What is budesonide and formoterol inhalation?
Budesonide is a steroid that reduces inflammation in the body.
Formoterol is a long-acting bronchodilator that relaxes muscles in the airways to improve
breathing.
The combination of budesonide and formoterol is used to prevent bronchospasm in people with
asthma or chronic obstructive pulmonary disease (COPD).
Budesonide and formoterol inhalation may also be used for other purposes not listed in this
medication guide.
What should I discuss with my healthcare provider before taking budesonide and formoterol inhalation?
You should not use this medication if you are allergic to budesonide (Entocort, Pulmicort,
Rhinocort) or formoterol (Foradil, Perforomist).
Budesonide and formoterol inhalation may increase the risk of asthma-related death.
It
is critical that you use only the prescribed dose of this medicine
and follow all patient
instructions for safe use. Talk with your doctor about your individual risks and benefits in using
budesonide and formoterol inhalation.
If you have certain conditions, you may need a dose adjustment or special tests to safely use
this medication. Before using budesonide and formoterol, tell your doctor if you are allergic to
budesonide or formoterol, or if you have:
-
heart disease or high blood pressure;
-
epilepsy or other seizure disorder;
-
diabetes;
-
herpes infection of the eyes;
-
tuberculosis;
-
any active infection;
-
a metabolic disorder (such as low potassium levels in your
blood); or
-
a thyroid disorder.
FDA pregnancy category C. It is not known whether this medication is
harmful to an unborn baby. Before using budesonide and formoterol, tell your doctor if you are
pregnant or plan to become pregnant during treatment.
Budesonide can pass into breast milk and could harm a nursing baby. Do not use
budesonide and formoterol inhalation without telling your doctor if you are breast-feeding a baby.
Budsesonide can affect growth in children. Talk with your doctor if you think your child is
not growing at a normal rate while using this medication.
Do not give this medication to a child younger than 12 years old.
Long-term use of a steroid medicine may lead to bone loss (osteoporosis). Other factors such
as smoking, lack of exercise, poor nutrition, and family history of osteoporosis can increase your risk of
bone loss. Talk with your doctor if you have any of these risk factors.
How should I take budesonide and formoterol inhalation?
Asthma is usually treated with a combination of different drugs. To best treat your condition, use
all of your medications as directed by your doctor.
Use this medication exactly as it was prescribed for you. Do not use the medication in larger
amounts, or use it for longer than recommended by your doctor. Using too much can make your
asthma worse. Follow the directions on your prescription label.
Do not
use budesonide and formoterol to treat an asthma attack that has
already begun. It will not work fast enough. Use only a fast-acting inhalation medicine to treat an
asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in
treating or preventing asthma attacks.
Budesonide and formoterol comes with patient instructions for safe and effective use. Follow
these directions carefully. This device is not to be used with a spacer. Ask your doctor or pharmacist
if you have any questions. Always rinse your mouth after using the inhaler device.
Prime the inhaler device before the first use by pumping 2 test sprays into the air, away from
your face. Shake the inhaler for at least 5 seconds before each spray. Prime the inhaler if it has not
been used for longer than 7 days, or if the inhaler has been dropped.
It may take up to 2 weeks of using this medicine before your symptoms improve. For best
results, keep using the medication as directed.
Call your doctor if your symptoms do not
improve after the first week of treatment, or if your symptoms get worse
.
Your dosage needs may change if you have surgery, are ill, are under stress, or have recently
had an asthma attack. Do not change your doses or medication schedule without advice from your
doctor.
Seek medical attention if you think any of your asthma medications are not working as well as
usual. An increased need for medication could be an early sign of a serious asthma attack. If you use a
peak flow meter at home, call your doctor if your numbers are lower than normal.
If you also use a steroid medication, do not stop using the steroid suddenly or you may have
unpleasant withdrawal symptoms. You may also have withdrawal symptoms if you stop using
budesonide and formoterol after using it over a long period of time. Talk to your doctor about how to
avoid withdrawal symptoms when you stop using any asthma medication.
Carry an ID card or wear a medical alert bracelet stating that you have asthma, in case of an
emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that
you may need to be treated with certain medications during a severe asthma attack.
To be sure budesonide and formoterol is not causing harmful effects, your doctor will need to
check your progress on a regular basis. Your eyes may also need to be checked for cataracts or
glaucoma. Do not miss any scheduled visits to your doctor.
