Symbicort



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

What is Symbicort?

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).

Symbicort may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Symbicort?

Do not use Symbicort 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.

Symbicort 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 discuss with my healthcare provider before using Symbicort?

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

Symbicort may increase the risk of asthma-related death. It is critical that you use only the prescribed dose of this medicineand 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 Symbicort 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 use Symbicort?

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?

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.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

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 Symbicort?

Avoid using other long-acting inhaled bronchodilators such as salmeterol (Advair, Serevent) or formoterol (Foradil Aerolizer) while you are using Symbicort.

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 are the possible side effects of Symbicort?

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 other drugs will affect budesonide and formoterol?

Before using Symbicort 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 Symbicort. 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.

Where can I get more information?

Your pharmacist can provide more information about Symbicort.


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.

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.