FDA approved a REMS for budesonide to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of budesonide and consists of the following: communication plan. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
BUDESONIDE (bue DES oh nide) nasal spray is a corticosteroid. It helps decrease inflammation in your nose. This medicine is used to treat the symptoms of allergies like sneezing, itching, and runny or stuffy nose.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This medicine is for use in the nose. Follow the directions on your prescription label. This medicine works best if used regularly. Do not use more often than directed.
Make sure that you are using your inhaler correctly. You will get an information sheet with each prescription and refill. Read this sheet carefully each time. This sheet may change.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. This medicine has been used in children as young as 6 years of age.
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 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 and continue with your regular schedule. Do not use double or extra doses.
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 should I watch for while using this medicine?
Visit your health care professional for regular checks on your progress. Check with your doctor if your symptoms do not improve in 2 weeks of regular use or if they get worse. Do not stop using your medicine unless your doctor tells you to.
Do not come in contact with people who have chickenpox or the measles while you are taking this medicine. If you do, call your doctor right away.
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
wheezing
white patches or sores in the nose
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
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.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F) in an upright position. Do not freeze. Throw away the canister after 120 sprays or after the expiration date, whichever comes first.
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.
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.
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