Welcome to FORADIL.US
Important safety-related changes have been made to the Prescribing Information and Medication Guide of FORADIL AEROLIZER.
As part of these safety-related changes, the following sections of the Medication Guide provided to patients have been updated:
- What is the most important information I should know about FORADIL AEROLIZER?
- What is FORADIL AEROLIZER?
- Who should not use FORADIL AEROLIZER?
- What are the possible side effects with FORADIL AEROLIZER?
These updated sections, and the rest of the Medication Guide can be accessed below. Click on an individual question to see the information from
Medication Guide responsive to that question.
Medication Guide
Foradil® [FOR-a-dil] Aerolizer®
(formoterol fumarate inhalation powder)
Important: Do not swallow FORADIL capsules. FORADIL capsules
are used only with the Aerolizer inhaler that comes with FORADIL
AEROLIZER. Never place a capsule in the mouthpiece of the
AEROLIZER Inhaler.
Read the Medication Guide that comes with FORADIL AEROLIZER before you start
using it and each time you get a refill. There may be new information. This
Medication Guide does not take the place of talking to your health care provider
about your medical condition or treatment.
What is the most important information I should know about FORADIL AEROLIZER?
FORADIL AEROLIZER can cause serious side effects, including:
1. People with asthma who take long-acting beta2-adrenergic agonist
(LABA) medicines, such as formoterol fumarate inhalation powder
(FORADIL AEROLIZER), have an increased risk of death from asthma
problems.
- Call your healthcare provider if breathing problems worsen over
time while using FORADIL AEROLIZER. You may need a different
treatment.
- Get emergency medical care if:
- breathing problems worsen quickly, and
- you use your rescue inhaler medicine, but it does not relieve
your breathing problems.
2. Do not use FORADIL AEROLIZER as your only asthma medicine.
FORADIL AEROLIZER must only be used with a long-term asthma control medicine, such as an inhaled corticosteroid.
3. When your asthma is well controlled, your healthcare provider may tell you to stop taking FORADIL AEROLIZER. Your healthcare provider will decide if you can stop FORADIL AEROLIZER without loss of asthma control. You will continue taking your long-term asthma control medicine, such as an inhaled corticosteroid.
4. Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.
|
What is FORADIL AEROLIZER?
FORADIL AEROLIZER is a long-acting beta2-agonist
(LABA). LABA medicines help
the muscles around the airways in your lungs stay relaxed to prevent asthma
symptoms, such as wheezing and shortness of breath. These symptoms can
happen when the muscles around the airways tighten. This makes it hard to
breathe. In severe cases, wheezing can stop your breathing and cause death if
not treated right away.
FORADIL AEROLIZER is used for asthma, exercise-induced bronchospasm (EIB)
and chronic obstructive pulmonary disease (COPD) as follows:
Asthma
FORADIL AEROLIZER is used with a long-term asthma control medicine, such as
an inhaled corticosteroid, in adults and children ages 5 and older:
- to control symptoms of asthma, and
- to prevent symptoms such as wheezing
LABA medicines, such as FORADIL AEROLIZER, increase the risk of death from asthma problems. FORADIL AEROLIZER is not for adults and children with asthma who are well controlled with long-term asthma control medicine, such as low to medium dose of an inhaled corticosteroid medicine.
Exercise-Induced Bronchospasm (EIB)
FORADIL AEROLIZER is used to prevent wheezing caused by exercise in adults
and children 5 years of age and older.
- If you have EIB only, your healthcare provider may prescribe only
FORADIL AEROLIZER for your condition
- If you have EIB and asthma, your healthcare provider should also
prescribe a long-term asthma control medicine, such as an inhaled
corticosteroid.
Chronic Obstructive Pulmonary Disease (COPD)
FORADIL AEROLIZER is used long-term, 2 times each day (morning and
evening), to control symptoms of COPD and prevent wheezing in adults with COPD.
|
Who should not use FORADIL AEROLIZER?
- Do not take FORADIL AEROLIZER to treat your asthma without a long-term
asthma control medicine, such as an inhaled corticosteroid.
