floo-TIK-a-sone PROE-pee-oh-nate, sal-ME-ter-ol zye-NAF-oh-ate
Long-acting beta 2-adrenergic agonists (LABA) increase the risk of asthma-related deaths. In a large trial that compared the safety of salmeterol or placebo added to usual asthma therapy, there was an increase in asthma-related deaths with salmeterol. Available data have not determined whether concurrent inhaled corticosteroid or other long-term asthma control drug use mitigates the increased risk of asthma-related death from LABA. Data from pediatric and adolescent trials suggest that LABA increase the risk of asthma-related hospitalization. Therefore, when treating patients with asthma, fluticasone propionate/salmeterol inhalation powder or aerosol should only be used for patients not adequately controlled on a long-term asthma control medication or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue fluticasone propionate/salmeterol) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication. Do not use fluticasone propionate/salmeterol for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids .
Antiasthma, Anti-Inflammatory/Bronchodilator Combination
Fluticasone and salmeterol is a combination of two medicines that are used to help control the symptoms of asthma and improve breathing. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day. This medicine will not relieve an asthma attack that has already started.
This medicine is also used to treat air flow blockage and reduce the worsening of chronic obstructive pulmonary disease (COPD). This includes chronic bronchitis and emphysema.
Inhaled fluticasone belongs to the family of medicines known as corticosteroids or steroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.
Inhaled salmeterol is a long-acting bronchodilator. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. It relieves cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.
This medicine must be used with a short-acting medicine (e.g. albuterol) for an asthma attack or asthma symptoms that need attention right away.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Advair® Diskus® to treat asthma in children older than 4 years of age. Safety and efficacy have not been established in children younger than 4 years of age.
Appropriate studies have not been performed on the relationship of age to the effects of Advair® HFA oral inhalation in children younger than 12 years of age. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluticasone and salmeterol combination in the elderly. However, elderly people with heart and blood vessel problems may require special caution when receiving fluticasone and salmeterol combination.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Inhaled fluticasone and salmeterol is used to prevent asthma attacks and to treat chronic obstructive pulmonary disease (COPD). It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.
Inhaled fluticasone and salmeterol is used with a special inhaler that comes with patient directions or a medication guide. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the Diskus® or inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the Diskus® or inhaler to make sure you are using it properly.
Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.
In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.
Do not stop using this medicine or other asthma medicines that your doctor has prescribed for you unless you have discussed this with your doctor.
When you use the Advair® HFA inhaler for the first time, or if you have not used it for 7 days or longer, or if the inhaler has been dropped, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine four times into the air away from the face, and shaking it well for 5 seconds before each spray. Avoid spraying it in your eyes.
Rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. However, do not swallow the water after rinsing.
To use the Diskus®:
To use the Advair® HFA inhaler:
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.
Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
If you will be using this medicine for a long time, it is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.
Tell your doctor if you or your child are also using other medicines for your COPD. Your doctor may want you to stop using the medicine and use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.
This medicine should not be used if you are having a severe COPD attack, or if symptoms of a COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.
This medicine should only be used as an additional treatment for patients who cannot be treated with other asthma medicines (such as inhaled corticosteroids) or for asthma patients that require two medicines, including salmeterol. Ask your doctor if you have any questions.
Although this medicine decreases the number of asthma episodes, it may increase the chance of a severe asthma attack when they do occur. Be sure to read about these risks in the Medication Guide and talk to your doctor or pharmacist about any questions or concerns that you have.
You should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Make sure you understand how to use the short-acting inhaler. Talk to your doctor if you need instructions.
Talk with your doctor or get medical care right away if:
Do not use this medicine to treat wheezing that is getting worse. Call your doctor right away if wheezing worsens while using this medicine.
Do not use any other asthma medicine or medicine for breathing problems without talking to your doctor. This medicine should not be used with other inhalers that contain budesonide and formoterol combination (Symbicort®), formoterol (Foradil® Aerolizer®, Perforomist™), or arformoterol (Brovona™).
This medicine may cause a fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat; or pain when eating or swallowing.
Patients with COPD may be more likely to have pneumonia. Call your doctor if you or your child start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or an increase in breathing problems.
Do not change your dose or stop using your medicine without first asking your doctor.
Your doctor may want you to carry a medical identification (ID) card stating that you or your child are using this medicine. The card will say that you may need additional medicine during an emergency, a severe asthma attack or other illness, or unusual stress.
Using too much of this medicine or using it for a long time may cause may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or vomiting.
This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using this medicine and check with your doctor right away if you or your child are having a cough, difficulty with breathing, shortness of breath, or wheezing after using this medicine.
If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, stop using the medicine and check with your doctor as soon as possible.
Check with your doctor right away if you or your child have chest pain, a fast heartbeat, nervousness, shaking of the hands or feet, noisy breathing, a feeling of choking, or tightness or irritation of the throat while using this medicine.
This medicine may affect blood sugar and potassium levels. If you have heart disease or are diabetic and notice a change in the results of your blood or urine sugar or potassium tests, check with your doctor.
Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).
This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.
This medicine may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.
This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.