Dosing & Uses
Dosage 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 used
Dosage 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
Adverse Effects
>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%)
Warnings
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 & Lactation
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 condition
Pregnancy 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.Pharmacology
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%)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| budesonide nasal - | 32 mcg/actuation aerosol |  | |
| budesonide nasal - | 32 mcg/actuation aerosol |  | |
| budesonide nasal - | 32 mcg/actuation aerosol |  | |
| Uceris rectal - | 2 mg/actuation foam |  | |
| Pulmicort inhalation - | 1 mg/2 mL nebulizer soln |  | |
| Pulmicort inhalation - | 0.25 mg/2 mL nebulizer soln |  | |
| Pulmicort inhalation - | 0.5 mg/2 mL nebulizer soln |  | |
| Uceris oral - | 9 mg tablet |  | |
| Pulmicort Flexhaler inhalation - | 90 mcg/actuation aerosol |  | |
| Pulmicort Flexhaler inhalation - | 180 mcg/actuation aerosol |  | |
| Pulmicort Flexhaler inhalation - | 90 mcg/actuation aerosol |  | |
| budesonide oral - | 3 mg capsule |  | |
| budesonide oral - | 3 mg capsule |  | |
| budesonide oral - | 3 mg capsule |  | |
| budesonide oral - | 3 mg capsule |  | |
| budesonide oral - | 3 mg capsule |  | |
| budesonide oral - | 3 mg capsule |  | |
| budesonide oral - | 3 mg capsule |  | |
| budesonide oral - | 9 mg tablet |  | |
| budesonide oral - | 9 mg tablet |  | |
| budesonide oral - | 9 mg tablet | | |
| budesonide oral - | 3 mg capsule |  | |
| budesonide inhalation - | 1 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 1 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.5 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.5 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.25 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 1 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.5 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.25 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.5 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.25 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.25 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.5 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 1 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.5 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 1 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.25 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.5 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.5 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.5 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.25 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.25 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.5 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.25 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 1 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.5 mg/2 mL nebulizer soln |  | |
| budesonide inhalation - | 0.25 mg/2 mL nebulizer soln |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
budesonide 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 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. 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. 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.
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.
Information last revised November 2022. Copyright(c) 2022 First Databank, Inc.
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.
Formulary
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