BUDESONIDE AQ ( Nasal Spray )

Budesonide belongs to the family of medications known as corticosteroids. It is used to treat seasonal allergic rhinitis, allergic and non-allergic perennial rhinitis, and vasomotor rhinitis that has not responded to usual therapies. Budesonide works by reducing inflammation in the nasal passages. It relieves symptoms such as congestion (blocked nose), runny nose, sneezing, and nasal itching.

It is also used to treat nasal polyps, prevent new polyps from appearing, and prevent recurrences of nasal polyps after surgery to remove polyps. The effects of treatment with budesonide nasal spray may not be noticed until after 2 to 3 days of treatment.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful to people to use this medication if their doctor has not prescribed it.

To treat rhinitis, the usual adult dose for adults and children over 12 years of age is 2 sprays into each nostril once daily in the morning, or 1 spray into each nostril morning and evening.

To treat rhinitis, the usual dose for children between 6 and 12 years of age is 1 spray into each nostril once daily, in the morning. If this dose does not control symptoms, your child’s doctor may suggest that the dose be increased. After the symptoms have been brought under control, the smallest amount necessary to control the symptoms should be used.

To treat and prevent nasal polyps in adults and children over the age of 12, the recommended dose is 1 spray into each nostril, morning and evening.

The full effect of budesonide therapy may not be reached until after 2 weeks of treatment. Treatment of seasonal rhinitis should, if possible, start before exposure to allergens.

To use the spray:

• Clear the nasal passage by gently blowing your nose.
• Tilt your head forward slightly, then insert the nozzle of the spray into one nostril and close the other nostril with your finger.
• Press down on the nozzle once while breathing in through the nose and keeping your mouth closed.
• Exhale through your mouth.

Repeat the same procedure with the other nostril. Use your right hand to spray the left nostril and the left hand to spray the right nostril.

If you are using two sprays in each nostril, repeat the entire process for each nostril for the second application. Try to aim the first spray high into the nose and the second one into the lower half of the nose.

To make sure that you’re getting the proper amount and effects of the medication, you should ask your health care professional to explain how to use this nasal spray correctly.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, use it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not administer a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

64 µg/dose
Each metered dose of a white-to-off-white, thixotropic aqueous suspension contains 64 µg of budesonide. Nonmedicinal ingredients: Avicel RC-591, dextrose anhydrous, disodium edetate, hydrochloric acid, polysorbate 80, potassium sorbate, and purified water.

100 µg/dose
Each metered dose of a white-to-off-white, thixotropic aqueous suspension contains 100 µg of budesonide. Nonmedicinal ingredients: carboxymethylcellulose sodium, dextrose, disodium edetate, hydrochloric acid, microcrystalline cellulose, potassium sorbate, Tween 80 (polysorbate), and water.

Do not use this medication if you:

• are allergic to budesonide or any ingredients of this medication
• have active or dormant tuberculosis
• have an untreated fungal, bacterial, or viral infection

Do not give this medication to children under 6 years of age.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• bleeding or crusting inside the nose
• burning, dryness, or other irritation inside the nose (mild and lasting only a short time)
• cough
• dizziness
• fatigue
• headache
• nausea
• nose irritation
• throat irritation
• throat itching

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• bloody mucus or unexplained nosebleeds
• burning or stinging after use of spray or irritation inside nose (continuing)
• hives
• holes or ulcers in the skin inside the nose
• infections of the sinuses and nasal passages
• nasal perforation (constant whistling sound when you breathe from the nose)
• shortness of breath
• skin rash
• slowed growth in children (with prolonged use)
• slowed wound healing (nasal and sinus)
• sore throat, cough, or hoarseness
• stomach pain
• symptoms of too much medication (e.g., rapid weight gain, rounded face, sweating, thinning skin, dry skin, easy bruising)
• vision changes (e.g., glare, blurred vision, eye pain)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breastfeeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Continuous long-term use: If you are using this medication continuously over a long period of time, your doctor should inspect your nasal passages every 6 months.

Growth in children and adolescents: Corticosteroids such as budesonide nasal spray may impair the growth of children and adolescents. Your doctor will monitor this. Talk to your doctor if you have any concerns.

Infection: Budesonide may mask the signs and symptoms of an infection, or infection may start while you are on budesonide therapy. Children using this medication may experience a more severe case of chickenpox or measles if they come into contact with these viruses.

Liver problems: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Thyroid problems: The effects of budesonide may be more pronounced if you have an underactive thyroid gland. If you have a thyroid condition, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Treatment withdrawal: Treatment with budesonide should be tapered off gradually and not stopped abruptly. If you feel it is necessary to stop using this medication, discuss the most appropriate schedule with your doctor.

Vision changes: Using corticosteroids for a prolonged period of time may cause vision problems. Cataracts and glaucoma have been associated with long-term use of these medications and may be more likely to occur if you have a history of eye problems. If you experience vision changes, such as blurred vision, glare, or eye pain, contact your doctor as soon as possible.

Wound healing: The use of corticosteroids such as budesonide, may slow wound healing. If you have nasal surgery or nasal trauma, you should be monitored closely while using this medication until healing has occurred.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor.

Breast-feeding: This medication passes into breast milk. If you are a breastfeeding mother and are taking budesonide nasal spray, it may affect your baby. Talk to your doctor about whether you should continue breastfeeding.

Children: The safety and effectiveness of using this medication have not been established for children under 6 years of age. This medication should not be used to treat or prevent nasal polyps in children under 12 years of age.

There may be an interaction between budesonide and any of the following:

• “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• cobicistat
• clarithromycin
• delavirdine
• desmopressin
• HIV protease inhibitors (atazanavir, darunavir, lopinavir, ritonavir)
• idelalisib
• mifepristone
• nelfinavir
• other corticosteroids

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also, tell them about any supplements you take. Since caffeine, alcohol, nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.