Uses

Budesonide is used to prevent and treat seasonal and year-round allergy symptoms (such as stuffy/runny nose, itchy eyes/nose/throat, sneezing). Budesonide belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) in the nasal passages.

Other Uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

In Canada, this drug may also be used for growths in the nose (nasal polyps).

How To Use

If you are taking the over-the-counter product to self-treat, read and follow all directions on the product package before using this medication. If you have any questions, consult your pharmacist. If your doctor has prescribed this medication, read the Patient Information Leaflet before you start using budesonide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is for use in the nose, usually 1 or 2 sprays in each nostril once or twice a day or as directed by your doctor. Avoid spraying this medication in your eyes. Gently blow your nose before using this drug. Gently shake the container before each use. Follow the instructions to properly prime the spray pump if you are using it for the first time or if you have not used it for 2 or more days. Follow the instructions to clean/prime the spray pump if you have not used it for 14 or more days.

To use the spray, first remove the plastic cap. Close one nostril by pressing it with your finger. Tilt your head slightly forward and, keeping the bottle upright, carefully insert the nasal applicator into the other nostril. Press down firmly on the pump to deliver the prescribed number of sprays while gently breathing in through the nose, keeping your mouth closed. Do not spray directly onto the middle wall of your nose (nasal septum). After spraying, remove the applicator tip and tilt your head back for a few seconds. This will allow the medication to spread over the back of your nose. Repeat in the other nostril. Wipe the applicator tip and replace the plastic cap. Avoid blowing your nose for 15 minutes after using this medication.

The dosage is based on your age, medical condition and response to treatment. Younger children may need a smaller dose and help from an adult to use this medication properly. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. Do not increase your dose or use this drug more often or for longer than directed. Your condition will not improve any faster, and your risk of side effects will increase.

This medication does not work right away. Some people will feel this medication working within 1 to 2 days, but it may take up to 2 weeks before the full benefit of this drug takes effect. Ask your doctor or pharmacist if you should also use other medications (such as nose drops/spray, allergy drugs taken by mouth) along with this drug until it takes full effect. Talk to you child's doctor if your child needs to use this medication more than 2 months a year.

Keep track of the number of sprays used from the bottle. Discard the bottle after you have used the number of sprays specified on the manufacturer's package. Do not pour any remaining medication into another container. Follow the package instructions to unblock the spray tip if needed and to clean the spray bottle.

If your condition does not improve after 2 weeks, or if it worsens, stop using this medication and consult your doctor or pharmacist. If you think you may have a serious medical problem, get medical help right away.

Side Effects

Nose/throat dryness or irritation, cough, sneezing, nosebleeds, or unpleasant taste/smell may occur. If any of these side effects last or get worse, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• loss of taste or smell
• pain/sores in your nose

Rarely, it is possible that corticosteroids given in the nose will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time and in high doses. Tell your doctor right away if any of the following side effects occur:

• unusual/extreme tiredness
• weight loss
• headache
• swelling ankles/feet
• increased thirst/urination
• vision problems

Corticosteroids may weaken the body's ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. This effect might also rarely occur with corticosteroids inhaled through the nose (such as budesonide). The risk may be increased if high doses are used, especially when used for a long time. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, ear pain, fever, chills, white patches inside the nose or on the back of the throat).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• wheezing/trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using nasal budesonide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• eye problems (such as glaucoma, cataracts)
• infections (including tuberculosis)
• recent nose problems (such as injury, ulcers, surgery)

Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked.

Tell your doctor if you are pregnant before using nasal budesonide. Rarely, infants born to mothers who have been using corticosteroids (including budesonide) for a long time may have low levels of corticosteroid hormone. Tell your doctor right away if you notice symptoms such as nausea/vomiting that doesn't stop, severe diarrhea, or weakness in your newborn. Discuss the risks and benefits with your doctor.

It is unknown if nasal budesonide passes into breast milk. However, similar drugs pass into breast milk. Nasal budesonide might also pass into breast milk in very small amounts that are unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Check all prescription medicine labels carefully since similar medications (other corticosteroids such as prednisone) may increase your risk of side effects if taken together with this drug. Ask your doctor or pharmacist if you have any questions about your medications.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Keep all regular medical and lab appointments.

If you use this medication for a long time, lab and/or medical tests (such as nose exams, height measurement in children) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Avoid substances (such as pollen, pet dander, dust mites, mold, and smoke) that can worsen allergy symptoms.

Missed Dose

If you are using this product on a regular schedule and miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature with the protective cap in place away from light and moisture. Keep container upright. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.