Drug Notebook

FDA Alerts

  • Possible increase in asthma-related deaths in patients receiving long-acting β2-adrenergic bronchodilators (e.g., salmeterol) in addition to usual asthma therapy.
  • Reserve use of long-acting β2-adrenergic agonists in patients with asthma for those whose disease is inadequately controlled with other anti-asthma therapy (e.g., low-to-medium dosage of inhaled corticosteroids) or whose disease severity warrants treatment with 2 maintenance therapies. (See Increased Risk of Asthma-related Death under Cautions.)

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(for MOE ter all)

What is the most important information I should know about formoterol inhalation?

Formoterol capsules are for use only in the Foradil Aerolizer device. Use only one capsule at a time. Do not take the capsules by mouth. Never place a capsule in the mouthpiece of the inhaler. Do not use formoterol inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, short-acting inhalation medication to treat an asthma attack.

Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. Formoterol inhalation may increase the risk of asthma-related death. It is critical that you use only the prescribed dose of this medicine and follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits in using formoterol inhalation.

What is formoterol inhalation?

Formoterol is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing.

Formoterol inhalation is used to prevent bronchospasm in people with reversible obstructive airways disease, including symptoms of night-time asthma. It is also used in people with chronic obstructive pulmonary disease (COPD) such as emphysema and chronic bronchitis.

Formoterol inhalation may also be used for other purposed not listed in this medication guide.

What should I discuss with my healthcare provider before using formoterol inhalation?

Formoterol may increase the risk of asthma-related death. It is critical that you use only the prescribed dose of this medicine and follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits in using formoterol inhalation.

Before using this medication, tell your doctor if you are allergic to formoterol, or if you have:

If you have any of these conditions, you may need a dose adjustment or special tests to safely use formoterol inhalation.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use formoterol inhalation without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child younger than 5 years old.
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