Description
Budesonide nasal spray is used to treat an itchy or runny nose, sneezing, or other symptoms caused by hay fever (allergic rhinitis). It is a steroid (cortisone-like medicine) that works by preventing the inflammation that occurs with allergic reactions.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Spray
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of budesonide nasal spray in children younger than 6 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of budesonide nasal spray in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Desmopressin
- Levoketoconazole
- Rotavirus Vaccine, Live
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adagrasib
- Amiodarone
- Amprenavir
- Aprepitant
- Aspirin
- Atazanavir
- Avacopan
- Balofloxacin
- Bemiparin
- Berotralstat
- Besifloxacin
- Boceprevir
- Bupropion
- Carbamazepine
- Ceritinib
- Cilostazol
- Cimetidine
- Ciprofloxacin
- Clarithromycin
- Clofazimine
- Cobicistat
- Conivaptan
- Cosyntropin
- Cyclosporine
- Dabrafenib
- Darunavir
- Delavirdine
- Diltiazem
- Dronedarone
- Duvelisib
- Encorafenib
- Enoxacin
- Ethinyl Estradiol
- Fedratinib
- Fexinidazole
- Fleroxacin
- Fluconazole
- Flumequine
- Fluvoxamine
- Fosamprenavir
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Apalutamide
- Auranofin
- Erythromycin
- Mavacamten
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Cataracts, history of or
- Glaucoma, history of—Use with caution. May make these conditions worse.
- Chicken pox (includes recent exposure) or
- Herpes simplex infection of the eye or
- Infections (virus, bacteria, fungus, or parasite), any type and untreated or
- Measles (includes recent exposure) or
- Tuberculosis, active or history of—Can reduce the body's ability to fight off these infections.
- Injury to the nose, recent or
- Nose surgery, recent or
- Sores or ulcers in the nose, recent—This medicine may prevent proper healing of these conditions.
- Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.
Proper Use
Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the amount that is absorbed from the nose and the chance of unwanted effects. Do not change your dose or stop using this medicine without checking with your doctor first.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
This medicine is only used in the nose. Do not get it in your eyes. If it does get in the eyes, rinse them with water right away and call your doctor.
In order for this medicine to help you, it must be used on a regular basis as ordered by your doctor. This medicine usually begins to work in about 2 days, but up to 2 weeks may pass before you feel its full effects.
Do not use this medicine for any other nose problem without checking with your doctor first.
To use the spray:
- Shake the bottle gently before each use.
- When you use the spray for the first time, you must prime the bottle. Pump the bottle 8 times or until a fine spray comes out.
- Gently blow your nose before using the spray. Insert the tip of the bottle into your nostril.
- Close the opposite nostril with a finger and lean your head slightly forward.
- Spray into your nostril and breathe gently inward. Lean your head backward for a few seconds.
- If a second dose is needed in the same nostril, lean the head slightly forward and repeat the same steps.
- Spray the opposite nostril using the same steps.
- Do not blow your nose for 15 minutes after using the spray.
- Wipe the tip of the bottle with a clean tissue and put the cap back on.
- If you do not use the bottle for 2 days, prime it again by releasing one spray.
- If you do not use the bottle for more than 14 days, clean the spray tip and prime it again by releasing two sprays.
- After you prime the bottle, there will only be 120 doses or sprays. Keep track of the number of sprays you use. Throw the bottle away after you use 120 sprays even if some liquid remains in the bottle.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For nasal dosage form (spray):
- For treatment of allergic rhinitis:
- Adults, teenagers, and children 12 years of age and older—At first, one spray in each nostril once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 4 sprays in each nostril per day.
- Children 6 to 11 years of age—At first, one spray in each nostril once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 2 sprays in each nostril per day.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For treatment of allergic rhinitis:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
After you prime the bottle, there will only be 120 doses or sprays. Keep track of the number of sprays you use. Throw the bottle away after you use 120 sprays even if some liquid remains in the bottle.
Precautions
It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
If you or your child feel that your symptoms do not improve within a few days or if they become worse, check with your doctor.
This medicine may increase your risk of having some unwanted effects in the nose. Check with your doctor right away if you or your child have bloody mucus; sores inside the nose; unexplained nosebleeds; or a whistling sound when you breathe while you are using this medicine.
This medicine may cause thrush (a type of fungus infection) in the nose or throat. Tell your doctor right away if you or your child have white patches in the throat, or pain when you eat or swallow.
This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
You may get infections more easily while you are using this medicine. Avoid close contact with anyone who has chickenpox or measles if you have never had these infections. This is especially important for children. Tell your doctor right away if you think you have been exposed to chickenpox or measles.
Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or weight loss.
This medicine may slow down a child's growth if it is used for a long time. Talk to your child's doctor if you think your child is not growing properly or if you have any questions about this.
Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bloody nose
Less common
- Body aches or pain
- congestion
- cough
- difficulty with breathing
- dryness or soreness of the throat
- fever
- hoarseness
- noisy breathing
- runny nose
- shortness of breath
- tender, swollen glands in the neck
- tightness in the chest
- trouble with swallowing
- voice changes
- wheezing
Incidence not known
- Backache
- blistering, crusting, irritation, itching, or reddening of the skin
- bloody mucus
- blurred vision
- cracked, dry, or scaly skin
- darkening of the skin
- decreased vision
- diarrhea
- difficulty with swallowing
- dizziness
- eye pain
- facial hair growth in females
- fainting
- fast, irregular, pounding, or racing heartbeat or pulse
- full or round face, neck, or trunk
- headache
- hives or welts
- increased thirst or urination
- irritability
- itching
- lack or slowing of normal growth in children
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- loss of sexual desire or ability
- menstrual irregularities
- mental depression
- muscle wasting
- nausea or vomiting
- nosebleeds
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- skin rash
- swelling
- tearing
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Burning, itching, swollen, or sore throat
- loss of sense of smell
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20074729
