Budesonide Oral Inhalation

What is Budesonide Oral Inhalation?

• Budesonide Oral Inhalation (Pulmicort; Pulmicort Flexhaler; Pulmicort Respules) is an inhaled corticosteroid used in maintenance treatment of asthma and as prophylactic therapy.
• Budesonide powder for oral inhalation (Pulmicort Flexhaler) is used in adults and children 6 years of age and older.
• Budesonide suspension (liquid) for oral inhalation (Pulmicort Respules) is used in children 12 months to 8 years of age.

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Budesonide

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Budesonide

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What are the uses of this medicine?

• Budesonide inhalation suspension (Pulmicort Respules) is a long-term maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years.
• Budesonide powder for oral inhalation (Pulmicort Flexhaler) is used for long-term (maintenance) treatment of asthma and to prevent asthma symptoms in adults and children 6 years of age and older.

• Inhaled corticosteroids help to decrease inflammation in the lungs.
• Inflammation in the lungs can lead to asthma symptoms.
• Budesonide inhalation suspension helps reduce swelling and inflammation in the lungs, and helps keep the airways open to reduce asthma symptoms.

Limitations of use:

• Budesonide Oral Inhalation does not treat the sudden symptoms (wheezing, cough, shortness of breath, and chest pain or tightness) of an asthma attack.
• Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden symptoms.

How does this medicine work?

• Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity.
• The precise mechanism of corticosteroid actions on inflammation in asthma is not well known.
• Inflammation is an important component in the pathogenesis of asthma.
• Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic- and non-allergic-mediated inflammation.
• The anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• to treat sudden symptoms of asthma
• if your child is allergic to budesonide or any of the ingredients in budesonide inhalation suspension.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• antifungals such as itraconazole (Onmel, Sporanox) and ketoconazole (Nizoral)
• clarithromycin (Biaxin)
• HIV protease inhibitors such as atazanavir (Reyataz, in Evotaz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, in Viekira Pak, others), and saquinavir (Invirase)
• medications for seizures, nefazodone
• oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos)
• telithromycin (Ketek)

Is this medicine FDA approved?

• Initial U.S. Approval: 2000

How should this medicine be used?

Recommended dosage: Budesonide inhalation suspension (Pulmicort Respules):

• Recommended dosing based on previous therapy.

Start with the lowest recommended dose:

• Bronchodilators alone: 0.25 mg twice daily
• Inhaled corticosteroids: 0.25 mg twice daily up to 0.5 mg twice daily
• Oral corticosteroids: 0.5 mg twice daily
• Once asthma stability is achieved, titrate the dose downwards.

Budesonide powder for oral inhalation (Pulmicort Flexhaler): Patients 18 Years of Age and Older:

• For patients 18 years of age and older, the recommended starting dosage is 360 mcg twice daily.
• In some adult patients, a starting dose of 180 mcg twice daily may be adequate.
• The maximum dosage should not exceed 720 mcg twice daily.

Patients 6 to 17 Years of Age:

• The recommended starting dosage is 180 mcg twice daily.
• In some pediatric patients, a starting dose of 360 mcg twice daily may be appropriate.
• The maximum dosage should not exceed 360 mcg twice daily.

Administration:

• Budesonide comes as a powder to inhale by mouth using an inhaler and as a suspension to inhale by mouth using a special jet nebulizer (machine that turns medication into a mist that can be inhaled).
• Budesonide powder for oral inhalation is usually inhaled twice a day.
• Budesonide suspension for oral inhalation is usually inhaled once or twice a day.
• Try to use budesonide at around the same time(s) every day.
• If you were taking an oral steroid such as dexamethasone, methylprednisolone (Medrol), or prednisone (Rayos), your doctor may want to gradually decrease your steroid dose starting after you begin to use budesonide.
• Budesonide controls symptoms of asthma but does not cure it.
• Improvement in your asthma may occur as soon after using the medication, but full effects of may not be seen for 1 to 2 weeks after using the powder and 4 to 6 weeks after using the suspension on a regular basis. Continue to use budesonide even if you feel well.
• Do not stop using budesonide without talking to your doctor.
• Each budesonide inhaler is designed to provide 60 or 120 inhalations, depending on its size.
• After the labeled number of inhalations has been used, later inhalations may not contain the correct amount of medication.
• You should keep track of the number of inhalations you have used.
• Dispose of the inhaler after you have used the labeled number of inhalations even if it still contains some liquid and continues to release a spray when it is pressed.
• Do not swallow budesonide nebulizer suspension.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Inhalation suspension: 0.25 mg/2 mL and 0.5 mg/2 mL.
• FLEXHALER device containing budesonide (90 mcg or 180 mcg) as an inhalation powder

This medicine is available in fallowing brand namesː

• Pulmicort; Pulmicort Flexhaler; Pulmicort Respules

What side effects can this medication cause?

