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|Advair Diskus Inhalation-Local

FLUTICASONE AND SALMETEROL (Inhalation-Local)

Some commonly used brand names are:

In the U.S.—

• Advair Diskus

In Canada—

• Advair
• Advair Diskus

Category

• Antiasthmatic
• anti-inflammatory (inhalation)
• bronchodilator

Description

Fluticasone (floo-TIK-a-sone) and salmeterol (sal-ME-te-role) is a combination of two medicines that are used to help control the symptoms of asthma and improve lung function. However, this medicine will not relieve an asthma attack that has already started.

Inhaled fluticasone belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms. It will not relieve an asthma attack that has already started.

Inhaled salmeterol is a long-acting bronchodilator and it belongs to the family of medicines known as bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) of the lungs. Salmeterol is different than other bronchodilators because it does not act quickly enough to relieve an asthma attack that has already started.

This medicine must be used with a short-acting beta₂ agonist (e.g. albuterol) for the treatment of an asthma attack or asthma symptoms that need immediate attention.

This medicine is available only with your doctor"s prescription, in the following dosage form:

• Inhalation
• Inhalation aerosol (Canada)
• Inhalation powder (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fluticasone and salmeterol, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to fluticasone or salmeterol.

Pregnancy—The combination of fluticasone and salmeterol has not been studied in pregnant women. However, studies in animals have shown that the fluticasone and salmeterol causes problems. Before taking this medicine, make sure your doctor knows if you are pregnant or plan to become pregnant.

Breast-feeding—It is not known whether the combination of fluticasone and salmeterol passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Corticosteroids taken by mouth or injection have been shown to slow or stop growth in children and cause reduced adrenal gland function. If enough fluticasone is absorbed following inhalation, it is possible it also could cause these effects. Your doctor will want you to use the lowest possible dose of fluticasone that controls asthma. This will lessen the chance of an effect on growth or adrenal gland function. It is also important that children taking fluticasone visit their doctors regularly so that their growth rates may be monitored. Children who are taking this medicine may be more susceptible to infections, such as chickenpox or measles. Care should be taken to avoid exposure to chickenpox or measles. If the child is exposed or the disease develops, the doctor should be contacted and his or her directions should be followed carefully. Before this medicine is given to a child, you and your child"s doctor should talk about the good this medicine will do as well as the risks of using it.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing the use of fluticasone and salmeterol in the elderly with other age groups, this medicine has been used in elderly patients and is not expected to cause different side effects or problems in older people than it does in younger adults. Elderly people who have cardiovascular disease may have increased chances of side effects from this medicine.

Other medicines—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 fluticasone and salmeterol, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Norpramin], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Pamelor], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil]) or
• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking fluticasone and salmeterol while you are taking or within 2 weeks of taking MAO inhibitors may increase side effects

• Beta-adrenergic receptor blocking agents (acebutolol [e.g., Sectral], atenolol [e.g., Tenormin], betaxolol [e.g., Kerlone], bisoprolol [e.g., Zebeta], carteolol [e.g., Cartrol], carvedilol [e.g., Coreg], celiprolol [e.g., Cardem], esmolol [e.g., Brevibloc], labetalol [e.g., Normodyne], metoprolol [e.g., Lopressor], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Betapace], timolol [e.g., Blocadren])—Use of these medicines can block the beneficial effect of salmeterol

• Beta₂ -adrenergic agonist, long lasting (e.g., Bitolterol mesylate)—You should not use additional salmeterol or other inhaled long-lasting beta₂ -agonist

• Ritonavir (e.g. Norvir)—Use may increase your risk of fluticasone side effects

Other medical problems—The presence of other medical problems may affect the use of fluticasone and salmeterol combination. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, severe or
• Infection or
• Stress or
• Surgery or
• Trauma—Supplementary oral corticosteroids may be needed. Check with your doctor.

• Chickenpox (including recent exposure) or
• Measles or
• Herpes simplex (virus) infection of the eye or
• Infections (virus, bacteria, or fungus) or
• Tuberculosis (active or history of)—Inhaled fluticasone can reduce the body"s ability to fight off these infections

• Diabetes mellitus or
• Ketoacidosis—Blood sugar levels may increase

• Heart or blood vessel disease or
• High blood pressure or
• Overactive thyroid or
• Seizures—This medicine may worsen these conditions

• Eosinophilic conditions—Fluticasone may make these conditions worse

• Osteoporosis (bone disease)—Inhaled corticosteroids in high doses may make this condition worse.

Proper Use of This Medicine

Inhaled fluticasone and salmeterol is used to prevent asthma attacks. 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 health care professional.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking 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.

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.

Inhaled fluticasone and salmeterol is used with a special inhaler that comes with patient directions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your health care professional to show you what to do. Also, ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly.

To use the disposable inhaler for inhalation powder:

• To open the inhaler, push the thumbgrip away from you as far as it will go. You will hear a click and feel a snap. When open, the mouthpiece will appear.
• Slide the mouthpiece lever away from you as far as it will go until it clicks. The inhaler is now ready to use. If you close the inhaler or push the lever again, you will lose medicine.
• Turn your head away from the inhaler, and breathe out to the end of a normal breath. Do not breathe into the inhaler.
• Holding the inhaler level, put the mouthpiece between your lips and teeth, and close your lips around the mouthpiece. Do not bite down on the mouthpiece. Do not block the mouthpiece with your teeth or tongue.
• Breathe in through your mouth as deeply as you can until you have taken a full deep breath. Do not breathe through your nose.
• Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
• Turn your head away from the inhaler, and breathe out slowly to the end of a normal breath. Do not breathe into the inhaler.
• If your doctor has told you to inhale more than one puff of medicine at each dose, take the second puff following exactly the same steps you used for the first puff.
• When you are finished, close the inhaler. Place your thumb on the thumbgrip, and slide it back toward you as far as it will go. You will hear it click shut.
• Keep the inhaler dry. Do not wash the mouthpiece, or any other part of the inhaler. You may use a dry cloth to wipe it clean.
• The inhaler has a window that shows the number of doses remaining. This tells you when you are getting low on medicine. The doses counting down from 5 to 0 will show up in red to remind you to refill your prescription.

Dosing—The dose of inhaled fluticasone and salmeterol will be different for different patients. Follow your doctor"s orders or the direction on the label. The following information includes only the average doses of inhaled fluticasone and salmeterol. If your dose is different, do not change it unless your doctor tells you to do so.

• For powder for inhalation
  • For bronchial asthma
    • Adults and children 4 years of age and older: One inhalation twice a day, about 12 hours apart.
    • Children up to 4 years of age: Use and dose must be determined by your doctor.
  • For chronic obstructive pulmonary disease with chronic bronchitis
    • Adults: One inhalation (250/50) twice a day, about 12 hour apart.
    • Children: Use and dose must be determined by your doctor.

Missed dose— If you miss a dose of this medicine skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store at room temperature.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Store away from direct heat or sunlight.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Check with your doctor if your asthma symptoms do not improve or your condition worsens. Check with your doctor if you notice:

• Your short-acting inhaler does not seem to work as well as it used to
• You need to use your short-acting inhaler more often
• You have a significant decrease in your peak flow when measured as directed by your doctor

Do not use this medicine to treat wheezing that is getting worse. Call your doctor right away if wheezing worsens while using this medicine.

Although this medicine decreases the number of asthma episodes, these medicines may increase the chances of a severe asthma episode 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.

Side Effects of This Medicine

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.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in the product labeling, fluticasone and salmeterol combination is used in certain patients with the following medical conditions:

• Emphysema

Developed: 12/04/2000
Revised: 12/02/2005

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