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Information about ADVAIR DISKUS
(fliticasone pripieiate 101,250, SGI meg and salaeteroi 51 neg iihalatim pwd«r)
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 of the
medications in 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 (CQPD) 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 prescribed for you.
What is ADVAIR DISKUS?
There 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 tor the maintenance treatment of asthma m patients 4 years of age and
older. ADVAIR should only be used if your doctor decides that another asthma controller
medicine atone does not control your asthma or that you need 2 asthma controller medications.
• The strength of ADVAIR approved for patients ages 4 to 11 years who experience
symptoms on 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 dose 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-inflammatories work
in the treatment of COPD is not well defined.
Who should not take ADVAIR DISKUS?
You should not start ADVAIR if your asthma is becoming significantly or rapidly worse, which can
be life threatening. Serious respiratory events, including death, have been reported in patients
who 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 lactose). Tell your doctor if you are allergic to AOVAIR, 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 vour fast-acting inhaler for 2 or more days in a row or a whole
canister of your fast-acting inhaler in 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 (e.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 right for you.
» If you have asthma and your symptoms do not improve after using ADVAIR regularly for 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 tor 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 condition 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 biood 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 measles,
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). ADVAIR 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 told 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 in 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.
Can I take ADVAIR DISKUS with other medications?
Tell your doctor about all the medications you take, including prescription and nonpresenption
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 ritonavir (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 Kaietra 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 AOVAIR 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 m 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 drugs 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 have your bone density evaluated
Glaucoma and cataracts: Glaucoma, increased pressure in the eyes, and cataracts have been
reported with the use of inhaied steroids, including fluticasone propionate, a medicine contained
in 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 in 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-recommended 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 a,e 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. Ybur 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.ADVAIR.com or call 1-888-825-5249.
Patients receiving ADVAIR 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 Laboratones.
GlaxoSmithKline
GlaxoSmithKline
Research Triangle Park, NC 27709
RL-2260
©2006 The GlaxoSmithKline Group of Companies. Ail rights reserved. Printed in USA. AD33BORO April 2006
Canyon de Chelly recalls two Indian
civilizations, the prehistoric-era Anasazi and
the Navajo, who have dwelt amid the stun
ning sandstone spires and sheer red cliffs for
centuries.
People who prefer greenery in their
visual diet enjoy trekking through Muir
Woods National Monument 12 miles north
of San Francisco. “This is the best tree-lovers
monument that could possibly be found in
all the forests of the world," declared conser
vationist John Muir of the coastal redwood
forest that now bears his name.
Ancient redwood trees tower overhead at
Muir Woods National Monument in California.
2T
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American Profile