AdultPediatricDosage Forms & Strengths suspension for nebulizer 0.25mg/2mL 0.5mg/2mL 1mg/2mL powder for inhalation 90mcg/actuation 180mcg/actuation Asthma Maintenance treatment Inhaled powder: 360 mcg PO q12hr; in some patients, may be initiated at 180 mcg q12hr; not to exceed 720 mcg q12hr Administration Suspension should be administered via jet nebulizer connected to air compressor with adequate air flow and equipped with mouthpiece or suitable face mask; ultrasonic nebulizer should not be usedDosage Forms & Strengths suspension for nebulizer 0.25mg/2mL 0.5mg/2mL 1mg/2mL powder for inhalation 90mcg/actuation 180mcg/actuation Asthma Maintenance treatment Nebulized suspension <1 years: Safety and efficacy not established 1-8 years (prior therapy with bronchodilators alone): 0.5 mg once daily or divided q12hr; not to exceed 0.5 mg/day 1-8 years (prior therapy with inhaled corticosteroids): 0.5 mg once daily or divided q12hr; not to exceed 1 mg/day 1-8 years (prior therapy with PO corticosteroids): 1 mg once daily or divided q12hr; not to exceed 1 mg/day Symptomatic children not responding to nonsteroidal therapy: May be initiated at 0.25 mg q12hr Inhaled powder <6 years: Safety and efficacy not established >6 years: 180 mcg PO q12hr; in some patients, may be initiated at 360 mcg q12hr; not to exceed 360 mcg q12hr >10% Respiratory infection (34-38%) Rhinitis (7-12%) Otitis media (1-12%) 1-10% Nasopharyngitis (10%) Nasal congestion (3%) Pharyngitis (3%) Allergic rhinitis (2%) Viral gastroenteritis (2%) Viral upper respiratory tract infection (2%) Oral candidiasis (1%) Contraindications Hypersensitivity Status asthmaticus, acute bronchospasm Cautions Respiratory tract tuberculosis, untreated fungal or bacterial infections, viral or parasitic infections, ocular herpes simplex Risk of more serious or fatal course of chickenpox or measles in susceptible patients (eg, unvaccinated or immunologically unexposed individuals); care must be taken to avoid exposure Localized infections with Candida albicans in mouth and pharynx in some patients; mouth must be rinsed after inhalation to reduce risk Deaths from adrenal insufficiency have occurred after abrupt withdrawal of oral steroids; taper withdrawal gradually Potential decrease in growth velocity in children Immunocompromised patients Hepatic impairment Risk of infections of nose and pharynx, including C albicans Decrease in bone mineral density after long-term administration of corticosteroids; monitor patients at risk Excessive use may suppress hypothalamic-pituitary-adrenal function; monitor closely, especially postoperatively or during periods of stress During periods of stress or severe status asthmaticus, supplementary systemic corticosteroids may be immediately required Not to be administered for rapid relief of acute bronchospasm (agent is not a bronchodilator) Nasal septum perforation, wheezing Cataracts, glaucoma, increased intraocular pressure Risk of systemic eosinophilic conditions, some consistent with Churg-Strauss syndrome Pregnancy There are no adequate well-controlled studies in pregnant women; however, there are published studies on use of budesonide, in pregnant women; studies of pregnant women have not shown that inhaled budesonide increases risk of abnormalities when administered during pregnancy There are no well-controlled human studies that have investigated effects of therapy during labor and delivery Animal data In animal reproduction studies, therapy, administered by subcutaneous route, caused structural abnormalities, was