budesonide inhaled (Rx)

Brand and Other Names:Pulmicort Respules, Pulmicort Flexhaler
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Dosing & Uses

AdultPediatric

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
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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%)

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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

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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.

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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%)

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Pulmicort inhalation
-
1 mg/2 mL nebulizer soln
Pulmicort inhalation
-
0.5 mg/2 mL nebulizer soln
Pulmicort inhalation
-
0.25 mg/2 mL nebulizer soln
budesonide oral
-
3 mg capsule
budesonide oral
-
3 mg capsule
budesonide oral
-
9 mg tablet
budesonide oral
-
9 mg tablet
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
Entocort EC oral
-
3 mg capsule
Uceris oral
-
9 mg tablet
budesonide nasal
-
32 mcg/actuation aerosol
budesonide nasal
-
32 mcg/actuation aerosol
budesonide nasal
-
32 mcg/actuation aerosol
Rhinocort Allergy nasal
-
32 mcg/actuation aerosol
Rhinocort Allergy nasal
-
32 mcg/actuation aerosol
Pulmicort Flexhaler inhalation
-
90 mcg/actuation aerosol
Pulmicort Flexhaler inhalation
-
180 mcg/actuation aerosol
Pulmicort Flexhaler inhalation
-
90 mcg/actuation aerosol
Uceris rectal
-
2 mg/actuation foam
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
-
0.5 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
-
0.5 mg/2 mL nebulizer soln
budesonide inhalation
-
1 mg/2 mL nebulizer soln
budesonide inhalation
-
0.5 mg/2 mL nebulizer soln
budesonide inhalation
-
0.25 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
-
0.25 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
-
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

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Select a drug:
Patient Education
budesonide oral

BUDESONIDE CAPSULES - ORAL

(bue-DES-oh-nide)

COMMON BRAND NAME(S): Entocort EC, Ortikos

USES: This medication is used to treat a certain bowel condition (Crohn's disease). While budesonide does not cure this condition, it may decrease symptoms such as pain and diarrhea. Budesonide is an anti-inflammatory drug (corticosteroid hormone). It works by decreasing the body's natural defense response (immune response).

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking budesonide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Swallow this medication whole with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not crush or chew the capsules. Doing so can release all of the drug at once, increasing the risk of side effects.If you have trouble swallowing the capsules whole, certain brands may be opened and the contents sprinkled onto a tablespoonful of soft, cool applesauce in a clean container. Stir and take all of the mixture without chewing. Drink a full glass of cool water (8 ounces/240 milliliters) to make sure you have swallowed all of your dose. Take all of the mixture within 30 minutes after preparing it. Do not save the mixture for later use. Ask your pharmacist if you have questions about your particular brand.The dosage and length of treatment are based on your medical condition, age, and response to treatment.Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.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 taking 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, take it at the same time 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 taking 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 does not get better or if it gets worse.

SIDE EFFECTS: This medication usually has fewer side effects than other corticosteroids because budesonide works in the gut and only small amounts are absorbed into the body. Nausea, abdominal pain, or headache may occur. If any of these effects last or get 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.Because this drug works by weakening the immune system, it 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). This medication may sometimes cause oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, puffy face, unusual weight gain, menstrual period changes, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, bone pain, thinning skin, slow wound healing, increased thirst/urination, vision problems, symptoms of stomach/intestinal bleeding (such as stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds).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 taking budesonide, tell your doctor 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 cataracts, glaucoma), high blood pressure, liver problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), bone loss (osteoporosis), current/past infections (such as tuberculosis, herpes), bleeding problems, mental/mood problems (such as psychosis, anxiety, depression).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 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Consult your doctor or pharmacist for more information.This medication 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.Do not have immunizations/vaccinations without the consent of your doctor. 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).This medication may slow down a child's growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth 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 are: 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.This product may interfere with certain lab tests (such as skin tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

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: Do not share this medication with others.If this medication is used for a long time, lab and/or medical tests (such as blood count, bone density, eye exams, height/weight measurements) may be done while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.This medication may increase the risk of bone loss (osteoporosis) if used for a long time. Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. 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.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised August 2021. Copyright(c) 2021 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.

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.