Disp Pack
Chemical Name: FLUTICASONE (flew-TICK-uh-sone) and SALMETEROL (sal-MET-er-all)
Common uses Advair Diskus 28 250-50mcg/dose Aerosol is a
long-acting corticosteroid and bronchodilator combination. Advair Diskus 28 250-50mcg/dose Aerosol is used for
treating asthma in certain patients. It may also be used for long-term treatment of chronic obstructive pulmonary
disease (COPD) in certain patients. It may also be used to treat other breathing conditions as determined by your
doctor.
Before using
WARNING: Long-acting beta-agonists, such as one of the active ingredients in Advair Diskus 28 250-50mcg/dose
Aerosol (salmeterol), have been rarely associated with an increased risk of asthma-related death. They may also
increase the risk of asthma-related hospitalizations in CHILDREN and TEENAGERS. Advair Diskus 28 250-50mcg/dose
Aerosol should only be used to treat asthma in patients who are not controlled by using other long-term
asthma-control medicine. Advair Diskus 28 250-50mcg/dose Aerosol should not be used in patients whose asthma is
well controlled by inhaled corticosteroids. SOME MEDICINES MAY INTERACT with Advair Diskus 28 250-50mcg/dose
Aerosol. DO NOT TAKE ADVAIR DISKUS 28 250-50mcg/DOSE AEROSOL if you are using another type of long-acting inhaled
bronchodilator (eg, formoterol, salmeterol) or you are taking an azole antifungal (eg, itraconazole, ketoconazole),
certain HIV protease inhibitors (eg, atazanavir, indinavir, ritonavir), a macrolide antibiotic (eg,
clarithromycin), nefazodone, or telithromycin. TELL YOUR HEALTH CARE PROVIDER if you are taking any other
medicines, especially any of the following: diuretics (eg, hydrochlorothiazide, furosemide), beta-blockers (eg,
propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), delavirdine, HIV protease inhibitors
(eg, atazanavir, indinavir, ritonavir), macrolide antibiotics (eg, clarithromycin), or short-acting beta-agonist
bronchodilators (eg, albuterol). Tell your doctor if you are taking a monoamine oxidase inhibitor (MAOI) (eg,
phenelzine) or a tricyclic antidepressant (eg, amitriptyline), or if you have taken one within the past 14 days.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Advair Diskus
28 250-50mcg/dose Aerosol may interact with other medicines you take. DO NOT START OR STOP any medicine without
doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of diabetes;
eye problems (eg, cataracts, glaucoma, increased pressure in the eye); heart problems (eg, fast or irregular
heartbeat, heart blood vessel problems); high blood pressure; nervous system problems; liver problems; low blood
potassium levels; high blood acid levels (eg, ketoacidosis); seizures; thyroid problems; an adrenal gland tumor; or
an unusual reaction to a sympathomimetic medicine (eg, albuterol, pseudoephedrine), such as fast or irregular
heartbeat, overexcitement, or severe trouble sleeping. Tell your doctor if you have a fungal, bacterial, or
parasitic infection; a viral infection (eg, measles, chickenpox, shingles); herpes virus infection of the eye;
tuberculosis (TB); a history of a positive TB skin test; an immune system problem; a recent vaccination; allergies;
pregnancy; or breast-feeding. Tell your doctor if you have weak bones (osteoporosis) or risk factors of
osteoporosis (eg, a family history of osteoporosis, tobacco use, long-term use of corticosteroids or certain
seizure medicines, limited physical exercise, poor nutrition). Tell your doctor if you are having a COPD flare-up,
have recently been to an emergency room for asthma, have a history of frequent hospitalizations for asthma, or have
ever had a life-threatening asthma attack. USE OF ADVAIR DISKUS 28 250-50mcg/DOSE AEROSOL IS NOT RECOMMENDED if you
are having an asthma attack or severe breathing problems (eg, sudden, severe onset or worsening of asthma or COPD
symptoms, such as chest tightness, cough, shortness of breath, wheezing). USE OF ADVAIR DISKUS 28 250-50mcg/DOSE
AEROSOL IS NOT RECOMMENDED if you have asthma that is already well controlled with the use of a long-term
asthma-control medicine (eg, inhaled corticosteroid). Advair Diskus 28 250-50mcg/dose Aerosol should not be used in
CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed. Contact your
doctor or pharmacist if you have any questions or concerns about using Advair Diskus 28 250-50mcg/dose Aerosol.
