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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:
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.
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. 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.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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