Rarely, in patients treated for asthma, serious (sometimes fatal) asthma-related breathing problems have occurred with the use of long-acting inhaled beta agonists (such as salmeterol). Because arformoterol is similar to salmeterol, it may also cause these problems. Arformoterol is not approved to treat asthma. Consult your doctor or pharmacist for more details.

Arformoterol is used as a long-term (maintenance) treatment to prevent or decrease breathing problems caused by ongoing lung diseases (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and emphysema). It helps to reduce wheezing, coughing, and shortness of breath. Arformoterol works by opening air passages in the lungs to make breathing easier. It belongs to the class of drugs known as long-acting beta-agonist bronchodilators.

This medication does not work immediately and should not be used for sudden attacks of breathing trouble. Your doctor must prescribe a quick-relief medicine/inhaler (e.g., albuterol, also called salbutamol in other countries) for sudden shortness of breath while you are using arformoterol. You should always have a quick-relief inhaler with you.

Arformoterol is usually used in combination with other medications such as corticosteroids (inhaled or taken by mouth). However, it should not be used with other long-acting inhaled beta agonists (e.g., formoterol, salmeterol) since this may increase your risk for side effects.

Read the Medication Guide provided by your pharmacist before you start using this medication and each time you get a refill. This medication is used with a special machine called a nebulizer that changes the solution to a fine mist that you inhale. Learn all instructions for the use of this medication and the nebulizer equipment. Do not use the solution if it is discolored. Opened vials of solution should be used right away. If you have any questions, consult your doctor or pharmacist.

This medication does not require any mixing before use. Using a mouthpiece or face mask with the nebulizer, inhale the prescribed dose of medication into your lungs, usually twice daily (morning and evening) or as directed by your doctor. Each treatment usually takes about 5 to 10 minutes. Give this medication only through a nebulizer. Do not swallow the solution. Ask your doctor or pharmacist before mixing with any other medications given by nebulizer.

Use this medication regularly to receive the most benefit from it. To help you remember, use it at the same times each day. To prevent infections, clean the nebulizer and mouthpiece/face mask according to the manufacturer's directions.

Do not use more of this medication or use it more often than prescribed since this may cause serious side effects. Do not use more than 30 micrograms of arformoterol a day.

If you have been using a quick-relief inhaler (e.g., albuterol, salbutamol) on a regular daily schedule (such as 4 times daily), your doctor will direct you to stop this schedule and only use the quick-relief inhaler as needed for sudden shortness of breath. Consult your doctor for details.

Seek immediate medical attention if your breathing suddenly worsens, if this medication or your quick-relief inhaler stop working well, or if you need to use the quick-relief inhaler more often than usual (4 or more puffs daily or more than 1 inhaler every 8 weeks). Do not increase your dose of arformoterol.

Shakiness (tremor), nausea, headache, nervousness, dizziness, dry mouth, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/pounding/irregular/slow heartbeat, muscle weakness/cramps, increased thirst/urination.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, severe dizziness, fainting.

Rarely, this medication has caused severe (possibly fatal), sudden worsening of breathing problems (paradoxical bronchospasm). If you have trouble breathing or experience sudden wheezing, use your quick-relief inhaler and seek immediate medical attention.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using arformoterol, tell your doctor or pharmacist if you are allergic to it; or to formoterol; or to sympathomimetic drugs (e.g., phenylephrine, pseudoephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., irregular heartbeat, angina), high blood pressure, overactive thyroid (hyperthyroidism), seizures, diabetes, liver problems, certain metabolic problem (ketoacidosis), swelling of an artery (aneurysm), a certain tumor of the adrenal gland (pheochromocytoma).

Arformoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using arformoterol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using arformoterol safely.

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

See also Uses section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Many drugs besides arformoterol may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using arformoterol, report all medications you are currently using to your doctor or pharmacist.

This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: chest pain, fast/irregular heartbeat, severe dizziness, fainting.

Do not share this medication with others.

Avoid smoking and other factors that make breathing worse.

Laboratory and/or medical tests (e.g., blood pressure, heart rate, lung function) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Protect this medication from light and heat. Store in the sealed protective pouch until ready to use. Refrigerate this medication between 36-46 degrees F (2-8 degrees C).

Unopened pouches of medication may also be stored at room temperature between 68-77 degrees F (20-25 degrees C) for up to 6 weeks. If stored at room temperature, discard the medication if it is not used within 6 weeks or after its expiration date, whichever is sooner.

After opening the pouch, store unused vials in the pouch. An opened vial should be used immediately. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.