Directions Follow the directions for using Advair Diskus
28 250-50mcg/dose Aerosol provided by your doctor. Advair Diskus 28 250-50mcg/dose Aerosol comes with a MEDICATION
GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill Advair Diskus 28
250-50mcg/dose Aerosol. Ask your doctor, nurse, or pharmacist any questions that you may have about Advair Diskus
28 250-50mcg/dose Aerosol. Refer to the illustrated directions provided for instruction on the correct use of this
device. YOUR DOSE OF MEDICINE IS A VERY FINE POWDER. MOST, BUT NOT ALL, PATIENTS CAN TASTE OR FEEL THE DOSE. DO NOT
USE ANOTHER DOSE IF YOU DO NOT TASTE OR FEEL THE MEDICINE. If you are not sure if you are receiving your dose,
contact your doctor or pharmacist. Rinse your mouth with water after using Advair Diskus 28 250-50mcg/dose Aerosol.
Do NOT swallow the rinse solution. Spit the rinse water out. IF YOU ARE USING other inhaled medicines, wait a few
minutes between using Advair Diskus 28 250-50mcg/dose Aerosol and other inhalers, unless directed otherwise by your
doctor. YOU MAY BREATHE MORE EASILY after you use the first dose of Advair Diskus 28 250-50mcg/dose Aerosol.
However, it may take 1 week or longer before you get the most benefit. USE ADVAIR DISKUS 28 250-50mcg/DOSE AEROSOL
ON A REGULAR SCHEDULE to get the most benefit from it, unless your doctor tells you otherwise. Using Advair Diskus
28 250-50mcg/dose Aerosol at the same times each day will help you remember to use it. TAKE YOUR DOSES OF ADVAIR
DISKUS 28 250-50mcg/DOSE AEROSOL about 12 hours apart, unless your doctor tells you otherwise. NEVER WASH THE
MOUTHPIECE or any other part of the inhaler. Keep it dry. IF YOU HAVE BEEN REGULARLY USING A SHORT-ACTING
BRONCHODILATOR INHALER (such as albuterol), talk with your doctor about how to use it with Advair Diskus 28
250-50mcg/dose Aerosol. Short-acting bronchodilators are normally only used with Advair Diskus 28 250-50mcg/dose
Aerosol to treat breathing problems that may occur between doses. TALK WITH YOUR DOCTOR OR PHARMACIST about all of
your asthma medicines and how to use them. Do not start, stop, or change the dose of any asthma medicine unless
your doctor tells you to. STORE ADVAIR DISKUS 28 250-50mcg/DOSE AEROSOL at room temperature between 68 and 77
degrees F (20 and 25 degrees C) away from heat, moisture, or light. Throw Advair Diskus 28 250-50mcg/dose Aerosol
away 1 month after you remove it from the foil pouch, or after the dose indicator reads "0", whichever comes first.
KEEP ADVAIR DISKUS 28 250-50mcg/DOSE AEROSOL out of the reach of children and away from pets. CONTINUE TO USE
ADVAIR DISKUS 28 250-50mcg/DOSE AEROSOL even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF ADVAIR
DISKUS 28 250-50mcg/DOSE AEROSOL, skip the missed dose and go back to your regular dosing schedule. Do NOT use 2
doses at once.
Cautions DO NOT USE ADVAIR DISKUS 28 250-50mcg/DOSE
AEROSOL if you are allergic to any ingredient in Advair Diskus 28 250-50mcg/dose Aerosol or to milk proteins.
BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or
pharmacist. LAB TESTS may be performed while you use Advair Diskus 28 250-50mcg/dose Aerosol. Be sure to keep all
doctor and lab appointments. ADVAIR DISKUS 28 250-50mcg/DOSE AEROSOL MAY CAUSE DIZZINESS. This effect may be worse
if you take it with alcohol or certain medicines. Do not drive or perform other possibly unsafe tasks until you
know how you react to it. ADVAIR DISKUS 28 250-50mcg/DOSE AEROSOL WILL NOT STOP AN ASTHMA ATTACK ONCE ONE HAS
STARTED. Be sure to carry a short-acting bronchodilator inhaler (eg, albuterol) with you at all times to treat any
breathing problems that may occur between doses of Advair Diskus 28 250-50mcg/dose Aerosol. ADVAIR DISKUS 28
250-50mcg/DOSE AEROSOL SHOULD BE USED TO TREAT ASTHMA ONLY if your asthma is not well controlled while you are
using a certain long-term asthma-control medicine (eg, inhaled corticosteroid) or if you have severe asthma. TELL
YOUR DOCTOR OR DENTIST that you take Advair Diskus 28 250-50mcg/dose Aerosol before you receive any medical or
dental care, emergency care, or surgery. TELL YOUR DOCTOR AT ONCE if you notice your short-acting bronchodilator
inhaler does not work as well, if you need to use it more often, or if you have a decrease in your peak meter flow
results. USE CAUTION IF YOU SWITCH FROM AN ORAL STEROID (eg, prednisone) to Advair Diskus 28 250-50mcg/dose
Aerosol. It may take several months for your body to make enough natural steroids to handle events that cause
physical stress. Such events may include injury, surgery, infection, a sudden asthma attack, or severe fluid or
electrolyte loss. These may be severe and sometimes fatal. Contact your doctor right away if any of these events
occur. You may need to take an oral steroid again. Carry a card at all times that says you may need an oral steroid