- If you are allergic to formoterol fumarate or any of the ingredients in FORADIL
AEROLIZER. Ask your healthcare provider if you are not sure. See the end of
this Medication Guide for a complete list of ingredients in FORADIL
AEROLIZER.
|
What should I tell my healthcare provider before using FORADIL AEROLIZER?
Tell your healthcare provider about all of your health conditions,
including if you:
- have heart problems
- have high blood pressure
- have seizures
- have thyroid problems
- have diabetes
- are pregnant or planning to become pregnant. It is not known if FORADIL
AEROLIZER may harm your unborn baby.
- are breastfeeding. It is not known if FORADIL AEROLIZER passes into your
milk and if it can harm your baby.
- are allergic to FORADIL AEROLIZER, any other medicines, or food products.
FORADIL AEROLIZER contains lactose (milk sugar) and a small amount of milk
proteins. It is possible that allergic reactions may happen in patients who have a
severe milk protein allergy.
Tell your healthcare provider about all the medicines you take including
prescription and non-prescription medicines, vitamins, and herbal supplements.
FORADIL AEROLIZER and certain other medicines may interact with each other.
This may cause serious side effects.
Know the medicines you take. Keep a list and show it to your healthcare provider
and pharmacist each time you get a new medicine.
|
How do I use FORADIL capsules with the AEROLIZER inhaler?
See the step-by-step instructions for using FORADIL Capsules with the
AEROLIZER inhaler at the end of this Medication Guide. Do not use FORADIL
unless your healthcare provider has taught you and you understand everything.
Ask your healthcare provider or pharmacist if you have any questions.
|
What are the possible side effects with FORADIL AEROLIZER?
FORADIL AEROLIZER may cause serious side effects, including:
- See "What is the most important information I should know about FORADIL AEROLIZER?"
- Bronchospasm with wheezing or coughing and difficulty breathing
- Low blood potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm)
- Fast or irregular heart beat (palpitations)
- Serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.
Other possible side effects with FORADIL AEROLIZER include:
- chest pain
- increased blood pressure
- nervousness
- dry mouth
- muscle cramps
- nausea
- dizziness
- tiredness
- high blood sugar
- high blood acid
- trouble sleeping
Common side effects with FORADIL AEROLIZER include:
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all the side effects with FORADIL AEROLIZER. Ask your healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
|
How do I store FORADIL AEROLIZER?
- Store FORADIL AEROLIZER at room temperature between 68°F and 77°F(20°C to 25°C). Protect FORADIL AEROLIZER from heat and moisture. Do not not remove FORADIL capsules from their foil package until just before use.
- Always discard the old AEROLIZER inhaler by the "Use by" date and use the new one provided with each new prescription.
- Safely discard FORADIL capsules and the Aerolizer inhaler if no longer needed or is out-of-date.
- Keep FORADIL AEROLIZER and all medicines out of the reach of children.
|
General Information about FORADIL AEROLIZER
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FORADIL AEROLIZER for a condition for which it was not prescribed. Do not give FORADIL AEROLIZER to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about FORADIL AEROLIZER. If you would like more information, talk with your
healthcare provider. You can ask your healthcare provider or pharmacist for information about FORADIL AEROLIZER that was written for healthcare professionals. If you have any questions about the use of FORADIL AEROLIZER, call (toll-free) 1-800-526-4099 or go to www.foradil.us.
|
What are the ingredients in FORADIL AEROLIZER?
Active ingredient: formoterol fumarate
Inactive ingredients: lactose (contains milk proteins), gelatin (capsule shell)
|
Click here for Instructions for Using FORADIL AEROLIZER
We encourage you to read the updated Prescribing Information and Medication Guide, which can be accessed from the following links:
Prescribing Information for FORADIL
Medication Guide for FORADIL
Merck encourages health care providers and consumers to report any adverse experience associated with any Merck medication or vaccine. Physicians can report adverse events through their Merck sales representative, the Merck National Service Center (800-444-2080), or FDA MedWatch (www.fda.gov/medwatch), or call 1-800-FDA-1088. Patients can report adverse events through their health care provider, the Merck National Service Center, or FDA MedWatch.
If you have any questions about the updated Prescribing Information or Patient Information, please contact the Merck National Service Center at 800-444-2080.
