Symbicort

Pronunciation

Generic Name: budesonide and formoterol inhalation (bue DES oh nide and for MOE te rol)
Brand Name: Symbicort

What is budesonide and formoterol inhalation?

Budesonide is a steroid that reduces inflammation in the body.

Formoterol is a 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 purposes not listed in this medication guide.

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.

Budesonide and formoterol inhalation may increase the risk of asthma-related death. Use only the prescribed dose of budesonide and formoterol, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits in using this medication.

Slideshow: Flashback: FDA Drug Approvals 2013

Use all of your medications as directed by your doctor. Talk with your doctor if your medications do not seem to work as well in treating or preventing attacks. Do not change your doses or medication schedule without advice from your doctor.

Before using budesonide and formoterol, tell your doctor if you have heart disease, high blood pressure, a seizure disorder, an infection (including herpes infection of the eyes), diabetes, tuberculosis, a thyroid disorder, or an electrolyte imbalance (such as low potassium levels in your blood).

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.

What should I discuss with my healthcare provider before using budesonide and formoterol inhalation?

You should not use this medication if you are allergic to budesonide (Entocort, Pulmicort, Rhinocort) or formoterol (Foradil, Perforomist).

To make sure you can safely use budesonide and formoterol, tell your doctor if you have any of these other conditions:

  • heart disease or high blood pressure;

  • epilepsy or other seizure disorder;

  • diabetes;

  • herpes infection of the eyes;

  • tuberculosis;

  • any active infection;

  • an electrolyte imbalance (such as low potassium levels in your blood); or

  • a thyroid disorder.

FDA pregnancy category C. It is not known whether budesonide and formoterol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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.

Budesonide 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 steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis.

How should I use budesonide and formoterol inhalation?

Budesonide and formoterol inhalation may increase the risk of asthma-related death. Use only the prescribed dose of budesonide and formoterol, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits in using this medication.

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 medication.

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.

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.

It may take up to 2 weeks before your symptoms improve. 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 doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

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.

If you also use a steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the steroid before stopping completely.

Wear a medical alert tag or carry an ID card to let others know that you may need an oral steroid in an emergency.

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.

Use all of your medications as directed by your doctor. Talk with your doctor if your medications do not seem to work as well in treating or preventing attacks. Do not change your doses or medication schedule without advice from your doctor.

Store at room temperature, away from moisture, light, and heat. Always keep the cover on the inhaler device when not in use. 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?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause redness around your nose, runny nose, trouble breathing, nervousness, muscle cramps, dry mouth, nausea, vomiting, sleep problems (insomnia), tremors, chest pain, fast or pounding heartbeats, fainting, and seizure (convulsions).

What should I avoid while using budesonide and formoterol inhalation?

Do not use a second form of formoterol (such as Foradil, Performist) or use a similar inhaled bronchodilator such as salmeterol (Serevent, Advair) or arformoterol (Brovana) unless your doctor has told you to.

Using a steroid can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. 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.

Budesonide and formoterol inhalation side effects

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;

  • nausea, vomiting, diarrhea, upset stomach;

  • back pain;

  • stuffy nose;

  • muscle or joint 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.

See also: Side effects (in more detail)

What other drugs will affect budesonide and formoterol?

Tell your doctor about all other medicines you use, especially:

  • antibiotics such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);

  • antifungal medication such as ketoconazole (Nizoral), or itraconazole (Sporanox);

  • a diuretic (water pill);

  • an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);

  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), nortriptyline (Pamelor), and others; or

  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

This list is not complete and other drugs may interact with budesonide and formoterol inhalation. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about budesonide and formoterol inhalation.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.01. Revision Date: 2011-08-10, 4:12:10 PM.

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