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Information about ADVAIR DISKUS
ADVAIR
(fluticasone propionate 1,250,51 meg anil salmeterol 51 meg inhalation powder)
What is the most important information I should know about ADVAIR DISKUS?
in patients with asthma, long-acting beta -agonist medicines such as salmeterol (one o t the
medications m ADVAIR ) may increase the chance of death from asthma problems in a large
asthma study, more patients who used salmeterol died from asthma problems compared with
patients who did not use salmeterol So ADVAIR is not for patients whose asthma is well controlled
on another asthma controller medicine such as low- to medium-dose inhaled corticosteroids or
only need a fast-acting inhaler once in a while Talk with your doctor about this risk and the
benefits of treating your asthma with ADVAIR.
ADVAIR should not be used to treat a severe attack of asthma or chronic obstructive pulmonary
disease (COPD) requiring emergency medical treatment.
ADVAIR should not be used to relieve sudden symptoms or sudden breathing problems. Always
have a fast-acting inhaler with you to treat sudden breathing difficulty If you do not have a fast
acting inhaler, contact your doctor to have one presenbed for you
What is ADVAIR DISKUS*
T here are two medicines in ADVAIR. Fluticasone propionate, an inhaled anti-inflammatory
belonging to a group of medicines commonly referred to as corticosteroids; and salmeterol. a
long-acting, inhaled bronchodilator belonging to a group of medicines commonly referred to as
beta -agonists. There are 3 strengths of ADVAIR 100/50, 250/50.500/50
For Asthma
• ADVAIR is approved for the maintenance treatment of asthma in patients 4 years of age and
older. ADVAIR should only be used if your doctor decides that another asthma controller
medicine alone does not control your asthma or that you need 2 asthma controller medications.
• The strerr iof ADVAIR approved for patients ages 4 to 11 years who experience
symptoms „n an inhaled corticosteroid is ADVAIR DISKUS 100/50. All 3 strengths are
approved for patients with asthma ages 12 years and older
For COPD associated with chronic bronchitis
ADVAIR 250/50 is the only approved Cose for the maintenance treatment of airflow
obstruction in patients with COPD associated with chronic bronchitis. The benefit of using
ADVAIR for longer than 6 months has not been evaluated The way anti-mflammatones work
in the treatment of COPD is not well defined
Who should not take ADVAIR DISKUS?
You should not start AOVAIR if your asthma is becoming significantly or rapidly worse, which can
be life threatening Serious respiratory events, including death, have been reported in patients
whe started taking salmeterol in this situation, although it is not possible to tell whether
salmeterol contributed to these events This may also occur in patients with less severe asthma.
You should not take ADVAIR if you have had an allergic reaction to it or any of its components
(salmeterol. fluticasone propionate, or iactosei Tell your doctor if you are allergic to ADVAIR, any
other medications, or food products If you experience an allergic reaction after taking ADVAIR,
stop using ADVAIR immediately and contact your doctor Allergic reactions are when you
experience one or more of the following; choking; breathing problems; swelling of the face, mouth
and/or tongue rash; hives; itching: or welts on the skin
Tell your doctor about the following;
• If you are using your fast-acting inhaler more often or using more doses than you normally do
(e g., 4 or more inhalations of your fast-acting inhaler for 2 or more days in a row or a wnole
canister of your fast-acting inhaler m 8 weeks' time), it could be a sign that your asthma is
getting worse If this occurs, tell your doctor immediately
• if you have been using your fast-acting inhaler regularly ie.g.. four times a day) Your doctor
may tell you to stop the regular use of these medications.
• If your peak flow meter results decrease. Your doctor will tell you the numbers that are nght for you.
• If you have asthma and your symptoms do not improve after using ADVAIR regularly tor 1 week.
• If you have been on an oral steroid, like prednisone, and are now using ADVAIR. You should be
very careful as you may be less able to heal after surgery, infection, or serious injury It takes
a number of months for the body to recover its ability to make its own steroid hormones after
use of oral steroids. Switching from an oral steroid may also unmask a condition previously
suppressed by the oral steroid such as allergies, conjunctivitis, eczema, arthritis, and
eosinophilic conditions Symptoms of an eosinophilic concition can include rash, worsening
breathing problems, heart complications, and/or feeling of 'pins and needles’’ or numbness in
the arms and legs Talk to your doctor immediately if you experience any of these symptoms.
