Formoterol Powder Inhaler - Oral

Pronunciation: for-MOE-ter-ol

Common Brand Name(s): Oxeze

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.

Warning

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 formoterol is similar to salmeterol, it may also cause these problems. Therefore, in patients with asthma, this drug should only be prescribed when one long-term medication (such as inhaled corticosteroids) does not control breathing problems or when more than one long-term medication is clearly needed to control breathing problems. Formoterol must not be used alone to treat asthma. Before using this medication, it is important to learn how to use it properly. Discuss the risks and benefits of treatment with this medication with your doctor.

Once asthma symptoms are controlled, if possible, your doctor may stop treatment with formoterol and continue only your other asthma medications (such as inhaled corticosteroids). Follow your doctor's directions carefully.

Uses

Formoterol is used to improve breathing problems such as asthma. It is used on a regular schedule to help reduce wheezing, coughing, and shortness of breath. It should only be used long-term if your asthma symptoms are not controlled by your other asthma medications (such as inhaled corticosteroids). Formoterol must not be used alone to treat asthma. (See also Warning section.) It 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. Controlling symptoms of breathing problems can decrease time lost from work or school.

This drug is also used to prevent breathing trouble brought on by exercise.

Formoterol should be used with corticosteroids. However, it should not be used with other long-acting beta-agonist inhalers (such as arformoterol, salmeterol) because doing so may increase your risk for side effects.

This medication should not be used to treat a sudden asthma attack. Your doctor may direct you instead to treat sudden asthma attacks with a short-acting, quick-relief inhaler (such as salbutamol, also called albuterol in some countries). Consult your doctor or pharmacist to make sure you know what to do and which medications to use if an asthma attack occurs.

It is recommended that children and teenagers, who need to use formoterol to treat their asthma, should use a combination formoterol/budesonide product. Check with your child's doctor to see if this product is the right product for your child.

How To Use

Read the patient instruction sheet that comes with this product before you start using it and each time you get a refill. Learn how to use formoterol properly. If you have any questions, consult your doctor or pharmacist.

If you are using short-acting bronchodilators such as albuterol or salbutamol on a regular schedule every day (such as every 6 hours), stop that treatment when you start formoterol. However, continue to use albuterol or salbutamol to relieve sudden asthma attacks if your doctor has directed you to do so. Ask your doctor if you have any questions.

Inhale this medication by mouth, usually twice daily (about every 12 hours) or as directed by your doctor. Breathe in forcefully and deeply through the mouthpiece. Remove the inhaler from your mouth before breathing out. Do not exhale into the device.

The dosage is based on your medical condition and response to treatment. If your doctor has directed you to use 2 inhalations, wait at least 1 minute between them. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication.

Use this medication regularly to get the most benefit from it. This medication works best if used at evenly spaced intervals. To help you remember, use it at the same times each day.

To prevent shortness of breath brought on by exercise, use the inhaler before exercise as directed. Ask your doctor how soon you can take the next dose of formoterol.

Learn which of your inhalers you should use every day (controller drugs) 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.

Contact your doctor promptly if your usual dose of formoterol stops working well or if the effects of 1 dose of formoterol last less than 12 hours. These situations can also be signs of worsening asthma. If this occurs, do not increase your dose without your doctor's approval or use this medication more often than prescribed. Using too much formoterol can lead to serious side effects.

Side Effects

Shaking (tremor), fast/pounding heartbeat, or headache may occur as your body adjusts to this medication. 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.

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 any of these unlikely but serious side effects occur:

  • muscle weakness/cramps
  • increased thirst/urination

Seek immediate medical attention if any of these rare but serious side effects occur:

  • chest pain
  • 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 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 of the following symptoms of a serious allergic reaction:

  • 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 www.fda.gov/medwatch.

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

Precautions

Before using formoterol, tell your doctor or pharmacist if you are allergic to it; or to arformoterol; or if you have any other allergies. This product may contain inactive ingredients (such as lactose, milk proteins), 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 (such as irregular heartbeat, angina)
  • high blood pressure
  • overactive thyroid
  • seizures
  • diabetes
  • swelling of an artery (aneurysm)
  • a certain tumor of the adrenal gland (pheochromocytoma)

Formoterol 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 formoterol, 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 formoterol safely.

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

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, and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.

Drug Interactions

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.

Overdose

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/irregular heartbeat, severe dizziness, fainting.

Notes

Do not share this medication with others.

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

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

Avoid substances that can worsen breathing problems by causing irritation or allergic reactions, such as smoke, pollen, pet dander, dust, and mold.

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

Missed Dose

If you miss a dose and remember within 6 hours, use it as soon as possible and use your next dose at the regular time. If it is more than 6 hours past the time of the missed dose, skip that dose and use the next dose at the regularly scheduled time. Do not double the dose to catch up.

Storage

Store this medication at room temperature between 59-86 degrees F (15-30 degrees C) away from moisture. Do not store in the bathroom. Store with the mouthpiece cover on. 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).

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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