Umeclidinium Bromide

Umeclidinium Bromide is a prescription medication used for the treatment of chronic obstructive pulmonary disease.

• Umeclidinium Bromide  is available under various brand names: Incruse Ellipta

Common side effects of Umeclidinium Bromide include:

• upper respiratory infection,
• stuffy or runny nose,
• cough,
• sore throat,
• joint pain,
• muscle pain,
• tooth pain,
• stomach pain,
• bruising or dark areas of skin,
• chest pain,
• fast or irregular heartbeat, and
• constipation

Serious side effects of Umeclidinium Bromide include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• difficult or painful urination,
• wheezing,
• eye pain or swelling,
• redness of the eye,
• vision changes,
• seeing halos around lights,
• blurred vision, and
• severe dizziness

Rare side effects of Umeclidinium Bromide include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Powder for inhalation

• 62.5 mcg/actuation

Chronic Obstructive Pulmonary Disease

Adult dosage

• 62.5 mcg (1 actuation) inhaled orally every day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Umeclidinium Bromide has severe interactions with no other drugs.
• Umeclidinium Bromide has serious interactions with the following drugs:
  • glucagon
  • glucagon intranasal
  • revefenacin
• Umeclidinium Bromide has moderate interactions with at least 28 other drugs.
• Umeclidinium Bromide has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Severe hypersensitivity to milk proteins
• Demonstrated hypersensitivity to umeclidinium or any of the excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Umeclidinium Bromide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Umeclidinium Bromide?”

Cautions

• Anaphylactic reactions reported in patients with severe milk protein allergy after inhalation of other powder products containing lactose (see Contraindications)
• Hypersensitivity reactions such as anaphylaxis, angioedema, pruritus, rash, and urticaria may occur; discontinue if reactions occur
• Do not initiate in patients during rapidly deteriorating or potentially life-threatening episodes of COPD; not be used for the relief of acute symptoms (ie, as rescue inhaler) from acute episodes of bronchospasm
• Paradoxical bronchospasm reported; discontinue and treat immediately with an inhaled, prompt-acting bronchodilator (eg, albuterol)
• Worsening of narrow-angle glaucoma may occur
• Worsening of urinary retention may occur; caution in patients with prostatic hyperplasia or bladder-neck obstruction

Pregnancy & Lactation

• There are insufficient data on use in pregnant women to inform a drug-associated risk.
• Lactation
  • There is no information available on presence of drug in human milk, effects on breastfed child, or on milk production; the drug was detected in plasma of offspring of lactating rats treated with umeclidinium suggesting its presence in maternal milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from umeclidinium or from underlying maternal condition.