Revefenacin (inhalation)

Revefenacin is used to treat chronic obstructive pulmonary disease (COPD), which includes emphysema and chronic bronchitis.

Revefenacin relaxes the muscles in your lungs to help prevent wheezing, cough, chest tightness, and shortness of breath.

Revefenacin may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Revefenacin is an inhaled medicine that must be used only with a standard jet nebulizer connected to an air compressor. The usual dose is 1 vial per day. Do not mix revefenacin with other medicines in the nebulizer cup (reservoir).

Revefenacin is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Do not use the medicine if it has changed colors or looks cloudy. Call your pharmacist for new medicine.

Store revefenacin in the foil pouch at room temperature. Use the medicine right away after opening. Discard any pouch not used before the expiration date on the label.

You should not stop using revefenacin suddenly. Stopping suddenly may make your condition worse.

Revefenacin is not a medicine to use for sudden bronchospasm attacks. Use only fast-acting inhalation medicine during an attack. Get medical help if your breathing problems get worse quickly, or if you believe your medications are not working as effectively.

You should not use revefenacin if you are allergic to it.

Tell your doctor if you have ever had:

• glaucoma;
• urination problems;
• an enlarged prostate; or
• liver disease.

Tell your doctor if you are pregnant or breastfeeding.

Revefenacin is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you notice signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Revefenacin may cause serious side effects. Call your doctor immediately if you experience:

• wheezing, choking, or other breathing problems after using revefenacin;
• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
• painful or difficult urination; or
• trouble emptying your bladder (a weak stream of urine).

Common side effects of revefenacin may include:

• headache;
• back pain; or
• cold symptoms such as runny nose, stuffy nose, sneezing, cough, sore throat.

This is not a complete list of side effects; others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

One 175 mcg vial once a day via a nebulizer with a mouthpiece

Use the medicine as soon as possible, but skip the missed dose if it's nearly time for your next dose. Do not use two doses at once.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Signs of an overdose may include nausea, vomiting, vision problems, difficulty urinating, or feeling light-headed.

Follow your doctor's instructions regarding any limits on food, drinks, or activities.

Tell your doctor about all your other medicines, especially:

• medicine to treat depression, anxiety, mood disorders, or mental illness;
• cold or allergy medicine (Benadryl and others);
• medicine to treat Parkinson's disease;
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
• medicine to treat overactive bladder; or
• bronchodilator asthma medication.

This list is not complete. Other drugs may affect revefenacin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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