if any of these events occur. IF YOU HAVE NOT HAD CHICKENPOX, SHINGLES, OR MEASLES, avoid contact with anyone who
does. Contact your doctor at once if you have contact with anyone who has these infections. CHECK WITH YOUR DOCTOR
before you receive any vaccine while you are using Advair Diskus 28 250-50mcg/dose Aerosol. Use Advair Diskus 28
250-50mcg/dose Aerosol with caution in the ELDERLY; they may be more sensitive to its effects, especially
pneumonia, decreased bone density, and effects on the heart. Corticosteroids may affect growth rate in CHILDREN and
teenagers in some cases. They may need regular growth checks while they use Advair Diskus 28 250-50mcg/dose
Aerosol. PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to
discuss the benefits and risks of using Advair Diskus 28 250-50mcg/dose Aerosol while you are pregnant. It is not
known if Advair Diskus 28 250-50mcg/dose Aerosol is found in breast milk. If you are or will be breast-feeding
while you use Advair Diskus 28 250-50mcg/dose Aerosol, check with your doctor. Discuss any possible risks to your
baby. DIABETES PATIENTS - Advair Diskus 28 250-50mcg/dose Aerosol may affect your blood sugar. Check blood sugar
levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Possible side effects SIDE EFFECTS that may occur while
taking Advair Diskus 28 250-50mcg/dose Aerosol include: diarrhea; dizziness; headache; mild muscle or bone pain;
nausea; nervousness; throat irritation; tremor; vomiting. If they continue or are bothersome, check with your
doctor. ADVAIR DISKUS 28 250-50mcg/DOSE AEROSOL MAY SOMETIMES CAUSE severe breathing problems right after you use a
dose. If this happens, use your short-acting bronchodilator inhaler. Seek medical care at once if your breathing
does not improve after you use the short-acting bronchodilator. THE RISK OF SERIOUS HEART PROBLEMS (eg, irregular
heartbeat) may be greater if you use Advair Diskus 28 250-50mcg/dose Aerosol in high doses. Do NOT use more than
the recommended dose or use for longer than prescribed without checking with your doctor. SEEK MEDICAL ATTENTION
RIGHT AWAY if any of these SEVERE side effects occur: behavior changes; blurred vision or other vision changes;
chest pain; choking; fast or irregular heartbeat; numbness or tingling in the hands or feet; seizures; severe
muscle weakness, cramps, or spasms; severe or persistent bone pain; severe or persistent dizziness, headache,
nervousness, or tremor; signs of infection (eg, fever, chills, cough, persistent sore throat, ear pain, increased
mucus production, change in mucus color); swelling or tightness in the throat; symptoms of high blood sugar (eg,
increased thirst, urination, or hunger; unusual weakness or drowsiness; confusion); trouble sleeping; unusual
tiredness or weakness; vaginal odor or discharge; weight gain; white patches or sores on the tongue or mouth;
worsening of asthma or COPD symptoms (eg, increased wheezing, coughing, chest tightness, shortness of breath). AN
ALLERGIC REACTION to Advair Diskus 28 250-50mcg/dose Aerosol is unlikely, but seek immediate medical attention if
it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the
chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness. This is not a complete list of all side
effects that may occur. If you have questions about side effects, contact your health care provider. Call your
doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Drug interactions Drug interactions can result in unwanted
side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your
medicines interact with each other.
If you take too much IF OVERDOSE IS SUSPECTED, contact
your local poison control center or emergency room immediately. Symptoms may include chest pain; fainting; fast or
irregular heartbeat; muscle cramping; seizures; severe muscle weakness; severe or persistent dizziness, dry mouth,
fatigue, headache, nausea, nervousness, tremor, or trouble sleeping.
Additional information IF YOUR SYMPTOMS DO NOT GET BETTER
WITHIN 1 WEEK or if they get worse after you start using Advair Diskus 28 250-50mcg/dose Aerosol, check with your
doctor. Carry an identification card at all times that states you are taking Advair Diskus 28 250-50mcg/dose
Aerosol. Consult your doctor for more information. TALK TO YOUR DOCTOR about how to use a peak flow meter to
monitor your lung function. Use it daily and promptly report worsening asthma (such as readings in the yellow or
red range or increased use of quick-relief inhalers). Try to avoid irritants that may trigger an asthma attack such
as smoke, pollen, pet dander, dust, or molds. DO NOT SHARE ADVAIR DISKUS 28 250-50mcg/DOSE AEROSOL with others for
whom it was not prescribed. IF USING ADVAIR DISKUS 28 250-50mcg/DOSE AEROSOL FOR AN EXTENDED PERIOD OF TIME, obtain
refills before your supply runs out.
