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Budesonide; formoterol fumarate pressurized inhalation, suspension

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May.26.2021

Budesonide, Formoterol Fumarate Pressurized inhalation, suspension

What is this medicine?

BUDESONIDE; FORMOTEROL (byoo DES oh nide; for MOH te rol) inhalation is a combination of 2 drugs to treat asthma and COPD. Formoterol is a bronchodilator that helps keep airways open. Budesonide decreases inflammation in the lungs. Do not use this drug combination for acute asthma attacks or bronchospasm.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

How should I use this medicine?

This medicine is inhaled through the mouth. Shake well before using. Rinse your mouth with water after use. Make sure not to swallow the water. Take it as directed on the prescription label. Do not use it more often than directed. Keep taking it unless your health care provider tells you to stop.

This drug comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this drug. Read the information carefully. Talk to your pharmacist or health care provider if you have questions.

Talk to your health care provider about the use of this medicine in children. While it may be prescribed to children as young as 6 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • changes in vision
  • eye pain
  • heartbeat rhythm changes (trouble breathing; chest pain; dizziness; fast, irregular heartbeat; feeling faint or lightheaded, falls)
  • high blood sugar (increased hunger, thirst or urination; unusually weak or tired, blurry vision)
  • infection (fever, chills, cough, sore throat, pain or trouble passing urine)
  • muscle cramps, pain
  • thrush (white patches in the mouth or mouth sores)
  • trouble breathing
  • trouble sleeping
  • unusually weak or tired

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

  • back pain
  • changes in taste
  • headache
  • runny or stuffy nose
  • tremors
  • upset stomach
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep inhaler away from extreme heat, cold or humidity. This medicine is flammable. Avoid exposure to heat, fire, flame, and smoking. Throw away 3 months after removing it from the foil pouch, when the dose counter reads "0" or after the expiration date, whichever is first.

To get rid of medicines that are no longer needed or have expired:

  • Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
  • If you cannot return the medicine, ask your pharmacist or health care provider how to get rid of this medicine safely.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • diabetes
  • eye disease, such as glaucoma, cataracts, or blurred vision
  • heart disease
  • high blood pressure
  • immune system problems
  • infection
  • irregular heartbeat or rhythm
  • liver disease
  • osteoporosis, weak bones
  • pheochromocytoma
  • seizures
  • thyroid disease
  • an unusual or allergic reaction to budesonide, formoterol, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

What may interact with this medicine?

Do not take the medicine with any of the following medications:

  • cisapride
  • dronedarone
  • other medicines that contain long-acting beta-2 agonists (LABAs) like arfomoterol, formoterol, indacaterol, olodaterol, salmeterol, vilanterol
  • pimozide
  • thioridazine

This medicine may also interact with the following medications:

  • certain antibiotics like clarithromycin, telithromycin
  • certain antivirals for HIV or hepatitis
  • certain heart medicines like atenolol, metoprolol
  • certain medicines for blood pressure, heart disease, irregular heartbeat
  • certain medicines for depression, anxiety, or psychotic disturbances
  • certain medicines for fungal infections like ketoconazole, itraconazole
  • diuretics
  • grapefruit juice
  • MAOIs like Marplan, Nardil, and Parnate
  • mifepristone
  • other medicines that prolong the QT interval (an abnormal heart rhythm)
  • some vaccines
  • steroid medicines like prednisone or cortisone
  • stimulant medicines for attention disorders, weight loss, or to stay awake
  • theophylline
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What should I watch for while using this medicine?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

Follow the plan from your health care provider for treating an acute asthma attack or bronchospasm (wheezing). If your symptoms get worse or do not get better, call your health care provider right away.

If you have asthma, you and your health care provider should develop an Asthma Action Plan that is just for you. Be sure to know what to do if you are in the yellow (asthma is getting worse) or red (medical alert) zones.

Do not treat yourself for coughs, colds or allergies without asking your health care provider for advice. Some nonprescription medicines can affect this one.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. If you have not had the measles or chickenpox vaccines, tell your health care provider right away if you are around someone with these viruses.

Using this medicine for a long time may weaken your bones. The risk of bone fractures may be increased. Talk to your health care provider about your bone health.

This medicine may slow your child's growth if it is taken for a long time at high doses. Your health care provider will monitor your child's growth.

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