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 |
|---|---|---|---|
| Uceris rectal - | 2 mg/actuation foam |  | |
| Pulmicort Flexhaler inhalation - | 90 mcg/actuation aerosol |  | |
| Pulmicort Flexhaler inhalation - | 180 mcg/actuation aerosol |  | |
| Pulmicort Flexhaler inhalation - | 90 mcg/actuation aerosol |  | |
| Uceris oral - | 9 mg tablet |  | |
| 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 |  | |
| 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 |  | |
| budesonide nasal - | 32 mcg/actuation aerosol |  | |
| budesonide nasal - | 32 mcg/actuation aerosol |  | |
| budesonide nasal - | 32 mcg/actuation aerosol |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
budesonide rectal
BUDESONIDE FOAM - RECTAL
(bue-DES-oh-nide)
COMMON BRAND NAME(S): Uceris
USES: This medication is used to treat symptoms of a certain bowel disease (ulcerative colitis). It works by reducing swelling (inflammation). Budesonide belongs to a class of drugs known as corticosteroids. Budesonide does not cure ulcerative colitis, but it may help relieve symptoms such as abdominal pain, diarrhea, and bloody stools. Using this medication as a foam allows it to work directly on the bowel and rectum.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using budesonide 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.Use this medication as a foam in the rectum as directed by your doctor, usually in the morning and evening for the first 2 weeks, then once a day in the evening for the next 4 weeks. It is best to use this medication just before bedtime in the evening.This medication is flammable. Avoid smoking when applying this medication and immediately afterward. Do not use or store it near heat or open flame.It is best to use this medication after a bowel movement. You may apply this medication while standing, lying down, or sitting. Do not insert any part of the canister into the anus. Use the enclosed applicator to apply this drug. Follow the instructions for attaching the applicator to the canister. Warm the canister in your hands and shake the canister well for 10 to 15 seconds before use. Hold the canister upside down and gently insert the applicator tip into the anus. Push down on the pump and hold it in that position for 2 seconds to apply the foam. Afterward, release your finger from the pump and continue to hold the applicator in place for 10 to 15 seconds. Then, remove the applicator and throw it away. Wash your hands after use. Keep the medication in your rectum for as long as possible, for example overnight.If you are regularly taking a different corticosteroid by mouth (such as prednisone), you should not stop taking it unless directed by your doctor. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. If you suddenly stop taking the drug, you may also have withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness). To help prevent withdrawal, your doctor may slowly lower the dose of your old medication after you begin using budesonide. Tell your doctor or pharmacist right away if you have withdrawal. See also Precautions section.Use this medication regularly 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 prescribed. Your condition will not improve any faster, and your risk of side effects will increase.Do not stop using this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.Tell your doctor if your condition lasts or gets worse.
SIDE EFFECTS: Nausea may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because 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.Rarely, it is possible this medication 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. 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, bone pain, mental/mood changes (such as psychosis, anxiety, depression), symptoms of stomach/intestinal bleeding (such as stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds).This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).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, 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 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: liver disease, high blood pressure, personal or family history of diabetes, bone loss (osteoporosis), stomach/intestinal ulcer, a certain bowel disease (diverticulitis), mental/mood disorders (such as depression, psychosis), personal or family history of high pressure in the eye (glaucoma), cataracts, current/past infections (such as tuberculosis, ocular herpes simplex, fungal), thyroid problems.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).Budesonide may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. 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.Tell your health care professional that you are using budesonide before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).Older adults may be more sensitive to the side effects of this drug, especially bone loss/pain, stomach/intestinal bleeding, and mental/mood changes (such as confusion).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.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Babies born to mothers who have used corticosteroids for a long time may develop hormone problems. Tell your doctor right away if you notice symptoms such as nausea/vomiting that doesn't stop, severe diarrhea, or weakness in your newborn.This medication passes into breast milk. 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.Some products that may interact with this drug include: aldesleukin, mifepristone, drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs such as aspirin/celecoxib/ibuprofen).If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.
OVERDOSE: This medicine may be harmful if swallowed. 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: Do not share this medication with others.Lifestyle changes that may help reduce the risk of bone loss (osteoporosis) during long-term corticosteroid treatment include weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. Ask your doctor about lifestyle changes that may benefit you.
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. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: This medication is flammable. Store at room temperature away from heat and open flame. 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 April 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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