embryocidal, and reduced fetal weights in rats and rabbits at less than maximum recommended human daily inhalation dose (MRHDID), but these effects were not seen in rats that received inhaled doses approximately 2 times the MRHDID; experience with oral corticosteroids suggests that rodents are more prone to structural abnormalities from corticosteroid exposure than humans In women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in neonate; pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control Lactation There are no available data on effects of therapy on breastfed child or on milk production; budesonide, is present in human milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Anti-inflammatory corticosteroid; has potent glucocorticoid activity and weak mineralocorticoid activity Absorption Bioavailability: 6-13% Onset: 24 hr to 2 wk Peak plasma time: 1-2 hr Distribution Protein bound: 85-90% Vd: 3 L/kg Metabolism Metabolized in liver by CYP3A4 Metabolites: 16-Alpha hydroxyprednisolone, 6-beta hydroxybudesonide Elimination Half-life: 2-3 hr Excretion: Urine (60%), feces (40%) BRAND FORM. UNIT PRICE PILL IMAGE budesonide nasal- 32 mcg/actuation aerosolbudesonide nasal- 32 mcg/actuation aerosolbudesonide nasal- 32 mcg/actuation aerosolPulmicort inhalation- 1 mg/2 mL nebulizer solnPulmicort inhalation- 0.25 mg/2 mL nebulizer solnPulmicort inhalation- 0.5 mg/2 mL nebulizer solnbudesonide oral- 3 mg capsulebudesonide oral- 3 mg capsulebudesonide oral- 3 mg capsulebudesonide oral- 3 mg capsulebudesonide oral- 9 mg tabletbudesonide oral- 9 mg tabletbudesonide oral- 3 mg capsulebudesonide oral- 3 mg capsulebudesonide oral- 9 mg tabletbudesonide oral- 3 mg capsulebudesonide inhalation- 1 mg/2 mL nebulizer solnbudesonide inhalation- 1 mg/2 mL nebulizer solnbudesonide inhalation- 0.5 mg/2 mL nebulizer solnbudesonide inhalation- 0.25 mg/2 mL nebulizer solnbudesonide inhalation- 0.5 mg/2 mL nebulizer solnbudesonide inhalation- 1 mg/2 mL nebulizer solnbudesonide inhalation- 0.5 mg/2 mL nebulizer solnbudesonide inhalation- 0.25 mg/2 mL nebulizer solnbudesonide inhalation- 0.5 mg/2 mL nebulizer solnbudesonide inhalation- 0.25 mg/2 mL nebulizer solnbudesonide inhalation- 0.25 mg/2 mL nebulizer solnbudesonide inhalation- 0.5 mg/2 mL nebulizer solnbudesonide inhalation- 1 mg/2 mL nebulizer solnbudesonide inhalation- 1 mg/2 mL nebulizer solnbudesonide inhalation- 0.5 mg/2 mL nebulizer solnbudesonide inhalation- 1 mg/2 mL nebulizer solnbudesonide inhalation- 0.25 mg/2 mL nebulizer solnbudesonide inhalation- 0.5 mg/2 mL nebulizer solnbudesonide inhalation- 0.5 mg/2 mL nebulizer solnbudesonide inhalation- 0.5 mg/2 mL nebulizer solnbudesonide inhalation- 0.25 mg/2 mL nebulizer solnbudesonide inhalation- 0.25 mg/2 mL nebulizer solnbudesonide inhalation- 0.5 mg/2 mL nebulizer solnbudesonide inhalation- 0.25 mg/2 mL nebulizer solnbudesonide inhalation- 1 mg/2 mL nebulizer solnbudesonide inhalation- 0.5 mg/2 mL nebulizer solnbudesonide inhalation- 0.25 mg/2 mL nebulizer solnUceris rectal- 2 mg/actuation foamPulmicort Flexhaler inhalation- 90 mcg/actuation aerosolPulmicort Flexhaler inhalation- 180 mcg/actuation aerosolPulmicort Flexhaler inhalation- 90 mcg/actuation aerosolUceris oral- 9 mg tabletCopyright © 2010 First DataBank, Inc.Select a drug:budesonide nasalbudesonide oralbudesonide inhalationbudesonide rectalPrint Patient Educationbudesonide nasal BUDESONIDE LIQUID SPRAY - NASAL (bue-DES-oh-nide) 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. 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