Generic Name: formoterol (for-MOE-ter-ol)
Brand Name: Foradil Aerolizer
Long-acting beta-agonists such as formoterol have been rarely associated with an increased risk of asthma-related death. They may also increase the risk of asthma-related hospitalizations in CHILDREN and TEENAGERS. When used to treat asthma, formoterol must be used along with another asthma-control medicine (eg, inhaled corticosteroids). It should only be used to treat asthma patients who are not controlled by using other long-term asthma-control medicines. Formoterol should not be used in patients whose asthma is well controlled by inhaled corticosteroids.
Formoterol is used for:
Treating asthma in combination with another long-term asthma-control medicine (eg, inhaled corticosteroids). It may also be used to prevent breathing problems caused by exercise. It may also be used for long-term treatment of chronic obstructive pulmonary disease (COPD). It may also be used for other conditions as determined by your doctor.
Formoterol is a long-acting beta-agonist bronchodilator. It works by widening the airways in the lungs, which helps you breathe more easily.
Do NOT use formoterol if:
- you are allergic to any ingredient in formoterol
- you are using another medicine that has a long-acting beta-agonist (eg, salmeterol) in it
- you are having an asthma attack or sudden symptoms of COPD (eg, chest tightness, cough, shortness of breath, wheezing)
- you have asthma and you are not currently using a long-term asthma-control medicine (eg, inhaled corticosteroids)
- you have asthma that is already well controlled with the use of a long-term asthma-control medicine
Contact your doctor or health care provider right away if any of these apply to you.
Before using formoterol:
Some medical conditions may interact with formoterol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have had a severe allergic reaction to milk protein or are lactose intolerant
- if you have a history of diabetes, heart problems (eg, fast or irregular heartbeat), blood vessel problems, high blood pressure, low blood potassium levels, an adrenal gland tumor (pheochromocytoma), seizures, or thyroid problems
- if you have recently been to the emergency room for asthma, have a history of frequent hospitalizations for asthma, or have ever had a life-threatening asthma attack
- if you have had an unusual reaction to a sympathomimetic medicine (eg, albuterol, pseudoephedrine), such as fast or irregular heartbeat, overexcitement, or severe trouble sleeping
- if you are taking linezolid, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or a tricyclic antidepressant (eg, amitriptyline) or you have taken any of these medicines within the last 14 days
- if you are taking any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat.
Some MEDICINES MAY INTERACT with formoterol. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), or xanthines (eg, theophylline) because the risk of low blood potassium or irregular heartbeat may be increased
- Linezolid, other long-acting beta-agonists (eg salmeterol), MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of formoterol's side affects
- Beta-blockers (eg, propranolol) because they may decrease formoterol's effectiveness or worsen your condition
This may not be a complete list of all interactions that may occur. Ask your health care provider if formoterol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use formoterol:
Use formoterol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Formoterol comes with an extra patient information sheet called a Medication Guide. It also comes with detailed instructions for use. Read them carefully. Read it again each time you get formoterol refilled.
- An adult should supervise the use of formoterol if the patient is a CHILD.
- Formoterol is for inhalation only. Do NOT swallow the capsule.
- Store formoterol in the original blister in a dry place. Do not remove from the blister or the foil until right before use. Be sure your hands are completely dry before you handle the capsules.
- Use the new inhaler that comes with each refill. Do not reuse an old inhaler. Do not use formoterol with a different kind of inhaler. Do not try to use a spacer device with formoterol.
- To prepare the device for use, remove the inhaler cover. Hold the base of the inhaler in one hand. Twist the mouthpiece toward the arrow. Then push in the buttons on each side to make sure that you can see 4 pins in the capsule chamber.
- Place a capsule in the capsule chamber in the base of the inhaler. Do NOT place a capsule in the mouthpiece of the inhaler. Twist the mouthpiece back to the closed position. Hold the mouthpiece of the inhaler upright and press both buttons at the same time. You should hear a click as the capsule is pierced. Do NOT press the buttons more than once. Release the buttons. If they stay stuck, pull them out using the wings on the buttons. Do not press the buttons again.
- In rare cases, the gelatin capsule might break into small pieces. These tiny pieces may reach the mouth or the throat after you inhale. This will not harm you. However, to avoid this, store formoterol properly, remove the capsule from the blister right before use, and pierce the capsule only once.
- To use a dose of formoterol, breathe out fully. Do NOT exhale into the device for any reason. Keep the inhaler level, with the buttons to the left and the right (not up and down). Tilt your head back slightly. place the mouthpiece in your mouth and close your lips around it. Breathe in quickly and deeply though your mouth and hold your breath. You should hear a whirring noise and experience a sweet taste in your mouth.
