Fluticasone Propionate/Salmeterol, Inhalation

What are other names for this medicine?

Type of medicine: corticosteroid; bronchodilator

Generic and brand names: fluticasone propionate/salmeterol, inhalation; Advair Diskus; Advair HFA

What is this medicine used for?

This combination of two medicines is inhaled through the mouth. It helps prevent or decrease wheezing and trouble breathing from asthma or chronic lung disease.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine or to milk proteins
• an infection such as herpes or tuberculosis (TB)
• a weakened immune system from diseases such as HIV/AIDS or from cancer chemotherapy, or radiation therapy
• diabetes
• eye problems such as cataracts or glaucoma
• heart disease or irregular heartbeat
• high blood pressure
• liver disease
• osteoporosis
• seizures
• thyroid disorder

Also tell your healthcare provider if you are taking a corticosteroid such as prednisone by mouth.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Do not use this medicine to treat an asthma attack that has already started. This medicine is used to prevent asthma attacks.

Check the label on the medicine for directions about your specific dose. Use this medicine exactly as your healthcare provider prescribes. Do not use more or less than prescribed. Use it every day at the same times. You may feel better in a day or two after you start using this medicine, but you will probably need to use the medicine for 2 weeks to feel its full benefit.

Read the information sheet that comes in the medicine package. If you do not understand how to use the inhaler device, ask your healthcare provider or pharmacist to explain.

If you have the Diskus:

Do not shake the inhaler. Do not try to use a spacer with this medicine. To use the inhaler:

1. 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.
2. 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.
3. Turn your head away from the inhaler, and breathe out to the end of a normal breath. Do not breathe into the inhaler.
4. Hold the inhaler level and put the mouthpiece between your lips. Close your lips around the mouthpiece.
5. Breathe in through your mouth as deeply as you can. Do not breathe through your nose.
6. Hold your breath and remove the mouthpiece from your mouth. Hold your breath for 5 to 10 seconds, or as long as is comfortable before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
7. Turn your head away from the inhaler, and breathe out slowly. Do not breathe into the inhaler.
8. To 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.
9. Keep the inhaler dry. Do not wash it. You may use a dry cloth to wipe it clean.

The inhaler has a window that shows the number of doses that are left. Refill the prescription before the counter gets to 0 so that you will not run out of medicine.

If you have the Advair HFA and are not using a spacer, follow these directions:

1. Prime the inhaler before you use it the first time. To prime the inhaler, shake it well for 5 seconds then spray into the air. Do this 4 times. Do not spray in eyes. Each time you use the inhaler:
2. Use only the purple mouthpiece that comes with this medicine. Remove the plastic cap from the mouthpiece. Shake the inhaler for 5 seconds before each use.
3. Hold the inhaler upright so the mouthpiece is at the bottom.
4. Put the mouthpiece into your mouth. Close your lips around the mouthpiece, keeping your tongue below it.
5. Breathe out as fully as you comfortably can.
6. Press the inhaler down once so it releases a spray of medicine into your mouth while you breathe in slowly. (One spray is called a puff.) Each time you press down, a metered (measured) dose is delivered.
7. Continue breathing in as slowly and deeply as possible.
8. Hold your breath for 10 seconds or as long as is comfortable (this gives the medicine time to reach the airways).
9. Remove the inhaler from your mouth. Breathe out slowly.
10. If your health care provider has prescribed more than one puff (spray) for each dose, wait 30 seconds between puffs and then repeat steps 1 through 9. Take the number of puffs prescribed by your health care provider.

After each use, rinse your mouth with water and spit the water out. This helps prevent thrush (a fungal infection that shows up as white spots on your tongue and in your mouth).

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: chest pain, fast irregular heartbeat, seizures, tremors, weakness, headache, nausea, vomiting.

What should I watch out for?

If your healthcare provider prescribes another medicine to be inhaled, ask how long you should wait between doses of the different medicines.

Do not use this medicine for sudden breathing problems or asthma attacks that have already started. Your healthcare provider will prescribe a short-acting inhaled medicine to use when you have an asthma attack.

If your asthma is quickly getting worse, it may be life-threatening. Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Talk with your healthcare provider about this. If you have any of the following signs of worsening asthma, call your healthcare provider right away:

• You need to use more puffs than usual of your short-acting inhaler or use it more often.
• You have severe breathing trouble that does not improve, such as persistent wheezing, coughing, or shortness of breath.
• You have a bluish color in your lips or fingernails or are unable to speak.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. If you are exposed to an infectious disease, contact your healthcare provider right away. Also, do not have any vaccines without getting your healthcare provider's approval first.

Do not stop taking this medicine without your healthcare provider's approval. Suddenly stopping this medicine may be life-threatening.

This medicine may affect growth in children. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Trouble breathing or catching your breath, cough, chest pain, irregular heartbeat, unexplained bruising or sores, fever, joint or muscle pain, white patches in your mouth.

Other: Headache, runny or stuffy nose, nausea, vomiting, dry mouth, dizziness, hoarseness, diarrhea, shakiness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), doxycycline (Adoxa, Doryx, Vibramycin), erythromycin (EES, Ery-Tab, Erythrocin), and telithromycin (Ketek)
• antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• beta blockers such as atenolol (Tenormin), carteolol, bisoprolol (Zebeta), pindolol, metoprolol (Lopressor, Toprol XL), nadolol (Corgard), propranolol (Inderal), timolol, and betaxolol (Kerlone)
• diuretics (water pills) such as bumetanide (Bumex), ethacrynic acid (Edecrin), furosemide (Lasix), torsemide (Demadex), chlorothiazide (Diuril), hydrochlorothiazide (Microzide, Oretic), hydroflumethiazide (Diucardin), and polythiazide (Renese)
• imatinib (Gleevec)
• MAO inhibitor antidepressants such as isocarboxazid (Marplan), phenelzine (Nardil), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• medicines to treat HIV such as indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), delavirdine (Rescriptor), ritonavir (Norvir), and saquinavir (Fortovase, Invirase)
• other long-acting beta2-adrenergic agonists to treat breathing or lung problems such as formoterol (Foradil) or salmeterol (Serevent)
• tricyclic antidepressants such as amitriptyline, nortriptyline (Aventyl, Pamelor), imipramine (Tofranil), and doxepin (Sinequan) (Do not take this medicine and an antidepressant within 14 days of each other)

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Tell all healthcare providers who treat you about any other medicines you are taking by mouth, inhalation, or shots.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

Keep the device in the foil pouch until you are ready to use the medicine. Discard the device 1 month after opening the pouch or when the dosage counter shows 0, whichever comes first.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.