The most common side effects of this medicine include:

• respiratory infections. Symptoms may include stuffy nose, sore nose and throat.
• runny nose
• cough
• viral infections
• viral irritation and inflammation of the stomach and intestine (gastroenteritis).
• Gastroenteritis symptoms may include: stomach area pain, diarrhea, nausea and vomiting, and loss of appetite.
• ear infections
• nosebleed
• pink eye (conjunctivitis)
• rash

Budesonide Oral Inhalation may cause serious side effects which may include:

• thrush (candida), a fungal infection in your mouth and throat
• worsening of asthma or sudden asthma attacks
• allergic reactions
• Immune system effects and a higher chance of infections
• Adrenal insufficiency
• Decrease in bone mineral density
• Slowed or delayed growth problems in children
• Eye problems, including glaucoma and cataracts
• Increased wheezing

What special precautions should I follow?

• Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth following inhalation.
• Do not use for the relief of acute bronchospasm.
• Anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm have been reported with use of budesonide inhalation suspension. Discontinue budesonide inhalation suspension if such reactions occur.
• Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
• Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to budesonide inhalation suspension.
• Hypercorticism and adrenal Suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, reduce budesonide inhalation suspension slowly.
• Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. Monitor patients with major risk factors for decreased bone mineral content.
• Orally inhaled corticosteroids, including budesonide, may cause a reduction in growth velocity when administered to pediatric patients. Monitor growth of pediatric patients.
• Glaucoma, increased intraocular pressure, and cataracts have been reported following the long-term administration of inhaled corticosteroids, including budesonide. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
• As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If acute bronchospasm occurs following dosing with budesonide inhalation suspension, it should be treated immediately with a fast-acting inhaled bronchodilator.
• In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions. Some of these patients have clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroids therapy.
• Caution should be exercised when considering the co-administration of budesonide inhalation suspension with ketoconazole, and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) because adverse effects related to increased systemic exposure to budesonide may occur.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using budesonide.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• hypercorticism or growth suppression

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate well-controlled studies of budesonide inhalation suspension in pregnant women.
• There are no adequate well-controlled studies of Pulmicort Flexhaler in pregnant women.

Can this medicine be used in children?

• Budesonide powder for oral inhalation (Pulmicort Flexhaler) is used in adults and children 6 years of age and older.
• Budesonide suspension (liquid) for oral inhalation (Pulmicort Respules) is used in children 12 months to 8 years of age.

What are the active and inactive ingredients in this medicine?

Budesonide inhalation suspension:

• Active ingredient: budesonide
• Inactive ingredients: sodium chloride, disodium edetate, polysorbate 80, citric acid, tri sodium citrate, and water for injection.

Budesonide powder for oral inhalation (Pulmicort Flexhaler):

• Active ingredient: budesonide
• Inactive ingredient: lactose

Who manufactures and distributes this medicine?

Budesonide powder for oral inhalation (Pulmicort Flexhaler):

• Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington DE 19850
• By: AstraZeneca AB, Södertälje, Sweden
• Product of Sweden

Budesonide inhalation suspension: Manufactured by:

• Catalent Pharma Solutions
• Woodstock, IL USA

Manufactured for:

• Amneal Pharmaceuticals LLC
• Bridgewater, NJ
• Product of Spain

What should I know about storage and disposal of this medication?

Budesonide inhalation suspension:

• Store budesonide inhalation suspension in an upright position between 68° to 77°F (20° to 25°C).
• Keep budesonide inhalation suspension in the aluminum foil envelope to protect from light until ready to use.
• After a budesonide inhalation suspension ampule is opened it should be used right away.
• Budesonide inhalation suspension ampules can be stored for 2 weeks after opening the protective aluminum foil envelope.
• Throw away budesonide inhalation suspension ampules if not used within 2 weeks of opening the protective aluminum foil envelope.
• Do not refrigerate or freeze.

Budesonide powder for oral inhalation (Pulmicort Flexhaler):

• Store Pulmicort Flexhaler at 68° to 77°F (20° to 25°C).
• Keep Pulmicort Flexhaler dry.
• Keep your Pulmicort Flexhaler with the cover tightly in place when not in use.

• Dailymed label info on Budesonide Oral Inhalation
• FDA Budesonide Oral Inhalation

Budesonide Oral Inhalation Resources
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