- If you do not hear a whirring noise, the capsule may be stuck. If this occurs, open the inhaler and loosen the capsule by allowing it to spin freely. Do NOT push the buttons again. Then, repeat the inhalation process. If you are not sure if you are receiving your dose correctly, contact your doctor or pharmacist.
- After breathing in your dose, remove the inhaler from your mouth. Continue to hold your breath for as long as possible. Then, breathe out slowly.
- Open the inhaler to see if any powder is still in the capsule. If any powder remains in the capsule, close the inhaler. Repeat the inhalation process. Most people are able to empty the capsule in 1 or 2 inhalations.
- After you have taken your dose, open the inhaler, remove the capsule, and throw it away. Do not leave a used capsule in the inhaler. Close the mouthpiece and replace the cover.
- If you are using formoterol to prevent breathing problems caused by exercise, use it at least 15 minutes before you start to exercise. Do not use another dose for at least 12 hours. If you already use formoterol twice daily on a regular basis, do NOT take an extra dose before you exercise.
- Never wash the mouthpiece or any part of the inhaler. Keep it dry and always store it in a dry place. Do NOT try to take the inhaler apart.
- Continue to use formoterol even if you feel well. Do not miss any doses.
- If you miss a dose of formoterol, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use formoterol.
Important safety information:
- Formoterol may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use formoterol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Formoterol will not stop asthma attacks or other sudden, severe breathing problems once they have already started. Be sure to carry a rescue inhaler (eg, albuterol) with you at all times to treat any breathing problems that may occur between doses of formoterol (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop asthma attacks or other sudden, severe breathing problems, check with your doctor or pharmacist.
- If you have been regularly using a rescue inhaler (eg, albuterol), talk with your doctor about how to use it with formoterol. Rescue inhalers are normally used with formoterol to treat breathing problems that may occur between doses.
- Formoterol should be used to treat asthma only if you are currently taking a long-term asthma-control medicine (eg, inhaled corticosteroids) and your asthma is not well controlled. Using formoterol as your only asthma-control medicine has been rarely associated with an increased risk of asthma-related death. Contact your doctor if you have questions about this information.
- The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use formoterol in high doses. Do NOT use more than the recommended dose or use more often than prescribed.
- If your symptoms do not get better within 1 week of starting formoterol, or if they get worse, contact your doctor right away.
- Tell your doctor at once if you notice that your rescue inhaler does not work as well, if you need to use it often (eg, 4 or more times a day for more than 2 days in a row, more than 1 canister in 8 weeks), or if you have a decrease in your peak flow meter results.
- Contact your doctor or seek medical care right away if you have breathing problems that worsen quickly, or if you use your rescue inhaler and do not get relief.
- Formoterol is not to be used in place of a corticosteroid. If you are using a corticosteroid medicine for asthma, do not stop or reduce the dose unless your doctor tells you to.
- Talk with your doctor or pharmacist about all of your asthma medicines and how to use them. Your doctor may make changes to your asthma-control medicines once your asthma is well controlled. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.
- The medicine may cause severe breathing problems right after you use a dose. If this happens, use your rescue inhaler. Contact your doctor or seek other medical care at once.
- Formoterol may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Tell your doctor or dentist that you use formoterol before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including lung function and blood potassium levels, may be performed while you use formoterol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Caution is advised when using formoterol in CHILDREN; they may be more sensitive to its effects, especially nausea, stomach pain, and stomach upset.
- Formoterol should be used with extreme caution in CHILDREN younger than 5 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using formoterol while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use formoterol, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of formoterol:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Dizziness; dry mouth; headache; mild sore throat; nausea; nervousness; runny or stuffy nose; stomach pain or upset; tiredness; tremor; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness); chest pain; fainting; fast breathing; fast or irregular heartbeat; fever, chills, or persistent sore throat; muscle pain, weakness, or cramps; new or worsening asthma or COPD symptoms (eg, increased chest tightness, coughing, shortness of breath, wheezing); severe or persistent headache, dizziness, light-headedness, tremor, or nervousness; severe or persistent nausea, vomiting, or stomach pain; severe or unusual drowsiness; sluggishness; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; drowsiness; flushing of the skin; confusion; fruit-like breath odor); voice changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; fainting; fast breathing; fast or irregular heartbeat; muscle pain, weakness, or cramps; seizures; severe or persistent dizziness, dry mouth, fatigue, headache, light-headedness, nausea, nervousness, trouble sleeping, tremors, or vomiting; severe or unusual drowsiness; shortness of breath; sluggishness; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; drowsiness; flushing of the skin; confusion; fruit-like breath odor).Proper storage of formoterol:
Store formoterol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and direct sunlight. Do not use formoterol if it is past the "use by" date on the container. Keep formoterol out of the reach of children and away from pets.
- If you have any questions about formoterol, please talk with your doctor, pharmacist, or other health care provider.
- Formoterol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take formoterol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about formoterol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to formoterol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using formoterol.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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