Do not try to clean or take apart the inhaler device. Throw it away when the medicine runs out.
Do not float the medicine canister in water. The dose indicator on the inhaler will turn red when there
are 10 doses left in the device. Get your prescription refilled before you run out of medicine
completely. Always use the new device provided with the medication when you get your prescription
filled.
Store this medication at room temperature, away from moisture, light, and heat. Always
keep the cover on the inhaler device when you are not using it. Keep the medicine canister away from
open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do
not puncture or burn an empty inhaler canister.
What happens if I miss a dose of budesonide and formoterol inhalation?
Use the medication as soon as you remember. If it is almost time for the next dose, skip the
missed dose and use the medicine at the next regularly scheduled time.
Do not
use
extra medicine to make up the missed dose.
Where can I get more information about budesonide and formoterol inhalation?
Your pharmacist has information about budesonide and formoterol inhalation written for health professionals that you may read.
What are the possible side effects of budesonide and formoterol inhalation?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
-
worsening asthma symptoms;
-
chest pain, fast or pounding heartbeats, tremors,
nervousness;
-
wheezing, throat irritation, choking, or other breathing
problems after using this medication;
-
signs of infection such as fever, chills, sore throat, flu
symptoms, easy bruising or bleeding, unusual weakness;
-
blurred vision, eye pain, or seeing halos around lights;
-
white patches or sores in your mouth or throat; or
-
dangerously high blood pressure (severe headache, blurred
vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven
heartbeats, seizure).
Less serious side effects may include:
-
headache;
-
back pain;
-
nausea, vomiting, diarrhea, upset stomach;
-
back pain, muscle cramps;
-
sore throat, stuffy nose;
-
joint or muscle pain; or
-
changes in your voice.
This is not a complete list of side effects and others may occur. Call your
doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
What is the most important information I should know about budesonide and formoterol inhalation?
Do not
use budesonide and formoterol inhalation to treat an asthma
attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a
fast-acting inhalation medicine to treat an asthma attack.
Budesonide and formoterol inhalation may increase the risk of asthma-related death. It is
critical that you use only the prescribed dose of this medicine and follow all patient instructions for safe
use. Talk with your doctor about your individual risks and benefits in using budesonide and formoterol
inhalation.
Asthma is usually treated with a combination of different drugs. To best treat your condition, use
all of your medications as directed by your doctor.
Seek medical attention if you think any of your asthma medications are not working as well as
usual. An increased need for medication could be an early sign of a serious asthma attack.
What should I avoid while taking budesonide and formoterol inhalation?
Avoid using other long-acting inhaled bronchodilators such as salmeterol (Advair, Serevent)
or formoterol (Foradil Aerolizer) while you are using budesonide and formoterol inhalation.
Using a steroid can lower the blood cells that help your body fight infections. This can make it
easier for you to get sick from being around others who are ill. Call your doctor for preventive
treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal
in people who are using steroid medicines.
What other drugs will affect budesonide and formoterol inhalation?
Before using budesonide and formoterol inhalation tell your doctor if you are taking any of the
following medicines:
-
antibiotics such as azithromycin (Zithromax), clarithromycin
(Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), or telithromycin (Ketek);
-
antifungal medication such as ketoconazole (Nizoral), or
itraconazole (Sporanox);
-
an MAO inhibitor such as isocarboxazid (Marplan),
phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine
(Parnate);
-
antidepressants such as amitriptyline (Elavil, Etrafon),
amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine
(Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine
(Surmontil);
-
a beta-blocker such as acebutolol (Sectral), atenolol
(Tenormin), betaxolol (Betoptic, Kerlone), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol
(Coreg), esmolol (Brevibloc), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol),
nadolol (Corgard), penbutolol (Levatol), pindolol (Visken), propranolol (Inderal, InnoPran),
sotalol (Betapace), or timolol (Blocadren, Timoptic); or
-
a diuretic (water pill) such as bumetanide (Bumex),
chlorthalidone (Hygroton, Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix),
hydrochlorothiazide (HCTZ, HydroDiuril), indapamide (Lozol), metolazone (Mykrox, Zarxolyn),
torsemide (Demadex).
This list is not complete and there may be other drugs that can interact with
budesonide and formoterol inhalation. Tell your doctor about all the prescription and over-the-counter
medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other
doctors. Do not start using a new medication without telling your doctor.
What happens if I have an overdose of budesonide and formoterol inhalation?
