Foradil

The active ingredient in Foradil is formoterol fumarate, a bronchodilator. Formoterol fumarate is a long-acting beta-2 agonist (LABA) that works by relaxing the smooth muscle in your lungs to open them up and ease symptoms of COPD.

Though it may reduce the need for a rescue inhaler, Foradil is not intended to replace your short-acting inhaler in the case of severe breathlessness.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Foradil. However, the following is a synopsis of the general guidelines for the use of Foradil:

1. Remove the inhaler cover.

2. Holding the base of the inhaler, twist the mouthpiece in the direction of the arrow. Push the buttons on each side to ensure you see four pins in the capsule well.

3. When you are ready to use the inhaler, remove a Foradil capsule from the blister card and place it in the capsule chamber.

4. Replace the mouthpiece by twisting it back on.

5. Press both buttons of the inhaler simultaneously once. You should hear a click. Release the buttons.

6. Breathe out fully away from the inhaler.

7. Place the mouthpiece between your lips and tilt your head back.

8. Breathe in quickly and deeply. You should hear a whirring noise. If you do not, open the capsule chamber and try to loosen the capsule. Do not press the buttons again.

9. Once you have successfully heard the whirring while breathing in, remove the mouthpiece from your mouth and hold your breath for up to 10 seconds. Breathe out away from the device.

10. Open the capsule chamber to check for remaining powder in the capsule. If there is remaining powder, repeat steps 6-8. Once the capsule is empty, remove and discard it.

11. Replace the mouthpiece and cover.

The most common side effects of Foradil include:

• Upper respiratory tract infection.
• Cough.
• Tremor.
• Chest pain (angina).
• Dizziness.
• Muscle cramps.
• Dry mouth.
• Increased blood sugar.

Some individuals may experience serious side effects while using Foradil. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Worsening breathing, increased wheezing, or shortness of breath may be a sign that this medication is not right for you.
• Infections such as bronchitis, chest infections, or other viral infections may be more likely while on this medication.
• Heart problems, including irregular heartbeat or heart rhythm (palpitations), and high blood pressure.
• Serious life-threatening allergic reactions, which may present as skin rash, hives, swelling of the face, mouth, or tongue, and/ or trouble breathing.
• Change in blood potassium levels (hypokalemia).

This medication also has the potential to cause paradoxical bronchospasm, an initial worsening of your COPD symptoms. This may lead you to use it more often, experience nighttime awakenings due to your symptoms, or have acute asthma attacks (severe exacerbation). Contact your physician if this occurs at any time.

These are not all of the possible side effects of Foradil. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Foradil, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Heart problems, including coronary insufficiency, cardiac arrhythmias, and hypertension.
• Convulsive disorders.
• Thyroid problems, such as thyrotoxicosis.
• Diabetes.
• Ketoacidosis.
• Liver impairment.

• Treatment of sudden breathing problems.
• Use in asthma without co-treatment of an inhaled corticosteroid.
• Known or suspected hypersensitivity reactions to formoterol fumarate.

Formoterol acts quickly, within 5 minutes, to open up your airways and help you breathe easier. The full action of this medication may take several days to be seen.

When Foradil is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Other adrenergic agonists, such as albuterol or salmeterol, may increase the effects of formoterol fumarate when used together.
• Xanthine derivatives, steroids, and diuretics may increase the risk of hypokalemia (low potassium) when used with formoterol fumarate.
• Monoamine oxidase inhibitors and tricyclic antidepressants may increase the risk of arrhythmias when used with formoterol fumarate.
• Beta-blockers may reduce the efficacy of formoterol fumarate.
• Anesthesia with halogenated hydrocarbons may pose an increased risk of arrhythmias in those taking Foradil.

Foradil Aerolizer contains 12 mcg of formoterol fumarate per capsule.

It should be kept at room temperature, out of reach of children and pets.

It is manufactured by Novartis Pharma.

No, there is no generic version available, but there is also a brand-name Perforomist, which is formoterol for use in a nebulizer. Other LABA inhalers include Serevent or Symbicort, which do have generic counterparts.

Barring serious side effects as listed above or under direct advice of a physician, you should not discontinue this medication abruptly.

While there are concerns of interference with uterine contractility during labor with formoterol fumarate, it is considered safe for use during pregnancy.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is not known whether formoterol fumarate is found in breast milk, though it is generally considered acceptable for use while breastfeeding.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.