• Sometimes patients experience unexpected bronchospasm right after taking ADVAIR. This
condition can be life threatening and if it occurs, you should immediately stop using ADVAIR
and seek immediate medical attention
• if you have any type of heart disease such as coronary artery disease, irregular heart beat or
high blood pressure, ADVAIR should be used with caution. Be sure to talk with your doctor
about your condition because salmeterol. one of the components of ADVAIR, may affect the
heart by increasing heart rate and blood pressure it may cause symptoms such as heart
fluttering, chest pain, rapid heart rate, tremor, or nervousness
• If you have seizures, overactive thyroid gland, liver problems, or are sensitive to certain
medications for breathing
• If your breathing problems get worse over time or if your fast acting inhaler does not work as well
for you while using ADVAIR if your breathing problems worsen quickly, get emergency medical care.
• If you have been exposed to or currently have chickenpox or measles or if you have an immune
system problem Patients using medications that weaken the immune system are more likely
to get infections than healthy individuals. ADVAIR contains a corticosteroid (fluticasone
propionate) which may weaken the immune system Infections like chickenpox and measies.
for example, can be very serious or even fatal in susceptible patients using corticosteroids.
How should I take ADVAIR DISKUS?
ADVAIR should be used 1 inhalation, twice a day (morning and evening). AOVAIR should never be
taken more than 1 inhalation twice a day. The full benefit of taking ADVAIR may take 1 week or longer.
If you miss a dose of ADVAIR. just skip that dose Take your next dose at your usual time. Do not
take two doses at one time.
Do not stop using ADVAIR unless toW to do so by your doctor because your symptoms might get worse.
Do not change or stop any of your medicines used to control or treat your breathing problems.
Your doctor will adjust your medicines as needed
When using ADVAIR. remember:
• Never breathe into or take the DISKUS apart
• Always use the DISKUS m a level position
• After each inhalation, rinse your mouth with water without swallowing.
• Never wash any part of the DISKUS Always keep it in a dry place
• Never take an extra dose, even if you feel you did not receive a dose.
• Discard 1 month after removal from the foil overwrap
• Do not use ADVAIR with a spacer device.
Children should use ADVAIR with an adult s help as instructed by the child's doctor
II SKUS lUO/50. 250/50. 500/501
Can I take ADVAIR DISKUS with other medications?
Tell your doctor about all the medications you take, including prescription and nonprescription
medications, vitamins, and herbal supplements.
If you are taking ADVAIR. you should not take SEREVENT DISKUS or Foradil Aerolizer for any reason.
If you take ntonavir (an HIV medication), tell your doctor Ritonavir may interact with ADVAIR and
could cause serious side effects. The anti-HIV medicines Norvir Soft Gelatin Capsules. Norvir Oral
Solution, and Kaletra contain ritonavir
No formal drug interaction studies have been performed with ADVAIR
In clinical studies, there were no differences in effects on the heart when ADVAIR was taken with
varying amounts of albuterol. The effect of using ADVAIR in patients with asthma while taking
more than 9 puffs a day of albuterol has not been studied.
ADVAIR should be used with extreme caution during and up to 2 weeks after treatment with
monoamine oxidase (MAO) inhibitors or tricyclic antidepressants since these medications can
cause ADVAIR to have an even greater effect on the circulatory system.
ADVAIR should be used with caution in people who are taking ketoconazole (an antifungus
medication) or other drugs broken down by the body in a similar way These medications can
cause ADVAIR to have greater steroid side effects.
Generally, people with asthma should not take beta-blockers because they counteract the effects
of beta-agonists and may also cause severe bronchospasm However, in some cases for
instance, following a heart attack, selective beta-blockers may still be used if there is no
acceptable alternative
The ECG changes and/or low blood potassium that may occur with some diuretics may be made
worse by ADVAIR. especially at higher-than-recommended doses. Caution should be used when
these dnigs are used together.
in clinical studies, there was no difference in side effects when ADVAIR was taken with
methylxanthines (e.g„ theophylline) or with FLONASE
What are other important safety considerations with ADVAIR DISKUS?
