Arformoterol

Generic Name: arformoterol (AR-for-MOE-ter-ol)
Brand Name: Brovana

Long-acting beta-agonists such as arformoterol have been rarely associated with an increased risk of asthma-related death. Long-acting beta-agonists should not be used in asthma patients without another long-term asthma-control medicine (eg, inhaled corticosteroids). Arformoterol has not been approved to treat asthma. Safety and effectiveness of arformoterol in patients with asthma have not been confirmed.


Arformoterol is used for:

Long-term treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It may also be used for other conditions as determined by your doctor.

Arformoterol is a long-acting beta-agonist bronchodilator. It works by widening the airways in the lungs, which helps you breathe more easily.

Do NOT use arformoterol if:

  • you are allergic to any ingredient in arformoterol or to formoterol
  • you are using another medicine that has a long-acting beta-agonist (eg, salmeterol) in it
  • you are having severe breathing problems (eg, sudden, severe onset or worsening of COPD symptoms such as chest tightness, cough, shortness of breath, wheezing)
  • you have asthma and you are not currently using a long-term asthma-control medicine (eg, inhaled corticosteroids) or if you have asthma that is already well controlled with the use of a long-term asthma-control medicine

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using arformoterol:

Some medical conditions may interact with arformoterol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • you have a history of other breathing problems (eg, asthma), diabetes, heart problems (eg, fast or irregular heartbeat, heart blood vessel problems), liver problems, high blood pressure, low blood potassium levels, seizures, or thyroid problems
  • if you have high blood or urine ketone levels
  • if you have recently been to an emergency room for breathing problems, have a history of frequent hospitalizations for breathing problems, or have ever had life-threatening breathing problems
  • if you have had an unusual reaction to a sympathomimetic medicine (eg, albuterol, pseudoephedrine), such as fast or irregular heartbeat, overexcitement, or severe trouble sleeping
  • if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or a tricyclic antidepressant (eg, amitriptyline) or you have taken either of these medicines within the last 14 days
  • if you are taking any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat.

Some MEDICINES MAY INTERACT with arformoterol. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), or xanthines (eg, theophylline) because the risk of low blood potassium or irregular heartbeat may be increased
  • Linezolid, long-acting beta-agonists (eg, salmeterol), MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of arformoterol's side effects
  • Beta-blockers (eg, propranolol) because they may decrease arformoterol's effectiveness or worsen your condition

This may not be a complete list of all interactions that may occur. Ask your health care provider if arformoterol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use arformoterol:

Use arformoterol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Arformoterol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get arformoterol refilled.
  • Be sure to use arformoterol exactly as prescribed by your doctor. Space doses about 12 hours apart unless your doctor tells you otherwise. Do not use more than 2 vials in 1 day.
  • Arformoterol should only be inhaled using a nebulizer. Do not inject or swallow it.
  • A health care provider will teach you how to use the nebulizer. Be sure you know what type of nebulizer to use with arformoterol and how to use it. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Store arformoterol in the original foil pouch in a dry place. Do not remove from the foil pouch or the vial until right before use.
  • Do not use arformoterol if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Do not mix arformoterol with other medicines in your nebulizer machine.
  • To use arformoterol, twist open the top of the vial and pour the entire contents into the nebulizer reservoir.
  • Connect the nebulizer reservoir to the mouthpiece or face mask. Connect the nebulizer to the compressor.
  • Sit in a comfortable, upright position. Place the mouthpiece in your mouth (or put on the face mask) and turn on the nebulizer.
  • Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 10 minutes).
  • Clean the nebulizer according to the instructions. Failure to properly clean the nebulizer could lead to bacteria entering the medicine. This may lead to an infection. To avoid bacteria entering the medicine, use the entire contents right after opening the vial for the first time.
  • Continue to use arformoterol even if you feel well. Do not miss any doses.
  • If you miss a dose of arformoterol, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use arformoterol.

Important safety information:

  • Arformoterol may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use arformoterol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Arformoterol will not stop sudden symptoms of COPD once they have already started. Be sure to carry a short-acting bronchodilator inhaler (eg, albuterol) with you at all times to treat any breathing problems that may occur between doses of arformoterol (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop sudden symptoms, check with your doctor or pharmacist.
  • If you have been regularly using a short-acting bronchodilator inhaler, talk with your doctor about how to use it with arformoterol. Short-acting bronchodilators are normally used with arformoterol to treat breathing problems that may occur between doses.
  • The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use arformoterol in high doses. Do NOT use more than recommended dose or use more often than prescribed.
  • Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it often, or if your breathing problems get worse.
  • Contact your doctor or seek medical care right away if you have breathing problems that worsen quickly, or if you use your short-acting bronchodilator and do not get relief.
  • Talk with your doctor or pharmacist about all of your breathing medicines and how to use them. Do not start, stop, or change the dose of any breathing medicine unless your doctor tells you to.
  • The medicine may sometimes cause severe breathing problems right after you use a dose. If this happens, use your short-acting bronchodilator. Contact your doctor or seek other medical care at once.
  • Arformoterol may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Lab tests, including lung function and blood potassium levels, may be performed while you use arformoterol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Arformoterol should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using arformoterol while you are pregnant. It is not known if arformoterol is found in breast milk. If you are or will be breast-feeding while you use arformoterol, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of arformoterol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; diarrhea; dry mouth; headache; nausea; nervousness; stuffy nose; tiredness; tremor; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness); chest pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; leg swelling; muscle pain, weakness, or cramps; new or worsening breathing problems (eg, increased chest tightness, coughing, shortness of breath, wheezing); severe or persistent headache, dizziness, light-headedness, tremor, or nervousness; severe or persistent nausea or vomiting; sluggishness; symptoms of high blood sugar (eg, increased thirst, urination, or hunger; unusual weakness or drowsiness; confusion); trouble speaking.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; fainting; fast breathing; fast or irregular heartbeat; muscle pain, weakness, or cramps; severe or persistent dizziness, dry mouth, fatigue, headache, light-headedness, nausea, nervousness, trouble sleeping, tremors, or vomiting; severe or unusual drowsiness; shortness of breath; sluggishness; symptoms of high blood sugar (eg, increased thirst, urination, or hunger; drowsiness; flushing of the skin; confusion; fruit-like breath odor).

Proper storage of arformoterol:

Store arformoterol in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Unopened pouches may be stored at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), for up to 6 weeks. If arformoterol is stored at room temperature, throw it away after 6 weeks. Do not use arformoterol if it is past the expiration date on the container. Store arformoterol away from heat, moisture, and light. Keep arformoterol out of the reach of children and away from pets.

General information:

  • If you have any questions about arformoterol, please talk with your doctor, pharmacist, or other health care provider.
  • Arformoterol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take arformoterol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about arformoterol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to arformoterol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using arformoterol.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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