Arformoterol Tartrate

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Read the Patient Information Leaflet 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 how to prepare the solution and use the nebulizer properly. If a child is using this medication, a parent or other responsible adult may need to help the child use the nebulizer properly. If you have any questions, ask your doctor, pharmacist, or respiratory therapist.

This product should be clear and colorless. Before using, check this product for particles or discoloration. If either is present, do not use the liquid.

Using the nebulizer, inhale this medication into your lungs as directed by your doctor, usually 2 times a day (once in the morning and once in the evening). The 2 doses should be about 12 hours apart. Each treatment usually takes about 5 to 10 minutes. Use this medication only through a nebulizer. Do not swallow or inject the solution. Do not mix with other medicines in the nebulizer. To prevent infections, clean the nebulizer and mouthpiece/face mask according to the manufacturer's directions.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

The dosage is based on your medical condition, age, and response to treatment. 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 (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.

Learn which of your inhalers/medications you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

Tell your doctor if your symptoms do not get better or if they get worse.

Nervousness, dizziness, shaking (tremor), headache, nausea, dry mouth, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: muscle cramps/weakness, increased thirst/urination.

Get medical help right away if you have any very serious side effects, including: chest pain, rapid breathing, confusion, fast/irregular heartbeat, severe dizziness, fainting.

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

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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 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: diabetes, heart problems (such as irregular heartbeat, angina, previous heart attack), high blood pressure, liver problems, seizures, overactive thyroid (hyperthyroidism), swelling of an artery (aneurysm), a certain adrenal gland tumor (pheochromocytoma).

Arformoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause 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.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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 unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

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.

Do not use other LABA drugs (such as formoterol, salmeterol) while using this medication.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: chest pain, fast/irregular heartbeat, severe dizziness, fainting.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, heart rate, EKG) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Avoid allergens/irritants that can worsen breathing problems, such as smoke, pollen, pet dander, dust, or molds.

Learn to use a peak flow meter, use it daily, and promptly report worsening breathing problems (such as readings in the yellow/red range, increased use of quick-relief inhalers).

Because the flu virus can worsen breathing problems, ask your doctor or pharmacist if you should have a flu shot every year.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store in the refrigerator away from light. Keep the medication in the sealed foil pouch until ready to use. After opening the pouch, store the unused vials back in the pouch. Unopened foil pouches may also be stored at room temperature if needed. If the medication is stored at room temperature, discard after 6 weeks. Keep all medications 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.