Formoterol (inhalation)

Formoterol (inhalation) is used to manage the symptoms of chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema.

Formoterol may also be used for reasons not mentioned in this medication guide.

Formoterol is for use only in people with chronic obstructive pulmonary disease (COPD) and should not be used to treat asthma.

Formoterol is not a rescue medicine. It will not work fast enough to treat a bronchospasm attack.

Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

You should not use formoterol if you are allergic to it. Formoterol is only for people with COPD and should not be used to treat asthma.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• a seizure;
• diabetes;
• liver disease; or
• a thyroid disorder.

Tell your doctor if you are pregnant or breastfeeding.

Formoterol inhalation is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Formoterol may cause serious side effects. Call your doctor right away if you have:

• tremors, nervousness, chest pain, fast or pounding heartbeats;
• wheezing, choking, or other breathing problems after using formoterol;
• worsening breathing problems;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling.

Common side effects of formoterol may include:

• nausea, vomiting, diarrhea;
• nervousness, trouble sleeping;
• headache;
• dizziness;
• tremor;
• tiredness;
• muscle cramps; or
• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides. Use the medicine exactly as directed. Using too much of formoterol can cause life-threatening side effects.

Formoterol is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Formoterol solution for inhalation is for use only with a standard jet nebulizer machine connected to an air compressor. Do not mix formoterol with other medicines in the nebulizer.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Store this medicine in the refrigerator, protected from light and heat.

Keep each vial in the foil pouch until you are ready to use the medicine. Once a vial is opened, you must use the medicine right away. Throw the empty vial away where children and pets cannot get to it.

You may store an unopened foil pouch at room temperature but you must use it within 3 months or throw it away.

Do not use formoterol if it does not look clear and colorless in the vial. Do not use after the expiration date on the label has passed.

You should not stop using formoterol suddenly. Stopping suddenly may make your condition worse.

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Taking too much formoterol (inhalation) can be life-threatening.

Signs of an overdose may include chest pain, fast or uneven heartbeats, feeling anxious, shaking, muscle cramps, feeling dizzy, and fainting.

Do not use another inhaled bronchodilator that has formoterol or a similar medicine (such as arformoterol, indacaterol, olodaterol, salmeterol, or vilanterol).

If you also use a short-acting bronchodilator, do not use it every day while you are using formoterol. Use the short-acting bronchodilator only for a sudden bronchospasm attack.

Other drugs may affect formoterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all your current medicines and any medicine you begin or stop using.