Advair HFA

Generic Name: fluticasone and salmeterol (Inhalation route)

floo-TIK-a-sone PROE-pee-oh-nate, sal-ME-ter-ol zye-NAF-oh-ate

Commonly used brand name(s):

In the U.S.

• Advair Diskus
• Advair Diskus 100/50
• Advair Diskus 250/50
• Advair Diskus 500/50
• Advair HFA

In Canada

• Advair
• Advair Inhalation Aerosol

Available Dosage Forms:

• Aerosol Liquid
• Disk
• Aerosol Powder

Therapeutic Class: Antiasthma, Anti-Inflammatory/Bronchodilator Combination

Pharmacologic Class: Fluticasone

Uses For Advair HFA

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) of the lungs. Salmeterol does not act quickly enough to relieve an asthma attack that has already started.

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.

Before Using Advair HFA

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:

Allergies

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluticasone and salmeterol combination in children older than 4 years of age. Safety and efficacy have not been established for children younger than 4 years old.

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.

Geriatric

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.

Pregnancy

Breast Feeding

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.

Interactions with Medicines

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.

• Acebutolol
• Alprenolol
• Arotinolol
• Atazanavir
• Atenolol
• Befunolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Bopindolol
• Brofaromine
• Bucindolol
• Bupranolol
• Bupropion
• Carteolol
• Carvedilol
• Celiprolol
• Clarithromycin
• Clorgyline
• Darunavir
• Dilevalol
• Esmolol
• Furazolidone
• Indinavir
• Iproniazid
• Isocarboxazid
• Itraconazole
• Ketoconazole
• Labetalol
• Landiolol
• Lazabemide
• Levobetaxolol
• Levobunolol
• Linezolid
• Mepindolol
• Metipranolol
• Metoprolol
• Moclobemide
• Nadolol
• Nebivolol
• Nefazodone
• Nelfinavir
• Nialamide
• Nipradilol
• Oxprenolol
• Pargyline
• Penbutolol
• Phenelzine
• Pindolol
• Procarbazine
• Propranolol
• Rasagiline
• Ritonavir
• Saquinavir
• Selegiline
• Sotalol
• Talinolol
• Telithromycin
• Tertatolol
• Timolol
• Tipranavir
• Toloxatone
• Tranylcypromine

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.

• Erythromycin

Interactions with Food/Tobacco/Alcohol

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. Discuss with your healthcare professional the use of your medicine with 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:

• Asthma attack, acute or
• Bronchospasm (difficulty with breathing), acute or
• COPD flare-up or
• Milk protein allergy, severe—Should not be used in patients with these conditions.

• Blood vessel disease (e.g., Churg-Strauss syndrome) or
• Bone problems (e.g., osteoporosis) or
• Cataracts or
• Glaucoma or
• Heart disease or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Seizures, history of—Use with caution. May make these conditions worse.

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

• Diabetes mellitus or
• Ketoacidosis (high ketones in the blood)—Blood sugar levels may increase.

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

• Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of fluticasone and salmeterol

This section provides information on the proper use of a number of products that contain fluticasone and salmeterol. It may not be specific to Advair HFA. Please read with care.

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 inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

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.

When you use the 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 inhaler:

• To open the inhaler, push the thumb grip 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 thumb grip, 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 20 to 0 will show up in red to remind you to refill your prescription. Throw away the inhaler when the count is 000. You may not receive the right amount of medicine.

Dosing

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.

• For inhalation dosage form (aerosol):
  • For preventing an asthma attack:
    • Adults and children 12 years of age and older—Two puffs in the morning and another two puffs in the evening.
    • Children younger than 12 years of age—Use and dose must be determined by your child's doctor.

• For inhalation dosage form (powder):
  • For bronchial asthma:
    • Adults and children 4 years of age and older—One inhalation two times 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 (COPD) with chronic bronchitis or emphysema:
    • Adults—One inhalation (250/50) two times a day, about 12 hours apart.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

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.

Storage

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.

Precautions While Using Advair HFA

It is very important that your doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects caused by this medicine.

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:

• Your symptoms do not improve after using this medicine for 1 week or if they become worse.
• Your short-acting inhaler does not seem to work as well as it used to and you need it more often than normal.
• You have a big 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.

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™).

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

Patients with COPD may be more likely to have pneumonia. Call your doctor if you 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 asking your doctor first.

Your doctor may want you to carry a medical identification (ID) card stating that you 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.

This medicine may cause bronchospasm, which may be life-threatening. Check with your doctor right away if you are having a cough, difficulty with breathing, shortness of breath, or wheezing.

If you develop a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible.

Check with your doctor right away if you 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.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you 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.

Advair HFA Side Effects

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:

• Black, tarry stools
• blindness
• blurred vision
• burning, tingling, numbness, or pain in the hands, arms, feet, or legs
• chills
• cough
• decreased vision
• difficulty with breathing or swallowing
• eye pain
• fast heartbeat
• fever
• headache
• hives or welts
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nausea or vomiting
• noisy breathing
• painful or difficult urination
• sensation of pins and needles
• shortness of breath
• skin itching, rash, or redness
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stabbing pain in the arms or legs
• swelling of the face, throat, or tongue
• swollen glands
• tearing
• unusual bleeding or bruising
• wheezing

• Abdominal or stomach pain
• backache
• bruising
• darkening of the skin
• decrease in height
• diarrhea
• difficulty with moving
• dizziness
• facial hair growth in females
• fainting
• fast, slow, pounding, or irregular heartbeat or pulse
• flushed, dry skin
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• heavy bleeding
• increased hunger
• increased thirst or urination
• irritability
• large, flat, blue, or purplish patches in the skin
• loss of sexual desire or ability
• menstrual irregularities
• mental depression
• muscle pain or stiffness
• muscle wasting
• pain in the back, ribs, arms, or legs
• pain in the joints
• sweating
• troubled breathing
• unexplained weight loss
• unusual tiredness or weakness
• weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:

• Chest pain or tightness
• confusion
• convulsions (seizures)
• decreased urine output
• dry mouth
• faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• general feeling of discomfort or illness
• high blood pressure
• loss of appetite
• mood changes
• nervousness
• numbness or tingling in the hands, feet, or lips
• sudden sweating
• tremors
• trouble with sleeping

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:

• Body aches or pain
• choking
• congestion
• dryness of the throat
• high-pitched noise when breathing
• hoarseness
• runny nose
• sneezing
• trouble with swallowing
• voice changes

• Cough-producing mucus
• flu-like symptoms
• irritation or inflammation of the eye
• muscle pain
• pain or tenderness around the eyes and cheekbones
• sleep disorders
• stuffy nose
• white patches in the mouth or throat or on the tongue

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.

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