supplied in a light green and light grey plastic inhaler that contains 30 or 7 blisters. The inhaler comes packaged in a moisture-protective foil tray that has a peelable lid and a desiccant.

The drug should be stored at a temperature of between 20 and 25 degrees centigrade. Excursions are permitted from 15 to 30 degrees centigrade.

It should be stored away from direct heat and sunlight. It should not be stored in a bathroom, or other moist/wet room. It should also be kept away from the reach of children and pets.

Umeclidinium should not be removed from the moisture-protective foil tray. The drug should only be removed from the tray before initial use. Umeclidinium should be discarded six weeks after opening the foil tray, or when the counter reads zero (all the blisters will be used).

A pharmacist should advise on how to discard unused medicines. The inhaler cannot be reused, and no attempt should be made to take it apart.

Summary

Umeclidinium is useful for conditions it is prescribed for. However, if symptoms get worse or do not improve after use of the drug, a healthcare professional should be notified immediately.

A patient should never try to diagnose or treat him or herself in any way especially when taking umeclidinium. Any adverse effects of this medicine should be reported to a healthcare professional who can recommend appropriate interventions.

Other patients’ drugs should never be taken, and all drugs that are in use, including natural products, vitamins and minerals should be listed, and a doctor notified. The success of therapy is, to an extent, determined by cooperation with a knowledgeable healthcare professional.

A patient taking any drug, especially long-term therapies like umeclidinium should talk to a healthcare professional such as a doctor, nurse or pharmacist if they have any questions regarding the medicine.

No reports of overdosing on umeclidinium have ever been reported, but the drug must be used as prescribed. No matter how acute severe symptoms become, a second dose should never be administered within 24 hours. Suspected overdose should be reported immediately to a healthcare professional or a poison control center.

Even when using this drug as per the instructions of the prescribing doctor, specific side effects may be severe. A patient must discuss with their doctor what to look out for and get immediate medical help when such signs are observed.

The information contained here should not be used by a patient to decide whether or not to take umeclidinium. Only a trained medical professional can determine the benefits or risks of prescribing a particular drug. This information is also not meant to endorse umeclidinium as effective, safe or approved for any disease. This report should be used for general purposes only.

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Last Reviewed:
December 23, 2017
Last Updated:
December 22, 2017
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