IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
BUDESONIDE LIQUID SPRAY – NASAL
COMMON BRAND NAME(S): Rhinocort Aqua
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 medication may also be used to treat growths in the nose (nasal polyps) or to prevent their return after removal by surgery.
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Follow the illustrated directions for the proper use of this medication. 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.
Dosage is based on your 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 it more frequently than directed.
This medication does not work immediately. 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.
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.
Tell your doctor if your condition does not improve after 2 weeks or if it worsens.
SIDE EFFECTS: Nose/throat dryness or irritation, cough, sneezing, nosebleeds, and unpleasant taste/smell may occur. If any of these side effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these rare but serious side effects occur: 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 immediately if you have any signs of infection (such as ear pain, persistent sore throat, 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, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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.
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).
Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult 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. Therefore, 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 slow down a child’s growth if used for a long time. The effect on final adult height is unknown. 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 immediately if you notice symptoms such as persistent nausea/vomiting, 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: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using 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.
This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.
If you use this medication for a long time, laboratory and/or medical tests (such as nose exams, height measurement in children) may be performed to monitor your progress and check for side effects.
Avoid substances (such as pollen, pet dander, dust mites, mold, and smoke) that can worsen allergy symptoms.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) with the protective cap in place. Keep container upright. Keep all medicines 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 for more details about how to safely discard your product.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.