Osteoporosis: Long-term use of inhaled corticosteroids may result in bone loss (osteoporosis).
Patients who are at risk for increased bone loss (tobacco use. advanced age. inactive lifestyle,
poor nutrition, family history of osteoporosis, or long-term use of drugs such as corticosteroids)
may have a greater risk with ADVAIR. If you have risk factors for bone loss, you should talk to your
doctor about ways to reduce your risk and whether you should nave your bone density evaluated.
Glaucoma and cataracts: Glaucoma, increased pressure in the eyes, and cataracts have been
reported with the use of inhaled steroids, including fluticasone propionate, a medicine contained
m ADVAIR. Regular eye examinations should be considered if you are taking ADVAIR
Lower respiratory tract infection: Lower respiratory tract infections, including pneumonia, have
been reported with the use of inhaled corticosteroids, including ADVAIR.
Blood sugar Salmeterol may affect blood sugar and/or cause low blood potassium in some
patients, which could lead to a side effect like an irregular heart rate. Significant changes in blood
sugar and blood potassium were seen infrequently in clinical studies with ADVAIR.
Growth: inhaled steroids may cause a reduction in growth velocity m children and adolescents
Steroids: Taking steroids can affect your body's ability to make its own steroid hormones, which
are needed during infections and times of severe stress to your body, such as an operation. These
effects can sometimes be seen with inhaled steroids (but it is more common with oral steroids),
especially when taken at higher-than-recommendeo doses over a long period of time. In some
cases, these effects may be severe, inhaled steroids often help control symptoms with less side
effects than oral steroids.
Yeast infections: Patients taking ADVAIR may develop yeast infections of the mouth and/or throat
( “thrush") that should be treated by their doctor
Tuberculosis or other untreated infections: ADVAIR should be used with caution, if at all. in
patients with tuberculosis, herpes infections of the eye. or other untreated infections
What are the other possible side effects of ADVAIR DISKUS?
ADVAIR may produce side effects in some patients. In clinical studies, the most common side
effects with ADVAIR included:
• Respiratory infections • Bronchitis • Musculoskeletal pain
• Throat irritation • Cough • Dizziness
• Hoarseness • Headaches • Fever
• Sinus infection • Nausea and vomiting • Ear. nose, and throat infections
• Yeast infection of the mouth • Diarrhea • Nosebleed
Tell your doctor about any side effect that bothers you or that does not go away These are not all
the side effects with ADVAIR. Ask your doctor or pharmacist for more information.
What if I am pregnant, planning to become pregnant, or nursing?
Talk to your doctor about the benefits and risks of using ADVAIR during pregnancy, labor, or if you
are nursing. There have been no studies of ADVAIR used during pregnancy, labor, or in nursing
women Salmeterol is known to interfere with labor contractions. It is not known whether ADVAIR
is excreted in breast milk, but other corticosteroids have been detected in human breast milk.
Fluticasone propionate, like other corticosteroids, has been associated with birth defects in
animals (e g., cleft palate and fetal death). Salmeterol showed no effect on fertility in rats at 180
times the maximum recommended daily dose.
What other important tests were conducted with ADVAIR?
There is no evidence of enhanced toxicity with ADVAIR compared with the components administered
separately. In animal studies with doses much higher than those used in humans, salmeterol was
associated with uterine tumors. Your healthcare professional can tell you more about how drugs are
tested on animals and what the results of these tests may mean to your safety
For more information on ADVAIR DISKUS
This page is only a brief summary of important information about ADVAIR DISKUS. For more
information, talk to your doctor. You can also visit www.ADVAlß.com or call 1 -888-825-5249.
Patients receiving AOVAIR DISKUS should read the medication guide provided by the pharmacist
with the prescription
ADVAIR DISKUS. FLONASE. SEREVENT. and DISKUS are registered trademarks of GlaxoSmithKline
The following are registered trademarks of their respective manufacturers: Foradil Aerolizer/
Novartis Pharmaceuticals Corporation. Norvir and Kaletra/Abbott Laboratories
Ey
GlaxoSmithKline
GlaxoSmithKline
Research Triangle Park, NC 27709
RL-2260
©2006 The GlaxoSmithKline Group of Companies All rights reserved Printed in USA AD36BORO December 2006
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